Patent Publication Number: US-2023145791-A1

Title: Method of using medicinal fluid injection device

Description:
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS 
     Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. 
     This application is a continuation of U.S. application Ser. No. 15/930,244, filed on May 12, 2020, which is a continuation of U.S. application Ser. No. 16/080,651, filed on Aug. 28, 2018, which is a national phase of PCT Application No. PCT/KR2017/002036, filed on Feb. 24, 2017, now U.S. Pat. No. 10,682,465, which claims priority to Korean Patent Application No. KR 10-2016-0024677, filed on Feb. 29, 2016. Each of the above applications is incorporated herein by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to a device for finely injecting a medicinal fluid such as insulin and a cover body for use in the device. 
     BACKGROUND ART 
     Diabetes is a medical condition based on metabolic disorders caused by lack of insulin, which is one of the hormones produced by the pancreas. A diabetic patient has to use a method of injecting insulin into his/her body as one of the aggressive methods. An insulin injection device may be used to appropriately inject insulin into the body according to a change in a patient&#39;s blood glucose. 
     A medicinal fluid injection device such as an insulin injection device may be semi-permanently used while constantly replenishing a medicinal fluid therein. In such a case, foreign materials (e.g., air), other than the medicinal fluid, need to be prevented from being injected through an injection needle into the body or the medicinal fluid injection device needs to be prevented from being contaminated. 
     SUMMARY OF CERTAIN INVENTIVE ASPECTS 
     Provided are a cover body capable of preventing internal contamination of a device and undergoing a deformation due to air discharged through an injection needle and a medicinal fluid injection device having the cover body. 
     According to an aspect of the present disclosure, a medicinal fluid injection device includes a housing having an opening in a side surface thereof; a storage container arranged inside the housing and storing a medicinal fluid; an injection needle connected to the storage container and injecting the medicinal fluid through the opening; and a cover body covering the opening, wherein the cover body includes a cover part of which a shape changes according to an air pressure caused by the injection needle. 
     At least one region of the cover part may bulge in a direction away from the housing due to the air pressure. 
     The cover part may include an elastic material. 
     The elastic material may include a polymer. 
     The cover part may include a corrugation in a thickness direction of the cover part. 
     The at least one region of the cover part may be thinner than a peripheral region around the at least one region. 
     The cover body may further include a frame, the frame including a hole corresponding to the opening of the housing. 
     The frame may further include a sleeve protruding toward the cover part and combined with the cover part. 
     The cover body may further include an auxiliary cover part positioned opposite the cover part with the hole between the auxiliary cover part and the cover part. 
     The auxiliary cover part may include a polymer. 
     The medicinal fluid injection device may further include a shape that is concave in a direction toward the cover part to accommodate an initial medicinal fluid discharged from the injection needle penetrating through the auxiliary cover part. 
     According to another aspect of the present disclosure, a cover body for a medicinal fluid injection device includes a frame having a hole and a cover part combined with the frame, wherein a shape of the cover part changes with a change in an air pressure around the cover part. 
     The cover part may include an elastic material. 
     The elastic material may include a polymer. 
     The cover part may include a corrugation in a thickness direction of the cover part. 
     At least one region of the cover part may be thinner than a peripheral region around the at least one region. 
     The cover body may further include an auxiliary cover part positioned opposite the cover part with the hole between the auxiliary cover part and the cover part. 
     A space between the cover part and the auxiliary cover part may be a closed space fluidically separated from outside. 
     The auxiliary cover part may have a shape that is concave in a direction toward the cover part. 
     The auxiliary cover part may include a polymer. 
     Other aspects, features, and advantages than those described above will be clear from the accompanying drawings, the claims, and the descriptions of embodiments below. 
     According to embodiments of the present disclosure, a cover body and a medicinal fluid injection device having the same prevent the backflow of air during a priming operation for removing air from an injection needle and prevent device contamination. The scope of the present disclosure is not limited by these effects. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG.  1    is a schematic perspective view of a medicinal fluid injection device according to an embodiment of the present disclosure. 
         FIG.  2    is an exploded perspective view of  FIG.  1   . 
         FIG.  3    is a schematic perspective view of a main body according to an embodiment of the present disclosure. 
         FIGS.  4  and  5    are schematic exploded perspective views of a cover body according to an embodiment of the present disclosure. 
         FIG.  6    is a cross-sectional view of a cover body according to an embodiment of the present disclosure. 
         FIGS.  7 A and  7 B  are respectively cross-sectional views of a cover body and a main body before and after being combined with each other. 
         FIGS.  8  and  9    are respectively cross-sectional views of cover bodies according to embodiments of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION OF CERTAIN ILLUSTRATIVE EMBODIMENTS 
     The present disclosure may include various modifications and different embodiments. In this regard, specific embodiments are illustrated in the drawings and will be described in detail. Advantageous effects, features, and methods for achieving the effects and features will become more apparent by explaining the embodiments in detail with reference to the accompanying drawings. However, the present disclosure is not limited to these embodiments but may be implemented in various modes. 
     The embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings, in which like reference numerals denote like elements, and thus their description will be omitted. 
     The terms first, second, etc. are used in the description of the embodiments to only distinguish one element from another. 
     As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. 
     It will be further understood that the terms “comprises” and/or “comprising,” or “includes” and/or “including” when used in this specification, specify the presence of stated features or components, but do not preclude the presence or addition of one or more other features or components. 
     In the drawings, the size of elements may be exaggerated or reduced for clarity. For instance, the size and thickness of each element may be arbitrarily illustrated in the drawings, and therefore, the present disclosure is not limited to the drawings. 
     It will be understood that when a region or an element is referred to as being “connected” to another region or element, it can be directly connected to the other region or element, or intervening regions or elements may be present. 
       FIG.  1    is a schematic perspective view of a medicinal fluid injection device according to an embodiment of the present disclosure.  FIG.  2    is an exploded perspective view of  FIG.  1   .  FIG.  3    is a schematic perspective view of a portion of a main body according to an embodiment of the present disclosure. For convenience of description, a patch plate  117  of  FIG.  2    is omitted in  FIG.  3   . 
     Referring to  FIGS.  1  through  3   , a medicinal fluid injection device  1  may include a main body  100  and a cover body  200 . The main body  100  may include a housing  110  having an opening  113  in a side surface, a storage container  120  arranged inside the housing  110 , a pump  130 , and an injection needle  140  connected to the storage container  120  through the pump  130 . 
     The housing  110  may include a material such as plastic or a metallic material. The opening  113  may be formed in the side surface of the housing  110 . The opening  113  may be located at the center of the side surface of the housing  110  in  FIG.  1   , but the present disclosure is not limited thereto. 
     The housing  110  may include the patch plate  117  provided on the side surface of the housing  110  in which the opening  113  is formed. The patch plate  117  may have an adhesive surface  117 A which allows the medicinal fluid injection device  1  to be attached to a patient&#39;s skin surface. The adhesive surface  117 A may be protected by release paper (not shown). The release paper may be removed from the adhesive surface  117 A when the medicinal fluid injection device  1  needs to be fixed to the patient&#39;s skin surface via the adhesive surface  117 A. 
     The storage container  120  may store and hold as much medicinal fluid as necessary to be injected several times to several tens of times. When the medicinal fluid stored in the storage container  120  is all consumed, the storage container  120  may be newly filled with a new medicinal fluid. 
     The pump  130  may be a small size pump, e.g., a micropump, and may pump a predetermined amount of the medicinal fluid. In an embodiment, the pump  130  may pump several tens of nanoliters to several microliters of the medicinal fluid at a flow rate of several microliters to several tens of microliters per minute, but the present disclosure is not limited thereto. 
     The injection needle  140  may be connected to the storage container  120  through a tube  145 . The pump  130  may be positioned along a path between the storage container  120  and the injection needle  140 . The medicinal fluid in the storage container  120  may be moved by the pump  130  to the injection needle  140  through the tube  145 . When a button (not shown) in the main body  100  is pushed, the injection needle  140  protrudes outward through the opening  113  of the main body  100  under the control of a controller (not shown). Thus, the medicinal fluid may be injected into a patient through the injection needle  140 . 
     The cover body  200  may cover the opening  113  of the main body  100 . The cover body  200  may be coupled to a recess  115  formed in the side surface of the housing  110  and may be configured to be easily detachable using a handle  228 . 
     The cover body  200  may include a part that may include an elastic material. Thus, a shape of the portion of the cover body  200  may be changed by an air pressure inside the cover body  200  facing the main body  100 . In an embodiment, a shape of a cover part  210  of the cover body  200  may be changed by an air pressure around the cover part  210 , e.g., an air pressure from the inside of the cover part  210 . In an embodiment, at least one region of the cover part  210  may bulge in a direction (e.g., an X direction) away from the housing  110 . The cover part  210  may be combined with a frame  220  which supports the cover part  210 . 
     The cover body  200  will be described further below. 
       FIGS.  4  and  5    are each schematic exploded perspective views of a cover body according to an embodiment of the present disclosure.  FIG.  6    is a cross-sectional view of a cover body according to an embodiment of the present disclosure. 
     Referring to  FIGS.  4  through  6   , the cover part  210  may be connected to the frame  220  at a side of the frame  220 , and an auxiliary cover part  230  may be connected to the frame  220  at an opposite side of the frame  220 . 
     The cover part  210  may include an elastic material. In an embodiment, the cover part  210  may include a polymer. The polymer may include natural rubber, synthetic rubber, or a silicone-based polymer. The silicone-based polymer may include polydimethylsiloxane (PDMS) or hexamethyldisiloxane (HMDSO). In another embodiment, the elastic material may include various materials such as polyurethane and polyurethane acrylate. 
     The cover part  210  may include a front portion  212  and a lateral portion  214  around the front portion  212 . In an embodiment, the front portion  212  and the lateral portion  214  may be integrally formed with each other from one material. 
     The frame  220  may include a hole  222 . The hole  222  may correspond to the opening  113  of the main body  100  and penetrate the frame  220 . The frame  220  may include a sleeve  224  at a side (hereinafter, referred to as a first side surface) facing the cover part  210  and a protrusion  226  at an opposite side (hereinafter, referred to as a second side surface) facing the main body  100 . 
     The sleeve  224  may protrude from the frame  220  in the X direction. The sleeve  224  may be a structure to be combined with the cover part  210 . The lateral portion  214  of the cover part  210  may be combined with the sleeve  224  so that the cover part  210  may be connected to the frame  220 . 
     The protrusion  226  may protrude in a direction opposite the sleeve  224 . As a structure for a combination with the main body  100 , the protrusion  226  may be inserted into the recess  115  (see  FIG.  2   ) provided in the housing  110  of the main body  100 . The frame  220  may include the handle  228  extending along a side thereof. When the cover body  200  needs to be removed to inject the medicinal fluid into a patient, the cover body  200  may be easily detached from the main body  100  using the handle  228 . 
     The auxiliary cover part  230  may be positioned opposite the cover part  210  with the hole  222  of the frame  220  between the auxiliary cover part  230  and the cover part  210 . The auxiliary cover part  230  may be connected to the frame  220  when a coupling protrusion  232  is inserted and locked into a coupling hole  220   a  formed in the frame  220 . 
     The auxiliary cover part  230 , as described below with reference to  FIGS.  7 A and  7 B , may include a polymer material such that the injection needle  140  may penetrate through the auxiliary cover part  230 . The auxiliary cover part  230  may be convex in a direction facing the main body  100 , i.e., concave in a direction (i.e., the X direction) facing the cover part  210 . 
     Due to the cover part  210  and the auxiliary cover part  230 , which are connected to the frame  220  at opposite sides of the frame  220  with the hole  222  between the cover part  210  and the auxiliary cover part  230 , a space S is formed between the cover part  210  and the auxiliary cover part  230 . Although the space S is a closed space, as shown in  FIG.  7 A , the space S may be fluidically connected to the injection needle  140  as the injection needle  140  penetrates through the auxiliary cover part  230 , as described below with reference to  FIG.  7 B . 
       FIGS.  7 A and  7 B  are respectively cross-sectional views of a cover body and a main body before and after being combined with each other. 
     Referring to  FIGS.  7 A and  7 B , the cover body  200  is positioned to cover the opening  113  of the main body  100 , and the protrusion  226  of the cover body  200  is inserted into the recess  115 . In an embodiment, when the cover body  200  is combined with the main body  100 , the injection needle  140  in the opening  113  may penetrate through the auxiliary cover part  230  of the cover body  200 . 
     For injection of the medicinal fluid, the cover body  200  is detached from the main body  100 , and the medicinal fluid in the storage container  120  is injected into a patient through the injection needle  140  according to an operation of the pump  130 , as described above with reference to  FIGS.  1  through  3   . 
     When air is in the injection needle  140  before the medicinal fluid is injected, there is a risk that the air may be injected into a patient, and therefore, an operation of removing the air, e.g., a priming operation, is performed. For example, the medicinal fluid is moved by the pump  130  (see  FIG.  3   ) which operates according to a signal of the controller. The air in the injection needle  140  may be discharged by the movement of the medicinal fluid as shown in  FIG.  7 B . The discharged air stays in the space S. At this time, a shape of the cover part  210  changes due to the pressure of the discharged air, thereby the cover part  210  bulging outward. 
     In a comparative example, when the cover part  210  includes a nonelastic material, e.g., reinforced plastic, a shape of the cover part  210  does not change. In this case, even when the air is discharged from the injection needle  140 , the space S has no margin to accommodate the discharged air, and therefore, the air flows backward into the injection needle  140  and may be injected into a patient. However, according to embodiments of the present disclosure, the shape of the cover part  210  changes due to the pressure of the air discharged from the injection needle  140 , and therefore, the problem described above may be prevented. 
     During the priming operation, a little medicinal fluid F may be discharged together with the air. The little medicinal fluid F may gather in the auxiliary cover part  230  having a shape that is concave in a direction (e.g., the X direction) in which medicinal fluid is discharged. Since the little medicinal fluid F is in the space S of the cover body  200 , the inside of the main body  100  may be prevented from being contaminated by the little medicinal fluid F. 
     In the embodiments described above with reference to  FIGS.  7 A and  7 B , the injection needle  140  penetrates through the auxiliary cover part  230  when the cover body  200  is combined with the main body  100 , but the present disclosure is not limited thereto. In other embodiments, the injection needle  140  may be positioned further inside than a position shown in  FIG.  7 A , and when the priming operation is necessary, the injection needle  140  may be moved by the operation of the controller to penetrate through the auxiliary cover part  230 , as shown in  FIG.  7 B . 
       FIGS.  8  and  9    are respectively cross-sectional views of cover bodies according to different embodiments of the present disclosure. 
     Referring to  FIG.  8   , a cover body  200 ′ has a similar structure to the cover body  200 . Thus, redundant descriptions will be omitted and descriptions will be focused on the differences between the cover bodies  200  and  200 ′. 
     A cover part  210 ′ in  FIG.  8    may have corrugations. In an embodiment, the front portion  212  may have a corrugated shape in a thickness direction. Since the front portion  212  has corrugations, the shape of the cover part  210 ′ may be easily changed by air discharged from the injection needle  140  during a priming operation. In an embodiment, the cover part  210 ′ may include the elastic material described above. In another embodiment, the cover part  210 ′ may include a non-elastic material since the cover part  210 ′ has corrugations. 
     Referring to  FIG.  8   , although corrugations are formed throughout the front portion  212 , the present disclosure is not limited thereto. The front portion  212  may be partially corrugated. 
     Referring to  FIG.  9   , a cover body  200 ″ has the similar structure to the cover body  200 . Thus, redundant descriptions will be omitted, and descriptions will be focused on the differences between the cover bodies  200  and  200 ″. 
     A cover part  210 ″ in  FIG.  9    may have different thicknesses in different portions. In an embodiment, a thickness “t” of the front portion  212  may be less than a thickness T of the lateral portion  214 . Accordingly, the shape of the cover part  210 ″ may be easily changed by the pressure of air discharged during a priming operation. The cover part  210 ″ may include the elastic material described above. 
     Although the front portion  212  has the uniform thickness “t” (where t&lt;T) in  FIG.  9   , the present disclosure is not limited thereto. In another embodiment, a thickness of at least one region of the front portion  212  may be less than the thickness T of the lateral portion  214 . 
     While the present disclosure has been described with reference to embodiments shown in the drawings, it will be understood by those skilled in the art that the embodiments are just exemplary and various changes in form and details may be made therein. Therefore, the scope of the present disclosure will be defined by the technical ideas of the appended claims.