Patent Description:
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 are also disclosed. The document <CIT> describes a medical deployment instrument forming part of a vessel closure system. The document <CIT> describes a system for creating a mechanical barrier to seal a vascular puncture site, the components of the system prepackaged in a site access kit and a barrier component kit. <CIT> describes medical devices for delivering a plug to a void within a patient.

Certain optional features of the invention are defined in the dependent claims. The methods described herein do not form part of the invention.

The written disclosure herein describes illustrative embodiments that are nonlimiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which:.

Certain medical procedures include delivery of a plug (such as a pledget) into a void within a patient'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 Once the coaxial introducer is positioned within the patient, the trocar may be withdrawn from the coaxial introducer.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'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'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. 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's body to which a plug may be delivered.

<FIG> illustrates a perspective view of a medical device that may include a plug holder <NUM> (which may also be referred to as a medical plug delivery device or an inline coupler) and a medical plug or pledget <NUM>.

Plug <NUM> may be generally elongate in shape and have a variety of different cross-sections, such as circular, square, triangular, etc. Plug <NUM> illustrated in <FIG> has a substantially circular cross-section. In some embodiments, plug <NUM> 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 <NUM> is an elongate piece of material that has been rolled into a substantially cylindrical shape between <NUM> and <NUM> (e.g., approximately <NUM>) in diameter. Plug <NUM> may have a length that is at least <NUM>-fold, at least <NUM>-fold, and/or at least <NUM>-fold longer than the diameter of plug <NUM>. In some embodiments, plug <NUM> is between <NUM> and <NUM> (e.g., approximately <NUM>) in length.

Plug <NUM> may further include a channel <NUM> (which may also be referred to as a fluid bypass pathway) along the outer surface of plug <NUM>. Channel <NUM> may extend from a first end <NUM> to a second end <NUM> of plug <NUM>. <FIG> illustrates a front view of plug <NUM> with channel <NUM>. Channel <NUM> may have an arc shape or a semi-circle cross-section. However, various other shapes may be used. <FIG> illustrates a top view of plug <NUM> and channel <NUM>. As illustrated in <FIG>, channel <NUM> may extend the entire length of plug <NUM>, from first end <NUM> to second end <NUM>. As described in further detail below, channel <NUM> provides a fluid bypass pathway to enable air and fluid to bypass plug <NUM> when plug <NUM> is wetted. The movement of the fluid through channel <NUM> forces any air within a lumen <NUM> of plug holder <NUM> out of plug holder <NUM>. In addition, when plug <NUM> is wetted, plug <NUM> may swell thereby closing channel <NUM>.

Channel <NUM> may be formed by placing a mandrel in plug <NUM> while plug <NUM> is formed. Thus, the shape of channel <NUM> is similar to the shape of the mandrel when the mandrel is removed from plug <NUM>.

<FIG> illustrate front views of various other potential embodiments of plugs. The plugs of <FIG> may be used in connection with devices or systems described in connection with plug <NUM> of <FIG>. Disclosure given in connection with plug <NUM> analogously may be applied to the plugs of <FIG> or vice versa. <FIG> illustrates a plug <NUM>' with two channels <NUM>' along the outer surface of plug <NUM>'. Channels <NUM>' may extend from a first end to a second end of plug <NUM>'. Alternatively, plug <NUM>' may have more than two channels, such as three, four, or more. Channels <NUM>' may be equally spaced from each other, or channels <NUM>' may be unequally spaced around the outer surface of plug <NUM>'. Each channel <NUM>' may be an arc shape or a semi-circle cross-section. Various other shapes for channel <NUM>' may be used.

<FIG> illustrates a plug <NUM>" with channel <NUM>" wholly disposed within plug <NUM>", giving plug <NUM>" a donut shape. Channel <NUM>" may be centered in plug <NUM>", or channel <NUM>" may be off-center of plug <NUM>". Channel <NUM>" may have a circular cross-section and channel <NUM>" may extend the entire length of plug <NUM>", from a first end to a second end. However, channel <NUM>" may have various other cross-sectional shapes. Plug <NUM>" may also include more than one channel <NUM>" disposed within plug <NUM>". For example, <FIG> illustrates a plug <NUM>‴ with two channels <NUM>‴ disposed within plug <NUM>'''. In other embodiments, plug <NUM>‴ may include a channel <NUM>‴ along the outer surface of plug <NUM>‴ (similar to channel <NUM> of <FIG>) and a channel <NUM>‴ wholly disposed within plug <NUM>‴ (similar to channel <NUM>' of <FIG>).

With reference to <FIG>, plug <NUM> may be composed of any suitable composition or material. For example, in some embodiments, plug <NUM> 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 <NUM> includes or consists of a non-bioabsorbable material, such as polyvinyl alcohol or polyvinyl acetate. In some embodiments, plug <NUM> includes a dye. The dye may facilitate visualization of plug <NUM> when plug <NUM> is disposed within plug holder <NUM>. In some embodiments, plug <NUM> may change colors when contacted with fluid (e.g., water or saline), thereby allowing a practitioner to visually determine when plug <NUM> has been wetted.

<FIG> illustrate various views of plug holder <NUM> of <FIG>. <FIG> illustrates a side view of plug holder <NUM>. <FIG> illustrates a front view of plug holder <NUM>. <FIG> illustrates a cross-sectional view of plug holder <NUM> along cross-section line <NUM>-<NUM>. <FIG> illustrates a cross-sectional view of plug holder <NUM> along cross-section line <NUM>-<NUM> according to one embodiment. <FIG> illustrates a cross-sectional view of plug holder <NUM> along cross-section line <NUM>-<NUM> according to another embodiment. <FIG> illustrates a cross-sectional view of plug holder <NUM> along cross-section line <NUM>-<NUM> according to another embodiment.

With reference to <FIG> and <FIG>, plug holder <NUM> may include a proximal portion <NUM>, a distal portion <NUM>, and a central portion <NUM>. Plug holder <NUM> may include a lumen <NUM> configured to pass from a proximal end <NUM> to a distal end <NUM>. Lumen <NUM> may be configured to accommodate plug <NUM>. Thus, lumen <NUM> may define a cavity configured to retain plug <NUM>. Lumen <NUM> may be centrally disposed within plug holder <NUM> and may be configured to orient plug <NUM> within plug holder <NUM> such that the longitudinal axis of plug <NUM> is aligned with the longitudinal axis of plug holder <NUM> or lumen <NUM>. Lumen <NUM> may be generally tapered from proximal end <NUM> to distal end <NUM> with the largest diameter located at proximal end <NUM> and the smaller diameter located at distal end <NUM>. For example, <FIG> and <FIG> depict three diameters, D1, D2, and D3. D1 is the smallest and located at distal end <NUM> and D3 is the largest and located at proximal end <NUM>.

As illustrated in <FIG>, lumen <NUM> may include a plug retention section <NUM> positioned near the distal end <NUM>. Plug retention section <NUM> may be interference fit. Plug retention section <NUM> may be configured to retain plug <NUM> within lumen <NUM> until displacement of plug <NUM> is desired and to permit removal of air from lumen <NUM>. Plug retention section <NUM> may be a portion of lumen <NUM> with an inner diameter, e.g., D1, less than the outer diameter of plug <NUM>. For example, the outer diameter of plug <NUM> may be one gauge size different from plug retention section <NUM> (such as plug <NUM> being <NUM> gauge and the inner diameter of plug retention section <NUM> being <NUM> gauge). Plug retention section <NUM> may be <NUM> to <NUM> in length (for example, approximately <NUM> in length) and be configured to frictionally engage a portion of plug <NUM>. A proximal end of plug retention section <NUM> may include a chamfer <NUM> to facilitate passage of a stylet that may engage plug <NUM>.

In the embodiment illustrated in <FIG>, the plug retention <NUM> may be positioned near the proximal end of the plug <NUM> instead of the distal end of the plug <NUM>. In the embodiment illustrated in <FIG>, the plug retention section <NUM> may extend from the distal end of the plug <NUM> to the proximal end of the plug <NUM>.

<FIG> illustrates a front view of plug holder <NUM> and plug <NUM>. This view clearly illustrates channel <NUM> or the fluid bypass pathway. Channel <NUM> creates a pathway for air disposed inside lumen <NUM> to escape when fluid is applied to proximal end <NUM> of lumen <NUM>.

<FIG> and <FIG> illustrate a cross-sectional view of plug holder <NUM> based on cross-section line <NUM>-<NUM> and <NUM>-<NUM> provided in <FIG>. <FIG> illustrates channel <NUM> that provides air a pathway to escape, in accordance with the arrow, when fluid is applied to proximal end <NUM> of lumen <NUM>. In certain configurations, plug <NUM> is in frictional contact with lumen <NUM> at the plug retention section <NUM>, as illustrated in <FIG>. Accordingly, during use, any of the air within the system may be forced out via channel <NUM> such that fluid exits channel <NUM>. This is indicative the air has been purged from the system.

Proximal portion <NUM> may include a proximal adaptor <NUM> that is configured to couple to a medical fluid delivery device <NUM>, such as a syringe (see <FIG>). For example, proximal portion <NUM> may include a female Luer connection that mates with a male Luer connection of the syringe body to form a fluid tight connection (see <FIG>). The female Luer connection may include a female Luer lock fitting <NUM>. Female Luer lock fitting <NUM> 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 <NUM> of lumen <NUM>.

A distal portion of central portion <NUM> may include a male Luer lock fitting <NUM>. Male Luer lock fitting <NUM> may be configured to sealingly mate with a female Luer lock fitting of a coaxial introducer <NUM> which is disposed within a patient (as illustrated in <FIG>) or with a catheter <NUM> (as illustrated in <FIG>).

Distal portion <NUM> of plug holder <NUM> may have a frustoconical-shaped extension within lumen <NUM> extending through the extension. The extension may extend into coaxial introducer <NUM> and may or may not create a fluid tight seal with coaxial introducer <NUM>. The extension may be configured to extend lumen distal end <NUM> to be near and in alignment with the proximal end of the introducer needle allowing for passage of plug <NUM> from plug holder <NUM> into coaxial introducer <NUM> without plug <NUM> getting caught within coaxial introducer <NUM> and folding on itself.

Alternative plug holders may be used instead of plug holder <NUM>. For example, plug holders capable of delivering multiple plugs as described in<CIT>.

<FIG> describe various methods of delivering plug <NUM> to the patient. The practitioner may select a dry technique or a wet technique for delivering plug <NUM> into a void of a patient. Plug holder <NUM> and plug <NUM> 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 <NUM> into the patient, as illustrated in <FIG>. A practitioner may insert a coaxial introducer <NUM> into a patient by placing a trocar within coaxial introducer <NUM> such that a pointed distal end of the trocar protrudes from a distal end of coaxial introducer <NUM>. With the pointed end of the trocar protruding from coaxial introducer <NUM>, the trocar and coaxial introducer <NUM> may together be inserted into the patient. Once coaxial introducer <NUM> is positioned within the patient, the trocar may be withdrawn from coaxial introducer <NUM>. At this stage of the procedure, coaxial introducer <NUM> provides a conduit in an introducer cannula that allows access to a patient's internal tissue. A cutting stylet <NUM> may be introduced into the conduit of coaxial introducer <NUM> and a sample of tissue may be excised from the patient, creating a void. The practitioner may then remove cutting stylet <NUM> and the tissue sample from coaxial introducer <NUM>.

After cutting stylet <NUM> is removed from coaxial introducer <NUM>, the practitioner may introduce plug <NUM> into the void where the biopsy was excised. Distal portion <NUM> of plug holder <NUM> which houses plug <NUM> may be connected or attached to the proximal end of coaxial introducer <NUM>. A preliminary stylet <NUM> may be configured to push or displace plug <NUM> from plug holder <NUM> into coaxial introducer <NUM> or alternatively, directly into the patient.

<FIG> illustrates a perspective view of plug holder <NUM>, a preliminary stylet <NUM>, and coaxial introducer <NUM>. Preliminary stylet <NUM> may include a stylet rod <NUM> and a handle <NUM> or finger grip. Stylet rod <NUM> may be metal or rigid plastic, such as polycarbonate. Stylet rod <NUM> may be configured to pass through lumen <NUM> from proximal end <NUM> to distal end <NUM> and into coaxial introducer <NUM>. A distal end <NUM> of stylet rod <NUM> may be squared-off to provide a flat surface to push against plug <NUM>, as illustrated in <FIG>. As stylet rod <NUM> is advanced through lumen <NUM> of plug holder <NUM>, distal end <NUM> of stylet rod <NUM> may make contact with the proximal end of plug <NUM>. As a distally directed force is applied to plug <NUM> by stylet rod <NUM>, the force may exceed the frictional engagement force between plug <NUM> and lumen retention section <NUM> of plug holder <NUM>. As the frictional engagement force is surpassed, plug <NUM> will be displaced from lumen <NUM> into coaxial introducer <NUM>.

The diameter of stylet rod <NUM> may be sized to pass through plug retention section <NUM> of lumen <NUM> as well as into coaxial introducer <NUM>. The length of stylet rod <NUM> may be sized to extend through plug holder <NUM> and partially into the conduit of coaxial introducer <NUM> for displacement of plug <NUM> into the conduit of coaxial introducer <NUM>. Alternatively, stylet rod <NUM> may have a length that enables stylet rod <NUM> to push plug <NUM> through conduit <NUM> of coaxial introducer <NUM> and into the void of the patient. Stylet rod <NUM> may include insertion depth markings <NUM>. Markings <NUM> may be single or multiple bands spaced approximately <NUM> apart. The practitioner may determine the length of stylet rod <NUM> needed to displace plug <NUM> into the desired location within the void of the patient or within coaxial introducer <NUM>.

Preliminary stylet handle <NUM> may be configured to be held between the thumb and at least one finger of the practitioner. Handle <NUM> may comprise features to enhance gripability, such as roughed surface, ribs, detents, and other features known in the art. Handle <NUM> may be configured to connect to proximal adaptor <NUM> of plug holder <NUM>. The distal portion of handle <NUM> may be structured as a male Luer lock or Luer slip adaptor <NUM> comprising a distal protrusion <NUM>. Distal protrusion <NUM> of handle <NUM> may also be used to interface with and couple to a protective cover (not shown) for stylet rod <NUM>.

In some embodiments, once plug <NUM> is properly introduced in conduit <NUM> of coaxial introducer <NUM>, the practitioner may use cutting stylet <NUM> to place plug <NUM> into the void within the patient. Since cutting stylet <NUM> excises the tissue sample, cutting stylet <NUM> is the proper length to introduce plug <NUM> to the void within the patient. Cutting stylet <NUM> may comprise a handle <NUM>, a male Luer lock or Luer slip adaptor <NUM> and a distal protrusion <NUM>.

In some embodiments, the practitioner may select a wet medical plug delivery technique, as illustrated in <FIG>. Proximal adaptor <NUM> of plug holder <NUM> may be connected to a fluid delivery device <NUM>, such as a syringe at least partially filled with a fluid <NUM>. Fluid delivery device <NUM> may deliver fluid <NUM> into lumen <NUM> of plug holder <NUM> such that lumen <NUM> becomes free of air and plug <NUM> is wetted. In some embodiments, plug holder <NUM> is transparent, thereby allowing the practitioner to visualize wetting and ejection of plug <NUM>. Fluid delivery device <NUM> may deliver a fluid <NUM> such as water, saline, contrast, or any mixture thereof, or any other fluid. If desired, air may be removed from lumen <NUM> by orienting plug holder <NUM> such that distal end <NUM> of plug holder <NUM> is pointed upward, tapping plug holder <NUM>, and ejecting air bubbles by delivering fluid <NUM> through plug holder <NUM>. Channel <NUM> of plug <NUM> permits the passage of fluid <NUM> through plug <NUM> and plug retention section <NUM> to allow air to escape. Once plug <NUM> is wetted, plug <NUM> may swell, thus closing channel <NUM>.

Male Luer lock fitting <NUM> may be connected to a female Luer lock connector of catheter <NUM> that has been inserted into a patient, as illustrated in <FIG>. The connection may bring lumen distal end <NUM> close to alignment with the proximal end of catheter <NUM>. The practitioner may then eject fluid <NUM> from fluid delivery device <NUM>, thereby distally displacing fluid <NUM> into lumen <NUM>. As fluid <NUM> is displaced in a distal direction, fluid <NUM> may exert a distal force on plug <NUM> disposed within lumen <NUM>. The hydraulic force may surpass the engagement force of plug retention section <NUM> on a portion of plug <NUM>, thereby causing distal displacement and ejection of plug <NUM> from lumen <NUM> of plug holder <NUM> into catheter <NUM> that is in fluid communication with a void of the patient. As fluid <NUM> is advanced, displaced fluid <NUM> may push plug <NUM> through catheter <NUM> into the void of the patient, as illustrated in <FIG>. Plug <NUM> 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 <NUM> may include a plunger <NUM> and a syringe body <NUM>. Plunger <NUM> may include a handle <NUM> adjacent the proximal end of plunger <NUM> and a seal <NUM> adjacent the distal end of plunger <NUM>. Plunger <NUM> may be configured to be at least partially disposed within syringe body <NUM> such that advancement and retraction of plunger <NUM> causes displacement of fluid <NUM> within a reservoir in syringe body <NUM>.

Accordingly, the practitioner may select which technique to use at the time of the procedure as plug holder <NUM> and plug <NUM> are interchangeable between wet and dry techniques.

<FIG> illustrates a kit <NUM> for a plurality of medical plug delivery systems <NUM>. Each medical plug delivery system <NUM> may comprise a medical plug delivery device <NUM> having an elongate medical plug <NUM> disposed within the lumen of medical plug delivery device <NUM> at a distal end thereof. Thus, in the illustrated embodiment, the medical plug delivery system <NUM> is comprised of one or more medical plug delivery devices <NUM> as described in connection with certain embodiments above. In other embodiments, the medical plug delivery system <NUM> may comprise other medical dvices in addition to, or in place of, the medical plug delivery devices <NUM> described above. Kit <NUM> may comprise an enclosure, such as sealed enclosure <NUM> within which one or more medical plug delivery systems <NUM> may be disposed. Other components may be included in kit <NUM> and disposed within sealed enclosure <NUM>, such as additional medical plug delivery systems <NUM>, a stylet <NUM>, and a fluid delivery device <NUM> (not shown). Sealed enclosure <NUM> may initially be unsealed so as to accommodate disposition of the contents within sealed enclosure <NUM>. Sealed enclosure <NUM> may be subsequently sealed or otherwise closed to maintain the position of the medical plug delivery devices <NUM> within the sealed enclosure <NUM>. Embodiments wherein the sealed enclosure <NUM> is sealed <NUM> to maintain sterility as well as embodiments wherein the sealed enclosure <NUM> is configured to simply maintain the grouping of medical plug delivery devices <NUM> (not necessarily sealed with respect to sterility) are both within the scope of this disclosure.

Referring to <FIG>, stylet <NUM> may comprise a stylet rod <NUM> coupled to a stylet handle <NUM>. Stylet handle <NUM> may comprise a protrusion <NUM> extending from stylet handle <NUM> along a portion of stylet rod <NUM>. Stylet <NUM> may comprise a cover <NUM> configured to protect stylet rod <NUM>. Cover <NUM> may be formed in a tubular shape having an internal diameter larger than the outside diameter of stylet rod <NUM>. The outer dimensions of protrusion <NUM> and the inner diameter of cover <NUM> may be configured to be releasably coupled together.

Other embodiments of stylets such as preliminary stylet <NUM> and cutting stylet <NUM> (such as those described in connection with the embodiments above, such as in <FIG>) may be included in kit <NUM> and disposed within sealed enclosure <NUM>. Preliminary stylet <NUM> and cutting stylet <NUM> may also comprise tubular protective covers having internal dimensions configured to couple to distal protrusions <NUM> and <NUM> respectively.

Kit <NUM> may comprise human and/or machine-readable indicia <NUM>. Indicia <NUM> may be printed directly on sealed enclosure <NUM> or printed on a label adhesively applied to sealed enclosure <NUM>. Indicia <NUM> may include product identification, manufacturing information (for example date and/or serial number), instructions for use, a shelf life expiration date, etc. Indicia <NUM> may further include other information as may be contemplated by one of ordinary skill having the benefit of this disclosure.

Sealed enclosure <NUM> may comprise an envelope or enclosure which may be comprised of flexible walls, such as opposing flexible walls <NUM>. Opposing flexible walls <NUM> may be sealed or otherwise coupled together along at least a portion of a perimeter. A seal <NUM> may be disposed inward from the perimeter of opposing flexible walls <NUM> along at least a portion of the perimeter. As noted above, this seal <NUM> 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 <NUM> may be formed from a single film folded along an edge, a tubular structure or separate films. Opposing flexible walls <NUM> 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 <NUM> may be transparent or translucent. Seal <NUM> may be peelable and the shape of seal <NUM> may comprise a shape feature to facilitate ease of peeling such as a chevron. Sealed enclosure <NUM> may be sealed using RF welding, heat welding, or any other suitable method. Sealed enclosure <NUM> 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 <NUM> may be disposed at a central region <NUM> of sealed enclosure <NUM>. The medical plug delivery system <NUM> may be oriented such that a longitudinal axis of one or more medical plug delivery devices <NUM>, or other elements, are aligned with a longitudinal axis of sealed enclosure <NUM>.

Sealed enclosure <NUM> may comprise a proximal portion <NUM> and a distal portion <NUM>. The proximal direction of sealed enclosure <NUM> may correlate to the proximal direction of medical plug delivery device <NUM> disposed therein in embodiments wherein the medical plug delivery devices <NUM> of the medical plug delivery system <NUM> are aligned and oriented in the same direction as shown in illustrated embodiment. Similarly the distal direction of the sealed enclosure <NUM> may be defined by the distal direction of medical plug delivery device <NUM> when arranged as shown in the illustrated embodiment. Proximal portion <NUM> is defined as the portion of sealed enclosure <NUM> between proximal end <NUM> of medical plug delivery device <NUM> and a proximal end <NUM> of opposing flexible walls <NUM>. Similarly, distal portion <NUM> is defined as the portion of sealed enclosure <NUM> between distal end <NUM> of medical plug delivery device <NUM> and a distal end <NUM> of opposing flexible walls <NUM>.

As described above, elongate medical plug <NUM> may be frictionally coupled to medical plug delivery device <NUM> so as to establish an engagement force holding the elongate medical plug <NUM> within the medical plug delivery device <NUM>. The engagement force may be configured to maintain the position of the elongate medical plug <NUM> until the elongate medical plug <NUM> 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 <NUM>. In certain instances, however, the vibration and/or shock conditions may produce acceleration levels of the medical plug delivery device <NUM> sufficient to subject the elongate medical plug <NUM> to forces great enough to overcome the engagement force, resulting in displacement of elongate medical plug <NUM> relative to medical plug delivery device <NUM>. In some embodiments, the packaging designs and techniques as described herein may be used to isolate medical devices within the sealed enclosure <NUM> from vibration or shock, such as by limiting acceleration levels of medical plug delivery device <NUM> so as to further prevent or limit displacement of elongate medical plug <NUM> relative to medical plug delivery device <NUM>.

In some instances, the environmental conditions which produce acceleration levels sufficient to displace the elongate medical plugs <NUM> 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 <NUM>) 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 <NUM> as described herein may be used to create compliance between medical plug delivery system <NUM> 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 <NUM>. In some instances, sealed enclosure <NUM> may be configured to provide compliance in a specific direction relative to medical plug delivery system <NUM>. As the engagement force between elongate medical plug <NUM> and medical plug delivery device <NUM> is in the longitudinal direction, sealed enclosure <NUM> may be configured to provide additional compliance in the longitudinal direction, for example.

Proximal and distal portions <NUM>, <NUM> may define compliance, i.e. cushioning, in the respective longitudinal directions of medical plug delivery device <NUM>. Proximal and distal portions <NUM>, <NUM> may be configured to provide a predetermined compliance level. The level of compliance sufficient for prevention of displacement of elongate medical plug <NUM> relative to medical plug delivery device <NUM> may be determined and/or verified empirically through shake and drop testing.

In some instances, the compliance mechanism of proximal and distal portions <NUM>, <NUM> may be deformation, such as bending and/or buckling, of proximal and distal portions <NUM>, <NUM>. The tendency for longitudinal deformation of proximal and distal portions <NUM>, <NUM> may be defined by one or several dimensions or shapes of proximal and distal portions <NUM>, <NUM>. 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 <NUM> is dropped onto a hard floor surface in an orientation so that the proximal end of sealed enclosure <NUM> is downward, the proximal end <NUM> of opposing flexible walls <NUM> may impact the floor. The impact may cause medical plug delivery device <NUM> to longitudinally accelerate. The longitudinal acceleration of medical plug delivery device <NUM> may in turn result in the mass of elongate medical plug <NUM> creating a longitudinally directed force between elongate medical plug <NUM> and medical plug delivery device <NUM>. If the force is great enough, it may overcome the frictional engagement force resulting in displacement of elongate medical plug <NUM> relative to medical plug delivery device <NUM>. However, in such a scenario, proximal portion <NUM> of sealed enclosure <NUM> may deform and absorb the energy of impact, thereby reducing the acceleration of medical plug delivery device <NUM>, which in turn reduces the longitudinally directed force between elongate medical plug <NUM> and medical plug delivery device <NUM>. In such a scenario, the reduction of force may result in no displacement of elongate medical plug <NUM> relative to medical plug delivery device <NUM>. Deformation of proximal and distal portions <NUM>, <NUM> may also absorb longitudinally directed energy when kit <NUM> is exposed to vibration and thus prevent displacement of elongate medical plug <NUM> relative to medical plug delivery device <NUM>.

In some embodiments, the sealed enclosure <NUM> may comprise a vacuum <NUM> within an interior of the sealed enclosure <NUM>. For example, a vacuum may be applied after one or more medical plug delivery systems <NUM> is disposed therein and as sealed enclosure <NUM> is sealed. Vacuum <NUM> may define a pressure difference such that the opposing flexible walls <NUM> apply a force on the components within sealed enclosure <NUM>, such as on the medical plug delivery device <NUM>. The force may facilitate constraint of the medical plug delivery device <NUM> in a predetermined (and/or initially disposed location and/or orientation) within the sealed enclosure <NUM>. The location may be in a central region <NUM> so as to establish a predetermined length of proximal and distal portions <NUM>, <NUM>. The level of vacuum <NUM> may be such that when kit <NUM> is exposed to the environmental conditions described above, longitudinal displacement of medical plug delivery system <NUM> within sealed enclosure <NUM> is less than a predetermined limit. In other words, the level of vacuum <NUM> may be sufficient to maintain the established length of proximal and distal portions <NUM>, <NUM> during shipping and other conditions. The level of vacuum <NUM> may also be sufficient to prevent any displacement of medical plug delivery system <NUM> during handling, shipping, or other shocks to the sealed enclosure <NUM>. In some embodiments, the vacuum <NUM> level may be between <NUM> and <NUM> mmHg, including between <NUM> and <NUM> mmHg.

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.

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.

Claim 1:
A medical plug delivery system (<NUM>), comprising:
a medical plug holding device (<NUM>) that includes a housing defining a lumen (<NUM>) that extends from a proximal end (<NUM>) to a distal end (<NUM>) of the medical plug holding device, wherein the housing comprises a distal connector (<NUM>) configured to connect to a distal medical device (<NUM>) in communication with a patient; characterized by
an elongate medical plug (<NUM>; <NUM>'; <NUM>"; <NUM>"') that is substantially cylindrical in shape and is disposed within the lumen (<NUM>) of the medical plug holding device (<NUM>), wherein the elongate medical plug (<NUM>) defines a channel (<NUM>; <NUM>'; <NUM>"; <NUM>'") that extends from a proximal end (<NUM>) to a distal end (<NUM>) of the elongate medical plug (<NUM>), wherein said channel provides a fluid bypass pathway.