Patent Publication Number: US-2023140353-A1

Title: Subcutaneous device with leak prevention

Description:
BACKGROUND 
     The present disclosure relates, in general, to subcutaneous devices such as, but not limited to subcutaneous sensors, infusion sets, injection ports, stimulation devices or other medical devices having at least one subcutaneous interface, and methods of making and using such devices. Particular examples relate to such devices and methods that are configured to reduce or prevent leakage of blood at or around an insertion site. 
     Certain biological conditions may be monitored or sensed, according to modern medical techniques, through one or more sensors inserted subcutaneously from a medical device. For example, blood glucose levels are commonly monitored with subcutaneous sensors. In addition, certain diseases or conditions may be treated by delivering a medication or other substance to the body of a user, subcutaneously, through an infusion set, injection port or other medical device. For example, diabetes is commonly treated by delivering defined amounts of insulin to the user at appropriate times. 
     Sensor devices as described herein include one or more subcutaneous sensor probe, needle or cannula that is configured to be inserted under the skin of a patient, to sense or monitor one or more biological conditions. 
     An infusion set or an injection port device as described herein can be used to facilitate subcutaneous infusion of a medication or other infusion media through one or more cannulas that can be inserted under the skin of the patient. Various examples of other infusions sets are described in U.S. Patent Application Publication No. 2018/0318550 (Application Ser. No. 15/973,471; and U.S. Patent Application Publication No. 2020/0384187 (Application Ser. No. 16/436,486), each of which is incorporated herein by reference, in its entirety. In some examples, a medical device as described herein may include one or more (or any combination of) sensors, infusion sets, or injection ports. 
     Sensor devices, infusion sets and injection ports may be configured to secure to (or adjacent) the patient&#39;s skin, at an insertion site, where one or more probes, needles or cannulas (or a combination thereof) is inserted through the patient&#39;s skin. Some devices operate with an insertion needle that facilitates insertion of the one or more probes, needles or cannulas. 
     At the time of insertion, or within a few minutes after insertion of an insertion needle, probe, cannula or other needle of some devices, a small amount of blood or other fluid may leak from the insertion site. Typically, such fluid dries on or around the medical device, on the patient&#39;s skin or on an adhesive patch under the medical device, within a few minutes. Typically, a small amount of such fluid may not have a negative operational effect on the medical device or a negative biological effect on the patient. However, the blood or other fluid can be unsightly and can scare users, which can result in users prematurely removing the medical devices, or contacting medical staff. Accordingly, various examples of medical devices described herein are configured to reduce or eliminate leakage of blood or other fluid from an injection site. 
     SUMMARY 
     A medical device according to certain examples described herein includes a base having a needle channel and a first surface configured to be secured to a patient&#39;s skin and an insertable member configured to be secured to the base with a length portion of the insertable member extending out of the needle channel at the first surface, for insertion through the patient&#39;s skin at an insertion site. The medical device also includes a septum extending across the needle channel, the septum having a body through which an insertion needle may be selectively extended to facilitate the subcutaneous insertion of the length portion of the insertable member, the septum providing a liquid seal across the needle channel. The needle channel and the septum provide a sealed volume in which a limited amount of blood or other fluid from the insertion site may be held. 
     In further examples, an adhesive material layer is attached to the first surface of the base, for securing the first surface of the base to the patient&#39;s skin. In that example, the base has a second surface facing opposite to the first surface, the needle channel extends through the base from the second surface to the first surface, and the septum is located at least partially in the needle channel at the second surface of the base. 
     In further examples, an adhesive material layer is attached to the first surface of the base, for securing the first surface of the base to the patient&#39;s skin and, in that example, the base has a second surface facing opposite to the first surface, the needle channel extends through the base from the second surface to the first surface, and the septum is located at least partially in the needle channel at the first surface of the base. 
     In further examples, the septum includes a piercable body having a valve configuration formed therein, for allowing passage of the insertion needle toward the patient&#39;s skin and inhibiting passage of fluid into the needle channel. 
     In further examples, the septum has a first surface that faces the patient&#39;s skin at the insertion site when the first surface of the base is secured to the patient&#39;s skin, and a first material is held on the first surface of the septum, the first material having at least one of a hydrophilic material, a blood clotting material, or a pain reducing material. 
     In further examples, the medical device includes an annular body attached to the first surface of the septum and having an opening in alignment with the needle channel in the base, the annual body being impregnated or coated with the first material, or having a layer of the first material. 
     In further examples, the medical device includes an adhesive material layer attached to the first surface of the base, for securing the first surface of the base to the patient&#39;s skin, the adhesive material layer having an opening in alignment with the needle channel in the base; and an annular substrate located within the opening in the adhesive material layer and having an opening in alignment with the needle channel in the base and through which the insertable member extends when the insertable member is inserted through the patient&#39;s skin. The annual substrate is impregnated or coated with at least one of a hydrophilic material, a blood clotting material, or a pain reducing material, or having a layer of at least one of a hydrophilic material, a blood clotting material, or a pain reducing material that at least partially surrounds the insertion site. 
     In further examples, the medical device includes an annular adhesive material layer provided on one side of the annular substrate for adhering the annular substrate to the first surface of the base. 
     In further examples, the medical device includes an adhesive material layer attached to the first surface of the base, for securing the first surface of the base to the patient&#39;s skin, the adhesive material layer having an opening in alignment with the needle channel in the base; and an annular substrate located within the opening in the adhesive material layer and having an opening in alignment with the needle channel in the base and through which the insertable member extends when the insertable member is inserted through the patient&#39;s skin. A layer of gauze or other blood absorbing material is attached to a skin-facing surface of the annular substrate. 
     In further examples, the medical device includes an annular adhesive material layer provided on a side of the annular substrate opposite to the skin-facing side for adhering the annular substrate to the first surface of the base, the annular adhesive material having an opening in alignment with the channel in the base. 
     In further examples, the septum comprises a piercable body. 
     In further examples, the insertable member comprises one or more of a sensor probe, a cannula, a needle, or an electrical stimulus delivery device. 
     Further examples relate to a medical device including a base having a needle channel and a first surface configured to be secured to a patient&#39;s skin. An adhesive material layer is attached to the first surface of the base, for securing the first surface of the base to the patient&#39;s skin, the adhesive material layer having an opening in alignment with the needle channel in the base. An insertable member is configured to be secured to the base with a length portion of the insertable member extending out of the needle channel at the first surface and through the opening in the adhesive material layer, for insertion through the patient&#39;s skin at an insertion site. The medical device further includes an annular substrate located within the opening in the adhesive material layer and having an opening in alignment with the needle channel in the base and through which the insertable member extends when the insertable member is inserted through the patient&#39;s skin. The annual substrate is impregnated or coated with a first material, has a layer of the first material, or is attached to a layer of gauze or other absorbent material, that at least partially surrounds or covers the insertion site, and wherein the first material comprises at least one of a hydrophilic material, a blood clotting material, or a pain reducing material. 
     In further examples, the medical device includes a septum located in the needle channel, wherein the needle channel and the septum provide a sealed volume in which a limited amount of blood or other fluid from the insertion site may be held. 
     In further examples, that septum includes a piercable body. 
     In further examples, that medical device includes an annular adhesive material layer provided on one side of the annular substrate for adhering the annular substrate to the first surface of the base. 
     In further examples, that insertable member includes one or more of a sensor probe, a cannula, a needle, or an electrical stimulus delivery device. 
     Further examples relate to a method of making a medical device, including providing a base having a needle channel and a first surface configured to be secured to a patient&#39;s skin, and securing an insertable member to the base with a length portion of the insertable member extending out of the needle channel at the first surface, for insertion through the patient&#39;s skin at an insertion site. The method further includes extending a septum across the needle channel, the septum having a body through which an insertion needle may be selectively extended to facilitate the subcutaneous insertion of the length portion of the insertable member, the septum providing a liquid seal across the needle channel. The needle channel and the septum provide a sealed volume in which a limited amount of blood or other fluid from the insertion site may be held. 
     Further examples of that method include attaching an adhesive material layer to the first surface of the base, for securing the first surface of the base to the patient&#39;s skin, where the base has a second surface facing opposite to the first surface, and the needle channel extends through the base from the second surface to the first surface. 
     Further examples of the method include attaching an adhesive material layer to the first surface of the base, for securing the first surface of the base to the patient&#39;s skin, the adhesive material layer having an opening in alignment with the needle channel in the base, and attaching an annular substrate within the opening in the adhesive material layer. In that example, the annular substrate has an opening in alignment with the needle channel in the base and through which the insertable member extends when the insertable member is inserted through the patient&#39;s skin. The method further includes coating the annular substrate with at least one of a hydrophilic material, a blood clotting material, or a pain reducing material, or supporting a layer of at least one of a hydrophilic material, a blood clotting material, or a pain reducing material on the annular substrate to at least partially surrounds the insertion site. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The above and other aspects and features of the present invention will become more apparent to those skilled in the art from the following detailed description of the example embodiments with reference to the accompanying drawings, in which: 
         FIG.  1    is a perspective view of an example of a medical device. 
         FIG.  2    is a cross-section view of the medical device of  FIG.  1   . 
         FIG.  3    is a cross-section view of another example of a medical device. 
         FIG.  4    is a cross-section view of another example of the medical device of  FIG.  3   . 
         FIG.  5    is a cross-section view of another example of the medical device of  FIG.  3   . 
         FIG.  6    is a perspective view of an example of a septum and a drug-carrying ring of the medical device of  FIG.  5   . 
         FIG.  7    is a cross-section view of another example of the medical device of  FIG.  3   . 
         FIG.  8    is a perspective view of an example of a drug-carrying ring of the medical device of  FIG.  7   . 
         FIG.  9    is a cross-section view of another example of the medical device of  FIG.  3   . 
         FIG.  10    is a perspective view of an example of a drug-carrying ring of the medical device of  FIG.  9   . 
         FIG.  11    is a cross-section view of another example of the medical device of  FIG.  3   . 
         FIG.  12    is a cross-section view of another example of the medical device of  FIG.  3   . 
         FIG.  13    is a perspective view of an example of an absorbent member of the medical device of  FIG.  11   . 
     
    
    
     DETAILED DESCRIPTION 
     Hereinafter, example embodiments will be described in more detail with reference to the accompanying drawings. The present invention, however, may be embodied in various different forms, and should not be construed as being limited to only the illustrated embodiments herein. Rather, these embodiments are provided as examples so that this disclosure will be thorough and complete, and will fully convey the aspects and features of the present invention to those skilled in the art. Accordingly, processes, elements, and techniques that are not necessary to those having ordinary skill in the art for a complete understanding of the aspects and features of the present invention may not be described. Unless otherwise noted, like reference numerals denote like elements throughout the attached drawings and the written description, and thus, descriptions thereof may not be repeated. Further, features or aspects within each example embodiment should typically be considered as available for other similar features or aspects in other example embodiments. 
     Certain terminology may be used in the following description for the purpose of reference only, and thus are not intended to be limiting. For example, terms such as “top”, “bottom”, “upper”, “lower”, “above”, and “below” could be used to refer to directions in the drawings to which reference is made. Terms such as “front”, “back”, “rear”, “side”, “outboard”, and “inboard” could be used to describe the orientation and/or location of portions of the component within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the component under discussion. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms “first”, “second”, and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context. 
     It will be understood that when an element or feature is referred to as being “on,” “secured to,” “connected to,” or “coupled to” another element or layer, it can be directly on, connected to, or coupled to the other element or feature, or one or more intervening elements or features may be present. In addition, it will also be understood that when an element or features is referred to as being “between” two elements or features, it can be the only element or feature between the two elements or features, or one or more intervening elements or features may also be present. 
     The terminology used herein is for the purpose of describing particular embodiments and is not intended to be limiting of the present invention. As used herein, the singular forms “a” and “an” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises,” “comprising,” “includes,” and “including,” “has, ” “have, ” and “having,” when used in this specification, specify the presence of the stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. Expressions such as “at least one of,” when preceding a list of elements, modify the entire list of elements and do not modify the individual elements of the list. 
     As used herein, the term “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art. Further, the use of “may” when describing embodiments of the present invention refers to “one or more embodiments of the present invention.” As used herein, the terms “use,” “using,” and “used” may be considered synonymous with the terms “utilize,” “utilizing,” and “utilized,” respectively. 
     Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and/or the present specification, and should not be interpreted in an idealized or overly formal sense, unless expressly so defined herein. 
     Example embodiments relate to sensor devices, infusion devices, infusion sets, injection ports, insertion sets, media delivery systems, simulation devices, combinations thereof, or other medical devices and systems (each generally referred to herein as a medical device or medical system) that include or operate with one or more subcutaneously insertable probe, cannula, needle, or the like (or a combination thereof). 
     In some examples, the medical device includes one or more sensor probes, cannulas or needles (or a combination thereof) that are connected to sensor electronics, and that are configured to convey electrically detectable signals or fluid from a subcutaneous site to the sensor electronics. In some examples, the medical device includes one or more probes or other electrical output devices that are connected to a stimulus signal source to convey one or more electrical stimulus signals to a subcutaneous site. 
     In some examples, the medical device includes one or more cannulas or needles in fluid flow communication with one or more fluid flow conduits. Such devices may include infusion devices or infusion sets that are configured to connect (or are connected) through one or more fluid flow tubing to an infusion media source (such as, but not limited to a reservoir containing an infusion media, a controlled infusion media pump, or the like), to provide individual, intermittent or continuous delivery of infusion media. In particular examples, the medical device includes an infusion set or of an injection port to permit multiple injections of medication into a patient without the need to re-puncture the patient&#39;s skin. In those examples, medication may be injected from a standard medical implement (such as, but not limited to a syringe), through a septum on the medical device, for subcutaneous delivery through the one or more cannulas or needles of the medical device. Other examples relate to methods of making and using such medical devices and medical systems. 
     An example of a medical device  10  is shown in a top, perspective view in  FIG.  1   . The medical device  10  is shown in a cross-section, schematic view in  FIG.  2   , attached to an epidermal surface S. The medical device  10  includes a base  20  and a subcutaneously insertable member  30 . The insertable member  30  may include a probe, a needle, a cannula, or the like. The subcutaneously insertable member  30  has a distal end  30   a  that is configured to be inserted through the epidermal surface S, to a subcutaneous location. The medical device  10  example in  FIGS.  1  and  2    includes one subcutaneously insertable member  30 . Other examples may include more than one (a plurality of) subcutaneously insertable member(s)  30 . 
     In certain examples, the base  20  may include a housing having an interior which contains one or more components  40  connected to the insertable member  30  (e.g., at a proximal end of the insertable member, opposite to the distal end  30   a ). In examples in which the medical device  10  is or includes a sensor, the components  40  may include one or more sensor electronics connected to the insertable member  30 , where the insertable member  30  is configured to deliver one or more electrical signals, fluids or combinations thereof to the sensor electronics. In other examples, the components  40  may include wireless electrical transmitters or other communication electronics, or electrical ports that are configured to communicate with or connect to sensor electronics (not shown) located external to the base  20 . 
     In examples in which the medical device  10  is or includes an electrical stimulating device, the components  40  may include one or more electrical stimulus source connected to the insertable member  30 , where the insertable member  30  is configured to deliver electrical stimulus signals subcutaneously. In examples in which the medical device  10  is or includes an infusion device, an infusion set, an injection port, or another media delivery system, the components  40  may include one or more (or a combination of) an infusion media reservoir containing an infusion media, an infusion media pump connected to a reservoir, or a fluid inlet or outlet port. In other examples, the components  40  may be omitted and the proximal end of the insertable member  30  may be located within the base  20 , in fluid flow communication with an internal channel or volume  20   a  of the base  20 . 
     The base  20  may include a single-part structure, or may be made of multiple parts (such as, but not limited to a bottom part and a top part that connect together in a clam-shell configuration). The base  20  may be made of any suitable material or materials having sufficient rigidity and strength to function in the manner described herein including, but not limited to plastic, metal, ceramic, composite material, or combinations thereof. 
     The base  20  includes an internal channel or volume  20   a,  a first surface  20   b  that is configured to face the epidermal surface S during use, and a second surface  20   c  facing opposite the first surface  20   b.  In the example in  FIG.  2   , the internal channel or volume  20   a  extends from the first surface  20   b  to the second surface  20   c  and is open at the first surface  20   b.  The internal channel or volume  20   a  is covered and sealed by a septum  50  at the second surface  20   c.    
     In some examples, an adhesive material layer  60  is secured to the first surface  20   b  of the base  20  (the downward-facing side in  FIGS.  1  and  2   ) and has an adhesive material that may be selectively exposed to adhere the base  20  to the epidermal surface S, at a desired infusion site. The adhesive material layer  60  may be secured to the base  20  by any suitable securing mechanism including, but not limited to a glue or other bonding agent, thermal bonding, sonic welding, or the like. 
     In certain examples, a backing or release material layer (not shown) is adhered to the adhesive material layer  60  to cover and protect the adhesive material layer  60  from exposure to dirt or other environmental contaminants before adhering the base  20  to a patient&#39;s skin. In those examples, the release material layer is selectively removable from the adhesive material layer  60  to expose the adhesive material for adhering the base  20  to the epidermal surface S. In other examples, the adhesive material layer  60  and the release material layer may be omitted from the system  10 . Alternatively or in addition, in further examples, the base  20  may include other suitable mechanisms for securing the base  20  to a patient&#39;s skin including, but not limited to bands, straps, sutures, suture eyelets for receiving sutures, or combinations thereof. 
     The insertable member  30  is connected to and supported by the base  20 , for example, in the channel or volume  20   a  of the base  20 . In certain examples, the proximal end of the insertable member  30  is connected to the base  20  and (or) to components  40  in the base  20 . In other examples, the proximal end of the insertable member  30  includes a collar that is received in and secured to the channel or volume  20   a,  such that the proximal end of the insertable member  30  terminates in the channel or volume  20   a  and connects in electrical communication with components  40  through a further electrical connection extending into the channel or volume  20   a.  Alternatively, the proximal end of the inersertable member  30  and collar may terminate in the channel or volume  20   a  and be in fluid flow communication with the channel or volume  20   a  and (or) with other components (not shown) that may be inserted through the septum  50  into the channel or volume  20   a.    
     When in the inserted state, the insertable member  30  extends through an open end of the channel or volume  20   a  at the first surface  20   b  of the base  20 , and into the epidermal surface S at an insertion site I. The open end of the channel or volume  20   a  faces the insertion site I and allows the insertable member  30  to extend out from the base  20 , into the epidermis of a patient. The open end of the channel or volume  20   a  faces and aligns with an opening through the adhesive material layer  60 . The adhesive material layer  60  forms a liquid seal around the open end of the channel or volume  20   a.    
     The septum  50  is secured to the base  20 , to cover and seal the other end of the channel or volume  20   a.  Accordingly, the wall of the channel or volume  20   a,  the wall of the aligned opening through the adhesive material layer  60 , and the septum  50  provide a sealed volume over the epidermal surface S, at the insertion site. Therefore, if a limited amount of blood is excreted from the injection site (e.g., during or after insertion), that blood may be received, trapped and held within the channel or volume  20   a.  Accordingly, the limited excreted amount of blood can remain out of view from outside of the device  10 . 
     The septum  50  may be secured to the base  20  by any suitable securing mechanism including, but not limited to molding, co-molding with the top portion of the base  20 , adhesive, bonding, thermal bonding, sonic welding, or the like. The septum  50  may be secured to the base  20  so as to be generally flush with the second surface  20   c  of the base  20 , as shown in  FIG.  2   . In those examples, the septum  50  may be secured within an annular recess around the open end of the channel or volume  20   a,  at the second surface  20   c.  In other examples, the septum  50  may be recessed within the second surface  20   c  or may extend partially or fully out from the second surface  20   c.    
     The septum  50  and the end of the channel or volume  20   a  covered by the septum  50  provide a port for receiving an insertion needle for facilitating inserting the insertable member  30  through the epidermal surface S. Alternatively or in addition, the septum  50  and the end of the channel or volume  20   a  covered by the septum  50  may provide a port for receiving a needle, cannula, catheter or fluid connector member, in fluid flow communication with the channel or volume  20   a  (or with the insertable member  30 ). 
     The medical device  10  shown in  FIG.  1    may be packaged for use in a sterile container. The base  20  may be removed from the container and secured to the epidermal surface S at the insertion site I, through the adhesive material layer  60  (or other securing mechanisms as described herein). For example, the user may peel off the cover layer over the adhesive material layer  60  to expose the adhesive. The user may apply the exposed adhesive (and the base  20 ) on the epidermal surface S, over a desired insertion site I, to secure the base  20  (or the bottom portion of the base  20 ) to the epidermal surface S. The user may insert the insertable member  30  into the epidermal surface S, through the channel or volume  20   a  of the base  20  (or of the bottom portion of the base  20 ). In some examples, the insertable member  30  is inserted by supporting the insertable member  30  on an insertion needle or within a hollow insertion needle, and moving the insertion needle (and the insertable member  30  thereon) through the septum  50 , through the channel  20   a,  and through the epidermal surface S, with an insertion tool. 
     When moved to the inserted state, the insertable member  30  (or the collar of the insertable member  30 ) may engage and lock with the base  20 , to secure the insertable member  30  to the base  20 . Then, with the insertable member  30  inserted to a desired insertion position, the insertion needle may be withdrawn, leaving the insertable member  30  in the inserted state. However, the insertion site I is covered by a volume in the base  20  that is sealed by the septum  50 . Accordingly, if a limited amount of blood is excreted at the insertion site I, the blood will be trapped within the volume defined by the wall of the channel  20   a,  the septum  50  covering the channel  20   a  and the wall of the opening in the adhesive material layer  60 , and will be inhibited from leaking out to a visible portion of the medical device  10 . 
     Another example of a medical device  100  is shown in  FIG.  3   . The medical device  100  includes certain features corresponding to those described above for the medical device  10 . The medical device  100  operates in a manner similar to the manner of operation of the medical device  10  described above. Accordingly, corresponding features are labeled with corresponding reference numbers, for which the above description applies, including the base  20 , the channel or volume  20   a,  the insertable member  30 , the components  40 , and the adhesive material layer  60 . However, in the medical device  100 , the septum  50  is omitted and, instead, a septum  150  is provided at the first surface  20   b  of the base  20 . The septum  150  may be made of a material corresponding to the materials described for the septum  50 . Also, the septum  150  may be secured to the base  20  in any suitable manner including, but not limited to those described with regard to the septum  50 . 
     In the example in  FIG.  3   , the septum  150  is molded or otherwise attached to the base  20 , and is located within the opening in the adhesive material layer  60 . The septum  150  is configured to be placed directly over the insertion site I, when the base  20  is secured to the epidermal surface S. In particular examples, the skin-facing surface of the septum  150  and of the adhesive material layer  60  are generally co-planar, or the skin facing surface of the septum  150  extends toward the epidermal surface S further than the skin facing surface of the adhesive material layer  60 , such that skin facing surface of the septum  150  is abutted against, or is slightly pressed or forced against the epidermal surface S, when the adhesive material layer  60  is adhered to the epidermal surface S. By abutting against, or by being pressed or forced against the injection site I, the septum  150  can provide a seal to prevent or reduce excretion of blood from the insertion site I. 
     In further examples of the medical device  100  in  FIG.  3   , a septum  50  is provided on the base  20 , at the second surface  20   c  of the base (as described above with regard to  FIG.  2   ), in addition to the septum  150  at the first surface  20   b  of the base. In yet other examples the septum  50  or the septum  150  may be secured to the base  20 , within the channel  20   a,  at a location separated from and between the first surface  20   b  and the second surface  20   c  of the base. 
     In certain examples, the septum  50  or  150  may be a piercable septum, made of a material that is configured to be pierced by a needle or cannula. In other examples, the septum  50  or  150  is a pre-pierced, septum that has one or more slits, holes or cuts formed through the septum material. A pre-pierced septum can help to reduce leakage by limiting piercing location on the septum. In those or other examples, the septum  50  or  150  may be configured as a self-sealing septum, for example, made of a substantially resilient material biased toward a sealed position. In some examples, the septum  50  or  150  is made of a molded disc of silicon, polyurethane or other appropriate material which can be molded to or otherwise secured to a wall or walls of the channel or volume  20   a  of the base  20 . 
     In particular examples, the septum  50  or the septum  150  may include a duckbill valve, other valve or other configuration that allows passage of the insertable member  30 , but also helps to prevent or reduce leakage. For example,  FIG.  4    shows the medical device  100  described above, but with a septum  250  that has a shape to form a one-way valve. The septum  250  has a cone-shaped recess on one side (the skin-facing side) and a pre-formed slit through the septum at the apex of the cone-shaped recess. The pre-formed slit and cone-shaped recess allow the insertable member  30  to be easily inserted through the septum  250 , from the upper side, toward the skin-facing side of the septum. In particular examples, the preformed slit provides a small self-sealing opening or flap at the apex of the cone-shaped recess, through which the insertable member  30  may be extended. 
     In particular examples, the septum  150  may include or operate with a coating, layer, ring or the like, made of or carrying a drug or other substance. In other examples, the septum  150 , itself, may be impregnated with a drug or other substance. In certain examples, the drug or other substance may include one or more of a hydrophilic material, a blood clotting material, a pain reducing material, or combinations thereof. In certain examples, the hydrophilic material comprises a hydrophilic polymer with potassium salt or Kaolin. In certain examples, substances that promote blood clotting may include Antifibrinolytic drugs such as, but not limited to aprotinin, tranexamic acid (TXA), epsilon-aminocaproic acid, aminomethylbenzoic acid, or other the like. 
     For example,  FIG.  5    shows the medical device  100  described above, but with a septum  350  having skin facing surface to which a drug-carrying ring  352  is attached. The septum  350  may correspond to the septum  150  or to the septum  250  described above, however, with the drug-carrying ring  352  attached thereto. In certain examples, the septum  350  and the drug-carrying ring  352  may be configured as a unit, as shown in  FIG.  6   , and then secured (as a unit) to the base  20  as shown in  FIG.  5   . 
     The drug-carrying ring  352  may include a foam, gauze, sponge or other absorbent material that is impregnated with one or more drugs or other substances as discussed above. In other examples, the drug-carrying ring  352  is a non-absorbant material that is made of or coated with one or more drugs or other substances as discussed above. In particular examples, the drug-carrying ring  352  has a central opening through which the insertable member  30  extends, such that the drug-carrying ring  352  surrounds the insertable member  30  at the insertion site I. In other examples, the drug-carrying ring  352  may be replaced with one or more ring sections or partial rings that partially surround the insertable member  30  at the insertion site I. The drug-carrying ring  352  may be attached to the septum  350  by any suitable securing mechanism including, but not limited to molding, co-molding with the septum  350 , adhesive, bonding, thermal bonding, sonic welding, or the like. 
     In the example in  FIG.  5   , the upper end of the channel or volume  20   a  of the base  20  is open, to selectively receive an insertion needle as described above. In other examples, the upper end of the channel or volume  20   a  in the example of  FIG.  5    may be covered with a septum  50  as described above with regard to  FIG.  2   . 
     In further examples, the adhesive material layer  60  may include or operate with a coating, layer, ring or the like, made of or carrying a drug or other substance as described above. For example,  FIG.  7    shows the medical device  200  as described above with regard to the medical device  10  or the medical device  100 , but with no septa  50 ,  150 ,  250 , or  350 . However, in  FIG.  7   , a substrate  450  and a drug-carrying ring  452  are provided on or in the skin facing surface of the adhesive material layer  60 . The substrate  450  may be an annular body forming a ring shape that corresponds to the diameter and shape of the drug-carrying ring  452 . The substrate  450  may be made of any suitably rigid material including, but not limited to a polyimide, PET or other suitable material. In other examples, the substrate  450  may be omitted and the drug-carrying ring  452  may be secured directly to the adhesive material layer  60  or to the first surface  20   c  of the base  20 . The drug-carrying ring  452  may be made of a material similar to that described above with regard to drug-carrying ring  352 , and may carry a drug or other substance as described above. 
     In particular examples, the substrate  450  and the drug-carrying ring  452  have central openings that align with each other and with the open end of the channel  20   a,  and through which the insertable member  30  extends. Accordingly, the substrate  450  and the drug-carrying ring  452  surround the insertable member  30  at the insertion site I. In other examples, the substrate  450  and the drug-carrying ring  452  may be replaced with one or more ring sections or partial rings that partially surround the insertable member  30  at the insertion site I. The drug-carrying ring  452  may be attached to the substrate  450  by any suitable securing mechanism including, but not limited to molding, co-molding with the substrate, adhesive, bonding, thermal bonding, sonic welding, or the like. In certain examples, the substrate  450  and the drug-carrying ring  452  may be configured as a unit, as shown in  FIG.  8   , and then secured (as a unit) to the base  20 , as shown in  FIG.  7   . The substrate  450  (or the drug-carrying ring  452 ) may be attached to the adhesive material layer  60  by any suitable securing mechanism including, but not limited to adhesive, bonding, thermal bonding, sonic welding, or the like. 
     In the example in  FIG.  7   , the upper end of the channel or volume  20   a  of the base  20  is open, to selectively receive an insertion needle as described above. In other examples, the upper end of the channel or volume  20   a  in the example of  FIG.  7    may be covered with a septum  50  as described above with regard to  FIG.  2   . Also, in the example in  FIG.  7   , the lower end of the channel or volume  20   a  of the base  20  is open to the channel or volume  20   a  as described above. In other examples, the lower end of the channel or volume  20   a  in the example of  FIG.  7    may be covered with a septum  150 ,  250  or  350  as described above. 
     In further examples, a coating, layer, ring or the like, made of or carrying a drug or other substance as described above, may be attached to or provided on the first surface  20   a  of the base  20 . For example,  FIG.  9    shows the medical device  200  as described above with regard to the medical device  10  or the medical device  100 , but with no septa  50 ,  150 ,  250 , or  350 . However, in  FIG.  8   , a substrate  550  and a drug-carrying ring  552  are secured to the skin-facing surface  20   a  of the base  20 . In  FIG.  9   , the substrate  550  is arranged between the drug-carrying ring  552  and a layer of adhesive  554  such as, but not limited to a double-sided pressure sensitive adhesive, a glue, or another adhesive material, for adhering the substrate  550  to the first surface  20   a  of the base  20 . In other examples, the substrate  550  may be attached to the first surface  20   a  by other securing mechanisms such as, but not limited to another bonding agent, thermal bonding, sonic welding, or the like. 
     In particular examples, the substrate  550 , the drug-carrying ring  552 , and a layer of adhesive  554  may each include an annular body forming a ring shape with corresponding diameters. The substrate  550  may be made of any suitably rigid material including, but not limited to a polyimide, PET or other suitable material. In other examples, the substrate  550  may be omitted and the drug-carrying ring  552  may be secured directly to the layer of adhesive  554 . The drug-carrying ring  552  may be made of a material similar to that described above with regard to drug-carrying ring  352 , and may carry a drug or other substance as described above. 
     In particular examples, the substrate  550 , the drug-carrying ring  552  and the layer of adhesive  554 , each have a central opening that aligns with each other and with the open end of the channel  20   a,  and through which the insertable member  30  extends. Accordingly, the substrate  550 , the drug-carrying ring  552  and the layer of adhesive surround the insertable member  30  at the insertion site I. In other examples, the substrate  550 , the drug-carrying ring  552  and the layer of adhesive  554  may be replaced with one or more ring sections or partial rings that partially surround the insertable member  30  at the insertion site I. The drug-carrying ring  552  and the layer of adhesive  554  may be attached to the substrate  550  by any suitable securing mechanism or mechanisms including, but not limited to molding, co-molding with the substrate, adhesive, bonding, thermal bonding, sonic welding, or the like. In certain examples, the substrate  550 , the drug-carrying ring  552  and the layer of adhesive  554  may be configured as a unit, as shown in  FIG.  10   , and then secured (as a unit) to the base  20 , as shown in  FIG.  9   . 
     In the example in  FIG.  9   , the upper end of the channel or volume  20   a  of the base  20  is open, to selectively receive an insertion needle as described above. In other examples, the upper end of the channel or volume  20   a  in the example of  FIG.  9    may be covered with a septum  50  as described above with regard to  FIG.  2   . Also, in the example in  FIG.  9   , the lower end of the channel or volume  20   a  of the base  20  is open to the channel or volume  20   a  as described above. In other examples, the lower end of the channel or volume  20   a  in the example of  FIG.  9    may be covered with a septum  150 ,  250  or  350  as described above. 
     In further examples, a layer of gauze or other absorbent material may be attached to or provided on the first surface  20   a  of the base  20 . For example,  FIGS.  11  and  12    each show the medical device  200  as described above with regard to the medical device  10  or the medical device  100 , but with no septa  50 ,  150 ,  250 , or  350 . However, in  FIGS.  11  and  12   , a substrate  650  and a layer of gauze or other absorbent material  652  is secured to the skin-facing surface  20   a  of the base  20 . In  FIGS.  11  and  12   , the substrate  650  is arranged between the layer of gauze or other absorbent material  652  and a layer of adhesive  654  such as, but not limited to a double-sided pressure sensitive adhesive, a glue, or another adhesive material, for adhering the substrate  650  to the first surface  20   a  of the base  20 . In other examples, the substrate  650  may be attached to the first surface  20   a  by other securing mechanisms such as, but not limited to another bonding agent, thermal bonding, sonic welding, or the like. The substrate  650 , the layer of gauze or other absorbent material  652  and the layer of adhesive  654  are located within the opening of the adhesive material layer  60 . 
     The substrate  650  may be made of any suitably rigid material including, but not limited to a polyimide, PET or other suitable material. In other examples, the substrate  650  may be omitted and the layer of gauze or other absorbent material  652  may be secured directly to the layer of adhesive  654 . The layer of gauze or other absorbent material  652  may be made of a gauze, foam, woven fabric or other absorbent material. The layer of gauze or other absorbent material  652  is configured to absorb and retain a limited amount of blood that may leak from the insertion site I. During use, the layer of gauze or other absorbent material  652  is located within the opening in the adhesive material layer  60 , between the base  20  and the epidermal surface S, and, therefore, may be hidden from view from outside of the base  20 . Accordingly, a limited amount of blood or other fluid absorbed by the layer of gauze or other absorbent material  652  may remain hidden from view. 
     In particular examples, the substrate  650 , the layer of absorbent material  652 , and the layer of adhesive  654  may each include an annular body forming a ring shape with corresponding diameters as shown in  FIGS.  11  and  13   . In other examples, the layer of absorbent material  652  may have a disc or plate shape and extends over the injection site I, but may be pierced through by the insertable member  30 , as shown in  FIG.  12   . The substrate  650  and the layer of adhesive  654  (and, in some examples, the layer of absorbent material  652 ), each may have a central opening that aligns with each other and with the open end of the channel  20   a,  and through which the insertable member  30  extends. 
     Accordingly, the substrate  650  and the layer of adhesive  654  surround the insertable member  30  at the insertion site I. The layer of absorbent material  652  and the layer of adhesive  554  may be attached to the substrate  550  by any suitable securing mechanism or mechanisms including, but not limited to molding, co-molding with the substrate, adhesive, bonding, thermal bonding, sonic welding, or the like. In certain examples, the substrate  650 , the layer of absorbent material  652 , and the layer of adhesive  654  may be configured as a unit, as shown in  FIG.  13   , and then secured (as a unit) to the base  20 , as shown in  FIG.  11    or  FIG.  12   . 
     In the examples in  FIGS.  11  and  12   , the upper end of the channel or volume  20   a  of the base  20  is open, to selectively receive an insertion needle as described above. In other examples, the upper end of the channel or volume  20   a  in the examples of  FIGS.  11  and  12    may be covered with a septum  50  as described above with regard to  FIG.  2   . Also, in the examples in  FIGS.  11  and  12   , the lower end of the channel or volume  20   a  of the base  20  is open to the channel or volume  20   a  as described above. In other examples, the lower end of the channel or volume  20   a  in the examples of  FIGS.  11  and  12    may be covered with a septum  150 ,  250  or  350  as described above. 
     While various exemplary embodiments have been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the described embodiment or embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope defined by the claims, which includes known equivalents and foreseeable equivalents at the time of filing this patent application.