Patent Publication Number: US-2023158228-A1

Title: Channel system in medical device to house materials to improve performance and longevity

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of U.S. provisional Application No. 63/018,401, filed Apr. 30, 2020, in the U.S. Patent and Trademark Office, the disclosures of which are incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to a medical device for delivering a fluid to a patient and filtering or removing selected compounds from the fluid before delivery to the patient. The medical device includes an adsorbent material disposed within the device, to remove selected compounds from the fluid just prior delivery of the fluid into the patient. The medical device in one embodiment is suitable for delivering a controlled dosage of an insulin formulation where the device is associated with an adsorbent for removing stabilizing agents and/or selected compounds from the insulin formulation prior to delivery to the patient. 
     BACKGROUND OF THE INVENTION 
     Insulin and other injectable medications are commonly delivered with patch injectors and infusion sets. 
     Drugs and pharmaceuticals often contain preservatives and/or stabilizing agents to extend the shelf-life of the drug or pharmaceutical. For example, insulin often contains phenol and/or m-cresol as stabilizers. These stabilizers can often produce side effects, such as irritation, inflammation, scarring, and lipohypertrophy at the injection site. 
     Existing infusion sets are disclosed in PCT Application PCT/US2019/028248, filed Jun. 28, 2019, the entire contents of which is hereby incorporated by reference 
     Although the prior devices have been suitable for the intended use, there is a continuing need in the industry for improved medical devices to reduce the irritation and inflammation at the injection site. 
     SUMMARY OF EMBODIMENTS 
     Accordingly, it is an aspect of the present invention to provide a medical device to reduce irritation and inflammation at an injection site. 
     The foregoing 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 a patient insertion position. The base body includes a fluid pathway that is one of fluidly connected with the hollow cannula and fluidly connectable with the hollow cannula. The fluid pathway includes a pathway portion sealed with a sealer, and the pathway portion includes an adsorbent operable to modify a fluid traversing 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. 
     The foregoing and/or other aspects of the present invention are also 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. Each of the base body, the fluid connector, the pump connector, and the tubing has a fluid pathway therethrough. The respective fluid pathways being fluidly connectable. The fluid pathway of at least one of the base body, the fluid connector, and the pump connector includes a pathway portion sealed with a sealer; and the pathway portion includes an adsorbent configured to modify a fluid traversing the pathway portion by removing one or more compounds or substances from the fluid prior to delivery of the fluid to the patient. 
     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 that includes a groove recessed from a surface of the at least one of the patch injector, the base, the fluid connector, and the pump connector. The method also includes providing an adsorbent in the groove, and sealing the groove with a sealer to form at least a portion of a fluid path through the at least one of the patch injector, the base, the fluid connector, and the pump connector. 
     Additional and/or other aspects and advantages of the present invention will be set forth in the description that follows, or will be apparent from the description, or may be learned by practice of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The above and/or other aspects and advantages of embodiments of the invention will be more readily appreciated from the following detailed description, taken in conjunction with the accompanying drawings, in which: 
         FIG.  1    illustrates an infusion set in accordance with an embodiment of the present invention; 
         FIG.  2    is an exploded view of a fluid connector of the infusion set of  FIG.  1   ; 
         FIG.  3    is a perspective view of the fluid connector of  FIG.  2    in an assembled state; 
         FIG.  4    is a plan bottom view of a fluid path portion of the fluid connector of  FIG.  2   ; 
         FIG.  5    is a cross-sectional view of the fluid connector of  FIG.  2   ; 
         FIG.  6    is a cross sectional view of the fluid connector of  FIG.  2    connected with a base of  FIG.  2     
         FIG.  7    is a cross-sectional view of a base in accordance with an embodiment of the present invention; 
         FIG.  8    is an enlarged portion of the base of  FIG.  7   ; 
         FIG.  9    is an enlarged cross-sectional view of the base  108  in accordance with another embodiment of the present invention; 
         FIG.  10    is a cross-sectional view of a pump connector in accordance with an embodiment of the present invention; 
         FIG.  11    is a perspective view of a patch injector in accordance with another embodiment of the present invention; 
         FIG.  12    is a partial perspective view of the patch injector of  FIG.  11    with a sealer removed for illustration; and 
         FIG.  13    is a flowchart of a method in accordance with an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION 
     Reference will now be made in detail to embodiments of the present invention, which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. The embodiments described herein exemplify, but do not limit, the present invention by referring to the drawings. 
     The embodiments are not intended to be mutually exclusive so that the features of one embodiment can be combined with other embodiments as long as they do not contradict each other. 
     It will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of other embodiments, and capable of being practiced or carried out in various ways. Phraseology and terminology used herein is for the purpose 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. 
     Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled”” and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as “up,” “down,” “bottom,” “top,” “front,” “rear,” “upper,” “lower,” “upwardly,” “downwardly,” and other orientational descriptors are intended to facilitate the description of the exemplary embodiments of the present invention, and are not intended to limit the structure of the exemplary embodiments of the present invention to any particular position or orientation. Terms of degree, such as “substantially” or “approximately” are understood by those skilled in the art to refer to reasonable ranges around and including the given value and ranges outside the given value, for example, general tolerances associated with manufacturing, assembly, and use of the embodiments. The term “substantially” when referring to a structure or characteristic includes the characteristic that is mostly or entirely. 
     Embodiments of the present invention are directed to a medical device or medical delivery device and method of manufacturing a medical device that receives or carries a fluid, such as insulin, medication, or a drug for delivery to a patient, and removes one or more compounds or substances from the insulin, medication, or drug, and subsequently delivers the modified fluid to the patient. 
     The medical device is particularly suitable for use in delivering insulin that contains a stabilizer or preservative so that at least a portion of the stabilizer or preservative is removed from the insulin before delivering the modified insulin to the patient. The medical device for introducing an insulin formulation into the patient is used in association with an adsorbent material that contacts the insulin formulation before introduction to the patient. 
     The medical device can deliver the fluid, such as insulin, to a patient by a bolus flow delivery and/or basal delivery. In one embodiment, the drug is an insulin formulation or solution that is delivered to the patient in a selected and controlled dosage at an injection or infusion site. 
     The insulin formulation is typically a solution containing a preservative and stabilizing agent to extend the shelf-life of the insulin solution until ready for use. The stabilizing agent in one embodiment is phenol, m-cresol and mixtures thereof. The majority of Type I diabetics, and a subset of Type II diabetics, manage the condition by multiple daily injections of insulin. The daily injections result in side effects including irritation, inflammation, scarring, and lipohypertrophy and the accumulation of subcutaneous fat at the insulin injection site or infusion site. The presence of phenol and m-cresol in insulin formulation is effective as a bacteriostat and for stabilizing the insulin formulation. But the presence of the phenol and m-cresol in the insulin with repeating or sustained injection at an injection site or infusion site can cause inflammation and irritation to the patient and can reduce insulin absorption at the site and reduce longevity of the insulin delivery site. 
     The phenolic excipients m-cresol and phenol present in insulin analog formulations as a bacteriostatic and stabilizing factor are cytotoxic in an in vitro system and contribute to adverse tissue reactions when delivered locally at formulation concentrations. The adverse tissue reactions result in increased pro-inflammatory cytokine levels and altered subcutaneous insulin pharmacokinetics. The deleterious reactions are often dose-dependent, so that as more excipient is delivered, such as in insulin infusion devices, pharmacokinetics are increasingly altered relative to initial values. Test data suggests that excipient-induced models of inflammation negatively affect the route of insulin administration and absorption. This can lead to issues of inadequate adherence. 
     One feature of the inventive medical device is to remove the phenolic excipients selectively from insulin formulations without interfering with the effectiveness of the insulin upon delivery to the patient. Experiments using activated charcoal as an adsorbent show the effective removal of the phenol and m-cresol from insulin formulation while maintaining the effluent insulin at formulation concentrations. The resulting treated insulin having a reduced concentration of the phenolic excipient is delivered to the patient within a period of time where substantially no denaturing or loss of potency of the insulin occurs. In one embodiment, the adsorbent is selected to remove only the phenolic excipients. 
     The adsorbent can be used with the medical device for removing at least a portion of the stabilizing agents, and particularly for removing at least a portion of the phenolic stabilizing agents from an insulin formulation prior to introducing to the patient. 
     In one embodiment, the adsorbent is activated charcoal that can be in a granular, extruded, or powder form to provide a contact surface area for the insulin that is sufficient to remove a selected amount of the phenolic stabilizers to inhibit inflammation at the delivery site without denaturing or loss of potency of the insulin at the time of delivery to the patient. In the present description of the device and method, the terms activated charcoal and activated carbon are used interchangeably. Acid treated activated charcoal, such as phosphoric acid activated carbon, is particularly suitable for removing phenol and m-cresol from insulin formulations. In one embodiment, the activated charcoal is a chemically active carbon obtained by treatment with phosphoric acid. The activation can be by phosphoric acid, for example, at pH 6.7. One skilled in the art will understand, however, that other pH levels can be employed. Commercially available phosphoric acid treated activated charcoal can be used for the removal of phenol and m-cresol from insulin formulations. An example of a commercially available acid treated activated charcoal is available under the trade name CN5-20 by Cabot Corporation. The activated charcoal has a surface area to provide sufficient contact with the insulin to remove an amount of the phenolic compounds sufficient to minimize irritation and inflammation at the injection site. 
     The activated charcoal can be obtained from a variety of carbon sources including, for example, wood, coconut shell, olive pits, peat, lignite, coal or another suitable carbon source. 
     The activation in one embodiment is by chemical activation with phosphoric acid to provide the beneficial porosity, pore volume, surface area, surface chemistry, and pore size distribution. The activated charcoal typically has a surface area of greater than 1,000 m 2 /g. The activated charcoal can have a pore volume of about 0.26-1.16 cm 3 /g, and generally about 0.40-0.70 cm 3 /g. In other embodiments, the activated charcoal can have a surface area of 1500 m 2 /g or greater. In further embodiments, the activated charcoal can have surface area of greater than 2300 m 2 /g and in some circumstances a surface area of greater than 3,000 m 2 /g depending on the method of activation. 
     The adsorbent is present in an amount to provide a contact time with the insulin formulation that is sufficient to remove a desired amount of the phenol, m-cresol or other stabilizing agents contained in the insulin formulation to reduce irritation and inflammation at the injection site without denaturing and without reducing the potency of the insulin. The adsorbent is located in the flow path of the insulin formulation as close to the injection member or delivery site as reasonably possible to limit degradation of the insulin formulation before introducing to the patient. 
     The amount of activated charcoal in the assembly complements the dosage and flow rate of the insulin depending on the delivery by basal flow or bolus flow delivery to provide the desired rate of adsorption of the phenolic stabilizers. In one embodiment, the amount of the adsorbent provides removal of about 95% of the m-cresol after 4 days and about 60% after 7 days at a basal flow rate. 
       FIG.  1    illustrates an infusion set  100  in accordance with an embodiment of the present invention. As shown, the infusion set  100  includes a fluid connector  102  connected with tubing  104  that is also connected to a pump connector  106  for connecting to a pump. The infusion set  100  also includes a base  108 , which includes 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 a top of the base  108 , as shown in  FIG.  6   . Each of the base body  109 , the fluid connector  102 , the pump connector  106 , and the tubing  104  has a fluid pathway therethrough. 
     According to one embodiment, the fluid connector  102  is a two-part fluid connector  102 . As shown in  FIG.  2   , the fluid connector  102  includes two components: a fluid path portion  110 , and a latching portion  112 . The latching portion  112  includes activation levers  114 , fluid connector latches  116 , and a rigid stop  118 . 
     According to one embodiment, the activation levers  114 , fluid connector latches  116 , and the rigid stop  118  are integrally formed as a unitary structure. Additionally, the activation levers  114  form arms with their respective fluid connector latches  116 . These arms are displaceable relative to the fluid path portion  110 . The fluid connector latches  116  are displaceable to a latching position in which the at least a portion of a fluid connector latch  116  of the base  108  is disposed within the fluid path portion  110  (see  FIG.  6   ). Further, the arms are resiliently biased toward the latching position. 
     The fluid path portion  110  includes a tubing connector portion  120  for connecting the fluid connector  102  with the tubing  104 . The fluid path portion  110  can be secured to the latching portion  112  via snap-fit engagement and according to one embodiment, the fluid path portion  110  and the latching portion  112  can be made of the same material. Although the exemplary embodiment of a two-piece fluid connector is illustrated, it will be appreciated by one skilled in the art that a one-piece fluid connector, or a fluid connector made of more than two pieces can be employed without departing from the scope of the present invention. 
       FIG.  4    is a plan bottom view of the fluid path portion  110  in accordance with an embodiment of the present invention (with the latching portion omitted for clarity), and  FIG.  5    is a cross-sectional view of the fluid connector  102  in accordance with an embodiment of the present invention. As shown in  FIGS.  4  and  5   , the fluid pathway of the fluid path portion  110  of the fluid connector  102  includes a pathway portion  150 , which includes a groove recessed  152  in the top interior ceiling or dome portion or roof an internal dome portion of the fluid path portion  110 , and a sealer  154 , such as a pressure sensitive adhesive or a membrane or film  154  that covers and fluidly seals the groove  152  to form the pathway portion or fluid connector pathway portion  150 . One skilled in the art will understand that other sealers can be employed, such as a molded component that is ultrasonically or chemically welded over the groove  152 . For simplicity, in describing this and other embodiments, films are employed as sealers. According to one embodiment, the film  154  is a pressure sensitive adhesive or film  154 , such as Mylar, that can fluidly seal the recessed groove  152 . 
     Preferably, the adsorbent, such as activated charcoal adsorbent, is placed in the groove  152  prior to sealing the groove  152  with the film  154 . As best shown in  FIG.  4   , the groove  152  is a torturous path. The groove  152  is configured so that the insulin formulation passing through the adsorbent has a residence time in the pathway portion  150  sufficient to remove the phenolic stabilizing agent from the insulin formulation before delivery to the patient, but also to obtain substantially no denaturing or loss of efficacy of the insulin formulation before delivery to the patient. One 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 goal is to provide sufficient contact with the adsorbent to remove a sufficient amount of the irritation causing stabilizing agent without losing efficacy of the insulin formulation. 
     As shown in  FIG.  6   , when the fluid connector  102  is connected with the base  108 , a blunt cannula  156 , which depends form the ceiling of the domed portion of the fluid connector  102 , penetrates a septum  158  of the base  108  to connect the fluid pathway of the fluid connector  102  with the fluid pathway of the base  108 . 
       FIG.  7    is a cross-sectional view of the base  108  in accordance with another embodiment of the present invention, and  FIG.  8    is an enlarged portion of  FIG.  7   . As shown in  FIGS.  7  and  8   , the hollow cannula  111  depends form a distal portion of the base body  109 . The base body  109  includes a proximal sealing member  158  fluidly sealing a proximal end of a column portion  160  of the base body  109 . According to one embodiment, the proximal sealing member  158  is a septum  158 , but other sealing members can be employed without departing from the present invention&#39;s scope. The base body  109  also includes a medial sealing member  162  fluidly sealing a medial portion of the column portion  160  and forming a first chamber  164  between the proximal and medial sealing members  158  and  162 , and a second chamber  166  between the medial sealing member  162  and a proximal portion of the hollow cannula  111 . According to one embodiment, the medial sealing member  162  is a septum  162 , but other sealing members can be employed without departing from the present invention&#39;s scope. 
     The first chamber  164  includes a first end port  170  and the second chamber  166  has a second end port  172 . The first and second end ports  170  and  172  are connected by a groove  174  recessed in the interior walls of the column portion  160 , and the recessed groove  174  is covered by a sealer  176 , such as a film  176 . Preferably, the adsorbent, such as activated charcoal adsorbent, is placed in the groove  174  prior to sealing the groove  174  with the film  176 . 
     The sealer  176  is preferably a pressure sensitive adhesive or film  176 , such as Mylar, that can fluidly seal the recessed groove  174 . According to one embodiment, the recessed groove  174  is spiral groove  174 . One skilled in the art will appreciate that a plurality of end ports and connecting grooves, or a pair of end ports with a plurality of connecting grooves, or a plurality of end ports, each with a plurality of connecting grooves can be disposed within the column portion without departing from the present invention&#39;s scope. But for clarity, only one set of end ports with a single connecting groove is shown in the depicted embodiment. 
       FIG.  9    is an enlarged cross-sectional view of the base  108  in accordance with another embodiment of the present invention. Like the previous embodiment, as shown in  FIG.  9   , the base body  109  includes the proximal sealing member  158  fluidly sealing the proximal end of the column portion  160  of the base body  109 . The base body  109  also includes the medial sealing member  162  fluidly sealing the medial portion of the column portion  160  and forming the first chamber  164  between the proximal and medial sealing members  158  and  162 , and the second chamber  166  between the medial sealing member  162  and a proximal portion of the hollow cannula  111 . 
     The first chamber  164  includes a first end port  180  and the second chamber  166  has a second end port  182 . The first and second end ports  180  and  182  are connected by a groove  184  recessed in the interior walls of the column portion  160 , and the recessed groove  184  is covered by a sealer  186 , such as a film  186 . Thus, the groove  184  fluidly connects the first and second chambers  164 ,  166 . Preferably, the adsorbent, such as activated charcoal adsorbent, is placed in the groove  184  prior to sealing the groove  184  with the film  186 . 
     The sealer  186  is preferably a pressure sensitive adhesive or film  186 , such as Mylar, that can fluidly seal the recessed groove  184 . According to one embodiment, the recessed groove  184  is linear groove  184 . Although multiple linear groove  184  are depicted in  FIG.  9   , one skilled in the art will appreciate that a single linear groove  184  can be employed without departing from the present invention&#39;s scope. Additionally, one skilled in the art will appreciate that the grooves  184  do not have to be linear, and can have other shapes without departing form the present invention&#39;s scope. For example, the grooves  184  could have a curved and/or a zig-zag shape, or can be a wandering path without a geometric shape. 
       FIG.  10    is a cross-sectional view of a pump connector  190  in accordance with an embodiment of the present invention. The connector  190  includes a main body  192  with a medial sealing member  194 , a proximal sealing member  196 , and a connector needle  198  proximally depending from the proximal sealing member  196  for fluidly communicating with a pump. The connector needle  198  fluidly connects with a first chamber  200  disposed between the medial and proximal sealing members  194  and  196 . The connector  190  also has a second chamber  202  disposed distally (toward the patient) of the medial sealing member  194 . The second chamber  202  fluidly connects with a tubing port  204  for connecting with tubing of a medicament delivery device. 
     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 recessed groove  210  connecting the first and second end ports  206  and  208 . The recessed groove  210  fluidly connects the first and second chambers  200 ,  202 . The recessed groove  210  is recessed from an internal wall of the connector  190 , and is covered by sealer  212 , such as a film  212 . Preferably, the adsorbent, such as activated charcoal adsorbent, is placed in the groove  210  prior to sealing the groove  210  with the film  212 . The film  212  is preferably a pressure sensitive adhesive or film  212 , such as Mylar, that can fluidly seal the recessed groove  210 . 
     According to one embodiment, the recessed groove  210  is linear. According to another embodiment, the recessed groove  210  is a spiral. According to another embodiment depicted in  FIG.  10   , the recessed groove  210  is wandering path without a particular geometric shape. Such a path can be advantageous to increase dwelling time of a medicament within the recessed groove  210 . 
     Although only one pair of end ports  206 ,  208  and one recessed groove  210  is depicted in  FIG.  10   , one skilled in the art will appreciate that a plurality of end ports and connecting grooves, or a pair of end ports with a plurality of connecting grooves, or a plurality of end ports, each with a plurality of connecting grooves can be disposed within the inventive connector without departing from the present invention&#39;s scope. 
       FIG.  11    is a bottom perspective view of a patch injector  300  in accordance with 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 sharpened. According to another embodiment, the hollow cannula  308  is flexible and the patch injector  300  also includes a sharpened 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 . Preferably, however, 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 in which the hollow cannula  308  does extend distally beyond the base body  306 , as shown in  FIGS.  11  and  12   . 
     According to one embodiment, the patch injector  300  includes a reservoir holding the fluid, such as insulin. The patch injector  300  includes a fluid pathway fluidly connecting the reservoir with the hollow cannula  308 . According to one embodiment, the base body  306  includes one or more grooves  310 ,  312  recessed from a surface of the base body  306 , and a sealer  314 , such as film  314 , seals the grooves  310 ,  312  forming a pathway portion of the fluid pathway. The manufacturer preferably provides an adsorbent, such as activated charcoal adsorbent, in the grooves  310 ,  312  prior to sealing the grooves  310 ,  312  with the sealer  314 . such as a film  314 . 
     The sealer  314  is preferably a pressure sensitive adhesive film  314 , such as Mylar, that can fluidly seal the recessed groove or grooves  310 ,  312 . 
       FIG.  12    omits the film  314  to better illustrate the grooves  310 ,  312 . According to one embodiment depicted in  FIGS.  11  and  12   , the grooves are proximally recessed from a distal surface of the base body  306 . In such an embodiment, because the pathway portion is disposed outside the cover  302 , the fluid pathway passes from an interior to an exterior, and in the embodiment of  FIGS.  11  and  12   , the fluid pathway passes back into an interior of the patch injector  300  prior to reaching the hollow cannula  308 . According to another embodiment, the grooves are disposed inside the cover  302 , distally recessed from a proximal surface of the base body  306 . A size and shape of the groove or grooves  310 ,  312  is operable to provide a residence time in the groove for the fluid, such as an insulin formulation, passing through the activated charcoal absorbent to minimize or prevent denaturing and/or loss of efficacy before delivery to the patient. 
     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 prior to delivery of the fluid to the patient through the hollow cannula  308 . 
       FIG.  13    is a flowchart of a method  400  in accordance with an embodiment of the present invention. In the first operation. For illustrative purposes, the method is described as being implemented by a manufacturer, but it will be understood that other entities can practice the method without departing from the present invention&#39;s scope. In operation  402 , the manufacturer provides at least one of a base, a fluid connector, and a pump connector of an infusion set, and the at least one of the base, the fluid connector, and the pump connector includes a groove recessed from an internal surface thereof. In operation  404 , the manufacturer provides an adsorbent in the groove. And in operation  406 , the manufacturer seals the groove with a film to form at least a portion of a fluid path. 
     The method can include additional operations. For example, in a base or a pump connector, the method can include inserting a medial sealing member between first and second end ports of the groove. The method can also include inserting another sealing member sealing or at least limiting access to the first end port from an external environment. 
     Embodiments of the present invention have been described with respect to multi-part infusion sets and patch injectors, but embodiments of the present invention could also include other medicament delivery devices, such as one-piece infusion sets. For brevity, however, these embodiments have been omitted. 
     Although 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 appreciated by those skilled in the art that changes may be made to these embodiments without departing from the principles and spirit of the invention. Any of the embodiments and/or elements disclosed herein may be combined with one another to form various additional embodiments not specifically disclosed, as long as they do not contradict each other. It is particularly noted that those skilled in the art can readily combine the various technical aspects of the various elements of the various exemplary embodiments that have been described above in numerous other ways, all of which are considered to be within the scope of the invention, which is defined by the appended claims and their equivalents. 
     Various aspects of the embodiments may be employed independently or in combinations thereof.