SEALANT DELIVERY DEVICE FOR USE IN PULMONARY PROCEDURES AND SYSTEMS AND METHODS FOR PREPARATION THEREOF - Patent application

Abstract

A sealant delivery apparatus for use in assisting in the prevention of pneumothorax in pulmonary access procedures includes a sealant applicator device and a needle assembly. The needle assembly has a hub and an elongated, hollow stylet. The hub is configured to removably connect to the sealant applicator device. The elongated, hollow stylet is configured to facilitate fluid communication with at least one output port of the sealant applicator device for receiving a multi-component sealant. The elongated, hollow stylet has a proximal portion, a distal portion having a closed distal end, and multiple side ports proximal to the closed distal end. The multiple side ports extend radially from an internal lumen at the distal portion through a sidewall of the elongated, hollow stylet. The multiple side ports are in fluid communication with at least one output port of the sealant applicator device.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 822,490, filed March 22, 2019, entitled "LUNG BIOPSY FLOWABLE SEALANT DELIVERY SYSTEM," which is incorporated herein by reference.

[0002]

[0002] The present invention relates to pulmonary access procedures such as lung biopsies, and more particularly to a sealant delivery device for use in connection with pulmonary procedures to assist in preventing pneumothorax, as well as systems and methods for preparing the same. [Background technology]

[0003]

[0003] Pneumothorax is a problematic complication of lung biopsy procedures, allowing air or fluid to enter the pleural cavity as a result of puncturing the parietal and visceral pleura. Pneumothorax, especially pneumothorax requiring chest tube placement, is a significant problem for clinicians performing percutaneous lung biopsies and for patients undergoing them. The incidence of pneumothorax in patients undergoing percutaneous lung biopsies has been reported to range from 9 to 54%, with an average of approximately 15%. On average, 6.6% of all percutaneous lung biopsies result in a pneumothorax requiring chest tube placement, resulting in an average hospital stay of 2.7 days.

[0004]

[0004] Factors that increase the risk of pneumothorax include older patient age, obstructive pulmonary disease, increasing depth of injury, multiple pleural passages, increasing time the access needle traverses the pleura, and traversing a fissure. Because pneumothorax can occur during or immediately after the procedure, a CT scan of the area of ​​interest is typically performed following needle removal. 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.

[0005] Approximately 30% of lung biopsies have been shown to result in some type of pneumothorax after the biopsy, making it difficult or impossible to place a plug. Current commercially available sealants are placed by a coaxial cannula after the biopsy, either before or after the pneumothorax has formed. Summary of the Invention [Problem to be solved by the invention]

[0006]

[0006] What is needed in the art is a sealant delivery device capable of depositing sealant components in the pleural cavity prior to a pulmonary procedure, such as a biopsy, to help prevent pneumothorax, as well as a system and method for preparing the same. [Means for solving the problem]

[0007]

[0007] The present invention provides a sealant delivery device capable of depositing sealant components in the pleural cavity prior to a pulmonary procedure such as a biopsy to assist in preventing pneumothorax, as well as a system and method for preparing the same.

[0008]

[0008] In one form, the invention is directed to a sealant delivery apparatus for use in assisting in the prevention of pneumothorax in pulmonary access procedures. The sealant delivery apparatus includes a sealant applicator device (also referred to as a sealant application device) and a needle assembly. The sealant applicator device is configured to individually deliver a first sealant component of a multi-component sealant and a second sealant component of the multi-component sealant. The sealant applicator device has at least one output port. The needle assembly has a hub and an elongated, hollow stylet extending distally from the hub. The hub is configured for removably connecting to the sealant applicator device. The elongated, hollow stylet is configured to facilitate fluid communication with the at least one output port of the sealant applicator device for receiving the multi-component sealant. The elongated, hollow stylet has a proximal portion and a distal portion. The distal portion has a closed distal end and a plurality of side ports (also referred to as side openings) proximal to the closed distal end. The elongated, hollow stylet has a sidewall surrounding a lumen, and at a distal portion of the elongated, hollow stylet, a plurality of side ports extend radially from the lumen through the sidewall, the plurality of side ports being in fluid communication with at least one output port of the sealant applicator device.

[0009] In another aspect, the invention is directed to a system for preparing a sealant delivery device for use in a pulmonary access procedure. The system includes a first pair of syringes associated with the sealant delivery device, a second pair of syringes, and a coupling mechanism. The first pair of syringes includes a first actuator, a first component chamber having a first component port, and a second component chamber having a second component port. The first actuator includes a first piston and a second piston. The first piston is disposed within the first component chamber, and the second piston is disposed within the second component chamber. The first component chamber initially contains a first powder or solution component of a first sealant component of a multi-component sealant, and the second component chamber initially contains a second powder or solution component of a second sealant component of the multi-component sealant. The second pair of syringes includes a second actuator, a first component reservoir having a first transfer port, and a second component reservoir having a second transfer port. The second actuator includes a third piston and a fourth piston. The third piston is disposed in the first component reservoir, and the fourth piston is disposed in the second component reservoir. The first component reservoir initially contains a first liquid component of a first sealant component of the multi-component sealant, and the second component reservoir initially contains a second liquid component of a second sealant component of the multi-component sealant. The coupling mechanism has a first coupling end and a second coupling end. The first coupling end is configured to releasably connect to the first pair of syringes, and the second coupling end is configured to releasably connect to the second pair of syringes. The coupling mechanism has a first passageway and a second passageway. The first passageway is configured to facilitate fluid communication between a first transfer port of the second pair of syringes and a first component port of the first pair of syringes, and the second passageway is configured to facilitate fluid communication between a second transfer port of the second pair of syringes and a second component port of the first pair of syringes.

[0010] In another form thereof, the invention is directed to a method for preparing a sealant delivery device for use in a pulmonary access procedure. The method includes the steps of providing a first pair of syringes including a first actuator, a first component chamber having a first component port, and a second component chamber having a second component port, wherein the first actuator includes a first piston and a second piston, the first piston being disposed in the first component chamber, the second piston being disposed in the second component chamber, the first component chamber containing a first powder or solution component of a first sealant component of the multi-component sealant, and the second component chamber containing a second powder or solution component of a second sealant component of the multi-component sealant; and providing a second pair of syringes including a second actuator, a first component reservoir having a first transfer port, and a second component reservoir having a second transfer port, wherein the second actuator includes a third piston and a fourth piston. providing a second pair of syringes, a third piston disposed in a first component reservoir, a fourth piston disposed in a second component reservoir, the first component reservoir containing a first liquid component of a first sealant component of the multi-component sealant, and the second component reservoir containing a second liquid component of a second sealant component of the multi-component sealant; and providing a coupling mechanism having a first coupling end and a second coupling end, the first coupling end coupling the first pair of syringes. and providing a coupling mechanism having a first coupling end releasably coupleable to the syringe and a second coupling end releasably coupleable to a second pair of syringes, the coupling mechanism having a first passageway and a second passageway, the first passageway facilitating fluid communication between a first transfer port of the second pair of syringes and a first component port of the first pair of syringes, and the second passageway facilitating fluid communication between a second transfer port of the second pair of syringes and a second component port of the first pair of syringes.

[0011] The above invention has the advantage of improving upon the conventional solution in that the multi-component sealant seals the pneumothorax area before the biopsy rather than after.

[0012] Another advantage of the invention is that it improves on typical pneumothorax prevention devices, since the needle assembly is placed at the beginning of the procedure rather than at the very end, and a flowable multi-component sealant, e.g., a polymer, can be delivered and incorporated into the space between the tissues, whereas, for example, a polymer plug only occupies the space where it is placed and therefore provides a weak seal.

[0012]

[0013] Another advantage of the present invention is that it also eliminates the need to measure the location of the needle relative to the pleura, which may be out of reach of the physician from the current procedure. The solution of the present invention should be seamlessly integrated into the pulmonary access procedure by preparing a flowable, multi-component sealant and dispensing it from the elongated, hollow stylet of the needle assembly as the elongated, hollow stylet is advanced across the pleura.

[0013]

[0014] The foregoing and other features and advantages of the invention and the manner in which they are achieved will become more apparent and will be better understood by referring to the following description of embodiments of the invention taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0014] [Figure 1]

[0015] 1 is a front view of a sealant dispensing apparatus according to one aspect of the present invention; [Figure 2]

[0016] 2 is an exploded view of the sealant delivery device of FIG. 1. [Figure 3]

[0017] 2 is a side view of the sealant delivery device of the sealant delivery apparatus of FIG. 1 with the actuator retracted. FIG. [Figure 4]

[0018] 4 is a cross-sectional view of the sealant delivery device depicted in FIG. 3 taken along line 4-4 of FIG. 3 with the actuator retracted, showing a first piston in a first component chamber proximal to a first sealant component of the multi-component sealant, and a second piston in a second component chamber proximal to a second sealant component of the multi-component sealant. [Figure 5]

[0019] 3 is a perspective view of a distal portion of an elongated stylet of a needle assembly of the sealant delivery device of FIGS. 1 and 2. FIG. [Figure 6]

[0020] 6 is a side view of a distal portion of an elongated stylet of a needle assembly of the sealant delivery device of FIGS. 1, 2, and 5. FIG. [Figure 7]

[0021] 7 is a cross-sectional view of a distal portion of an elongated stylet of the needle assembly of the sealant delivery device of FIGS. 1, 2, 5, and 6, taken along line 7-7 of FIG. 6. [Figure 8]

[0022] 3 is a front view of a system for preparing the sealant delivery device of FIGS. 1 and 2 for use in a pulmonary access procedure, including a coupling mechanism for a first pair of syringes and the sealant delivery device, and further including a second pair of syringes coupled to the first pair of syringes by the coupling mechanism. [Figure 9]

[0023] FIG. 9 is an exploded view of the system of FIG. 8. [Figure 10]

[0024] 9 is a side view of the system of FIG. 8 with the first actuator of the first pair of syringes and the second actuator of the second pair of syringes retracted. FIG. [Figure 11]

[0025] 11 is a cross-sectional view of the system depicted in FIG. 10 with the first actuator and the second actuator retracted, taken along line 11-11 of FIG. 10. The first component chamber of the first pair of syringes initially contains a powder or solution component of the first sealant component of the multi-component sealant, the second component chamber of the first pair of syringes initially contains a powder or solution component of the second sealant component of the multi-component sealant, the first component reservoir of the second pair of syringes initially contains a liquid component of the second sealant component of the multi-component sealant, and the second component reservoir of the second pair of syringes initially contains a liquid component of the second sealant component of the multi-component sealant. [Figure 12]

[0026] 3 is a flow diagram of a method for preparing the sealant delivery device of FIGS. 1 and 2, and more particularly, the twin syringes of the sealant delivery device for use in a pulmonary access procedure. DETAILED DESCRIPTION OF THE INVENTION

[0015]

[0027] Corresponding reference characters indicate corresponding parts throughout the several views. The examples presented herein illustrate at least one embodiment of the invention, and such examples should not be construed as limiting the scope of the invention.

[0016]

[0028] Referring now to the drawings, and more particularly to FIGS. 1 and 2, there is shown a sealant delivery device 10 according to one embodiment of the present invention for use in assisting in the prevention of pneumothorax in pulmonary access procedures.

[0017]

[0029] The sealant delivery apparatus 10 includes a sealant applicator device 12 and a needle assembly 14. The needle assembly 14 defines a longitudinal axis 16. When assembled, the sealant delivery apparatus 10 has a configuration for facilitating delivery of a flowable multi-component sealant to an injection site, where the multi-component sealant can be injected while the needle portion of the needle assembly 14 intersects two layers of the pleura, namely the parietal and visceral pleura. The needle assembly 14 is configured to puncture the patient's tissue to create an access pathway, e.g., a proposed biopsy pathway, through at least the patient's pleura and into the patient's tissue, so that the two layers of the pleura can be sealed by hardening the multi-component sealant at the delivery site, e.g., prior to a lung biopsy, to prevent air from leaking between the two layers and resulting in a pneumothorax. It should be noted that the multi-component sealant may be placed in other areas of the access pathway, such as the subcutaneous tissue and / or lung parenchyma.

[0018]

[0030] Optionally, the sealant delivery apparatus 10 can be used with an introducer cannula 18, which can facilitate withdrawal of the needle assembly 14 of the sealant delivery apparatus 10 from the patient while being left in place to maintain an access path to the site in the patient's tissue, for example, to receive and guide a second medical instrument, such as a biopsy device, to the site where a biopsy is to be performed.

[0019]

[0031] 3 and 4 , the sealant applicator device 12 includes a pair of syringes 20 and a manifold 22. The sealant applicator device 12 is configured to individually deliver a first sealant component 24 of a multi-component sealant and a second sealant component 26 of the multi-component sealant. The first sealant component 24 can include, for example, at least two N-hydroxysuccinimide (NHS) ester groups, and the second sealant component 26 can include, for example, at least two amine groups. For example, the first sealant component 24 can be a solution containing polyethylene glycol (PEG) succinimidyl succinate, and the second sealant component 26 can be a solution containing albumin and / or polyethyleneimine (PEI). In this embodiment, the first sealant component 24 and the second sealant component 26 are mixed together in the manifold 22.

[0020]

[0032] The twin syringe 20 includes an actuator 28, a first component chamber 30, and a second component chamber 32. The first component chamber 30 may be, for example, a cylindrical tube configured to deliver the first sealant component 24 of the multi-component sealant. The first component chamber 30 has a first component port 30-1. The second component chamber 32 may be, for example, a cylindrical tube configured to deliver the second sealant component 26 of the multi-component sealant. The second component chamber 32 has a second component port 32-1. The first component chamber 30 and the second component chamber 32 are arranged longitudinally parallel.

[0021]

[0033] Actuator 28 includes a first piston 34, a second piston 36, and a handle 38. Handle 38 is in the form of a link member extending perpendicularly between and connected to first piston 34 and second piston 36, facilitating simultaneous movement of first piston 34 and second piston 36 as handle 38 is depressed or retracted. First piston 34 is in the form of a plunger disposed proximal to first sealant component 24 within first component chamber 30, and second piston 36 is in the form of a plunger disposed proximal to second sealant component 26 within second component chamber 32.

[0022]

[0034] 1-4, in this embodiment, manifold 22 is removably connectable at a first coupling end 40-1 to the pair of syringes 20 of sealant applicator device 12 by pair of connectors 42-1, 42-2, and is removably connectable at a second end 40-2 to the needle assembly 14 by connector 44. More particularly, as best shown in FIG. 4, manifold 22 includes a Y-connector 39 releasably connected to a coupling mechanism 122, which acts as a removable extension of the two port portions of Y-connector 39. Thus, Y-connector 39 (more particularly, coupling mechanism 122) is removably connectable at a first coupling end 40-1 to the pair of syringes 20 of sealant applicator device 12 by pair of connectors 42-1, 42-2, and is removably connectable at a second end 40-2 to the needle assembly 14 by connector 44.

[0023]

[0035] The pair of connectors 42-1, 42-2 may form a threaded or snap-fit ​​connection to the pair of syringes 20 of the sealant applicator device 12. Similarly, the connector 44 may form a threaded or snap-fit ​​connection to the needle assembly 14.

[0024]

[0036] Those skilled in the art will recognize that the pair of connectors 42-1, 42-2 may be included as part of the pair of syringes 20 and be releasably connectable to the manifold 22. Alternatively, the pair of connectors 42-1, 42-2 may be included as part of the manifold 22 and be releasably connectable to the pair of syringes 20. Further alternatively, the pair of connectors 42-1, 42-2 may be included as separate components, each individually connectable to each of the pair of syringes 20 and the manifold 22.

[0025]

[0037] Manifold 22 has a first input port 22-1, a second input port 22-2, and at least one output port, hereinafter referred to as output port 22-3, which in this embodiment is a single output port. As best shown in FIG. 4 , in this embodiment, coupling mechanism 122 of manifold 22 has individual passages that are in fluid communication with Y passages 22-4 within Y-connector 39. In this embodiment, coupling mechanism 122 of manifold 22 directly includes first input port 22-1 and second input port 22-2, and Y-connector 39 of manifold 22 directly includes output port 22-3. Thus, Y-connector 39 places at least one output port, e.g., output port 22-3, in fluid communication with each of first input port 22-1 and second input port 22-2. Additionally, when the manifold 22 is connected to the pair of syringes 20 of the sealant applicator device 12, the first input port 22-1 is in fluid communication with the chamber 30 of the first component, and the second input port 22-2 is in fluid communication with the chamber 32 of the second component.

[0026]

[0038] 1 and 2, the needle assembly 14 includes a hub 46 and an elongated, hollow stylet 48 extending distally from the hub 46. The elongated, hollow stylet 48 has a proximal portion 48-1 and a distal portion 48-2. The hub 46 is fixedly attached to the proximal portion 48-1 of the elongated, hollow stylet 48, for example, by overmolding, adhesive, and / or press fit. The hub 46 is configured to removably connect to the sealant applicator device 12. More specifically, the hub 46 of the needle assembly 14 may include a connector 51 (see FIG. 2) that may form a threaded or snap-fit ​​connection with the connector 44 at the second end 40-2 of the manifold 40 of the sealant applicator device 12.

[0027]

[0039] The elongated, hollow stylet 48 of the injection needle assembly 14 is configured to facilitate fluid communication with at least one output port, such as the output port 22-3 of the manifold 22 of the sealant applicator device 12, for receiving the multi-component sealant from the sealant applicator device 12. Referring also to Figures 5-7, the distal portion 48-2 has a closed distal end 50 and a plurality of (e.g., at least three) side ports 52 proximal to the closed distal end 50. The closed distal end 50 of the elongated, hollow stylet 48 may be, for example, a closed stylet needle tip 54.

[0028]

[0040] The elongated, hollow stylet 48 may be constructed, for example, by an elongated cannula 56 fixedly connected to a closed stylet tip 54, with a plurality of side ports 52 disposed in the elongated cannula 56 proximate to the closed stylet tip 54. More specifically, the elongated cannula 56 of the elongated, hollow stylet 48 defines a sidewall 48-3 that surrounds a lumen 48-4 of the elongated, hollow stylet 48, with a plurality of side ports 52 extending radially from the lumen 48-4 through the sidewall 48-3 in a distal portion 48-2 of the elongated, hollow stylet 48. The closed stylet needle tip 54 is defined at least in part by the closed distal end 50 of the elongated hollow stylet 48 and is attached to the elongated cannula 56 in a lumen 48-4 of the elongated hollow stylet 48 proximal to the elongated cannula 56, for example, by welding, press fit, or adhesive. In other words, the closed stylet needle tip 54 terminates the distal extent of the lumen 48-4 of the elongated hollow stylet 48. When the sealant delivery apparatus 10 is assembled, the plurality of side ports 52 are in fluid communication with at least one output port, such as output port 22-3, of the manifold 22 of the sealant applicator device 12 by way of the lumen 48-4 of the elongated hollow stylet 48.

[0029]

[0041] In this embodiment, the plurality of side ports 52 in the distal portion 48-2 of the elongated, hollow stylet 48 includes side port 52-1, side port 52-2, and side port 52-3, which are located in the distal portion 48-2 and arranged in a circular pattern, such as at 120-degree intervals, around the circumference of the elongated, hollow stylet 48. In one application, for example, it is preferable for the plurality of side ports 52 to include at least three side ports (e.g., three to seven side ports), with the at least three side ports near but proximal to the closed stylet tip 54, so that a flowable, multi-component sealant can be delivered 360 degrees around the elongated, hollow stylet 48 to seal around / near the perforation created by the closed stylet tip 54. As another example, it is contemplated that in some applications it may be desirable for the plurality of side ports 52 to be configured as two or two pairs of diametrically opposed side ports.

[0030]

[0042] 5, it is further contemplated that the plurality of side ports 52 may include at least two longitudinally spaced side ports, such as side port 52-4 spaced longitudinally (e.g., by 1 to 3 millimeters) proximal to side port 52-1. For example, the plurality of side ports 52 may include two rings of three side ports arranged around the periphery of the elongated hollow stylet 48, the two rings of three side ports being longitudinally spaced apart at a distal portion 48-2 of the elongated hollow stylet 48.

[0031]

[0043] 1 , the needle assembly 14 can be used with an introducer cannula 18 (sometimes referred to in the art as a coaxial introducer needle) to allow the elongated, hollow stylet 48 to be removed from the introducer cannula 18 while maintaining access to the treatment site with the coaxial introducer needle. In other words, the sealant delivery apparatus 10 can be removed from the introducer cannula 18 and replaced with a variety of other instruments, such as a biopsy device or another stylet. In this embodiment, the introducer cannula 18 has a coaxial hub 18-1, a coaxial cannula 18-2, a cannula lumen 18-3, and a distal annular rim 18-4. For example, the cannula lumen 18-3 is configured, for example, cylindrically shaped, to receive the elongated, hollow stylet 48 of the needle assembly 14. When the elongated, hollow stylet 48 of the needle assembly 14 is fully inserted into the cannula lumen 18-3 of the introducer cannula 18 (e.g., distal movement of the elongated, hollow stylet 48 is blocked by contact between the coaxial hub 18-1 of the introducer cannula 18 and the hub 46 of the needle assembly 14), the multiple side ports 52 of the elongated, hollow stylet 48 are disposed distally from the distal annular rim 18-4 of the introducer cannula 18.

[0032]

[0044] 8-11, a system 100 for preparing the sealant delivery device 10 for use in a pulmonary access procedure is shown. More specifically, the system 100 is used to mix various chemicals which, when combined, result in the first sealant component 24 and the second sealant component 26 of the multi-component sealant depicted in FIG. 4. The system 100 generally includes a first pair of syringes 20, a second pair of syringes 120, and a coupling mechanism 122.

[0033]

[0045] As described above, the first pair of syringes 20 is configured with a first component chamber 30, a second component chamber 32, and a first actuator 28 having a first piston 34 and a second piston 36. However, as shown in FIG. 4, initially (e.g., upon delivery from the manufacturer), the first component chamber 30 does not yet contain a prepared first sealant component 24, and the second component chamber 32 does not yet contain a prepared second sealant component 26. Rather, with reference to FIG. 11, the first component chamber 30 initially contains a powder or solution component 24-1 of the first sealant component 24 of the multi-component sealant, and the second component chamber 32 initially contains a powder or solution component 26-1 of the second sealant component 26 of the multi-component sealant. As used herein, each solution forming component 24-1 and / or component 26-1 is a combination of a solute and a solvent, and may include, for example, a suspension or a hydrogel.

[0034]

[0046] 8 to 11, the second pair of syringes 120 includes a second actuator 128, a first component reservoir 130 having a first transfer port 130-1, and a second component reservoir 132 having a second transfer port 132-1.

[0035]

[0047] The second actuator 128 includes a third piston 134, a fourth piston 136, and a handle 138. The handle 138 is in the form of a linking member extending perpendicularly between and connected to the third piston 134 and the fourth piston 136, facilitating simultaneous movement of the third piston 134 and the fourth piston 136 as the handle 138 is depressed or retracted. The third piston 134 is in the form of a plunger disposed in a first component reservoir 130, and the fourth piston 136 is in the form of a plunger disposed in a second component reservoir 132. The first component reservoir 130 initially contains the liquid component 24-2 of the first sealant component 24 of the multi-component sealant, and the second component reservoir 132 initially contains the liquid component 26-2 of the second sealant component 26 of the multi-component sealant. As used herein, liquid component 24-2 and / or liquid component 26-2 may be or include water or some other liquid.

[0036]

[0048] Coupling mechanism 122 has first coupling end 40-1 and second coupling end 140-2. First coupling end 40-1 is configured to releasably connect to the first pair of syringes 20, and second coupling end 140-2 is configured to releasably connect to the second pair of syringes 120. With particular reference to FIGS. 9 and 11 , coupling mechanism 122 includes first input port 22-1 and second input port 22-2 at first coupling end 40-1 and includes ports 122-1 and 122-2 at second coupling end 140-2. Coupling mechanism 122 further includes a first passageway 150-1 that is in fluid communication with and extends between ports 22-1 and 122-1. Similarly, coupling mechanism 122 includes a second passageway 150-2 that is in fluid communication with and extends between ports 22-2 and 122-2.

[0037]

[0049] The pair of connectors 42-1, 42-2 may form a threaded or snap-fit ​​connection between the first pair of syringes 20 and the first coupling end 40-1 of the coupling mechanism 122. Similarly, the pair of connectors 144-1, 144-2 may form a threaded or snap-fit ​​connection between the second pair of syringes 120 and the second coupling end 140-2 of the coupling mechanism 122.

[0038]

[0050] The pair of connectors 42-1, 42-2 may be included as part of the first pair of syringes 20 and are releasably connectable to the coupling mechanism 122. Alternatively, the pair of connectors 42-1, 42-2 may be included as part of the coupling mechanism 122 and are releasably connectable to the first pair of syringes 20. As a further option, the pair of connectors 42-1, 42-2 may be included as separate components, each individually connectable to each of the pair of syringes 20 and to the coupling mechanism 122.

[0039]

[0051] Similarly, the pair of connectors 144-1, 144-2 may be included as part of the second pair of syringes 120 and be releasably connectable to the coupling mechanism 122. Alternatively, the pair of connectors 144-1, 144-2 may be included as part of the coupling mechanism 122 and be releasably connectable to the second pair of syringes 120. As a further option, the pair of connectors 144-1, 144-2 may be included as separate components, each individually connectable to each of the second pair of syringes 120 and to the coupling mechanism 122.

[0040]

[0052] 8-11 , first coupling end 40-1 of coupling mechanism 122 includes a first snap latch 146-1 and a second snap latch 146-2. First component chamber 30 (more specifically, connector 42-1) of first pair of syringes 20 includes a first snap catch 148-1 configured to releasably engage with first snap latch 146-1 of coupling mechanism 122. Similarly, second component chamber 32 (more specifically, connector 42-2) of first pair of syringes 20 includes a second snap catch 148-2 configured to releasably engage with second snap latch 146-2 of coupling mechanism 122.

[0041]

[0053] The second coupling end 140-2 of the coupling mechanism 122 includes a third snap latch 146-3 and a fourth snap latch 146-4. The first component reservoir 130 of the second pair of syringes 120 (more particularly, connector 144-1) includes a third snap catch 148-3 configured to releasably engage with the third snap latch 146-3 of the coupling mechanism 122. Similarly, the second component reservoir 132 of the second pair of syringes 120 (more particularly, connector 144-2) has a fourth snap catch 148-4 configured to releasably engage with the fourth snap latch 146-4 of the coupling mechanism 122.

[0042]

[0054] 9 and 11, the first passage 150-1 of the coupling mechanism 122 is configured to facilitate fluid communication between the first transfer port 130-1 of the second pair of syringes 120 and the first component port 30-1 of the first pair of syringes 20, and the second passage 150-2 of the coupling mechanism 122 is configured to facilitate fluid communication between the second transfer port 132-1 of the second syringe 120 and the second component port 32-1 of the first pair of syringes 20.

[0043]

[0055] 10 and 11, the first actuator 28 of the first pair of syringes 20 is configured to simultaneously move the first piston 34 and the second piston 36, and the second actuator 128 of the second pair of syringes 120 is configured to simultaneously move the third piston 134 and the fourth piston 136.

[0044]

[0056] Thus, by alternately actuating, e.g., alternately depressing, the second actuator 128 and the first actuator 28, the second pair of syringes 120 and the first pair of syringes 20 are configured to alternately move any contents of the first component reservoir 130 and the second component reservoir 132 to the first component chamber 30 and the second component chamber 32, respectively, and to move any contents of the first component chamber 30 and the second component chamber 32 to the first component reservoir 130 and the second component reservoir 132, respectively. For example, the first pair of syringes 20 and the second pair of syringes 120 may be configured to simultaneously (A) hydrate powder or solution component 24-1 with liquid component 24-2 to form first sealant component 24 of the multi-component sealant, which resides in first component chamber 30 of the first pair of syringes 20 when fully hydrated (see also FIG. 4 ), and (B) hydrate powder or solution component 26-1 with liquid component 26-2 to form second sealant component 26 of the multi-component sealant, which resides in second component chamber 32 of the second pair of syringes 20 when fully hydrated, as depicted in FIG. 4 .

[0045]

[0057] For example, upon a first depression of the second actuator 128, the third piston 134 and the fourth piston 136 move the liquid component 24-2 of the first sealant component 24 through the first passage 150-1 into the first component chamber 30 carrying the powder or solution component 24-1 of the first sealant component 24, and simultaneously move the liquid component 26-2 of the second sealant component 26 through the second passage 150-2 into the second component chamber 32 carrying the powder or solution component 26-1 of the second sealant component 26. Thereafter, a first depression of first actuator 28 causes first piston 34 and second piston 36 to simultaneously move the contents of first component chamber 30 and second component chamber 32 of first pair of syringes 20 into first component reservoir 130 and second component reservoir 132, respectively, of second pair of syringes 120. Then, a second depression of second actuator 128 causes third piston 134 and fourth piston 136 to simultaneously move the contents of first component reservoir 130 and second component reservoir 132 of second pair of syringes 120 into first component chamber 30 and second component chamber 32, respectively, of first pair of syringes 20. This process may be repeated as necessary to ensure proper hydration of powder or solution component 24-1 with liquid component 24-2 to form first sealant component 24 of the multi-component sealant, and to ensure proper hydration of powder or solution component 26-1 with liquid component 26-2 to form second sealant component 26 of the multi-component sealant.

[0046]

[0058] Upon completion of hydration / mixing, the first sealant component 24 is present in the first component chamber 30 of the first pair of syringes 20 and the second sealant component 26 is present in the second component chamber 32. As described above with reference to Figures 1-7, the coupling mechanism 122 may be separated from the first pair of syringes 20, the manifold 22 may then be coupled to the first pair of syringes 20, and the needle assembly 14 may then be coupled to the first pair of syringes 20 via the manifold 22 to form the sealant delivery device 10.

[0047]

[0059] Alternatively, once hydration / mixing is complete, the coupling mechanism 122 may be separated from the second pair of syringes 120, as described above with reference to Figures 1-7, and then the manifold 22 may be formed by coupling the Y-connector 39 to the coupling mechanism 122, and then the needle assemblies 14 may be coupled to the first pair of syringes 20 via the manifold 22 to form the sealant delivery device 10.

[0048]

[0060] It should be noted that a kit may be formed by combining the sealant delivery device 10 (assembled or disassembled) of Figures 1 and / or 2 with the pair of connectors 144-1, 144-2 and second pair of syringes 120 of Figure 9.

[0049]

[0061] FIG. 12 is a flow chart of a method in which the following steps may be performed sequentially to prepare the sealant delivery device 10 for use in a pulmonary access procedure, and more particularly to prepare the twin syringes 20 of the sealant delivery device 10:

[0050]

[0062] In step S200, the first pair of syringes 20 is coupled to the second pair of syringes 120 by the coupling mechanism 122.

[0063] In step S202, the first pair of syringes 20 and the second pair of syringes 120 are actuated sequentially (i.e., alternately) to hydrate powder or solution component 24-1 into liquid component 24-2 to form first sealant component 24 of the multi-component sealant, and simultaneously hydrate powder or solution component 26-1 into liquid component 26-2 to form second sealant component 26 of the multi-component sealant.

[0051]

[0064] The step of sequentially actuating the first pair of syringes 20 and the second pair of syringes 120 may be performed by alternately depressing the second actuator 128 of the second pair of syringes 120 and the first actuator 28 of the first pair of syringes 20 to move any contents of the first component reservoir 130 and the second component reservoir 132 into the first component chamber 30 and the second component chamber 32, respectively, and alternately moving any contents of the first component chamber 30 and the second component chamber 32 into the first component reservoir 130 and the second component reservoir 132.

[0052]

[0065] When fully hydrated, the first sealant component 24 of the multi-component sealant resides in the first component chamber 30 of the first pair of syringes 20, and the second sealant component 26 of the multi-component sealant resides in the second component chamber 32 of the first pair of syringes 20. To accomplish this, the desired amount of the first sealant component 24 and the second sealant component 26 is transferred into the first pair of syringes 20 by depressing the second actuator 128 of the second pair of syringes 120 until the desired amount has been transferred into the first pair of syringes 20.

[0053]

[0066] In step S204, the coupling mechanism 122 may be separated from the first pair of syringes 20, and the manifold 22 may be coupled to the first pair of syringes 20. Alternatively, the coupling mechanism 122 may be separated from the second pair of syringes 120, and the manifold 22 may be formed by coupling the Y-connector 39 to the coupling mechanism 122.

[0054]

[0067] In step S206, the needle assembly 14 is coupled to the first pair of syringes 20 (see FIG. 1), for example via the manifold 22, as described above with reference to FIGS. 1-7, to form the sealant delivery device 10, which is then ready to perform a pulmonary procedure to help prevent pneumothorax.

[0055]

[0068] In steps S200-S206 of the method of using the prepared sealant delivery device 10 described above, the elongated, hollow stylet 48 is inserted into the patient to create an access pathway, and while the access pathway is being created, the actuators 28 of the paired syringes 20 may be depressed to deliver the multi-component sealant through the multiple side ports 52 into the created access pathway into the subcutaneous tissue, the pleural layer, the pleural space, and / or the lung parenchyma.

[0056]

[0069] The following items also relate to the above invention.

[0070] In one form, the invention relates to a sealant delivery apparatus for pulmonary access procedures, particularly for preventing pneumothorax. The sealant delivery apparatus includes a sealant applicator device and an injection needle assembly. The sealant applicator device may be configured to individually deliver a first sealant component of a multi-component sealant and a second sealant component of the multi-component sealant. The sealant applicator device has at least one output port. The injection needle assembly has a hub and an elongated, hollow stylet extending distally from the hub. The hub may be configured to removably connect to the sealant applicator device. The elongated, hollow stylet may be configured to facilitate (provide) fluid communication with at least one output port of the sealant applicator device for receiving the multi-component sealant. The elongated, hollow stylet has a proximal portion and a distal portion. The distal portion has a closed distal end and multiple side ports proximal (near) the closed distal end. The elongated, hollow stylet has a sidewall surrounding a lumen, and a plurality of side ports extend radially from the lumen through the sidewall at a distal portion of the elongated, hollow stylet, the plurality of side ports being in fluid communication with at least one output port of the sealant applicator device.

[0057]

[0071] In some embodiments, the plurality of side ports in the distal portion of the elongate hollow stylet comprises at least three side ports in the distal portion arranged circumferentially around the elongate hollow stylet.

[0058]

[0072] In some embodiments, the plurality of side ports in the distal portion of the elongate hollow stylet includes at least two longitudinally spaced side ports.

[0073] In some embodiments, the closed distal end of the elongated hollow stylet may be a closed needle tip that terminates the distal extent of the lumen.

[0059]

[0074] In some embodiments, the elongated hollow stylet may include an elongated cannula defining a sidewall and a lumen, and the stylet needle tip may be defined by a closed distal end and may be attached to the elongated cannula to distally close the lumen of the elongated cannula.

[0060]

[0075] In any of the embodiments, the sealant applicator device may include a pair of syringes having an actuator, a first component chamber configured to deliver a first sealant component of a multi-component sealant, and a second component chamber configured to deliver a second sealant component of the multi-component sealant. The actuator may include a first piston and a second piston. The first piston may be disposed in the first component chamber proximal to the first sealant component, and the second piston may be disposed in the second component chamber proximal to the second sealant component. The manifold may include a first input port, a second input port, and at least one output port in fluid communication with each of the first input port and the second input port. The first input port is in fluid communication with the first component chamber, and the second input port is in fluid communication with the second component chamber.

[0061]

[0076] In some embodiments, the manifold may be a Y-connector having an internal Y-passage including a first input port, a second input port, and at least one output port configured as a single output port, which may be in fluid communication with multiple side ports at the distal end of an elongated, hollow stylet having a closed distal end.

[0062]

[0077] Optionally, the device may include an introducer cannula having a cannula lumen and a distal annular rim. The cannula lumen may be configured to receive an elongated, hollow stylet of a needle assembly, wherein the plurality of side ports are disposed distally from the distal annular rim of the introducer cannula when the elongated, hollow stylet of the needle assembly is fully inserted into the cannula lumen of the introducer cannula.

[0063]

[0078] The invention may also relate to a lung biopsy device comprising a sealant delivery device as described above.

[0079] In another aspect, the invention relates to a system for preparing a sealant delivery device for a pulmonary access procedure. The system includes a first pair of syringes associated with the sealant delivery device, a second pair of syringes, and a coupling mechanism. The first pair of syringes may include a first actuator, a first component chamber having a first component port, and a second component chamber having a second component port. The first actuator may include a first piston and a second piston. The first piston is disposed in the first component chamber, and the second piston is disposed in the second component chamber. The first component chamber initially contains a first powder or solution component of a first sealant component of a multi-component sealant, and the second component chamber initially contains a second powder or solution component of a second sealant component of the multi-component sealant. The second pair of syringes may include a second actuator, a first component reservoir having a first transfer port, and a second component reservoir having a second transfer port. The second actuator may include a third piston and a fourth piston. The third piston is disposed in the first component reservoir, and the fourth piston is disposed in the second component reservoir. The first component reservoir initially contains a first liquid component of a first sealant component of the multi-component sealant, and the second component reservoir initially contains a second liquid component of a second sealant component of the multi-component sealant. The coupling mechanism has a first coupling end and a second coupling end. The first coupling end may be configured to releasably connect to the first pair of syringes, and the second coupling end may be configured to releasably connect to the second pair of syringes. The coupling mechanism may have a first passageway and a second passageway. The first passageway may be configured to facilitate fluid communication between a first transfer port of the second pair of syringes and a first component port of the first pair of syringes, and the second passageway may be configured to facilitate fluid communication between a second transfer port of the second pair of syringes and a second component port of the first pair of syringes.

[0064]

[0080] In some system embodiments, a first actuator of a first pair of syringes may be configured to simultaneously move the first piston and the second piston, and a second actuator of a second pair of syringes may be configured to simultaneously move the third piston and the fourth piston.

[0065]

[0081] In any of the system embodiments, the second pair of syringes can be configured such that a first depression of the second actuator moves a first liquid component of the first sealant component into a first component chamber carrying a first powder or solution component of the first sealant component, and simultaneously moves a second liquid component of the second sealant component into a second component chamber carrying a second powder or solution component of the second sealant component.

[0066]

[0082] In any of the system embodiments, the first pair of syringes and the second pair of syringes may be configured to alternately move any contents of the first component reservoir and the second component reservoir into the first component chamber and the second component chamber, respectively, and move any contents of the first component chamber and the second component chamber into the first component reservoir and the second component reservoir, respectively, by alternately depressing the second actuator and the first actuator.

[0067]

[0083] In any of the system embodiments, the first and second pairs of syringes can be configured to hydrate a first powder or solution component into a first liquid component to form a first sealant component of a multi-component sealant that is present in the first component chamber of the first pair of syringes when fully hydrated, and the first and second pairs of syringes can be configured to hydrate a second powder or solution component into a second liquid component to form a second sealant component of the multi-component sealant that is present in the second component chamber of the first pair of syringes when fully hydrated.

[0068]

[0084] Optionally, the first coupling end of the coupling mechanism can include a first snap latch and a second snap latch, and the second coupling end of the coupling mechanism can include a third snap latch and a fourth snap latch. Additionally, the first component chambers of the first pair of syringes can be associated with a first snap catch configured to releasably engage with the first snap latch of the coupling mechanism. The second component chambers of the first pair of syringes can be associated with a second snap catch configured to releasably engage with the second snap latch of the coupling mechanism. The first component reservoirs of the second pair of syringes can be associated with a third snap catch configured to releasably engage with the third snap latch of the coupling mechanism. The second component reservoirs of the second pair of syringes can be associated with a fourth snap catch configured to releasably engage with the fourth snap latch of the coupling mechanism.

[0069]

[0085] In any of the system embodiments, the system may optionally include an injection needle assembly having a hub and an elongated, hollow stylet extending distally from the hub. The hub may be configured to removably connect to a sealant applicator device. The elongated, hollow stylet may be configured to facilitate fluid communication with a first component port and a second component port of the sealant applicator device for receiving a multi-component sealant. The elongated, hollow stylet has a proximal portion and a distal portion. The distal portion may have a closed distal end and multiple side ports proximal to the closed distal end. The elongated, hollow stylet may have a sidewall surrounding a lumen, with multiple side ports extending radially from the lumen through the sidewall at the distal portion of the elongated, hollow stylet. The multiple side ports are configured to be in fluid communication with the first component port and the second component port of the sealant applicator device.

[0070]

[0086] The invention may also relate to a lung biopsy system comprising a system as described above.

[0087] The invention may also relate to a combination comprising a sealant dispensing device as described above and a system for preparing a sealant dispensing device as described above.

[0071]

[0088] In another form thereof, the invention relates to a method for preparing a sealant delivery device for use in a pulmonary access procedure. The method includes the steps of providing a first pair of syringes including a first actuator, a first component chamber having a first component port, and a second component chamber having a second component port, wherein the first actuator includes a first piston and a second piston, the first piston being disposable in the first component chamber, the second piston being disposable in the second component chamber, the first component chamber containing a first powder or solution component of a first sealant component of the multi-component sealant, and the second component chamber containing a second powder or solution component of a second sealant component of the multi-component sealant; and providing a second pair of syringes including a second actuator, a first component reservoir having a first transfer port, and a second component reservoir having a second transfer port, wherein the second actuator includes a third piston and a fourth piston. providing a second pair of syringes, a third piston positionable in a first component reservoir and a fourth piston positionable in a second component reservoir, the first component reservoir containing a first liquid component of a first sealant component of the multi-component sealant, and the second component reservoir containing a second liquid component of a second sealant component of the multi-component sealant; and providing a coupling mechanism having a first coupling end and a second coupling end, the first coupling end being connected to the first coupling end. and providing a coupling mechanism, wherein the first coupling end may be releasably connectable to the syringe of the first pair, and the second coupling end may be releasably connectable to the syringe of the second pair, the coupling mechanism having a first passageway and a second passageway, the first passageway facilitating fluid communication between a first transfer port of the second pair of syringes and a first component port of the first pair of syringes, and the second passageway facilitating fluid communication between a second transfer port of the second pair of syringes and a second component port of the first pair of syringes.

[0072]

[0089] In some embodiments, the method may sequentially include connecting a first pair of syringes to a second pair of syringes by a coupling mechanism; moving a first actuator of the first pair of syringes to simultaneously move a first piston and a second piston; and moving a second actuator of the second pair of syringes to simultaneously move a third piston and a fourth piston.

[0073]

[0090] In any of the method embodiments, the method may include connecting a first pair of syringes to a second pair of syringes by a coupling mechanism; and depressing a second actuator of the second pair of syringes to move a first liquid component of a first sealant component from a first component reservoir into a first component chamber carrying a first powder or solution component of the first sealant component, and simultaneously moving a second liquid component of a second sealant component from a second component reservoir into a second component chamber carrying a second powder or solution component of the second sealant component.

[0074]

[0091] In any of the method embodiments, the method includes connecting a first pair of syringes to a second pair of syringes by a coupling mechanism; sequentially actuating the first and second pair of syringes to hydrate a first powder or solution component into a first liquid component to form a first sealant component of a multi-component sealant, the first sealant component of the multi-component sealant being present in the first component chamber of the first pair of syringes when fully hydrated; and concurrently with the act of sequentially actuating the first and second pair of syringes, the first and second pair of syringes are operated to hydrate a second powder or solution component into a second liquid component to form a second sealant component of the multi-component sealant, the second sealant component of the multi-component sealant being present in the second component chamber of the first pair of syringes when fully hydrated.

[0075]

[0092] In some of the method embodiments, the method includes alternately depressing the second actuator of the second pair of syringes and the first actuator of the first pair of syringes to move any contents of the first component reservoir and the second component reservoir into the first component chamber and the second component chamber, respectively, and to move any contents of the first component chamber and the second component chamber into the first component reservoir and the second component reservoir, respectively.

[0076]

[0093] In some of the method embodiments, the method may include the steps of decoupling a coupling mechanism from the first pair of syringes and coupling a needle assembly to the first pair of syringes.

[0077]

[0094] While this invention has been described with reference to at least one embodiment, it may be further modified within the spirit and scope of this disclosure. It is intended to cover any variations, uses, or adaptations using its general principles, and this application is intended to cover all such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and as fall within the scope of the appended claims. [Item 1] 1. A sealant delivery device for use in assisting in the prevention of pneumothorax in a pulmonary access procedure, comprising: a sealant applicator device configured to individually deliver each of a first sealant component of a multi-component sealant and a second sealant component of the multi-component sealant, the sealant applicator device having at least one output port; an injection needle assembly having a hub and an elongated, hollow stylet extending distally from the hub, the hub configured for releasable connection to the sealant applicator device, the elongated, hollow stylet configured to facilitate fluid communication with the at least one output port of the sealant applicator device for receiving the multi-component sealant; 1. A sealant delivery apparatus comprising: an elongate, hollow stylet having a proximal portion and a distal portion, the distal portion having a closed distal end and a plurality of side ports proximal to the closed distal end; the elongate, hollow stylet having a side wall surrounding an internal lumen; the plurality of side ports extending radially from the internal lumen through the side wall of the elongate, hollow stylet at the distal portion; and the plurality of side ports in fluid communication with the at least one output port of the sealant applicator device. [Item 2] The device according to item 1, The device wherein the plurality of side ports in the distal portion of the elongate hollow stylet comprises at least three side ports in the distal portion arranged circumferentially around the elongate hollow stylet. [Item 3] The device according to item 1 or 2, The device wherein the plurality of side ports in the distal portion of the elongate hollow stylet includes at least two longitudinally spaced side ports. [Item 4] 4. The device according to any one of items 1 to 3, The device wherein the closed distal end of the elongated hollow stylet is a closed needle tip that terminates the distal extent of the lumen. [Item 5] 5. The device according to any one of items 1 to 4, The elongated hollow stylet an elongate cannula defining said sidewall and said lumen; a stylet tip defined by the closed distal end, the stylet tip being attached to the elongate cannula to distally close the lumen of the elongate cannula; An apparatus comprising: [Item 6] 5. The device according to any one of items 1 to 4, the sealant applicator device comprises: a pair of syringes having an actuator and a first component chamber configured to deliver the first sealant component of the multi-component sealant and a second component chamber configured to deliver the second sealant component of the multi-component sealant, wherein the actuator includes a first piston and a second piston, the first piston being disposed in the first component chamber proximal to the first sealant component, and the second piston being disposed in the second component chamber proximal to the second sealant component; a first input port, a second input port, and the at least one output port; a manifold, wherein the at least one output port is in fluid communication with each of the first input port and the second input port, the first input port being in fluid communication with the chamber of the first component, and the second input port being in fluid communication with the chamber of the second component; 1. An apparatus comprising: [Item 7] Item 6. The device according to item 6, The device, wherein the manifold is a Y-connector having an internal Y-passage including the first input port, the second input port, and the at least one output port configured as a single output port, the single output port being in fluid communication with the multiple side ports at the distal end of the elongated hollow stylet having the closed distal end. [Item 8] 8. The device according to any one of items 1 to 7, the device further comprising an introducer cannula having a cannula lumen and a distal annular rim, the cannula lumen configured to receive the elongated, hollow stylet of the needle assembly, the plurality of side ports being disposed distally from the distal annular rim of the introducer cannula when the elongated, hollow stylet of the needle assembly is fully inserted into the cannula lumen of the introducer cannula. [Item 9] 1. A system for preparing a sealant delivery device for use in a pulmonary access procedure, comprising: the sealant delivery device, the sealant delivery device comprising a first pair of syringes, the first pair of syringes comprising a first actuator, a first component chamber having a first component port, and a second component chamber having a second component port, the first actuator comprising a first piston and a second piston, the first piston being disposed in the first component chamber and the second piston being disposed in the second component chamber, the first component chamber initially containing a first powder or solution component of a first sealant component of a multi-component sealant, and the second component chamber initially containing a second powder or solution component of a second sealant component of the multi-component sealant; a second pair of syringes including a second actuator, a first component reservoir having a first transfer port, and a second component reservoir having a second transfer port, wherein the second actuator includes a third piston and a fourth piston, the third piston being disposed in the first component reservoir and the fourth piston being disposed in the second component reservoir, the first component reservoir initially containing a first liquid component of the first sealant component of the multi-component sealant, and the second component reservoir initially containing a second liquid component of the second sealant component of the multi-component sealant; a coupling mechanism having a first coupling end and a second coupling end, the first coupling end configured to releasably connect to the first pair of syringes and the second coupling end configured to releasably connect to the second pair of syringes, the coupling mechanism having a first passageway and a second passageway, the first passageway configured to facilitate fluid communication between the first transfer port of the second pair of syringes and the first component port of the first pair of syringes, and the second passageway configured to facilitate fluid communication between the second transfer port of the second pair of syringes and the second component port of the first pair of syringes; A system comprising: [Item 10] Item 9. The system according to item 9, The first actuator of the first pair of syringes is configured to simultaneously move the first piston and the second piston, and the second actuator of the second pair of syringes is configured to simultaneously move the third piston and the fourth piston. The system. [Item 11] Item 11. The system according to item 9 or 10, the second pair of syringes are configured, upon a first depression of the second actuator, to move the first liquid component of the first sealant component into the first component chamber carrying the first powder or solution component of the first sealant component and simultaneously move the second liquid component of the second sealant component into the second component chamber carrying the second powder or solution component of the second sealant component. [Item 12] 12. The system according to any one of items 9 to 11, the first pair of syringes and the second pair of syringes are configured to alternately move any contents of the first component reservoir and the second component reservoir to the first component chamber and the second component chamber, respectively, and move any contents of the first component chamber and the second component chamber to the first component reservoir and the second component reservoir, respectively, by alternately depressing the second actuator and the first actuator. [Item 13] 13. The system according to any one of items 9 to 12, the first pair of syringes and the second pair of syringes are configured to hydrate the first powder or solution component into the first liquid component to form the first sealant component of the multi-component sealant, the first sealant component of the multi-component sealant being present in the first component chamber of the first pair of syringes when fully hydrated; the first pair of syringes and the second pair of syringes are configured to hydrate the second powder or solution component into the second liquid component to form the second sealant component of the multi-component sealant, the second sealant component of the multi-component sealant being present in the second component chamber of the first pair of syringes when fully hydrated. [Item 14] 14. The system according to any one of items 9 to 13, the first coupling end of the coupling mechanism includes a first snap latch and a second snap latch, the second coupling end of the coupling mechanism includes a third snap latch and a fourth snap latch, and the system: a first snap catch associated with the first component chamber of the first pair of syringes configured to releasably engage with the first snap latch of the coupling mechanism; a second snap catch associated with the second component chamber of the first pair of syringes configured to releasably engage with the second snap latch of the coupling mechanism; a third snap catch associated with the first component reservoir of the second pair of syringes configured to releasably engage with the third snap latch of the coupling mechanism; a fourth snap catch associated with the second component reservoir of the second pair of syringes, configured to releasably engage with the fourth snap latch of the coupling mechanism; The system further comprises: [Item 15] 15. The system according to any one of items 9 to 14, The sealant applicator device further includes an injection needle assembly having a hub and an elongated, hollow stylet extending distally from the hub, the hub configured for removably connecting to the sealant applicator device, the elongated, hollow stylet connecting the first component port and the second component port of the sealant applicator device for receiving the multi-component sealant. 1. A system configured to facilitate fluid communication with a first component port and a second component port of the sealant applicator device, wherein the elongated, hollow stylet has a proximal portion and a distal portion, the distal portion having a closed distal end and a plurality of side ports proximal to the closed distal end, the elongated, hollow stylet having a side wall surrounding a lumen, the plurality of side ports extending radially from the lumen and through the side wall of the elongated, hollow stylet at the distal portion, the plurality of side ports configured to be in fluid communication with the first component port and the second component port of the sealant applicator device. [Item 16] 1. A method for preparing a sealant delivery device for use in a pulmonary access procedure, comprising: providing a first pair of syringes including a first actuator, a first component chamber having a first component port, and a second component chamber having a second component port, wherein the first actuator includes a first piston and a second piston, the first piston being disposed in the first component chamber, the second piston being disposed in the second component chamber, the first component chamber containing a first powder or solution component of a first sealant component of a multi-component sealant, and the second component chamber containing a second powder or solution component of a second sealant component of the multi-component sealant; providing a second pair of syringes including a second actuator, a first component reservoir having a first transfer port, and a second component reservoir having a second transfer port, wherein the second actuator includes a third piston and a fourth piston, the third piston being disposed in the first component reservoir, the fourth piston being disposed in the second component reservoir, the first component reservoir containing a first liquid component of the first sealant component of the multi-component sealant, and the second component reservoir containing a second liquid component of the second sealant component of the multi-component sealant; providing a coupling mechanism having a first coupling end and a second coupling end, the first coupling end being releasably connectable to the first pair of syringes and the second coupling end being releasably connectable to the second pair of syringes, the coupling mechanism having a first passageway and a second passageway, the first passageway facilitating fluid communication between the first transfer port of the second pair of syringes and the first component port of the first pair of syringes, and the second passageway facilitating fluid communication between the second transfer port of the second pair of syringes and the second component port of the first pair of syringes; A method comprising: [Item 17] Item 16. The method according to item 16, connecting the first pair of syringes to the second pair of syringes by the coupling mechanism; moving the first actuator of the first pair of syringes to simultaneously move the first piston and the second piston; moving the second actuator of the second pair of syringes to simultaneously move the third piston and the fourth piston; A method including the steps of: [Item 18] Item 16. The method according to item 16, connecting the first pair of syringes to the second pair of syringes by the coupling mechanism; Depressing the second actuator of the second pair of syringes moves the first liquid component of the first sealant component from the first component reservoir into the first component chamber carrying the first powder or solution component of the first sealant component, and simultaneously moves the second liquid component of the second sealant component from the second component reservoir. moving the second sealant component into a chamber carrying the second powder or solution component; A method comprising: [Item 19] Item 16. The method according to item 16, connecting the first pair of syringes to the second pair of syringes by the coupling mechanism; sequentially actuating the first pair of syringes and the second pair of syringes to hydrate the first powder or solution component into the first liquid component to form the first sealant component of the multi-component sealant, wherein the first sealant component of the multi-component sealant is present in the first component chamber of the first pair of syringes when fully hydrated; wherein, concurrently with the act of sequentially actuating the first pair of syringes and the second pair of syringes, the first pair of syringes and the second pair of syringes are operable to hydrate the second powder or solution component into the second liquid component to form the second sealant component of the multi-component sealant, the second sealant component of the multi-component sealant being present in the second component chamber of the first pair of syringes when fully hydrated. [Item 20] 20. The method according to any one of items 17 to 19, and alternately depressing the second actuator of the second pair of syringes and the first actuator of the first pair of syringes to move any contents of the first component reservoir and the second component reservoir into the first component chamber and the second component chamber, respectively, and to move any contents of the first component chamber and the second component chamber into the first component reservoir and the second component reservoir. [Item 21] 21. The method according to any one of items 16 to 20, decoupling the coupling mechanism from the first pair of syringes; coupling the injection needle assembly according to item 1 to the first pair of syringes; A method comprising:

Claims

1. 1. A sealant delivery device for use in assisting in preventing pneumothorax in a pulmonary access procedure, comprising: a sealant applicator device configured to individually deliver each of a first sealant component of a multi-component sealant and a second sealant component of the multi-component sealant, the sealant applicator device having at least one output port; an injection needle assembly having a hub and an elongated, hollow stylet extending distally from the hub, the hub configured for releasable connection to the sealant applicator device, the elongated, hollow stylet configured to facilitate fluid communication with the at least one output port of the sealant applicator device for receiving the multi-component sealant; the elongated hollow stylet having a proximal portion and a distal portion, the distal portion having a closed distal end and a plurality of side ports proximal to the closed distal end, the elongated hollow stylet having a sidewall surrounding a lumen, the plurality of side ports extending radially from the lumen through the sidewall of the elongated hollow stylet at the distal portion, the plurality of side ports being in fluid communication with the at least one output port of the sealant applicator device, the plurality of side ports at the distal portion of the elongated hollow stylet including at least two longitudinally spaced side ports; an introducer cannula having a cannula lumen and a distal annular rim, the cannula lumen configured to receive the elongated, hollow stylet of the needle assembly, the plurality of side ports being disposed distally from the distal annular rim of the introducer cannula when the elongated, hollow stylet of the needle assembly is fully inserted into the cannula lumen of the introducer cannula; When the introducer cannula contacts the hub, the side port is disposed distally from the annular rim.

2. 2. The apparatus of claim 1, The device, wherein the plurality of side ports at the distal portion of the elongated hollow stylet comprises at least three side ports at the distal portion disposed about a circumference of the elongated hollow stylet.

3. 3. An apparatus according to claim 1 or 2, comprising: the plurality of side ports in the distal portion of the elongated hollow stylet includes a first side port spaced longitudinally proximal to a second side port and spaced 1-3 millimeters apart.

4. 4. An apparatus according to any one of claims 1 to 3, comprising: The device, wherein the closed distal end of the elongated hollow stylet is a closed needle tip that terminates the distal extent of the lumen.

5. 5. An apparatus according to any one of claims 1 to 4, comprising: The elongated hollow stylet comprises: an elongate cannula defining said sidewall and said lumen; a stylet tip defined by the closed distal end, the stylet tip being attached to the elongate cannula for closing distally of the lumen of the elongate cannula; An apparatus comprising:

6. 5. An apparatus according to any one of claims 1 to 4, comprising: said sealant applicator device comprising: a pair of syringes having an actuator, a first component chamber configured to deliver the first sealant component of the multi-component sealant, and a second component chamber configured to deliver the second sealant component of the multi-component sealant, the actuator including a first piston and a second piston, the first piston being disposed in the first component chamber proximal to the first sealant component, and the second piston being disposed in the second component chamber proximal to the second sealant component; a manifold including a first input port, a second input port, and the at least one output port, the at least one output port being in fluid communication with each of the first input port and the second input port, the first input port being in fluid communication with a chamber of the first component, and the second input port being in fluid communication with a chamber of the second component; 13. An apparatus comprising:

7. 7. The apparatus of claim 6, The device, wherein the manifold is a Y-connector having an internal Y-passage including the first input port, the second input port, and the at least one output port configured as a single output port, the single output port being in fluid communication with the multiple side ports at the distal end of the elongated hollow stylet having the closed distal end.

8. 1. A sealant delivery device for use in assisting in preventing pneumothorax in a pulmonary access procedure, comprising: a sealant applicator device configured to individually deliver each of a first sealant component of a multi-component sealant and a second sealant component of the multi-component sealant, the sealant applicator device having at least one output port; an injection needle assembly having a hub and an elongated, hollow stylet extending distally from the hub, the hub configured for releasable connection to the sealant applicator device, the elongated, hollow stylet configured to facilitate fluid communication with the at least one output port of the sealant applicator device for receiving the multi-component sealant; the elongated hollow stylet having a proximal portion and a distal portion, the distal portion having a closed distal end and a plurality of side ports proximal to the closed distal end, the elongated hollow stylet having a sidewall surrounding a lumen, the plurality of side ports extending radially from the lumen through the sidewall of the elongated hollow stylet at the distal portion, the plurality of side ports being in fluid communication with the at least one output port of the sealant applicator device, the plurality of side ports at the distal portion of the elongated hollow stylet including at least two longitudinally spaced side ports; the at least two longitudinally spaced side ports include a first plurality of side ports arranged in an annular fashion and a second plurality of side ports arranged in an annular fashion and longitudinally spaced from the first plurality of side ports; an introducer cannula having a cannula lumen and a distal annular rim, the cannula lumen configured to receive the elongated, hollow stylet of the needle assembly, the plurality of side ports being disposed distally from the distal annular rim of the introducer cannula when the elongated, hollow stylet of the needle assembly is fully inserted into the cannula lumen of the introducer cannula; When the introducer cannula contacts the hub, the side port is disposed distally from the annular rim.

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