Patent Description:
The present disclosure generally relates to sealant delivery systems, and more specifically, to systems and methods for preparing the same, for use associated with a lung procedure to aid in preventing pneumothorax.

Pneumothorax is a problematic complication of the lung biopsy procedure where air or fluid is allowed to pass into the pleural space as a result of the puncture of the parietal pleura and visceral pleura. Pneumothorax and, more so, pneumothorax requiring chest tube placement, are significant concerns for clinicians performing, and patients undergoing, percutaneous lung biopsies. The incidence of pneumothorax in patients undergoing percutaneous lung biopsy has been reported to be anywhere from <NUM>-<NUM>%, with an average of around <NUM>%. On average, <NUM>% of all percutaneous lung biopsies result in pneumothorax requiring a chest tube to be placed, which results in an average hospital stay of <NUM> days.

Factors that increase the risk of pneumothorax include increased patient age, obstructive lung disease, increased depth of a lesion, multiple pleural passes, increased time that an access needle lies across the pleura, and traversal of a fissure. Pneumothorax may occur during or immediately after the procedure, which is why typically a CT scan of the region is performed following removal of the needle. Other, less common, complications of percutaneous lung biopsy include hemoptysis (coughing up blood), hemothorax (a type of pleural effusion in which blood accumulates in the pleural cavity), infection, and air embolism.

It has been suggested that approximately <NUM>% of lung biopsies result in some form of pneumothorax that makes deploying a plug after the biopsy difficult or impossible. Current sealants on the market are deployed through a coaxial cannula after a biopsy is performed which may be before or after a pneumothorax forms.

United States Patent <CIT> discloses biological syringe has a manifold with inlets for first and second fluids e.g. from syringes. The manifold has separate channels for the fluids and is connected to a discharge assembly. The discharge assembly mixes and delivers the fluids in a spray. The discharge assembly has separate conduits and a mixing chamber pref. having a shaped spray nozzle providing swirling flows.

International Patent Application <CIT> discloses a dispensing appliance for a double cartridge comprising a housing for receiving multiple components and a rotatable portion having a thread, the two parts cooperating in such a manner that by rotating the rotatable portion, a multiple plunger acting upon the pistons in the housing is continuously displaceable relative to the housing in the dispensing direction.

In one aspect, a sealant delivery system includes a sealant applicator that includes two chambers separate from one another. Each chamber includes at least one output port on a distal end thereof. The sealant applicator further includes a quarter turn connector disposed on a distal end of the sealant applicator adjacent to the at least one output port of each chamber. The quarter turn connector is shaped to releasably interlock with a corresponding quarter turn connector of an injection needle assembly comprising a plurality of input ports or with a corresponding quarter turn connector of a dual chamber mixing syringe comprising a plurality of mixing ports. When the injection needle assembly or the dual chamber mixing syringe is coupled to the sealant applicator via the quarter turn connector, the plurality of input ports or the plurality of mixing ports are aligned and sealed with the at least one output port of each chamber of the sealant applicator. The quarter turn connector comprises a circular protrusion extending distally from the distal end of the sealant applicator, the circular protrusion comprising the at least one output port of each of the two chambers; a semi-circular channel disposed within the distal end of the sealant applicator along a periphery of the circular protrusion; and a pair of bayonet coupling members disposed radially outward of the circular protrusion and the semi-circular channel.

In another aspect, an injection needle assembly includes a hub having a hub quarter turn connector that releasably interlocks with a corresponding quarter turn connector disposed on a sealant applicator, a plurality of input ports disposed within the hub, and an elongate hollow stylet that extends distally from the hub. The elongate hollow stylet has a proximal portion at the hub and a distal portion spaced apart from the proximal portion. The elongate hollow stylet includes an outer side wall extending from the proximal portion to the distal portion and defining an outer lumen that is fluidly coupled to at least a first one of the plurality of input ports, an inner side wall extending from the proximal portion to the distal portion and defining an inner lumen disposed within the outer lumen such that the inner lumen is concentric with the outer lumen and has a cross-sectional size that is smaller than the outer lumen. The inner lumen is fluidly coupled to at least a second one of the plurality of input ports. The elongate hollow stylet further includes a mixing chamber disposed at the distal portion of the elongate hollow stylet. The mixing chamber is fluidly coupled to the outer lumen and the inner lumen and comprising at least one side port. When the hub quarter turn connector that interlocks with the quarter turn connector disposed on the distal end of the sealant applicator, the plurality of input ports are each aligned and sealed with a corresponding output port of a sealant applicator. The hub quarter turn connector comprises a circular recess sized to receive a circular protrusion on a distal end of the sealant applicator, the circular recess comprising the plurality of input ports disposed therein; a lip extending radially outward of the circular recess, the lip shaped and sized to be received within a pair of bayonet coupling members disposed on the sealant applicator; and a quarter circular boss extending proximally from the lip, the quarter circular boss shaped to be received within a semi-circular channel of the sealant applicator and slidable within the semi-circular channel in a quarter turn motion from an unlocked state to a locked state.

Additional features and advantages of the aspects described herein will be set forth in the detailed description which follows, and in part will be readily apparent to those skilled in the art from that description or recognized by practicing the aspects described herein, including the detailed description, which follows, the claims, as well as the appended drawings.

It is to be understood that both the foregoing general description and the following detailed description describe various aspects and are intended to provide an overview or framework for understanding the nature and character of the claimed subject matter. The accompanying drawings are included to provide a further understanding of the various aspects, and are incorporated into and constitute a part of this specification. The drawings illustrate the various aspects described herein, and together with the description serve to explain the principles and operations of the claimed subject matter.

The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, wherein like structure is indicated with like reference numerals and in which:.

The present disclosure, in one form, is related to sealant delivery systems for a lung access procedure, in particular for prevention of pneumothorax. The sealant delivery systems described herein include components that deliver the multicomponent sealant along an access path, including the pleura region, to the lung prior to performing a lung procedure, such as a biopsy or the like. The sealant delivery systems described herein include a dual chamber sealant applicator, a dual chamber mixing syringe, and an injection needle assembly. The sealant delivery systems described herein are configured such that a user can quickly and easily couple the dual chamber sealant applicator with the dual chamber mixing syringe in a manner that correctly aligns the applicator and mixing syringe so that the components within each can be mixed together. Once mixed, the user can just as easily disconnect the applicator from the mixing syringe and quickly and easily attach the injection needle assembly thereto for the purposes of delivering the sealant to a subject. To achieve this, the dual chamber sealant applicator includes a quarter turn connector that allows for the quick joining and releasing of the dual chamber mixing syringe and the injection needle assembly, which both have a corresponding quarter turn connector. In addition, because the sealant materials located in the dual chamber sealant applicator quickly form a sealant product when combined together, it is necessary to ensure the combination occurs at the side where the sealant product is to be distributed. As such, the needle assembly described herein includes an elongate hollow stylet having a mixing chamber at a distal end thereof, and utilizes an inner lumen disposed concentrically within an outer lumen to define separate passageways extending from the two chambers of the applicator to the mixing chamber at the distal end.

It should be understood that the term "quarter term" as used herein refers to a rotation that completes about one fourth of a full rotation. That is, a quarter turn rotation rotates about <NUM>° clockwise or counterclockwise. The components described herein are referred to as "quarter turn" components because the components allow about a <NUM>° rotation of components relative to one another.

An advantage of the present disclosure is that the various aspects described herein improve upon typical solutions in that the multi-component sealant seals the pneumothorax region before the biopsy, rather than after the biopsy.

Another advantage of the present disclosure is that the various aspects described herein require no measuring of where the needle is in relation to the pleura beyond what physicians currently do. The solution of the present disclosure should be able to be seamlessly integrated into the lung access procedure by preparation of the flowable multi-component sealant, and dispensing the flowable multi-component sealant from the elongate hollow stylet of the injection needle assembly as the elongate hollow stylet is advanced across the pleura.

Another advantage of the present disclosure is that the various quarter turn connectors that are used to couple components together provide a quick and easy way for a user to connect and disconnect components in a manner that ensures that the components are adequately aligned and sealed each time they are connected, thereby ensuring the correct mixture and delivery of materials. In addition, an advantage of the quarter turn connectors of the present disclosure is that the quarter turn connectors provide tactile or audible feedback provided to a user as extra confirmation that the components are correctly aligned and joined when coupled via the quarter turn connector.

Another advantage of the present disclosure is that the various aspects described herein improve over typical pneumothorax prevention devices in that, since the injection needle assembly is deployed at the beginning of the procedure rather than at the very end of a procedure, the flowable multi-component sealant, e.g., polymer, is able to be delivered and integrate into the spaces between tissues, whereas polymer plugs, for example, only occupy the space that they were cast and thus may result in a less effective seal.

Turning now to the drawings, <FIG> depicts an illustrative sealant delivery system <NUM> according to various embodiments. The sealant delivery system <NUM>, in accordance with an aspect of the present invention, may be for use in a lung access procedure to aid in preventing pneumothorax. The sealant delivery system <NUM> generally includes a sealant applicator <NUM>, a dual chamber mixing syringe <NUM>, and/or an injection needle assembly <NUM>. The various components for the sealant delivery system <NUM> are keyed via a quarter turn connection system such that the sealant applicator <NUM> can be coupled to the dual chamber mixing syringe <NUM> for mixing components of a multi-component sealant, removed from the dual chamber mixing syringe <NUM>, and coupled to the injection needle assembly <NUM> for further mixing and delivery of components, as indicated by the dashed lines in <FIG> and described herein. When coupled to the dual chamber mixing syringe <NUM>, the combination of the dual chamber mixing syringe <NUM> and the sealant applicator <NUM> may be referred to herein as a mixing apparatus <NUM>, as depicted in <FIG>. When coupled to the injection needle assembly <NUM>, the combination of the injection needle assembly <NUM> and the sealant applicator <NUM> may be referred to herein as a delivery apparatus <NUM>, as depicted in <FIG>.

Referring to <FIG>, when the sealant applicator <NUM> is coupled to the injection needle assembly <NUM>, the delivery apparatus <NUM> therefrom has a configuration to facilitate delivery of a flowable multi-component sealant to an injection site. The multi-component sealant may be injected while the needle portion of the injection needle assembly <NUM> crosses the two layers of the pleura, (e.g., the parietal and visceral pleura). The injection needle assembly <NUM> is configured to puncture tissue and create an access path (e.g., a proposed biopsy tract) in the tissue at least through the pleura of the subject, and thus allows for the two layers of the pleura to be sealed (e.g., prior to a lung biopsy), by the curing of the multi-component sealant at the delivery site so that air cannot leak between the two layers and cause a pneumothorax. It is noted that the multi-component sealant also may be deposited in other regions of the access path, such as in the subcutaneous tissue and/or lung parenchyma.

Referring to <FIG> and <FIG>, optionally, the delivery apparatus <NUM> may be used in conjunction with an introducer cannula <NUM>. The introducer cannula <NUM> may facilitate withdrawal of the injection needle assembly <NUM> of the delivery apparatus <NUM> from a subject, while the introducer cannula <NUM> may remain in place to maintain the access path in the tissue to the site, such as for example, to receive and guide a second medical instrument, such as a biopsy device, to the site where the biopsy is to be performed.

Referring again to <FIG>, the sealant applicator <NUM> generally includes a body <NUM> having a proximal end <NUM>-<NUM> and a distal end <NUM>-<NUM> spaced a distance apart from the proximal end <NUM>-<NUM>. The body <NUM> also defines a pair of syringes <NUM>. The sealant applicator <NUM> is configured to separately carry each of a first sealant component of the multi-component sealant and a second sealant component of the multi-component sealant. The first sealant component may include, for example, at least two N-hydroxysuccinimide (NHS) ester groups, and the second sealant component may include, for example, at least two amine groups. For example, the first sealant component may be a solution containing polyethylene glycol (PEG) succinimidyl succinate and the second sealant component may be a solution containing albumin and/or polyethylenimine (PEI). In the present embodiment, the first sealant component and the second sealant component are combined and mixed within a mixing chamber of the injection needle assembly <NUM>, as will be described in greater detail herein.

The pair of syringes <NUM> includes an actuator <NUM>, a first component chamber 112A, and a second component chamber 112B. The first component chamber 112A may be, for example, a cylindrical tube that is configured to carry the first sealant component of the multi- component sealant. The first component chamber 112A has a first output port 112A-<NUM> (e.g., a first component port). The second component chamber 112B also may be, for example, a cylindrical tube that is configured to carry the second sealant component of the multi-component sealant. The second component chamber 112B has a second output port 112B-<NUM> (e.g., a second component port). In some aspects, the first component chamber 112A and the second component chamber 112B are arranged in a substantially longitudinally parallel arrangement.

In some aspects, the actuator <NUM> includes a first piston 114A, a second piston 114B, and a handle <NUM>. The handle <NUM> is in the form of a link member that perpendicularly extends between, and is connected to, each of the first piston 114A and the second piston 114B to facilitate simultaneous movement of the first piston 114A and the second piston 114B with the depression or retraction of the handle <NUM>. The first piston 114A is in the form of a plunger that is positioned in the first component chamber 112A proximal to the first sealant component, and the second piston 114B is in the form of a plunger that is positioned in the second component chamber 112B proximal to the second sealant component.

The first output port 112A-<NUM> of the first component chamber 112A and the second output port 112B-<NUM> of the second component chamber 112B may be arranged within the distal end <NUM>-<NUM> of the body <NUM> of the sealant applicator <NUM>. The first output port 112A-<NUM> and the second output port 112B-<NUM> are generally fluid outputs that are aligned with other ports of other components as described herein such that the first and second sealant components can be dispensed from and/or received within the respective component chambers 112A, 112B. In some aspects, the first output port 112A-<NUM> may be concentrically aligned with the first component chamber 112A and the second output port 112B-<NUM> may be concentrically aligned with the second component chamber 112B. However, in other aspects, such as the aspect depicted in <FIG>, the first output port 112A-<NUM> may be located radially inward of a central area of the first component chamber 112A and the second output port 112B-<NUM> may be located radially inward of a central area of the second component chamber 112B such that the first output port 112A-<NUM> and the second output port 112B-<NUM> are as close as possible to a center axis C1 of the body <NUM> of the sealant applicator <NUM> to facilitate alignment with the other components of the sealant delivery system <NUM> described herein.

Turning to <FIG>, <FIG>, the body <NUM> of the sealant applicator <NUM> further includes a quarter turn connector <NUM> integrated with the distal end <NUM>-<NUM> of the sealant applicator <NUM>. More specifically, as depicted in <FIG>, the various components of the quarter turn connector <NUM> are integrated with the body <NUM> such that the quarter turn connector <NUM> and the body <NUM> are a single monolithic piece. However, it should be understood that this is merely illustrative and the various components of the quarter turn connector <NUM> may be separate pieces that are permanently or semi-permanently joined with the body <NUM> of the sealant applicator <NUM> (e.g., permanently or semi-permanently joined with a distal coupling piece <NUM> of the sealant applicator <NUM>).

The quarter turn connector <NUM> is generally located at the distal end <NUM>-<NUM> of the body <NUM> of the sealant applicator such that various components of the quarter turn connector <NUM> are positioned adjacent to first output port 112A-<NUM> and the second output port 112B-<NUM>. As will be described herein, the quarter turn connector <NUM> is generally shaped and sized to releasably interlock with a corresponding quarter turn connector <NUM> of the dual chamber mixing syringe <NUM> and/or with a corresponding quarter turn connector <NUM> of the injection needle assembly <NUM>. As will be described in greater detail herein, when the injection needle assembly <NUM> or the dual chamber mixing syringe <NUM> is coupled to the sealant applicator <NUM> via the quarter turn connectors <NUM>, <NUM>, <NUM> thereof, the various ports thereof are aligned and sealed with the first output port 112A-<NUM> and the second output port 112B-<NUM> of the sealant applicator <NUM>.

Still referring to <FIG>, <FIG>, the quarter turn connector <NUM> of the sealant applicator includes a circular protrusion <NUM> extending distally (e.g., in the -x direction of the coordinate axes of <FIG>) from the distal end <NUM>-<NUM> of the sealant applicator <NUM>, a semi-circular channel <NUM> (<FIG>) disposed within the distal end <NUM>-<NUM> of the sealant applicator <NUM> along a periphery of the circular protrusion <NUM>, and a pair of bayonet coupling members (e.g., a first coupling member 306A and a second coupling member 306B) disposed radially outward of the circular protrusion <NUM> and the semi-circular channel <NUM>. As shown in <FIG>, <FIG>, the first output port 112A-<NUM> and the second output port 112B-<NUM> are disposed within the circular protrusion <NUM>. That is, the openings into the first component chamber 112A and the second component chamber 112B are located on the circular protrusion <NUM>.

The circular protrusion <NUM> is generally shaped and sized to correspond to a recess formed in the injection needle assembly <NUM> and the dual chamber mixing syringe <NUM>, as described in greater detail herein. The circular protrusion may generally be disposed in or around a central area of the distal end <NUM>-<NUM> of the body <NUM>. In some embodiments, the circular protrusion <NUM> may be concentric with the body such that the center axis C1 of the body <NUM> extends through a center of the circular protrusion <NUM>. The distance that the circular protrusion <NUM> extends away from the distal end <NUM>-<NUM> of the body is generally a distance that corresponds to a depth of the recess formed in the injection needle assembly <NUM> and the dual chamber mixing syringe <NUM> such that the circular protrusion <NUM> can be completely inserted therein, but is otherwise not limited by the present disclosure.

As particularly depicted in <FIG>, the semi-circular channel <NUM> is disposed around the periphery of the circular protrusion <NUM> such that the semi-circular channel <NUM> defines an outer edge of half of the circular protrusion <NUM>. That is, the semi-circular channel <NUM> extends from a first side (e.g., in the +y direction of the coordinate axes of <FIG>) around the perimeter of the circular protrusion <NUM> to a second side (e.g., in the -y direction of the coordinate axes of <FIG>). The semi-circular channel <NUM> is generally shaped and sized to receive a quarter circular extension <NUM> (<FIG>) of the corresponding quarter turn connector <NUM> of the dual chamber mixing syringe <NUM> (<FIG>) or the quarter circular extension <NUM> of the corresponding quarter turn connector <NUM> of the injection needle assembly <NUM>, as described in greater detail herein. While the aspects depicted in <FIG> depict the semi-circular channel <NUM> as extending a full semi-circle, the present disclosure is not limited to such. That is, the semi-circular channel <NUM> may completely surround the circular protrusion <NUM> in other aspects (e.g., a full circular channel) or may only surround a portion of the circular protrusion <NUM> to an extent that is lesser than or greater than the semi-circular aspect depicted in <FIG> (e.g., a quarter circular channel or the like). However, it should be understood that, to ensure appropriate keying such that the various components of the sealant delivery system <NUM> (<FIG>) are appropriately aligned and rotatable via the respective quarter turn connectors <NUM>, <NUM>, <NUM>, the channel corresponds in size to the size of the extensions.

Referring again to <FIG>, <FIG>, the first coupling member 306A and the second coupling member 306B each extend from the distal end <NUM>-<NUM> of the body <NUM> of the sealant applicator <NUM> and are generally shaped and sized to retain the dual chamber mixing syringe <NUM> or the injection needle assembly <NUM> when coupled to the sealant applicator <NUM>. Each of the first coupling member 306A and the second coupling member 306B may be a bayonet style coupling member, an L-beam coupling member, or the like. For example, as particularly depicted in <FIG>, the first coupling member 306A extends distally at a particular distance from the distal end <NUM>-<NUM> of the body <NUM>, turns about <NUM> degrees, and extends inward toward the center axis C1 of the body <NUM>, resulting in a first extension piece 306A-<NUM> that extends in a direction generally coplanar with the center axis C1 of the body <NUM> (e.g., along the x-axis of the coordinate axes of <FIG>, <FIG>) and a second extension piece 306A-<NUM> that extends in a direction that is generally perpendicular to the center axis C1 of the body (e.g., along the z-axis of the coordinate axes of <FIG>, <FIG>), thereby defining a pocket 307A between the distal end <NUM>-<NUM> of the body <NUM> and the second extension piece 306A-<NUM>. Similarly, the second coupling member 306B extends distally at a particular distance from the distal end <NUM>-<NUM> of the body <NUM>, turns about <NUM> degrees, and extends inward toward the center axis C1 of the body <NUM>, resulting in a first extension piece 306B-<NUM> that extends in a direction generally coplanar with the center axis C1 of the body <NUM> (e.g., along the x-axis of the coordinate axes of <FIG>, <FIG>) and a second extension piece 306B-<NUM> that extends in a direction that is generally perpendicular to the center axis C1 of the body <NUM> (e.g., along the z-axis of the coordinate axes of <FIG>, <FIG>), thereby defining a pocket 307B between the distal end <NUM>-<NUM> of the body <NUM> and the second extension piece 306B-<NUM>.

As depicted in <FIG>, <FIG>, the first coupling member 306A and the second coupling member 306B are located opposite one another, radially outward of the circular protrusion <NUM> and the semi-circular channel <NUM>. However, this is merely illustrative, and other locations and spacing are contemplated and included within the scope of the present disclosure. Further, while the present aspect includes a pair of coupling members (e.g., the first coupling member 306A and the second coupling member 306B), this is also merely illustrative. That is, other amounts of coupling members are also contemplated and included within the scope of the present disclosure.

Turning now to <FIG> and <FIG>, the dual chamber mixing syringe <NUM> generally includes a body <NUM> having a distal end <NUM>-<NUM> and a proximal end <NUM>-<NUM> spaced a distance apart from the distal end <NUM>-<NUM>. The body <NUM> also defines a pair of syringes <NUM>.

As described above, the first pair of syringes <NUM> is configured having the first component chamber 112A, the second component chamber 112B, and the actuator <NUM> having the first piston 114A and the second piston 114B. However, initially (e.g., as a deliverable from the manufacturer), the first component chamber 112A does not yet contain the prepared first sealant component and the second component chamber 112B does not yet contain the prepared second sealant component. Rather, initially, the first component chamber 112A initially contains a powder or solution component of the first sealant component of the multi-component sealant, and the second component chamber 112B initially contains a powder or solution component of the second sealant component of the multi-component sealant. As used herein, each solution forming component is a solute and solvent combination, and may include, for example, a suspension or hydrogel.

The second pair of syringes <NUM> includes an actuator <NUM>, a first mixing chamber 122A having a first mixing port 122A-<NUM>, and a second mixing chamber 122B having a second mixing port 122B-<NUM>. In some aspects, the first mixing chamber 122A and the second mixing chamber 122B are arranged in a substantially longitudinally parallel arrangement.

The actuator <NUM> includes a third piston 124A, a fourth piston 124B, and a handle <NUM>. The handle <NUM> is in the form of a link member that perpendicularly extends between, and is connected to, each of third piston 124A and fourth piston 124B to facilitate simultaneous movement of the third piston 124A and the fourth piston 124B with the depression or retraction of the handle <NUM>. The third piston 124A is in the form of a plunger that is positioned in the first mixing chamber 122A and the fourth piston 124B is in the form of a plunger that is positioned in the second mixing chamber 122B. The first mixing chamber 122A initially contains a fluid component of the first sealant component of the multi-component sealant, and the second mixing chamber 122B initially contains a fluid component of the second sealant component of the multi-component sealant. As used herein, each of the fluid component within the first mixing chamber 122A and/or the fluid component within the second mixing chamber 122B may be, or include, water or some other liquid.

The first mixing port 122A-<NUM> of the first mixing chamber 122A and the second mixing port 122B-<NUM> of the second mixing chamber 122B may be arranged within a proximal end <NUM>-<NUM> of the body <NUM> of the dual chamber mixing syringe <NUM>. The first mixing port 122A-<NUM> and the second mixing port 122B-<NUM> are generally fluid outputs that are aligned with other ports of other components as described herein such that the respective fluid components initially within the mixing chambers 122A, 122B can be dispensed from and/or received (with the powder or solution initially within the component chambers 112A, 112B) within the respective mixing chambers 122A, 122B. In some aspects, the first mixing port 122A-<NUM> may be concentrically aligned with the first mixing chamber 122A and the second mixing port 122B-<NUM> may be concentrically aligned with the second mixing chamber 122B. However, in other aspects, such as the aspect depicted in <FIG>, the first mixing port 122A-<NUM> may be located radially inward of a central area of the first mixing chamber 122A and the second mixing port 122B-<NUM> may be located radially inward of a central area of the second mixing chamber 122B such that the first mixing port 122A-<NUM> and the second mixing port 122B-<NUM> are as close as possible to a center axis C2 of the body <NUM> of the dual chamber mixing syringe <NUM> to facilitate alignment with the other components of the sealant delivery system <NUM> described herein.

Still referring to <FIG> and <FIG>, the corresponding quarter turn connector <NUM> of the dual chamber mixing syringe <NUM> includes a circular recess <NUM> sized to receive the circular protrusion <NUM> on the distal end <NUM>-<NUM> of the sealant applicator <NUM> and a ramped lip <NUM> extending radially outward of the circular recess <NUM>. In some aspects, the corresponding quarter turn connector <NUM> of the dual chamber mixing syringe <NUM> may further include a quarter circular extension (not shown) that extends proximally (e.g., in the +x direction of the coordinate axes of <FIG>) from the ramped lip <NUM>.

The circular recess <NUM> is generally a recess that is defined by a wall <NUM> extending proximally (e.g., in the +x direction of the coordinate axes of <FIG>) from the proximal end <NUM>-<NUM> of the body <NUM> of the dual chamber mixing syringe <NUM>. The wall <NUM> extends around the center axis C2 of the body <NUM> of the dual chamber mixing syringe <NUM> to form the circular recess <NUM>. The wall <NUM> may be shaped and sized such that the circular recess <NUM> formed thereby corresponds to the shape and size of the circular protrusion <NUM> of the sealant applicator <NUM>. In some aspects, the wall <NUM> may be an extension of side walls of the body <NUM> of the dual chamber mixing syringe <NUM>.

The plurality of mixing ports 122A-<NUM>, 122B-<NUM> extend out of the proximal end <NUM>-<NUM> of the body <NUM> of the dual chamber mixing syringe <NUM> within the circular recess <NUM>. That is, the circular recess <NUM> includes the plurality of mixing ports 122A-<NUM>, 122B-<NUM> therein. In some aspects, the circular recess <NUM> may include one or more features (e.g., additional recesses, retention pieces, channels, etc.) that are adapted to hold at least one seal (e.g., a sealing element or the like) around the plurality of mixing ports 122A-<NUM>, 122A-<NUM>. For example, a first seal 126A may be held within the circular recess <NUM> around the first mixing port 122A-<NUM> and a second seal 126B may be held within the circular recess <NUM> around the second mixing port 122B-<NUM>. The seals 126A, 126B may each be any seal that allows the dual chamber mixing syringe <NUM> to form a seal with the sealant applicator <NUM> when brought together as described herein such that the first mixing port 122A-<NUM> is joined and sealed with the first output port 112A-<NUM> (e.g., to form a fluid coupling between the first mixing port 122A-<NUM> and the first output port 112A-<NUM>) and the second mixing port 122B-<NUM> is joined and sealed with the second output port 112B-<NUM> (e.g., to form a fluid coupling between the second mixing port 122B-<NUM> and the second output port 112B-<NUM>). For example, the seals may be O-rings, stadium shaped seals, oval seals, and/or the like. While a single seal is depicted herein for each port, the present disclosure is not limited to such. For example, a single seal, such as a figure eight shaped gasket or the like, may be used to individually seal the ports as described herein. However, it should be understood that the ports (e.g., the first mixing port 122A-<NUM> and the second mixing port 122B-<NUM>) remain sealed from one another to avoid cross contamination of the components within the respective mixing chambers 122A, 122B. It should also be understood that the term "seal" is not meant to be limiting, and may encompass any type of sealing element, sealing device, or the like.

The ramped lip <NUM> is generally formed by the wall <NUM> that defines the circular recess <NUM>. That is, the ramped lip <NUM> generally extends radially outward from the wall <NUM>. The ramped lip <NUM> shaped and sized to be received and retained by the pair of coupling members 306A, 306B when the corresponding quarter turn connector <NUM> is rotated relative to the quarter turn connector <NUM>, as described herein. That is, the ramped lip <NUM> has a first thickness (e.g., as defined along the x-axis of the coordinate axes of <FIG>) at one or more first portions thereof, which gradually increases to a second thickness (e.g., as defined along the x-axis of the coordinate axes of <FIG>) at one or more second portions thereof to allow for compressed holding of the ramped lip <NUM> by the pair of coupling members 306A, 306B within the pockets 307A, 307B thereof. In some aspects, the ramped lip may extend around an entire periphery of the wall <NUM>. In other aspects, the ramped lip may extend only around a portion of the periphery of the wall <NUM>. In such aspects, a plurality of ramped lips may be used.

While not depicted, in some aspects, the quarter circular extension may extend proximally from the ramped lip <NUM>. The quarter circular extension shaped to be received within the semi-circular channel <NUM> (<FIG>) and slidable within the semi-circular channel <NUM> (<FIG>) in a quarter turn motion from an unlocked state to a locked state. The arc length of such a quarter circular extension may correspond to the length of the semi-circular channel <NUM> such that, when the quarter circular extension is inserted into the semi-circular channel <NUM> and turned, the respective lengths prevent more than a quarter turn rotation.

In some aspects, the corresponding quarter turn connector <NUM> further includes a pair of stops <NUM> (only one depicted in <FIG>). Each one of the pair of stops <NUM> extends distally (e.g., in the -x direction of the coordinate axes of <FIG>, toward the distal end <NUM>-<NUM> of the body <NUM>) from the ramped lip <NUM>. Each one of the pair of stops <NUM> is aligned on the corresponding quarter turn connector <NUM> such that the pair of stops <NUM> contact the coupling members 306A, 306B during a quarter turn rotating motion to hinder further rotational movement of the corresponding quarter turn connector <NUM> relative to the quarter turn connector <NUM> beyond a quarter rotation. It should be understood that any number of stops may be used, though the number of stops generally corresponds to the same number of coupling members (or less than the number of coupling members). For example, if the quarter turn connector <NUM> includes two coupling members 306A, 306B, the corresponding quarter turn connector <NUM> may include one stop <NUM> or two stops <NUM>. In some aspects, the pair of stops <NUM> may extend radially outward from the wall <NUM> and may not be connected to the ramped lip <NUM>.

Referring now to <FIG> and <FIG>, the injection needle assembly <NUM> has a proximal end <NUM>-<NUM> that extends proximally (in the +x direction of the coordinate axes of <FIG>) and a distal end <NUM>-<NUM> that extends distally (e.g., in the -x direction of the coordinate axes of <FIG>). The injection needle assembly <NUM> generally includes a hub <NUM> and an elongate hollow stylet <NUM> that extends distally (e.g., in the -x direction of the coordinate axes of <FIG>) from hub <NUM>. The elongate hollow stylet <NUM> has a proximal end <NUM>-<NUM> and a distal end <NUM>-<NUM>. The hub <NUM> is fixedly attached, e.g., through overmolding, adhesive and/or pressed fit, to the proximal end <NUM>-<NUM> of the elongate hollow stylet <NUM>. The hub <NUM> includes a plurality of input ports (e.g., a first input port 132A-<NUM> and a second input port 132B-<NUM>) of the injection needle assembly <NUM>. The hub <NUM> is configured for removable connection to the sealant applicator <NUM> via the corresponding quarter turn connector <NUM> such that, when connected, the first input port 132A-<NUM> of the injection needle assembly <NUM> is aligned and sealed with the first output port 112A-<NUM> of the sealant applicator <NUM> and the second input port 132B-<NUM> of the injection needle assembly <NUM> is aligned and sealed with the second output port 112B-<NUM> of the sealant applicator <NUM>, as described in greater detail herein.

The elongate hollow stylet <NUM> of injection needle assembly <NUM> is configured to facilitate fluid communication with the plurality of output ports 112A-<NUM>, 112B-<NUM> of the sealant applicator <NUM> so as to receive the two components of the multi-component sealant from sealant applicator <NUM> and direct the two components to the distal end <NUM>-<NUM> thereof for mixing and delivery. Referring briefly to <FIG>, the distal end <NUM>-<NUM> has a closed distal end <NUM> and a plurality of side ports <NUM> (e.g., two, three, or more) proximal to the closed distal end <NUM>. The closed distal end <NUM> of the elongate hollow stylet <NUM> may be, for example, a closed stylet needle tip <NUM>.

Referring to <FIG>, <FIG>, and <FIG>, the elongate hollow stylet <NUM> may be constructed, for example, by an elongate cannula <NUM> being fixedly connected to the closed stylet needle tip <NUM>, with the plurality of side ports <NUM> being located in the elongate cannula <NUM> in a distal chamber <NUM> thereof that is immediately proximal to the closed stylet needle tip <NUM>. More particularly, the elongate cannula <NUM> of the elongate hollow stylet <NUM> defines an outer side wall <NUM> that surrounds an outer lumen <NUM> of the elongate hollow stylet <NUM>. In addition, located within the outer lumen <NUM> of the elongate cannula <NUM> is an inner side wall <NUM> that surrounds an inner lumen <NUM>, the inner lumen being concentric with the outer lumen such that a passageway is defined between the inner side wall <NUM> and the outer side wall <NUM>. Furthermore, a distal opening <NUM>-<NUM> of the outer lumen <NUM> and a distal opening <NUM>-<NUM> of the inner lumen <NUM> are open to the distal chamber <NUM> of the elongate hollow stylet <NUM>.

Referring to <FIG> and <FIG>, the hub <NUM> may further include a plurality of passageways therein for fluidly coupling the first input port 132A-<NUM> and the second input port 132B-<NUM> to the distal chamber <NUM>. For example, in some aspects, a first channel 142A may couple the first input port 132A-<NUM> to the outer lumen <NUM> by extending through the hub <NUM> from the first input port 132A-<NUM> to the outer lumen <NUM>. In another example, a second channel 142B may couple the second input port 132B-<NUM> to the inner lumen <NUM> by extending through the hub <NUM> from the second input port 132B-<NUM> to the inner lumen <NUM>. The positioning of the first channel 142A and the second channel 142B may be dependent on a location of the first input port 132A-<NUM> and the second input port 132B-<NUM>. For example, in the aspect depicted in <FIG> and <FIG>, the first input port 132A-<NUM> and the second input port 132B-<NUM> are spaced to be aligned with the output ports 112A-<NUM>, 112B-<NUM> of the sealant applicator <NUM>. As such, the first input port 132A-<NUM> and the second input port 132B-<NUM> are generally spaced the same distance radially outward from the center axis C3 of the injection needle assembly <NUM>. In such an aspect, the first channel 142A may extend longitudinally toward the distal end <NUM>-<NUM> of the injection needle assembly <NUM> (e.g., parallel with the center axis C3 of the needle assembly) and couple to the outer lumen near a distal end of the hub <NUM>. The second channel 142B may extend at an angle with respect to the center axis C3 from the second input port 132B-<NUM> to the inner lumen <NUM>. However, it should be understood that the present disclosure is not limited to such. For example, in another aspect, as depicted in <FIG>, an alternative first channel 842A may have a first channel portion 842A-<NUM> that extends longitudinally through the alternative hub <NUM>' and a second channel portion 842A-<NUM> that extends laterally (e.g., transverse to the first channel portion 842A-<NUM>) to fluidly couple the first input port 132A-<NUM> to the outer lumen <NUM>. An alternative second input port 132B-<NUM>' may be located at the center of the alternative hub <NUM>' and an alternative second channel 842B may extend longitudinally from the alternative second input port 132B-<NUM>' to the inner lumen <NUM>.

Referring again to <FIG> and <FIG>, the plurality of side ports <NUM> radially extend from the distal chamber <NUM> and through the outer side wall <NUM> of the elongate hollow stylet <NUM> at the distal end <NUM>-<NUM> thereof. The closed stylet needle tip <NUM> is defined, at least in part, by the closed distal end <NUM> of the elongate hollow stylet <NUM>. The closed stylet needle tip <NUM> is attached (e.g., welded, press fit, or with adhesive) to the elongate cannula <NUM> to distally close the distal chamber <NUM> of the elongate cannula <NUM> of the elongate hollow stylet <NUM>. That is, the closed stylet needle tip <NUM> terminates a distal extent of the distal chamber <NUM> of the elongate hollow stylet <NUM>. When the delivery apparatus <NUM> (<FIG>) is assembled, the plurality of side ports <NUM> are in fluid communication with the plurality of output ports 112A-<NUM>, 112B-<NUM> of the sealant applicator <NUM> by way of the plurality of input ports 132A-<NUM>, 132B-<NUM>, the outer lumen <NUM>, the inner lumen <NUM>, and the distal chamber <NUM> of the elongate hollow stylet <NUM>.

In some aspects, as particularly shown in <FIG>, the plurality of side ports <NUM> in the distal end <NUM>-<NUM> of elongate hollow stylet <NUM> includes a first side port 134A, a second side port 134B, and a third side port (not shown), which are located in the closed distal end <NUM> and arranged, e.g., in a ring pattern, around a perimeter of elongate hollow stylet <NUM>, such as, for example, in <NUM> degree increments. In one application, for example, the plurality of side ports <NUM> include at least three side ports (e.g., <NUM> to <NUM> side ports) to have the at least three side ports near, but proximal to, the closed stylet needle tip <NUM> such that the flowable multi-component sealant may be delivered <NUM> degrees around elongate hollow stylet <NUM>, so as to seal around the perforation/close to the perforation created by the closed stylet needle tip <NUM>. As another example, it is contemplated that in some applications it may be desirable to have the plurality of side ports <NUM> configured as two, or two pairs, of diametrically opposed side ports.

Optionally, it is further contemplated that the plurality of side ports <NUM> may include at least two longitudinally spaced side ports, such as for example, a side port longitudinally spaced (e.g. <NUM> to <NUM> millimeters) proximal to another side port. For example, the plurality of side ports <NUM> may include two rings of three side ports arranged around a perimeter of elongate hollow stylet <NUM>, wherein the two rings of three side ports are longitudinally spaced in the distal end <NUM>-<NUM> of the elongate hollow stylet <NUM>.

In an embodiment, these features of the injection needle assembly <NUM> (e.g., the elongate hollow stylet <NUM> including the inner lumen <NUM>, the outer lumen <NUM>, the distal chamber <NUM>, and the plurality of side ports <NUM> may advantageously result in an assembly that separately delivers the separate components of the multi-component sealant to the point where the sealant is to be applied such that the components are not mixed together until they reach the point where the sealant is to be applied, thereby avoiding issues relating to clogging or the like.

The injection needle assembly <NUM> may be used in conjunction with the introducer cannula <NUM> (also sometimes referred to in the art as a coaxial introducer needle) to allow elongate hollow stylet <NUM> to be removed from the introducer cannula <NUM>, while maintaining access to the procedure site with the coaxial introducer needle. That is, the delivery apparatus <NUM> may be removed from the introducer cannula <NUM> and replaced with a variety of other instruments, such as a biopsy device or another stylet. In some aspects, the introducer cannula <NUM> has a coaxial hub <NUM>, a coaxial cannula <NUM>, a cannula lumen <NUM> and a distal annular rim <NUM>. The cannula lumen <NUM>, for example, is configured (e.g., having a cylindrical shape) to receive the elongate hollow stylet <NUM> of the injection needle assembly <NUM>. When the elongate hollow stylet <NUM> of the injection needle assembly <NUM> is fully inserted into the cannula lumen <NUM> of the introducer cannula <NUM> (e.g., distal movement of the elongate hollow stylet <NUM> is stopped by contact of the hub <NUM> of the injection needle assembly <NUM> with the coaxial hub <NUM> of the introducer cannula <NUM>, the plurality of side ports <NUM> of the elongate hollow stylet <NUM> are located distal to the distal annular rim <NUM> of the introducer cannula <NUM>. That is, the distal end <NUM>-<NUM> of the elongate hollow stylet <NUM> extends beyond the distal annular rim <NUM> such that the introducer cannula <NUM> does not block the plurality of side ports <NUM>.

Referring to <FIG> and <FIG>, the corresponding quarter turn connector <NUM> of the injection needle assembly <NUM> includes a circular recess <NUM> sized to receive the circular protrusion <NUM> on the distal end <NUM>-<NUM> of the sealant applicator <NUM> and a ramped lip <NUM> extending radially outward of the circular recess <NUM>. In some aspects, the corresponding quarter turn connector <NUM> of the injection needle assembly <NUM> may further include a quarter circular extension <NUM> (<FIG>) that extends proximally (e.g., in the +x direction of the coordinate axes of <FIG>) from the ramped lip <NUM>.

The circular recess <NUM> is generally a recess that is defined by a wall <NUM> extending proximally (e.g., in the +x direction of the coordinate axes of <FIG>) from a proximal end <NUM>-<NUM> of the injection needle assembly <NUM> (e.g., extending proximally from the hub <NUM> of the injection needle assembly <NUM>). The wall <NUM> extends around the center axis C3 of the injection needle assembly <NUM> to form the circular recess <NUM>. The wall <NUM> may be shaped and sized such that the circular recess <NUM> formed thereby corresponds to the shape and size of the circular protrusion <NUM> of the sealant applicator <NUM>. In some aspects, the wall <NUM> may be an extension of side walls of the hub <NUM> of the injection needle assembly <NUM>.

The plurality of input ports 132A-<NUM>, 132B-<NUM> extend out of the proximal end <NUM>-<NUM> of the injection needle assembly <NUM> within the circular recess <NUM>. That is, the circular recess <NUM> includes the plurality of input ports 132A-<NUM>, 132B-<NUM> therein. In some aspects, the circular recess <NUM> may include one or more features (e.g., additional recesses, retention pieces, channels, etc.) that are adapted to hold at least one seal around the plurality of input ports 132A-<NUM>, 132B-<NUM>. For example, a first seal 136A may be held within the circular recess <NUM> around the first input port 132A-<NUM> and a second seal 136B may be held within the circular recess <NUM> around the second input port 132B-<NUM>. The seals 136A, 136B may each be any seal that allows the injection needle assembly <NUM> to form a seal with the sealant applicator <NUM> when brought together as described herein such that the first input port 132A-<NUM> is joined and sealed with the first output port 112A-<NUM> (e.g., to form a fluid coupling between the first input port 132A-<NUM> and the first output port 112A-<NUM>) and the second input port 132B-<NUM> is joined and sealed with the second output port 112B-<NUM> (e.g., to form a fluid coupling between the second input port 132B-<NUM> and the second output port 112B-<NUM>). For example, the seals may be O-rings, stadium shaped seals, oval seals, and/or the like. While a single seal is depicted herein for each port, the present disclosure is not limited to such. For example, a single seal, such as a figure eight shaped gasket or the like, may be used to individually seal the ports as described herein. However, it should be understood that the ports (e.g., the first input port 132A-<NUM> and the second input port 132B-<NUM>) remain sealed from one another to avoid premature combining of components prior to reaching the distal chamber <NUM> (<FIG>).

Still referring to <FIG>, <FIG>, and <FIG>, the ramped lip <NUM> is generally formed by the wall <NUM> that defines the circular recess <NUM>. That is, the ramped lip <NUM> generally extends radially outward from the wall <NUM>. The ramped lip <NUM> is shaped and sized to be received and retained by the pair of coupling members 306A, 306B when the corresponding quarter turn connector <NUM> is rotated relative to the quarter turn connector <NUM>, as described herein. That is, the ramped lip <NUM> has a first thickness (e.g., as defined along the x-axis of the coordinate axes of <FIG>) at one or more first portions thereof, which gradually increases to a second thickness (e.g., as defined along the x-axis of the coordinate axes of <FIG>) at one or more second portions thereof to allow for compressed holding of the ramped lip <NUM> by the pair of coupling members 306A, 306B within the pockets 307A, 307B thereof. In some aspects, the ramped lip <NUM> may extend around an entire periphery of the wall <NUM>. In other aspects, the ramped lip may extend only around a portion of the periphery of the wall <NUM>. In such aspects, a plurality of ramped lips may be used.

In some aspects, the quarter circular extension <NUM> may extend proximally from the ramped lip <NUM>. The quarter circular extension <NUM> is shaped to be received within the semi-circular channel <NUM> (<FIG>) and slidable within the semi-circular channel <NUM> (<FIG>) in a quarter turn motion from an unlocked state to a locked state. The arc length of such a quarter circular extension <NUM> may correspond to the length of the semi-circular channel <NUM> such that, when the quarter circular extension <NUM> is inserted into the semi-circular channel <NUM> and turned, the respective lengths prevent more than a quarter turn rotation.

In some aspects, the corresponding quarter turn connector <NUM> further includes a pair of stops <NUM> (only one depicted in <FIG>). Each one of the pair of stops <NUM> extends distally (e.g., in the -x direction of the coordinate axes of <FIG>, toward the distal end <NUM>-<NUM> of the injection needle assembly <NUM>) from the ramped lip <NUM>. Each one of the pair of stops <NUM> is aligned on the corresponding quarter turn connector <NUM> such that the pair of stops <NUM> contact the coupling members 306A, 306B during a quarter turn rotating motion to hinder further rotational movement of the corresponding quarter turn connector <NUM> relative to the quarter turn connector <NUM> beyond a quarter rotation. It should be understood that any number of stops may be used, though the number of stops generally corresponds to the same number of coupling members (or less than the number of coupling members). For example, if the quarter turn connector <NUM> includes two coupling members 306A, 306B, the corresponding quarter turn connector <NUM> may include one stop <NUM> or two stops <NUM>. In some aspects, the pair of stops <NUM> may extend radially outward from the wall <NUM> and may not be connected to the ramped lip <NUM>.

In an embodiment, the features of the quarter turn connectors <NUM>, <NUM>, <NUM> may advantageously result in a structure that allows a user to quickly connect and subsequently disconnect components (e.g., the sealant applicator <NUM> with the dual chamber mixing syringe <NUM> and the needle assembly <NUM>) in such a manner that a user can easily confirm that components are correctly sealed and aligned with one another to ensure the correct materials held within are mixed together and then subsequently delivered to a site on a subject. This improvement is shown in the quarter turn operation of the various components of the sealant delivery system <NUM> (<FIG>) is depicted in <FIG>. While <FIG> depict a coupling of the corresponding quarter turn connector <NUM> of the injection needle assembly <NUM> (<FIG>), it should be understood that the quarter turn connector <NUM> of the dual chamber mixing syringe <NUM> may function in a similar manner. As shown in <FIG>, the corresponding quarter turn connector <NUM> and the quarter turn connector <NUM> are brought together. Initially, the pair of coupling members 306A, 306B are not engaged with the ramped lip <NUM> (e.g., the ramped lip <NUM> is not received within the pockets 307A, 307B. Referring to <FIG>, as the corresponding quarter turn connector <NUM> is rotated relative to the quarter turn connector <NUM> (e.g., by rotating one or both of the corresponding quarter turn connector <NUM> and the quarter turn connector <NUM>), the ramped lip <NUM> begins to engage with the coupling members 306A, 306B by sliding into the pockets 307A, 307B thereof. This motion continues until the stops <NUM> prevent further rotational movement due to contact with the coupling members 306A, 306B (e.g., as shown in <FIG>), at which point the output ports 112A-<NUM>, 112B-<NUM> are appropriately aligned and sealed with the input ports (not shown). It should be appreciated that, given the components described herein, the corresponding quarter turn connector <NUM> and the quarter turn connector <NUM> can only be aligned in one particular manner with respect to each other, thereby avoiding issues related to misalignment or incorrect alignment.

As a result of the quarter turn operation depicted in <FIG>, the various ports are appropriately arranged and sealed with respect to one another to ensure that materials can pass through without leakage. For example, as depicted in <FIG>, as a result of coupling via the respective quarter turn connectors <NUM>, <NUM>, the first output port 112A-<NUM> is aligned and sealed with the first mixing port 122A-<NUM> using the seal 126A therebetween. In addition, the second output port 112B-<NUM> is aligned and sealed with the second mixing port 122B-<NUM> using the seal 126B therebetween. In another example, as depicted in <FIG>, as a result of coupling via the respective quarter turn connectors <NUM>, <NUM>, the first output port 112A-<NUM> is aligned and sealed with the first input port 132A-<NUM> using the seal 136A therebetween. In addition, the second output port 112B-<NUM> is aligned and sealed with the second input port 132B-<NUM> using the seal 136B therebetween. As a result, a fluid connection is achieved between the first output port 112A-<NUM> and the outer lumen <NUM> via the first input port 132A-<NUM> and the first channel 142A. Similarly, a fluid connection is achieved between the second output port 112B-<NUM> and the inner lumen <NUM> via the second input port 132B-<NUM> and the second channel 142B.

It should be understood that the various quarter turn connectors described herein with respect to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> are merely illustrative and other quarter turn connectors are also contemplated and included within the scope of the present disclosure. For example, other illustrative quarter turn connectors are depicted in FIGS.

Referring now to <FIG>, another illustrative quarter turn connector <NUM> disposed on the sealant applicator <NUM> is depicted. As shown in <FIG>, the quarter turn connector <NUM> includes a first arc shaped protrusion 702A, a second arc shaped protrusion 702B, one or more seal containment protrusions <NUM> and/or a pair of coupling members 706A, 706B.

The one or more seal containment protrusions <NUM> extend a distance distally (e.g., in the -x direction of the coordinate axes depicted in <FIG>) from the distal end <NUM>-<NUM> of the sealant applicator <NUM>. The one or more seal containment protrusions <NUM> are generally disposed around the output ports 112A-<NUM>, 112B-<NUM> and are shaped and sized to retain seals 736A, 736B therein such that the seals 736A, 736B surround the output ports 112A-<NUM>, 112B-<NUM>. Accordingly, the one or more seal containment protrusions <NUM> may generally be shaped and sized to correspond to the shape and size of the seals 736A, 736B such that the seals 736A, 736B can be press fit within the one or more seal containment protrusions <NUM>. In some aspects, the one or more seal containment protrusions <NUM> may be a single structure that is shaped and sized to hold the seals 736A, 736B, as generally depicted in <FIG>. In other aspects, the one or more seal containment protrusions <NUM> may be separate structures disposed around each of the output ports 112A-<NUM>, 112A-B to retain separate seals 736A, 736B therein. In some embodiments, the one or more seal containment protrusions <NUM> may be omitted. Rather, the seals 736A, 736B may be disposed within recesses, channels, or the like or may be fixedly attached to the distal end <NUM>-<NUM> of the sealant applicator <NUM> (e.g., via an adhesive, an attachment device, or the like). The seals 736A, 736B may be similar to the seals 136A, 136B (<FIG>) as previously discussed herein.

The first arc shaped protrusion 702A extends a distance distally (e.g., in the -x direction of the coordinate axes depicted in <FIG>) from the distal end <NUM>-<NUM> of the sealant applicator <NUM>. In addition, the first arc shaped protrusion 702A is generally disposed radially outward from the one or more seal containment protrusions <NUM>, the seals 736A. 736B, and the output ports 112A-<NUM>, 112B-<NUM>. The distance that the first arc shaped protrusion 702A extends from the distal end <NUM>-<NUM> of the sealant applicator <NUM> is generally the same or slightly less than that of the distance that the one or more seal containment protrusions <NUM> and/or the seals 736A, 736B such that, when the sealant applicator <NUM> is joined together with one of the other components described herein, the seals 736A, 736B are compressed between components to an extent that avoids leakage. However, it should be understood that the distance may also be longer in embodiments where the second arc shaped protrusion 702B is fit within a channel of a corresponding quarter turn connector. The first arc shaped protrusion 702A is generally shaped and sized to fit within a corresponding recess and rotate within the corresponding recess, as described in greater detail herein.

The second arc shaped protrusion 702B extends a distance distally (e.g., in the -x direction of the coordinate axes depicted in <FIG>) from the distal end <NUM>-<NUM> of the sealant applicator <NUM>. In addition, the second arc shaped protrusion 702B is generally disposed radially outward from the one or more seal containment protrusions <NUM>, the seals 736A. 736B, and the output ports 112A-<NUM>, 112B-<NUM>. In some aspects, the distance that the second arc shaped protrusion 702B extends from the distal end <NUM>-<NUM> of the sealant applicator <NUM> is generally the same or slightly less than that of the distance that the one or more seal containment protrusions <NUM> and/or the seals 736A, 736B such that, when the sealant applicator <NUM> is joined together with one of the other components described herein, the seals 736A, 736B are compressed between components to an extent that avoids leakage. However, it should be understood that the distance may also be longer in embodiments where the second arc shaped protrusion 702B is fit within a channel of a corresponding quarter turn connector. The second arc shaped protrusion 702B is generally shaped and sized to fit within a corresponding recess and rotate within the corresponding recess, as described in greater detail herein.

In some aspects, the second arc shaped protrusion 702B may include a tab <NUM> extending radially outward therefrom. That is, the tab <NUM> extends from the second arc shaped protrusion 702B in a radially outward direction. The tab <NUM> may generally be any shape and size, particularly a shape and size that can slide within a channel of a corresponding quarter turn connector and move from one end of the channel to another end of the channel, as described herein. In some aspects, the tab <NUM> may be particularly located to ensure appropriate alignment of the quarter turn connector <NUM> with a corresponding quarter turn connector, as described herein. It should be appreciated that the tab <NUM> may be omitted in some aspects.

The first coupling member 706A and the second coupling member 706B each extend from the distal end <NUM>-<NUM> of the sealant applicator <NUM> and are generally shaped and sized to retain the dual chamber mixing syringe <NUM> (<FIG>) or the injection needle assembly <NUM> (<FIG>) when coupled to the sealant applicator <NUM>. Still referring to <FIG>, each of the first coupling member 706A and the second coupling member 706B may be a bayonet style coupling member, an L-beam coupling member, or the like. For example, as particularly depicted in <FIG>, the first coupling member 706A extends distally at a particular distance from the distal end <NUM>-<NUM>, turns about <NUM> degrees, and extends inward toward the center of the sealant applicator <NUM>, resulting in a first extension piece 706A-<NUM> that extends in a direction generally coplanar with the center of the sealant applicator <NUM> (e.g., along the x-axis of the coordinate axes of <FIG>) and a second extension piece 706A-<NUM> that extends in a direction that is generally perpendicular to the center of the sealant applicator <NUM> (e.g., along the z-axis of the coordinate axes of <FIG>), thereby defining a pocket 707A between the distal end <NUM>-<NUM> and the second extension piece 706A-<NUM>. Similarly, the second coupling member 706B extends distally at a particular distance from the distal end <NUM>-<NUM> of the sealant applicator <NUM>, turns about <NUM> degrees, and extends inward toward the center of the sealant applicator <NUM>, resulting in a first extension piece 706B-<NUM> that extends in a direction generally coplanar with the center of the sealant applicator <NUM> (e.g., along the x-axis of the coordinate axes of <FIG>) and a second extension piece 706B-<NUM> that extends in a direction that is generally perpendicular to the center of the sealant applicator <NUM> (e.g., along the z-axis of the coordinate axes of <FIG>), thereby defining a pocket 707B between the distal end <NUM>-<NUM> of the sealant applicator <NUM> and the second extension piece 706B-<NUM>.

As depicted in <FIG>, the first coupling member 706A and the second coupling member 706B are located opposite one another, radially outward of the one or more seal containment protrusions <NUM>, the seals 736A. 736B, the output ports 112A-<NUM>, 112B-<NUM>, and/or the first and second arc shaped protrusions 702A, 702B. However, this is merely illustrative, and other locations and spacing are contemplated and included within the scope of the present disclosure. Further, while the present aspect includes a pair of coupling members (e.g., the first coupling member 706A and the second coupling member 706B), this is also merely illustrative. That is, other amounts of coupling members are also contemplated and included within the scope of the present disclosure. In some embodiments, the first coupling member 706A and the second coupling member 706B are aligned to in a direction that is transverse to the direction in which the tab <NUM> extends. For example, as shown in <FIG>, the tab <NUM> extends outwardly in the +y direction of the coordinate axes of <FIG>, whereas the first coupling member 706A and the second coupling member 706B are aligned with each other along the +z/-z directions of the coordinate axes of <FIG>. Such an alignment may provide, for example, appropriate alignment of components and a quarter turn rotation, as described in greater detail herein.

<FIG> also depict a notch <NUM> disposed on a side of the distal end <NUM>-<NUM> of the sealant applicator <NUM>. The notch <NUM> is generally provided as a visual indicator for verifying alignment of the quarter turn connector <NUM> with a corresponding quarter turn coupling member when joined. As such, the notch <NUM> may be particularly shaped, sized, and positioned to provide such a visual indicator. It should be understood that a notch is merely one illustrative example of a visual indicator that may be used. For example, other visual indicators such as indicia (numbers, words, arrows, and/or the like) that are embossed, formed, printed, attached (e.g., a sticker or the like) on the sealant applicator <NUM> may also be used.

Turning now to <FIG>, the corresponding quarter turn connector <NUM> located on the injection needle assembly is depicted. While <FIG> specifically show the quarter turn connector <NUM> of the injection needle assembly <NUM>, it should be understood that the dual chamber mixing syringe <NUM> (<FIG>) may also be similarly structured with the components depicted in <FIG>.

As shown in <FIG>, the corresponding quarter turn connector <NUM> of the injection needle assembly <NUM> includes a circular recess <NUM> sized to receive the first and second arc shaped protrusions 702A, 702B on the distal end <NUM>-<NUM> of the sealant applicator <NUM> (<FIG>) and a ramped lip <NUM> extending radially outward of the circular recess <NUM>.

The circular recess <NUM> is generally a recess that is defined by a wall <NUM> extending proximally (e.g., in the +x direction of the coordinate axes of <FIG>) from the proximal end <NUM>-<NUM> of the injection needle assembly <NUM> (e.g., extending proximally from the hub <NUM> of the injection needle assembly <NUM>). The wall <NUM> extends around the center axis C3 (<FIG>) of the injection needle assembly <NUM> to form the circular recess <NUM>. The wall <NUM> may be shaped and sized such that the circular recess <NUM> formed thereby corresponds to the shape and size of the first and second arc shaped protrusions 702A, 702B of the sealant applicator <NUM>. In some aspects, the wall <NUM> may be an extension of side walls of the hub <NUM> of the injection needle assembly <NUM>.

The plurality of input ports 132A-<NUM>, 132B-<NUM> extend out of the proximal end <NUM>-<NUM> of the injection needle assembly <NUM> within the circular recess <NUM>. That is, the circular recess <NUM> includes the plurality of input ports 132A-<NUM>, 132B-<NUM> therein. In some aspects, the circular recess <NUM> may include one or more features around the plurality of input ports 132A-<NUM>, 132B-<NUM>. For example, a platform within the circular recess <NUM> may extend out of the proximal end <NUM>-<NUM> of the injection needle assembly <NUM> around the input ports 132A-<NUM>, 132B-<NUM> such that a channel is disposed within the circular recess <NUM> surrounding at least a portion of the input ports 132A-<NUM>. 132B-<NUM>. Such a platform may provide a contact surface upon which the seals 736A, 736B (<FIG>) abut when the injection needle assembly <NUM> is joined with the sealant applicator <NUM> as described herein.

Still referring to <FIG>, the ramped lip <NUM> is generally formed by the wall <NUM> that defines the circular recess <NUM>. That is, the ramped lip <NUM> generally extends radially outward from the wall <NUM>. Referring also to <FIG>, the ramped lip <NUM> is shaped and sized to be received and retained by the pair of coupling members 706A, 706B when the corresponding quarter turn connector <NUM> is rotated relative to the quarter turn connector <NUM>, as described herein. That is, the ramped lip <NUM> has a first thickness (e.g., as defined along the x-axis of the coordinate axes of <FIG>) at one or more first portions thereof, which gradually increases to a second thickness (e.g., as defined along the x-axis of the coordinate axes of <FIG>) at one or more second portions thereof to allow for compressed holding of the ramped lip <NUM> by the pair of coupling members 706A, 706B within the pockets 707A, 707B thereof. In some aspects, the ramped lip <NUM> may extend around an entire periphery of the wall <NUM>. In other aspects, the ramped lip may extend only around a portion of the periphery of the wall <NUM>. In such aspects, a plurality of ramped lips may be used.

In some aspects, the corresponding quarter turn connector <NUM> may further include an arc shaped channel <NUM> disposed along a periphery of the circular recess <NUM>. That is, the arc shaped channel <NUM> may be disposed radially outward of the circular recess <NUM> and radially inward of the ramped lip <NUM>. In some aspects, the arc shaped channel <NUM> may be an extension of the circular recess <NUM>, may have the same depth as the circular recess <NUM>, and/or may not be divided from the circular recess <NUM>. In other aspects, the arc shaped channel <NUM> may have a different depth than a depth of the circular recess <NUM> (e.g., may be shallower or deeper than the depth of the circular recess <NUM>). Referring to <FIG> and <FIG>, the arc shaped channel <NUM> is otherwise generally shaped and sized to receive the tab <NUM> extending from the second arc shaped protrusion 702B. That is, the arc shaped channel <NUM> may be shaped to receive the tab <NUM> when the injection needle assembly <NUM> is joined with the sealant applicator <NUM> and further may be shaped such that, when the injection needle assembly <NUM> and/or the sealant applicator <NUM> are rotated with respect to one another, the tab <NUM> rotates within the arc shaped channel <NUM>. In some aspects, the arc shaped channel <NUM> may have an opening <NUM>-<NUM> on one end thereof to provide a visual indicator of the alignment of the tab prior to the rotating motion.

Referring to <FIG>, in some aspects, the corresponding quarter turn connector <NUM> further includes a pair of stops <NUM> (only one depicted in <FIG>). Each one of the pair of stops <NUM> extends distally (e.g., in the -x direction of the coordinate axes of <FIG>, toward the distal end <NUM>-<NUM> (<FIG>) of the injection needle assembly <NUM>) from the ramped lip <NUM>. Referring also to <FIG>, each one of the pair of stops <NUM> is aligned on the corresponding quarter turn connector <NUM> such that the pair of stops <NUM> contact the coupling members 706A, 706B during a quarter turn rotating motion to hinder further rotational movement of the corresponding quarter turn connector <NUM> relative to the quarter turn connector <NUM> beyond a quarter rotation. It should be understood that any number of stops may be used, though the number of stops generally corresponds to the same number of coupling members (or less than the number of coupling members). For example, if the quarter turn connector <NUM> includes two coupling members 706A, 706B, the corresponding quarter turn connector <NUM> may include one stop <NUM> or two stops <NUM>. In some aspects, the pair of stops <NUM> may extend radially outward from the wall <NUM> and may not be connected to the ramped lip <NUM>.

In some aspects, the corresponding quarter turn connector <NUM> may further include a notch <NUM> in a portion of the ramped lip <NUM>. The notch <NUM> is generally provided as a visual indicator for verifying alignment of the quarter turn connector <NUM> (<FIG>) with the corresponding quarter turn connector <NUM> when joined. For example, the notch <NUM> may align with the notch <NUM> (<FIG>) when the components are joined (e.g., after rotation to interlock the components). As such, the notch <NUM> may be particularly shaped, sized, and positioned to provide such a visual indicator. It should be understood that a notch is merely one illustrative example of a visual indicator that may be used. For example, other visual indicators such as indicia (numbers, words, arrows, and/or the like) that are embossed, formed, printed, attached (e.g., a sticker or the like) on the sealant applicator <NUM> may also be used.

Referring to <FIG>, in some embodiments, the corresponding quarter turn connector <NUM> further includes an extension piece <NUM> extending distally (e.g., in the -x direction of the coordinate axes of <FIG>) from a distally facing portion 754A (e.g., in the - x direction of the coordinate axes of <FIG>) of the ramped lip <NUM>. Referring also to <FIG>, the extension piece <NUM> is generally shaped, sized, and/or configured to contact one of the coupling members 706A, 706B (e.g., the second extension piece 706A-<NUM> of the first coupling member 706A or the second extension piece 706B-<NUM> of the second coupling member) when the injection needle assembly <NUM> is joined with the sealant applicator <NUM> and during a rotational movement of the corresponding quarter turn connector <NUM> relative to the quarter turn connector <NUM> and cause the coupling member 706A, 706B to flex radially outward and then snap back into place when the rotational movement is completed, providing a haptic and audible feedback mechanism that the corresponding quarter turn connector <NUM> and the quarter turn connector <NUM> are appropriately coupled. That is, the extension piece <NUM> is shaped and located relative to the various other components described herein so that the extension piece clears (e.g., moves out of contact with) the coupling member 706A, 706B at the point where the quarter turn movement has been completed, thereby causing the snapping back of the coupling member 706A, 706B. In an embodiment, use of this feature (e.g., the extension piece <NUM>) may advantageously result in feedback being provided to the user such that the user is provided with extra confirmation that the components are correctly connected and aligned via the quarter turn connectors.

Referring again to <FIG>, the other illustrative hub <NUM>' is depicted. The hub <NUM>', similar to the hub depicted in <FIG>, <FIG>, and <FIG>, includes a corresponding quarter turn connector <NUM> that includes a circular recess <NUM> defined by a wall <NUM>, a ramped lip <NUM>, a pair of stops 808A, 808B, and quarter circular protrusion <NUM>. Such components are similar to the components previously described herein and are not discussed further herein for the purposes of brevity. However, as previously noted, the second input port 132B-<NUM>' is centrally located in the alternative hub <NUM>'. Since this location is not aligned with the second output port 112B-<NUM> when the components are mated as described herein, a stadium shaped gasket or the like as depicted in <FIG> may provide a sealed fluid connection between the second output port 112B-<NUM> with the second input port 132B-<NUM>' such that fluid can flow therebetween.

While the present disclosure relates primarily to the quarter turn coupling described herein, other components that can be used to quickly provide and remove a fluid connection between the various components of the sealant delivery system <NUM> (<FIG>) described herein. One such illustrative example is depicted in <FIG>. As shown in <FIG> and with reference to <FIG>, a clip fit connection <NUM> includes a male clip portion <NUM> (e.g., containing a first prong 902A and a second prong 902B) on one component (e.g., the sealant applicator <NUM> or the dual chamber mixing syringe <NUM>/injection needle assembly <NUM>) and a female receptacle portion <NUM> (e.g., containing a first receptacle 904A and a second receptacle 904B on another component (e.g., the other of the sealant applicator <NUM> or the dual chamber mixing syringe <NUM>/injection needle assembly <NUM>). As can be appreciated, the female receptacle portion <NUM> is shaped and sized to receive and restrain the male clip portion <NUM> therein to retain the two components together, as depicted in <FIG>. The connection is reversible by engaging a release mechanism disposed on one or more of the male clip portion <NUM> and/or the female receptacle portion <NUM>. For example, in the aspect depicted in <FIG>, the first prong 902A and the second prong 902B of the male clip portion <NUM> can be squeezed toward one another to release a retention mechanism such that the male clip portion <NUM> can be slid out of the female receptacle portion <NUM>. In addition, the components can be keyed so as to ensure appropriate alignment, as described herein. For example, as depicted in <FIG> and with reference to <FIG>, a first male port 910A and a first female port 910B may be disposed on one component (e.g., the sealant applicator <NUM> or the dual chamber mixing syringe <NUM>/injection needle assembly <NUM>). Similarly, a second female port 910c and a second male port 910D may be disposed on another component (e.g., the other of the sealant applicator <NUM> or the dual chamber mixing syringe <NUM>/injection needle assembly <NUM>). As such, when the two components are joined together, the first male port 910A joins with the second female port 910C and the first female port 910B joins with the second male port 910D to fluidly couple components together, as described in greater detail herein.

<FIG> depicts a flow diagram of an illustrative method <NUM> of using the various components of the sealant delivery system <NUM> (<FIG>) as described herein. While the method <NUM> of <FIG> generally relates to use of the quarter turn connectors described herein, it should be understood that a similar process may be used for other connectors (e.g., the connectors described herein with respect to <FIG>), albeit without the rotating steps.

Referring to <FIG>, the method <NUM> includes joining the quarter turn connectors of the sealant applicator and the dual chamber mixing syringe together as described herein at block <NUM>. That is, the distal end of the sealant applicator (containing the quarter turn connector thereon) is brought together and placed in an initial alignment with the proximal end of the dual chamber mixing syringe (containing the corresponding quarter turn connector thereon). Once brought together and aligned, the sealant applicator and/or the dual chamber mixing syringe are rotated with respect to one another in a ¼ turn at block <NUM> to lock the components together. In some aspects, an indicator of a correct alignment can be checked to verify the connection, as described herein. In some aspects, a tactile or audible click may provide feedback of a correct joining and alignment. In an embodiment, this feature may advantageously result in additional feedback that is provided to the user to reassure the user that the components are correctly aligned and joined.

At block <NUM>, the actuators (e.g., plungers) of the applicator and the dual chamber mixing syringe, respectively, may be depressed sequentially to cause the four separate contents contained therein (e.g., contents in each of the two chambers of the sealant applicator and in each of the two chambers of the dual chamber mixing syringe) to be mixed into two mixtures. The sequential depressing of the actuators may be completed any number of times. Accordingly, at decision block <NUM> a determination may be made as to whether the two mixtures are sufficiently hydrated. Such a determination should generally be understood. If the mixtures are not sufficiently hydrated, the process may repeat at block <NUM>. If the mixtures are sufficiently hydrated, the process may continue to block <NUM>. Before proceeding to block <NUM>, the two mixtures may be located within the two chambers of the sealant applicator.

At block <NUM>, the sealant applicator may be disconnected from the dual chamber mixing syringe by rotating the two components relative to one another in a quarter turn in a direction opposite as the initial quarter turn completed at block <NUM>. The dual chamber mixing syringe may be discarded after being disconnected.

At block <NUM>, the disconnected sealant applicator may be joined with the needle assembly as described herein. That is, the distal end of the sealant applicator (containing the quarter turn connector thereon) is brought together and placed in an initial alignment with the proximal end of the needle assembly (containing the corresponding quarter turn connector thereon). Once brought together and aligned, the sealant applicator and/or the needle assembly are rotated with respect to one another in a ¼ turn at block <NUM> to lock the components together. In some aspects, an indicator of a correct alignment can be checked to verify the connection, as described herein. In some aspects, a tactile or audible click may provide feedback of a correct joining and alignment. In an embodiment, this feature may advantageously result in additional feedback that is provided to the user to reassure the user that the components are correctly aligned and joined.

At block <NUM>, the components within the two chambers of the sealant applicator may be deployed via the needle assembly such that the components travel down the inner and outer lumens thereof to the distal mixing chamber, where they mix and exit out of the plurality of side ports. It should be understood that deploying the material according to block <NUM> may be completed at a site where sealant is desired (e.g., the pleura region of a subject or the like).

It should now be understood that the present disclosure relates to various sealant delivery systems that include components that deliver a multicomponent sealant along an access path, including the pleura region, to the lung prior to performing a lung procedure, such as a biopsy or the like. The sealant delivery systems described herein include a dual chamber sealant applicator, a dual chamber mixing syringe, and an injection needle assembly. The sealant delivery systems described herein are configured such that a user can quickly and easily couple the dual chamber sealant applicator with the dual chamber mixing syringe in a manner that correctly aligns the applicator and mixing syringe so that the components within each can be mixed together. Once mixed, the user can just as easily disconnect the applicator from the mixing syringe and quickly and easily attach the injection needle assembly thereto for the purposes of delivering the sealant to a subject. To achieve this, the dual chamber sealant applicator includes a connector such as a quarter turn connector that allows for the quick joining and releasing of the dual chamber mixing syringe and the injection needle assembly, which both have a corresponding quarter turn connector. In addition, because the sealant materials located in the dual chamber sealant applicator quickly form a sealant product when combined together, it is necessary to ensure the combination occurs at the side where the sealant product is to be distributed. As such, the needle assembly described herein includes an elongate hollow stylet having a mixing chamber at a distal end thereof, and utilizes an inner lumen disposed concentrically within an outer lumen to define separate passageways extending from the two chambers of the applicator to the mixing chamber at the distal end.

Claim 1:
A sealant applicator (<NUM>), comprising:
two chambers (112A, 112B) separate from one another, each chamber comprising at least one output port (112A-<NUM>, 112B-<NUM>) on a distal end thereof; and
a quarter turn connector (<NUM>, <NUM>) disposed on a distal end (<NUM>-<NUM>) of the sealant applicator adjacent to the at least one output port of each chamber, the quarter turn connector shaped to releasably interlock with a corresponding quarter turn connector (<NUM>) of an injection needle assembly (<NUM>) comprising a plurality of input ports (132A-<NUM>, 132B-<NUM>) or with a corresponding quarter turn connector (<NUM>) of a dual chamber mixing syringe (<NUM>) comprising a plurality of mixing ports (122A-<NUM>, 122B-<NUM>), wherein, when the injection needle assembly or the dual chamber mixing syringe is coupled to the sealant applicator via the quarter turn connector, the plurality of input ports or the plurality of mixing ports are aligned and sealed with the at least one output port of each chamber of the sealant applicator;
wherein the quarter turn connector comprises:
a circular protrusion (<NUM>) extending distally from the distal end of the sealant applicator, the circular protrusion comprising the at least one output port of each of the two chambers;
a semi-circular channel (<NUM>) disposed within the distal end of the sealant applicator along a periphery of the circular protrusion; and
a pair of bayonet coupling members (306A, 306B) disposed radially outward of the circular protrusion and the semi-circular channel.