Patent Publication Number: US-2019183468-A1

Title: Medical plugs, devices for delivering the plugs to voids, and related kits and methods

Description:
RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application No. 62/598,869 filed Dec. 14, 2017, and titled “Medical Plugs and Devices for Delivering the Plugs to Voids,” and U.S. Provisional Application No. 62/716,499 filed Aug. 9, 2018, and titled “Medical Plugs, Devices for Delivering the Plugs to Voids, and Related Kits and Methods,” which are hereby incorporated by reference in their entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates generally to the field of medical devices. More particularly, some embodiments relate to a medical plug, such as a pledget, and medical devices for delivering the medical plug to at least partially fill a void in a patient, and kits for packaging such medical devices Related components and methods are also disclosed. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The written disclosure herein describes illustrative embodiments that are non-limiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which: 
         FIG. 1  illustrates a perspective view of a medical device, according to an embodiment. 
         FIG. 2  illustrates a front view of the plug of the medical device of  FIG. 1 . 
         FIG. 3  illustrates a side view of the plug of  FIG. 2 . 
         FIG. 4  illustrates a front view of a plug according to an embodiment. 
         FIG. 5  illustrates a front view of a plug according to an embodiment. 
         FIG. 6  illustrates a front view of a plug according to an embodiment. 
         FIG. 7  illustrates a side view of the plug holder of  FIG. 1 , according to an embodiment. 
         FIG. 8  illustrates a front view of the plug holder of  FIG. 7 , according to an embodiment. 
         FIG. 9  illustrates a cross-sectional view of the plug holder along cross-section line of  9 - 9  of  FIG. 8 , according to an embodiment. 
         FIG. 10A  illustrates a cross-sectional view of the plug holder along cross-section line  10 - 10  of  FIG. 8 , according to an embodiment. 
         FIG. 10B  illustrates a cross-sectional view of the plug holder along cross-section line  10 - 10  of  FIG. 8 , according to another embodiment. 
         FIG. 10C  illustrates a cross-sectional view of the plug holder along cross-section line  10 - 10  of  FIG. 8 , according to another embodiment. 
         FIG. 11  illustrates a perspective view of the plug holder of  FIG. 7  and a preliminary stylet that engages the plug within the plug holder, according to an embodiment. 
         FIG. 12  illustrates a cross-sectional view of the plug holder and the preliminary stylet of  FIG. 11  and a coaxial introducer, according to an embodiment. 
         FIG. 13  illustrates a cross-sectional view of the plug holder of  FIG. 11  attached to a coaxial introducer with a stylet about to engage the plug. 
         FIG. 14  illustrates a cross-sectional view of the plug holder of  FIG. 11  attached to the coaxial introducer and the stylet engaging the plug. 
         FIG. 15  illustrates a side view of a medical device configured to deliver a plug through a catheter by a syringe. 
         FIG. 16  illustrates a side view of the medical device of  FIG. 15  with the plug delivered through the catheter by the syringe. 
         FIG. 17  illustrates a perspective view of a kit including a flexible package with various components disposed therein. 
         FIG. 18  illustrates an exploded view of a stylet assembly with a protective cover. 
     
    
    
     DETAILED DESCRIPTION 
     Certain medical procedures include delivery of a plug (such as a pledget) into a void within a patient&#39;s body. Plugs may be inserted into a void to, inter alia, partially or completely fill a wound site, to occlude the passage of fluid through a lumen, to induce blood coagulation, to prevent or reduce leakage of biological fluid, and/or to provide a scaffold to promote and/or permit tissue growth. 
     For instance, during a biopsy procedure, a practitioner may insert a coaxial introducer into a patient by placing a trocar within a coaxial introducer such that a pointed distal end of the trocar protrudes from the distal end of the coaxial introducer. With the pointed end of the trocar protruding from the coaxial introducer, the trocar and the coaxial introducer may together be inserted into the patient. Once the coaxial introducer is positioned within the patient, the trocar may be withdrawn from the coaxial introducer. At this stage of the procedure, the coaxial introducer provides a conduit that allows access to a patient&#39;s internal tissue. 
     A cutting device (e.g., a needle or some other device configured to obtain bodily samples) may then be inserted through the coaxial introducer. Once the cutting device reaches the internal tissue, the cutting device may be used to excise (e.g., cut out) internal tissue from the patient. Such excision may leave behind a void in the space that was occupied by the internal tissue. 
     In some circumstances, a practitioner may desire to deliver a plug into the void created by excised tissue from the biopsy procedure. For example, in some embodiments, a plug may be inserted into the void to at least partially fill the space created by the void, to promote blood coagulation at the wound site, and/or to provide a scaffold to promote or permit tissue regrowth. 
     Plugs may be inserted into a void in other medical procedures as well. For example, a plug may be delivered to block fluid flow through a lumen. In other words, a plug may be delivered as an embolic agent to prevent the flow of fluid to a particular location. Plugs may be delivered to various other locations in a patient&#39;s body, or may be delivered under alternative circumstances or for different purposes. This disclosure relates broadly to the delivery of plugs for various purposes, and is not limited to the specific contexts or examples discussed herein. 
     Medical devices and related components, as described in greater detail below, may be configured to facilitate delivery of a plug into a void. In some circumstances, the medical devices are designed to facilitate wetting (e.g., hydration) of a plug and subsequent delivery of the plug through a lumen to a void within a patient. 
     Medical devices may be packaged to protect against environmental conditions associated with transportation and handling from the time of manufacture until use by a medical practitioner. Such protections may be configured to facilitate proper function of the device when it is eventually used. For example, a package or enclosure may be designed to shield the medical device from environmental conditions that otherwise might damage the medical device or otherwise render it unusable. In some instances, packaging materials may be used to maintain the sterility of a sterile medical device by creating a sterile barrier such as a sealed flexible pouch. Additionally, mechanical shock and vibration associated with handling and transportation of a medical device may also damage the medical device. Secondary packaging such as foam or other shock absorbing materials may be used in connection with a primary package (such as a flexible pouch) to prevent such damage. As described below, in some embodiments a primary package may be configured to both seal and provide shock absorption to enclosed medical devices. 
     The components of the embodiments as generally described and illustrated in the figures herein can be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments, as represented in the figures, is not intended to limit the scope of the present disclosure, but is merely representative of various embodiments. While various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated. 
     The phrase “coupled to” is broad enough to refer to any suitable coupling or other form of interaction between two or more entities. Two components may be coupled to each other even though they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component. The phrase “fluid communication” is used in its ordinary sense, and is broad enough to refer to arrangements in which a fluid (e.g., a gas or a liquid) can flow from one element to another element when the elements are in fluid communication with each other. 
     The terms “proximal” and “distal” are opposite directional terms. For example, the distal end of a device or component is the end of the component that is furthest from the practitioner during ordinary use. The proximal end refers to the opposite end or the end nearest the practitioner during ordinary use. The term “void” relates to a region or an opening within a patient&#39;s body to which a plug may be delivered. 
       FIG. 1  illustrates a perspective view of a medical device that may include a plug holder  100  (which may also be referred to as a medical plug delivery device or an inline coupler) and a medical plug or pledget  200 . 
     Plug  200  may be generally elongate in shape and have a variety of different cross-sections, such as circular, square, triangular, etc. Plug  200  illustrated in  FIG. 1  has a substantially circular cross-section. In some embodiments, plug  200  may have a first cross-section, such as a square, and then be crimped to a second cross-section, such as a circle. In some embodiments, plug  200  is an elongate piece of material that has been rolled into a substantially cylindrical shape between 1 mm and 5 mm (e.g., approximately 2 mm) in diameter. Plug  200  may have a length that is at least 2-fold, at least 5-fold, and/or at least 10-fold longer than the diameter of plug  200 . In some embodiments, plug  200  is between 10 mm and 30 mm (e.g., approximately 20 mm) in length. 
     Plug  200  may further include a channel  210  (which may also be referred to as a fluid bypass pathway) along the outer surface of plug  200 . Channel  210  may extend from a first end  202  to a second end  204  of plug  200 .  FIG. 2  illustrates a front view of plug  200  with channel  210 . Channel  210  may have an arc shape or a semi-circle cross-section. However, various other shapes may be used.  FIG. 3  illustrates a top view of plug  200  and channel  210 . As illustrated in  FIG. 3 , channel  210  may extend the entire length of plug  200 , from first end  202  to second end  204 . As described in further detail below, channel  210  provides a fluid bypass pathway to enable air and fluid to bypass plug  200  when plug  200  is wetted. The movement of the fluid through channel  210  forces any air within a lumen  102  of plug holder  100  out of plug holder  100 . In addition, when plug  200  is wetted, plug  200  may swell thereby closing channel  210 . 
     Channel  210  may be formed by placing a mandrel in plug  200  while plug  200  is formed. Thus, the shape of channel  210  is similar to the shape of the mandrel when the mandrel is removed from plug  200 . 
       FIGS. 4-6  illustrate front views of various other potential embodiments of plugs. The plugs of  FIGS. 4-6  may be used in connection with devices or systems described in connection with plug  200  of  FIGS. 1-3 . Disclosure given in connection with plug  200  analogously may be applied to the plugs of  FIGS. 4-6  or vice versa.  FIG. 4  illustrates a plug  200 ′ with two channels  210 ′ along the outer surface of plug  200 ′. Channels  210 ′ may extend from a first end to a second end of plug  200 ′. Alternatively, plug  200 ′ may have more than two channels, such as three, four, or more. Channels  210 ′ may be equally spaced from each other, or channels  210 ′ may be unequally spaced around the outer surface of plug  200 ′. Each channel  210 ′ may be an arc shape or a semi-circle cross-section. Various other shapes for channel  210 ′ may be used. 
       FIG. 5  illustrates a plug  200 ″ with channel  210 ″ wholly disposed within plug  200 ″, giving plug  200 ″ a donut shape. Channel  210 ″ may be centered in plug  200 ″, or channel  210 ″ may be off-center of plug  200 ″. Channel  210 ″ may have a circular cross-section and channel  210 ″ may extend the entire length of plug  200 ″, from a first end to a second end. However, channel  210 ″ may have various other cross-sectional shapes. Plug  200 ″ may also include more than one channel  210 ″ disposed within plug  200 ″. For example,  FIG. 6  illustrates a plug  200 ″′ with two channels  210 ″&#39; disposed within plug  200 ″′. In other embodiments, plug  200 ″′ may include a channel  210 ″′ along the outer surface of plug  200 ″′ (similar to channel  210  of  FIG. 2 ) and a channel  210 ″′ wholly disposed within plug  200 ″′ (similar to channel  210 ′ of  FIG. 4 ). 
     With reference to  FIGS. 1-3 , plug  200  may be composed of any suitable composition or material. For example, in some embodiments, plug  200  may include, comprise, or consist of a bioabsorbable material. In some embodiments, the bioabsorbable material (or a portion thereof) is derived from animal tissue, such as pig skin or cow skin. In some embodiments, the bioabsorbable material is a collagen-containing material, such as a gelatin foam from an animal source. In other or further embodiments, the bioabsorbable material (or a portion thereof) is a synthetic polymer, such as polylactic acid, polyglycolide, or poly(lactic-co-glycolic acid). In some embodiments, plug  200  includes or consists of a non-bioabsorbable material, such as polyvinyl alcohol or polyvinyl acetate. In some embodiments, plug  200  includes a dye. The dye may facilitate visualization of plug  200  when plug  200  is disposed within plug holder  100 . In some embodiments, plug  200  may change colors when contacted with fluid (e.g., water or saline), thereby allowing a practitioner to visually determine when plug  200  has been wetted. 
       FIGS. 7-10C  illustrate various views of plug holder  100  of  FIG. 1 .  FIG. 7  illustrates a side view of plug holder  100 .  FIG. 8  illustrates a front view of plug holder  100 .  FIG. 9  illustrates a cross-sectional view of plug holder  100  along cross-section line  9 - 9 .  FIG. 10A  illustrates a cross-sectional view of plug holder  100  along cross-section line  10 - 10  according to one embodiment.  FIG. 10B  illustrates a cross-sectional view of plug holder  100  along cross-section line  10 - 10  according to another embodiment.  FIG. 10C  illustrates a cross-sectional view of plug holder  100  along cross-section line  10 - 10  according to another embodiment. 
     With reference to  FIGS. 1 and 7-10C , plug holder  100  may include a proximal portion  110 , a distal portion  120 , and a central portion  130 . Plug holder  100  may include a lumen  102  configured to pass from a proximal end  112  to a distal end  122 . Lumen  102  may be configured to accommodate plug  200 . Thus, lumen  102  may define a cavity configured to retain plug  200 . Lumen  102  may be centrally disposed within plug holder  100  and may be configured to orient plug  200  within plug holder  100  such that the longitudinal axis of plug  200  is aligned with the longitudinal axis of plug holder  100  or lumen  102 . Lumen  102  may be generally tapered from proximal end  112  to distal end  122  with the largest diameter located at proximal end  112  and the smaller diameter located at distal end  122 . For example,  FIGS. 9 and 10  depict three diameters, D 1 , D 2 , and D 3 . D 1  is the smallest and located at distal end  122  and D 3  is the largest and located at proximal end  112 . 
     As illustrated in  FIG. 10A , lumen  102  may include a plug retention section  104  positioned near the distal end  122 . Plug retention section  104  may be interference fit. Plug retention section  104  may be configured to retain plug  200  within lumen  102  until displacement of plug  200  is desired and to permit removal of air from lumen  102 . Plug retention section  104  may be a portion of lumen  102  with an inner diameter, e.g., D 1 , less than the outer diameter of plug  200 . For example, the outer diameter of plug  200  may be one gauge size different from plug retention section  104  (such as plug  200  being 20 gauge and the inner diameter of plug retention section  104  being 21 gauge). Plug retention section  104  may be 3 mm to 8 mm in length (for example, approximately 5 mm in length) and be configured to frictionally engage a portion of plug  200 . A proximal end of plug retention section  104  may include a chamfer  106  to facilitate passage of a stylet that may engage plug  200 . 
     In the embodiment illustrated in  FIG. 10B , the plug retention  104  may be positioned near the proximal end of the plug  200  instead of the distal end of the plug  200 . In the embodiment illustrated in  FIG. 10C , the plug retention section  104  may extend from the distal end of the plug  200  to the proximal end of the plug  200 . 
       FIG. 8  illustrates a front view of plug holder  100  and plug  200 . This view clearly illustrates channel  210  or the fluid bypass pathway. Channel  210  creates a pathway for air disposed inside lumen  102  to escape when fluid is applied to proximal end  112  of lumen  102 . 
       FIGS. 9 and 10A-10C  illustrate a cross-sectional view of plug holder  100  based on cross-section line  9 - 9  and  10 - 10  provided in  FIG. 8 .  FIG. 9  illustrates channel  210  that provides air a pathway to escape, in accordance with the arrow, when fluid is applied to proximal end  112  of lumen  102 . In certain configurations, plug  200  is in frictional contact with lumen  102  at the plug retention section  104 , as illustrated in  FIGS. 10A-10C . Accordingly, during use, any of the air within the system may be forced out via channel  210  such that fluid exits channel  210 . This is indicative the air has been purged from the system. 
     Proximal portion  110  may include a proximal adaptor  114  that is configured to couple to a medical fluid delivery device  600 , such as a syringe (see  FIGS. 15 and 16 ). For example, proximal portion  110  may include a female Luer connection that mates with a male Luer connection of the syringe body to form a fluid tight connection (see  FIGS. 15 and 16 ). The female Luer connection may include a female Luer lock fitting  116 . Female Luer lock fitting  116  may be configured to sealingly mate with a male Luer lock fitting of a fluid delivery device or other medical device. The outlet or orifice at the distal end of the syringe body may thus be in fluid communication with proximal end  112  of lumen  102 . 
     A distal portion of central portion  130  may include a male Luer lock fitting  132 . Male Luer lock fitting  132  may be configured to sealingly mate with a female Luer lock fitting of a coaxial introducer  400  which is disposed within a patient (as illustrated in  FIGS. 13 and 14 ) or with a catheter  700  (as illustrated in  FIGS. 15 and 16 ). 
     Distal portion  120  of plug holder  100  may have a frustoconical-shaped extension within lumen  102  extending through the extension. The extension may extend into coaxial introducer  400  and may or may not create a fluid tight seal with coaxial introducer  400 . The extension may be configured to extend lumen distal end  122  to be near and in alignment with the proximal end of the introducer needle allowing for passage of plug  200  from plug holder  100  into coaxial introducer  400  without plug  200  getting caught within coaxial introducer  400  and folding on itself. 
     Alternative plug holders may be used instead of plug holder  100 . For example, plug holders capable of delivering multiple plugs as described in U.S. Pat. No. 15/479,149, filed Apr. 4, 2016, herein incorporated by reference in its entirety. 
       FIGS. 11-16  describe various methods of delivering plug  200  to the patient. The practitioner may select a dry technique or a wet technique for delivering plug  200  into a void of a patient. Plug holder  100  and plug  200  may be interchangeable between dry and wet techniques, enabling the practitioner to select the desired technique when performing the procedure. 
     In some embodiments, a stylet may be used to introduce a dry plug  200  into the patient, as illustrated in  FIGS. 11-14 . A practitioner may insert a coaxial introducer  400  into a patient by placing a trocar within coaxial introducer  400  such that a pointed distal end of the trocar protrudes from a distal end of coaxial introducer  400 . With the pointed end of the trocar protruding from coaxial introducer  400 , the trocar and coaxial introducer  400  may together be inserted into the patient. Once coaxial introducer  400  is positioned within the patient, the trocar may be withdrawn from coaxial introducer  400 . At this stage of the procedure, coaxial introducer  400  provides a conduit in an introducer cannula that allows access to a patient&#39;s internal tissue. A cutting stylet  500  may be introduced into the conduit of coaxial introducer  400  and a sample of tissue may be excised from the patient, creating a void. The practitioner may then remove cutting stylet  500  and the tissue sample from coaxial introducer  400 . 
     After cutting stylet  500  is removed from coaxial introducer  400 , the practitioner may introduce plug  200  into the void where the biopsy was excised. Distal portion  120  of plug holder  100  which houses plug  200  may be connected or attached to the proximal end of coaxial introducer  400 . A preliminary stylet  300  may be configured to push or displace plug  200  from plug holder  100  into coaxial introducer  400  or alternatively, directly into the patient. 
       FIG. 11  illustrates a perspective view of plug holder  100 , a preliminary stylet  300 , and coaxial introducer  400 . Preliminary stylet  300  may include a stylet rod  310  and a handle  320  or finger grip. Stylet rod  310  may be metal or rigid plastic, such as polycarbonate. Stylet rod  310  may be configured to pass through lumen  102  from proximal end  112  to distal end  122  and into coaxial introducer  400 . A distal end  312  of stylet rod  310  may be squared-off to provide a flat surface to push against plug  200 , as illustrated in  FIG. 12 . As stylet rod  310  is advanced through lumen  102  of plug holder  100 , distal end  312  of stylet rod  310  may make contact with the proximal end of plug  200 . As a distally directed force is applied to plug  200  by stylet rod  310 , the force may exceed the frictional engagement force between plug  200  and lumen retention section  104  of plug holder  100 . As the frictional engagement force is surpassed, plug  200  will be displaced from lumen  102  into coaxial introducer  400 . 
     The diameter of stylet rod  310  may be sized to pass through plug retention section  104  of lumen  102  as well as into coaxial introducer  400 . The length of stylet rod  310  may be sized to extend through plug holder  100  and partially into the conduit of coaxial introducer  400  for displacement of plug  200  into the conduit of coaxial introducer  400 . Alternatively, stylet rod  310  may have a length that enables stylet rod  310  to push plug  200  through conduit  410  of coaxial introducer  400  and into the void of the patient. Stylet rod  310  may include insertion depth markings  314 . Markings  314  may be single or multiple bands spaced approximately 1 cm apart. The practitioner may determine the length of stylet rod  310  needed to displace plug  200  into the desired location within the void of the patient or within coaxial introducer  400 . 
     Preliminary stylet handle  320  may be configured to be held between the thumb and at least one finger of the practitioner. Handle  320  may comprise features to enhance gripability, such as roughed surface, ribs, detents, and other features known in the art. Handle  320  may be configured to connect to proximal adaptor  114  of plug holder  100 . The distal portion of handle  320  may be structured as a male Luer lock or Luer slip adaptor  330  comprising a distal protrusion  331 . Distal protrusion  331  of handle  320  may also be used to interface with and couple to a protective cover (not shown) for stylet rod  310 . 
     In some embodiments, once plug  200  is properly introduced in conduit  410  of coaxial introducer  400 , the practitioner may use cutting stylet  500  to place plug  200  into the void within the patient. Since cutting stylet  500  excises the tissue sample, cutting stylet  500  is the proper length to introduce plug  200  to the void within the patient. Cutting stylet  500  may comprise a handle  520 , a male Luer lock or Luer slip adaptor  530  and a distal protrusion  531 . 
     In some embodiments, the practitioner may select a wet medical plug delivery technique, as illustrated in  FIGS. 15 and 16 . Proximal adaptor  114  of plug holder  100  may be connected to a fluid delivery device  600 , such as a syringe at least partially filled with a fluid  610 . Fluid delivery device  600  may deliver fluid  610  into lumen  102  of plug holder  100  such that lumen  102  becomes free of air and plug  200  is wetted. In some embodiments, plug holder  100  is transparent, thereby allowing the practitioner to visualize wetting and ejection of plug  200 . Fluid delivery device  600  may deliver a fluid  610  such as water, saline, contrast, or any mixture thereof, or any other fluid. If desired, air may be removed from lumen  102  by orienting plug holder  100  such that distal end  122  of plug holder  100  is pointed upward, tapping plug holder  100 , and ejecting air bubbles by delivering fluid  610  through plug holder  100 . Channel  210  of plug  200  permits the passage of fluid  610  through plug  200  and plug retention section  104  to allow air to escape. Once plug  200  is wetted, plug  200  may swell, thus closing channel  210 . 
     Male Luer lock fitting  132  may be connected to a female Luer lock connector of catheter  700  that has been inserted into a patient, as illustrated in  FIG. 15 . The connection may bring lumen distal end  122  close to alignment with the proximal end of catheter  700 . The practitioner may then eject fluid  610  from fluid delivery device  600 , thereby distally displacing fluid  610  into lumen  102 . As fluid  610  is displaced in a distal direction, fluid  610  may exert a distal force on plug  200  disposed within lumen  102 . The hydraulic force may surpass the engagement force of plug retention section  104  on a portion of plug  200 , thereby causing distal displacement and ejection of plug  200  from lumen  102  of plug holder  100  into catheter  700  that is in fluid communication with a void of the patient. As fluid  610  is advanced, displaced fluid  610  may push plug  200  through catheter  700  into the void of the patient, as illustrated in  FIG. 16 . Plug  200  may serve any suitable purpose, such as obstructing fluid flow, inducing blood coagulation, and/or providing a scaffold to promote tissue growth. 
     Fluid delivery device  600  may include a plunger  620  and a syringe body  630 . Plunger  620  may include a handle  622  adjacent the proximal end of plunger  620  and a seal  624  adjacent the distal end of plunger  620 . Plunger  620  may be configured to be at least partially disposed within syringe body  630  such that advancement and retraction of plunger  620  causes displacement of fluid  610  within a reservoir in syringe body  630 . 
     Accordingly, the practitioner may select which technique to use at the time of the procedure as plug holder  100  and plug  200  are interchangeable between wet and dry techniques. 
       FIG. 17  illustrates a kit  900  for a plurality of medical plug delivery systems  905 . Each medical plug delivery system  905  may comprise a medical plug delivery device  100  having an elongate medical plug  200  disposed within the lumen of medical plug delivery device  100  at a distal end thereof. Thus, in the illustrated embodiment, the medical plug delivery system  905  is comprised of one or more medical plug delivery devices  100  as described in connection with certain embodiments above. In other embodiments, the medical plug delivery system  905  may comprise other medical devices in addition to, or in place of, the medical plug delivery devices  100  described above. Kit  900  may comprise an enclosure, such as sealed enclosure  910  within which one or more medical plug delivery systems  905  may be disposed. Other components may be included in kit  900  and disposed within sealed enclosure  910 , such as additional medical plug delivery systems  905 , a stylet  800 , and a fluid delivery device  600  (not shown). Sealed enclosure  910  may initially be unsealed so as to accommodate disposition of the contents within sealed enclosure  910 . Sealed enclosure  910  may be subsequently sealed or otherwise closed to maintain the position of the medical plug delivery devices  100  within the sealed enclosure  910 . Embodiments wherein the sealed enclosure  910  is sealed  910  to maintain sterility as well as embodiments wherein the sealed enclosure  910  is configured to simply maintain the grouping of medical plug delivery devices  100  (not necessarily sealed with respect to sterility) are both within the scope of this disclosure. 
     Referring to  FIG. 18 , stylet  800  may comprise a stylet rod  810  coupled to a stylet handle  820 . Stylet handle  820  may comprise a protrusion  840  extending from stylet handle  820  along a portion of stylet rod  810 . Stylet  800  may comprise a cover  850  configured to protect stylet rod  810 . Cover  850  may be formed in a tubular shape having an internal diameter larger than the outside diameter of stylet rod  810 . The outer dimensions of protrusion  840  and the inner diameter of cover  850  may be configured to be releasably coupled together. 
     Other embodiments of stylets such as preliminary stylet  300  and cutting stylet  500  (such as those described in connection with the embodiments above, such as in  FIGS. 11-14 ) may be included in kit  900  and disposed within sealed enclosure  910 . Preliminary stylet  300  and cutting stylet  500  may also comprise tubular protective covers having internal dimensions configured to couple to distal protrusions  331  and  531  respectively. 
     Kit  900  may comprise human and/or machine-readable indicia  940 . Indicia  940  may be printed directly on sealed enclosure  910  or printed on a label adhesively applied to sealed enclosure  910 . Indicia  940  may include product identification, manufacturing information (for example date and/or serial number), instructions for use, a shelf life expiration date, etc. Indicia  940  may further include other information as may be contemplated by one of ordinary skill having the benefit of this disclosure. 
     Sealed enclosure  910  may comprise an envelope or enclosure which may be comprised of flexible walls, such as opposing flexible walls  911 . Opposing flexible walls  911  may be sealed or otherwise coupled together along at least a portion of a perimeter. A seal  912  may be disposed inward from the perimeter of opposing flexible walls  911  along at least a portion of the perimeter. As noted above, this seal  912  may comprise a seal configured to maintain sterility, such as a hermetic seal, or may be a coupling region configured to maintain the positions of medical devices within the sealed enclosure, but not necessarily sealed with respect to sterility. Opposing flexible walls  911  may be formed from a single film folded along an edge, a tubular structure or separate films. Opposing flexible walls  911  may have the same or different shapes, thicknesses and materials, and the materials may be compatible with sterilization techniques. One or both opposing flexible walls  911  may be transparent or translucent. Seal  912  may be peelable and the shape of seal  912  may comprise a shape feature to facilitate ease of peeling such as a chevron. Sealed enclosure  910  may be sealed using RF welding, heat welding, or any other suitable method. Sealed enclosure  910  and the contents within may be sterilized using radiation, E-Beam or other methods suitable for sterilizing hermetically sealed enclosures. 
     As shown, the medical plug delivery system  905  may be disposed at a central region  925  of sealed enclosure  910 . The medical plug delivery system  905  may be oriented such that a longitudinal axis of one or more medical plug delivery devices  100 , or other elements, are aligned with a longitudinal axis of sealed enclosure  910 . 
     Sealed enclosure  910  may comprise a proximal portion  920  and a distal portion  930 . The proximal direction of sealed enclosure  910  may correlate to the proximal direction of medical plug delivery device  100  disposed therein in embodiments wherein the medical plug delivery devices  100  of the medical plug delivery system  905  are aligned and oriented in the same direction as shown in illustrated embodiment. Similarly the distal direction of the sealed enclosure  910  may be defined by the distal direction of medical plug delivery device  100  when arranged as shown in the illustrated embodiment. Proximal portion  920  is defined as the portion of sealed enclosure  910  between proximal end  112  of medical plug delivery device  100  and a proximal end  921  of opposing flexible walls  911 . Similarly, distal portion  930  is defined as the portion of sealed enclosure  910  between distal end  122  of medical plug delivery device  100  and a distal end  931  of opposing flexible walls  911 . 
     As described above, elongate medical plug  200  may be frictionally coupled to medical plug delivery device  100  so as to establish an engagement force holding the elongate medical plug  200  within the medical plug delivery device  100 . The engagement force may be configured to maintain the position of the elongate medical plug  200  until the elongate medical plug  200  is displaced by a medical practitioner. Thus, the engagement force may be configured to withstand environmental conditions such as vibration and/or shock conditions related to handling and/or transporting of medical plug delivery system  905 . In certain instances, however, the vibration and/or shock conditions may produce acceleration levels of the medical plug delivery device  100  sufficient to subject the elongate medical plug  200  to forces great enough to overcome the engagement force, resulting in displacement of elongate medical plug  200  relative to medical plug delivery device  100 . In some embodiments, the packaging designs and techniques as described herein may be used to isolate medical devices within the sealed enclosure  910  from vibration or shock, such as by limiting acceleration levels of medical plug delivery device  100  so as to further prevent or limit displacement of elongate medical plug  200  relative to medical plug delivery device  100 . 
     In some instances, the environmental conditions which produce acceleration levels sufficient to displace the elongate medical plugs  200  may occur while a device is disposed within a package. For example, acceleration may occur when a package is dropped on a solid floor or at other times during transportation in a delivery truck. In certain instances, the use of secondary packaging materials may be employed to shield the package contents from such acceleration. The secondary packaging materials establish compliance between the package contents and external contact points of the package. The required level of compliance may be determined and/or verified empirically through shake and drop testing. 
     As noted herein in certain embodiments, the primary packaging design (such as the sealed enclosure  910 ) and techniques as described herein may be used to provide compliant package portions to prevent of the packaging contents from being exposed to high acceleration levels without the addition of secondary compliant packaging materials such as foam, bubble wrap, etc. 
     Sealed enclosure  910  as described herein may be used to create compliance between medical plug delivery system  905  and a contact surface such as a floor, inside wall of a box, etc. The addition of such compliance may prevent vibration, shock, and high acceleration levels from reaching medical plug delivery system  905 . In some instances, sealed enclosure  910  may be configured to provide compliance in a specific direction relative to medical plug delivery system  905 . As the engagement force between elongate medical plug  200  and medical plug delivery device  100  is in the longitudinal direction, sealed enclosure  910  may be configured to provide additional compliance in the longitudinal direction, for example. 
     Proximal and distal portions  920 ,  930  may define compliance, i.e. cushioning, in the respective longitudinal directions of medical plug delivery device  100 . Proximal and distal portions  920 ,  930  may be configured to provide a predetermined compliance level. The level of compliance sufficient for prevention of displacement of elongate medical plug  200  relative to medical plug delivery device  100  may be determined and/or verified empirically through shake and drop testing. 
     In some instances, the compliance mechanism of proximal and distal portions  920 ,  930  may be deformation, such as bending and/or buckling, of proximal and distal portions  920 ,  930 . The tendency for longitudinal deformation of proximal and distal portions  920 ,  930  may be defined by one or several dimensions or shapes of proximal and distal portions  920 ,  930 . For example, the tendency for longitudinal deformation under a longitudinally directed compressive load may increase with an increase in length, and decrease with an increase in width and wall thickness. Other variations in dimensions and/or shapes as may be anticipated by one of ordinary skill having the benefit of this disclosure are within the scope of this disclosure. 
     For example, in an instance where the kit  900  is dropped onto a hard floor surface in an orientation so that the proximal end of sealed enclosure  910  is downward, the proximal end  921  of opposing flexible walls  911  may impact the floor. The impact may cause medical plug delivery device  100  to longitudinally accelerate. The longitudinal acceleration of medical plug delivery device  100  may in turn result in the mass of elongate medical plug  200  creating a longitudinally directed force between elongate medical plug  200  and medical plug delivery device  100 . If the force is great enough, it may overcome the frictional engagement force resulting in displacement of elongate medical plug  200  relative to medical plug delivery device  100 . However, in such a scenario, proximal portion  920  of sealed enclosure  910  may deform and absorb the energy of impact, thereby reducing the acceleration of medical plug delivery device  100 , which in turn reduces the longitudinally directed force between elongate medical plug  200  and medical plug delivery device  100 . In such a scenario, the reduction of force may result in no displacement of elongate medical plug  200  relative to medical plug delivery device  100 . Deformation of proximal and distal portions  920 ,  930  may also absorb longitudinally directed energy when kit  900  is exposed to vibration and thus prevent displacement of elongate medical plug  200  relative to medical plug delivery device  100 . 
     In some embodiments, the sealed enclosure  910  may comprise a vacuum  913  within an interior of the sealed enclosure  910 . For example, a vacuum may be applied after one or more medical plug delivery systems  905  is disposed therein and as sealed enclosure  910  is sealed. Vacuum  913  may define a pressure difference such that the opposing flexible walls  911  apply a force on the components within sealed enclosure  910 , such as on the medical plug delivery device  100 . The force may facilitate constraint of the medical plug delivery device  100  in a predetermined (and/or initially disposed location and/or orientation) within the sealed enclosure  910 . The location may be in a central region  925  so as to establish a predetermined length of proximal and distal portions  920 ,  930 . The level of vacuum  913  may be such that when kit  900  is exposed to the environmental conditions described above, longitudinal displacement of medical plug delivery system  905  within sealed enclosure  910  is less than a predetermined limit. In other words, the level of vacuum  913  may be sufficient to maintain the established length of proximal and distal portions  920 ,  930  during shipping and other conditions. The level of vacuum  913  may also be sufficient to prevent any displacement of medical plug delivery system  905  during handling, shipping, or other shocks to the sealed enclosure  910 . In some embodiments, the vacuum  913  level may be between 20 and 700 mmHg, including between 20 and 200 mmHg. 
     EXAMPLES 
     Example 1 
     A kit for a medical plug delivery system, comprising: a medical plug delivery system, comprising a medical plug delivery device including a housing defining a lumen extending from a proximal end to a distal end of the medical plug delivery device, the medical plug delivery device having an elongate medical plug disposed within the lumen of the medical plug delivery device and frictionally coupled to the medical plug delivery device; and an enclosure comprising flexible walls disposed around the medical plug delivery system, the flexible walls configured to inhibit displacement of the elongate medical plug relative to the medical plug delivery device. 
     Example 2 
     The kit of example 1, wherein the displacement of the elongate medical plug relative to the medical plug delivery device is inhibited by preventing longitudinal acceleration of the medical plug delivery device. 
     Example 3 
     The kit of example 1 or example 2, wherein the enclosure comprises a proximal portion and a distal portion and wherein the medical plug delivery system is disposed centrally between the proximal and distal portions. 
     Example 4 
     The kit of example 1, wherein a longitudinal axis of the medical plug delivery system is aligned with a longitudinal axis of the enclosure. 
     Example 5 
     The kit of example 1, wherein the proximal and distal portions are configured to deform under a compressive load. 
     Example 6 
     The kit of any one of examples 1-5, wherein the enclosure is configured to constrain relative displacement between the medical plug delivery system and the flexible walls. 
     Example 7 
     The kit of any one of examples 1-6, wherein the flexible wall comprise opposing flexible walls and the kit comprises a pressure difference across each opposing flexible wall such that the pressure difference is configured to frictionally couple the medical plug delivery system to the opposing flexible walls. 
     Example 8 
     The kit of example 7, wherein the pressure difference is defined by a vacuum within the enclosure. 
     Example 9 
     The kit of example 8, wherein the vacuum is between 20 and 700 mmHg. 
     Example 10 
     The kit of any one of examples 1-9, wherein the medical plug delivery system comprises a plurality of medical plug delivery devices. 
     Example 11 
     The kit of any one of examples 1-10, wherein the kit further comprises a stylet configured for applying a distally directed force to the elongate medical plug to overcome the frictional coupling between the elongate medical plug and the medical plug delivery device. 
     Example 12 
     The kit of example 11, wherein the stylet comprises a protective cover. 
     Example 13 
     The kit of any one of examples 1-12, wherein the enclosure comprises a sterile barrier. 
     Example 14 
     The kit of any one of examples 1-13, wherein at least a portion of the enclosure is transparent or translucent. 
     Example 15 
     The kit of any one of examples 1-14, wherein the enclosure comprises human and/or machine-readable indicia. 
     Example 16 
     The kit of any one of examples 1-15, wherein the lumen of the medical plug delivery device comprises a reduced diameter portion at the distal end configured to engage the elongate medical plug, and wherein the diameter of the reduced diameter portion is smaller than a diameter of the elongate medical plug. 
     Example 17 
     The kit of any one of examples 1-16, wherein the elongate medical plug comprises at least one channel that extends from a proximal end to a distal end of the elongate medical plug. 
     Example 18 
     The kit of any one of examples 1-17, wherein the medical plug delivery device comprises a distal connector configured to connect to a distal medical device in communication with a patient. 
     Example 19 
     A method of isolating a medical device from vibration, the method comprising: disposing the medical device an enclosure between opposing flexible walls such that a proximal and distal portion of the enclosure extend beyond the medical device, and applying a vacuum to an interior of the enclosure such that the opposing flexible walls frictionally couple to the medical device. 
     Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method. 
     Reference throughout this specification to “an embodiment” or “the embodiment” means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment. 
     Similarly, it should be appreciated by one of skill in the art with the benefit of this disclosure that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. 
     Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the present disclosure.