A device for delivering occlusive dressings used in lung procedures, and a system and method for preparing the same.

Abstract

To provide a sealant delivery apparatus for use in a lung access procedure to aid in preventing pneumothorax.SOLUTION: A sealant delivery apparatus includes a sealant applicator device and an injection needle assembly. The injection needle assembly has a hub and an elongate hollow stylet. The hub is configured for removable connection to the sealant applicator device. The elongate hollow stylet is configured to facilitate fluid communication with at least one output port of the sealant applicator device to receive a multi-component sealant. The elongate hollow stylet has a proximal portion, a distal portion having a closed distal end, and a plurality of side ports proximal to the closed distal end. The plurality of side ports radially extend from a lumen and through a side wall of the elongate hollow stylet in the distal portion. The plurality of side ports are in fluid communication with the at least one output port of the sealant applicator device.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - reference to related applications

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

[0002]

[0002] The present invention relates to lung access procedures such as lung biopsies, and more particularly to a sealant delivery device for use in lung procedures to assist in preventing pneumothorax, as well as a system and method for preparing the same.

Background Art

[0003]

[0003] Pneumothorax is a problematic complication of lung biopsy procedures where the pleural cavity is made accessible to air or liquid as a result of puncturing the parietal and visceral pleura. Pneumothorax, and particularly pneumothorax that requires chest tube placement, is a significant problem for clinicians performing percutaneous lung biopsies and for patients undergoing the same. The incidence of pneumothorax in patients undergoing percutaneous lung biopsy has been reported to be 9 - 54%, with an average of about 15%. On average, pneumothorax requiring chest tube placement occurs in 6.6% of all percutaneous lung biopsies, resulting in an average hospital stay of 2.7 days.

[0004]

[0004] Factors that increase the risk of pneumothorax include patient aging, obstructive lung disease, increased depth of injury, multiple passages in the pleura, increased time the access needle traverses the pleura, and crossing of fissures. Since pneumothorax can occur during or immediately after the procedure, generally a CT scan of the target area is performed following removal of the needle. Other, less common complications of percutaneous lung biopsy include hemoptysis (spitting of blood), hemothorax (a type of pleural effusion where blood accumulates in the pleural cavity), infection, and air embolism.

[0005] ​

[0005] It has been shown that approximately 30% of lung biopsies result in a type of pneumothorax where it is difficult or impossible to place a plug after the biopsy. Current commercially available sealants are placed by a coaxial cannula after the biopsy, either before or after the formation of pneumothorax. [Overview of the Initiative] [Problems that the invention aims to solve]

[0006]

[0006] What is required in this technology is a sealant delivery device having the ability to deposit sealant components into the pleural cavity prior to lung procedures such as biopsy in order to support the prevention of pneumothorax, as well as a system and method for preparing it. [Means for solving the problem]

[0007]

[0007] The present invention provides a sealant delivery device having the ability to deposit sealant components into the pleural cavity prior to lung procedures such as biopsy in order to support the prevention of pneumothorax, as well as a system and method for preparing the same.

[0008]

[0008] In one embodiment, the above invention relates to a occlusive dressing device used to assist in the prevention of pneumothorax in lung access procedures. The occlusive dressing device includes an occlusive dressing applicator device (also called an occlusive dressing application device) and an injection needle assembly. The applicator device is configured to transport each of the first and second sealant components of the multi-component sealant separately. 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 is configured to be detachably connected 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 in order to receive 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 called side openings) proximal to the closed distal end. The elongated hollow stylet has side walls surrounding a lumen, and in the distal portion of the elongated hollow stylet, the plurality of side ports extend radially from the lumen through the side walls. Multiple side ports are in fluid communication with at least one output port of the sealing applicator device.

[0009]

[0009] In another embodiment, the invention relates to a system for preparing a sealant delivery device for use in lung access procedures. The system includes a first pair of syringes, a second pair of syringes, and a coupling mechanism associated with the sealant delivery device. The first pair of syringes includes a first actuator, a first component chamber having a port for the first component, and a second component chamber having a port for the second component. The first actuator includes a first piston and a second piston. The first piston is located in the first component chamber, and the second piston is located in the second component chamber. The first component chamber initially contains a first powder or solution component of the first sealant component of a multi-component sealant, and the second component chamber initially contains a second powder or solution component of the second sealant component of a multi-component sealant. The second pair of syringes includes a second actuator, a reservoir for a first component having a first transfer port, and a reservoir for a second component having a second transfer port. The second actuator includes a third piston and a fourth piston. The third piston is located in the reservoir for the first component, and the fourth piston is located in the reservoir for the second component. The reservoir for the first component initially contains the first liquid component of the first sealing component of the multi-component sealant, and the reservoir for the second component initially contains the second liquid component of the second sealing 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 be releasably connected to the first pair of syringes, and the second coupling end is configured to be releasably connected to the second pair of syringes. The coupling mechanism has a first passage and a second passage. The first passage is configured to facilitate fluid communication between the first transfer port of the second pair of syringes and the port for the first component of the first pair of syringes, and the second passage is configured to facilitate fluid communication between the second transfer port of the second pair of syringes and the port for the second component of the first pair of syringes.

[0010]

[0010] In another embodiment, the invention relates to a method for preparing a sealant delivery device for use in lung access procedures. The method comprises the steps of preparing a first pair of syringes comprising a first actuator, a first component chamber having a port for a first component, and a second component chamber having a port for a second component, wherein the first actuator comprises a first piston and a second piston, the first piston being located in the first component chamber, the second piston being located in the second component chamber, the first component chamber containing a first powder or solution component of the first sealant component of a multicomponent sealant, and the second component chamber containing the multicomponent sealant The steps include: preparing a first pair of syringes containing a second powder or solution component of a second sealant component; and preparing a second pair of syringes comprising a second actuator, a reservoir of the first component having a first transfer port, and a reservoir of the second component having a second transfer port, wherein the second actuator comprises a third piston and a fourth piston, the third piston being located in the reservoir of the first component, the fourth piston being located in the reservoir of the second component, and the reservoir of the first component containing the first liquid component of the first sealant component of the multi-component sealant. The present invention provides a second pair of syringes, wherein the reservoir for the second component contains the second liquid component of the second sealing component of the multi-component sealing material; and provides a coupling mechanism having a first coupling end and a second coupling end, wherein the first coupling end is releasably coupling to the first pair of syringes, and the second coupling end is releasably coupling to the second pair of syringes, and the coupling mechanism has a first passage and a second passage, wherein the first passage facilitates fluid communication between a first transfer port of the second pair of syringes and a port for the first component of the first pair of syringes, and the second passage facilitates fluid communication between a second transfer port of the second pair of syringes and a port for the second component of the first pair of syringes.

[0011]

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

[0012] For example, polymer plugs have a weak sealing effect because they only occupy the space in which they are placed, whereas the above invention has another advantage over conventional pneumothorax prevention devices, as the injection needle assembly is placed at the beginning of the procedure rather than at the very end, and a fluid, multi-component sealant, such as a polymer, can be delivered and incorporated into the space between tissues.

[0012]

[0013] Another advantage of the present invention is that it eliminates the need for the physician to measure the location of the needle related to the pleura, which is inaccessible from the site currently being treated. The solution of the present invention is to prepare a fluid multi-component occlusive agent and apply the fluid multi-component occlusive agent from the elongated hollow stylet of the injection needle assembly as the elongated hollow stylet moves across the pleura, thereby integrating smoothly with the lung access procedure.

[0013]

[0014] By referring to the following description of embodiments of the above invention together with the accompanying drawings, the other aforementioned features and advantages of the above invention, as well as the methods for achieving them, should become clearer and better understood. [Brief explanation of the drawing]

[0014] [Figure 1]

[0015] This is a front view of a sealing material dispensing device according to one aspect of the present invention. [Figure 2]

[0016] Figure 1 is an exploded view of the sealing material dispensing device. [Figure 3]

[0017] Figure 1 is a side view of the sealing material dispensing device of the sealing material dispensing apparatus, with the actuator retracted. [Figure 4]

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

[0019] Perspective view of the distal portion of the elongated stylet of the injection needle assembly of the sealant delivery device in FIGS. 1 and 2. [Figure 6]

[0020] Side view of the distal portion of the elongated stylet of the injection needle assembly of the sealant delivery device in FIGS. 1, 2, and 5. [Figure 7]

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

[0022] Front view of a system for preparing the sealant delivery device of FIGS. 1 and 2 for use in a lung access procedure, including a first pair of syringes and a coupling mechanism for 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] Exploded view of the system of FIG. 8. [Figure 10]

[0024] 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. [Figure 11]

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

[0026] FIGS. 1 and 2 are flow diagrams of a method for preparing a pair of syringes of a sealant delivery device, more particularly a sealant delivery device for use in a pulmonary access procedure.

Best Mode for Carrying Out 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 above invention and such examples should not be construed as limiting the scope of the above 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 aspect of the present invention for use in assisting in the prevention of pneumothorax in a pulmonary access procedure.

[0017]

[0029] The occlusive dressing dispenser 10 includes an occlusive dressing applicator device 12 and a needle assembly 14. The needle assembly 14 defines a longitudinal axis 16. When assembled, the occlusive dressing dispenser 10 has a configuration for facilitating the delivery of a fluid multi-component occlusive dressing to the injection site, and the multi-component occlusive dressing can be injected while the needle portion of the needle assembly 14 intersects with the two layers of the pleura, namely the parietal pleura and the visceral pleura. The needle assembly 14 is configured to puncture the patient's tissue, creating an access route into the patient's tissue, at least through the patient's pleura, such as a proposed biopsy route, and thus the two layers of the pleura can be sealed by curing the multi-component occlusive dressing at the dispenser site, for example, prior to a lung biopsy, so that air does not leak between the two layers and cause pneumothorax. Note that the multi-component occlusive dressing may also be placed in other areas of the access route, such as the subcutaneous tissue and / or lung parenchyma.

[0018]

[0030] Optionally, the occlusive dressing dispenser 10 can be used with the introduction cannula 18, which may be left in place to facilitate the withdrawal of the injection needle assembly 14 of the occlusive dressing dispenser 10 from the patient, while maintaining an access route to the site in the patient's tissue, such as to receive a second medical device, such as a biopsy device, and guide it to the site where the biopsy is performed.

[0019]

[0031] See also Figures 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 transport each of the first sealant component 24 and the second sealant component 26 of the multicomponent sealant separately. The first sealant component 24 may contain, for example, at least two N-hydroxysuccinimide (NHS) ester groups, and the second sealant component 26 may contain, for example, at least two amine groups. For example, the first sealant component 24 may be a solution containing polyethylene glycol (PEG) succinimidyl succinate, and the second sealant component 26 may 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 pair of syringes 20 include an actuator 28, a chamber 30 for the first component, and the The system includes two chambers 32 for the first component. The first component chamber 30 may be a cylindrical tube configured to transport, for example, the first sealing component 24 of a multi-component sealing material. The first component chamber 30 has a port 30-1 for the first component. The second component chamber 32 may be a cylindrical tube configured to transport, for example, the second sealing component 26 of a multi-component sealing material. The second component chamber 32 has a port 32-1 for the second component. The first component chamber 30 and the second component chamber 32 are arranged parallel to each other in the longitudinal direction.

[0021]

[0033] The actuator 28 includes a first piston 34, a second piston 36, and a handle 38. The handle 38 is in the form of a link member that extends perpendicularly between the first piston 34 and the second piston 36 and connects to each of them, facilitating the simultaneous movement of the first piston 34 and the second piston 36 as the handle 38 is pushed in or retracted. The first piston 34 is in the form of a plunger positioned near the first sealing component 24 in the first component chamber 30, and the second piston 36 is in the form of a plunger positioned near the second sealing component 26 in the second component chamber 32.

[0022]

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

[0023]

[0035] The pair of connectors 42-1 and 42-2 can form a screw-type or snap-type connection of the sealing material applicator device 12 to the pair of syringes 20. Similarly, connector 44 can form a screw-type or snap-type connection to the injection 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, 2-2 may be included as part of the manifold 22 and be releasably connectable to the pair of syringes 20. Furthermore, as an alternative, the pair of connectors 42-1, 42-2 may be included as separate parts, each releasably connectable to each of the pair of syringes 20 and to the manifold 22.

[0025]

[0037] The manifold 22 has a first input port 22-1, a second input port 22-2, and at least one output port, which in this embodiment is a single output port and is referred to below as output port 22-3. As best shown in Figure 4, in this embodiment, the coupling mechanism 122 of the manifold 22 has individual passages that are in fluid communication with the Y passages 22-4 inside the Y connector 39. In this embodiment, the coupling mechanism 122 of the manifold 22 directly includes the first input port 22-1 and the second input port 22-2, and the Y connector 39 of the manifold 22 directly includes output port 22-3. Thus, the Y connector 39 is in fluid communication with at least one output port, such as output port 22-3, each of the first input port 22-1 and the second input port 22-2. Furthermore, when the manifold 22 is connected to the pair of syringes 20 of the sealing material 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] Referring to Figures 1 and 2, the injection 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-fitting. The hub 46 is configured to be removably connected to the sealant applicator device 12. More specifically, the hub 46 of the injection needle assembly 14 may include a connector 51 (see Figure 2) at a second end 40-2 of the manifold 40 of the sealant applicator device 12, which can form a screw-type or snap-type connection to a connector 44.

[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, in order to receive a multi-component sealant from the sealant applicator device 12. See also Figures 5-7, the distal portion 48-2 has a closed distal end 50 and a number 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 needle tip 54, in which a plurality of side ports 52 are located immediately adjacent to the closed stylet needle tip 54. More specifically, the elongated cannula 56 of the elongated hollow stylet 48 defines the side wall 48-3 surrounding the lumen 48-4 of the elongated hollow stylet 48, and the plurality of side ports 52 extend radially from the lumen 48-4 through the side wall 48-3 in the distal portion 48-2 of the elongated hollow stylet 48. The closed stylet tip 54 is at least partially defined by the closed distal end 50 of the elongated hollow stylet 48 and is attached to the elongated cannula 56 to the nearby distal lumen 48-4 of the elongated hollow stylet 48, for example, by welding, press-fitting, or adhesive. In other words, the closed stylet tip 54 terminates the distal widening of the lumen 48-4 of the elongated hollow stylet 48. When the sealant dispenser 10 is assembled, the multiple side ports 52 are in fluid communication with at least one output port of the manifold 22 of the sealant applicator device 12, such as output port 22-3, via 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 include 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 an annular pattern, for example, at 120-degree intervals around the elongated hollow stylet 48. In one application, to seal around / near the puncture generated by the closed stylet needle tip 54, it is preferable that the plurality of side ports 52 include at least three side ports (e.g., three to seven side ports), with the at least three side ports located near, but proximal to, the closed stylet needle tip 54, so that a fluid multi-component sealant can be delivered 360 degrees around the elongated hollow stylet 48. In another example, in some applications, it is desirable that the plurality of side ports 52 be configured as two or two pairs of diametrically opposed side ports.

[0030]

[0042] Optionally, as shown by the very thin lines in Figure 5, multiple side ports 52 may be arranged such that at least two side ports are spaced longitudinally apart, for example, side port 52-4 located proximal to side port 52-1 and spaced longitudinally (e.g., 1 to 3 millimeters apart). It is further intended that the following may be included. For example, the multiple side ports 52 may include two rings of three side ports arranged around an elongated hollow stylet 48, where the two rings of three side ports are spaced longitudinally apart in the distal portion 48-2 of the elongated hollow stylet 48.

[0031]

[0043] Referring again to Figure 1, the injection needle assembly 14 can be used with an introduction cannula 18 (sometimes referred to in the art as a coaxial introduction needle) that allows the elongated hollow stylet 48 to be removed from the introduction cannula 18 while maintaining access to the treatment site with the coaxial introduction needle. In other words, the sealant delivery device 10 can be removed from the introduction cannula 18 and replaced with various other measuring instruments such as a biopsy device or another stylet. In this embodiment, the introduction 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, to receive the elongated hollow stylet 48 of the injection needle assembly 14, for example, in a tubular shape. When the elongated hollow stylet 48 of the injection needle assembly 14 is fully inserted into the cannular lumen 18-3 of the injection cannula 18 (for example, when distal movement of the elongated hollow stylet 48 is obstructed by contact between the coaxial hub 18-1 of the injection cannula 18 and the hub 46 of the injection needle assembly 14), the multiple side ports 52 of the elongated hollow stylet 48 are positioned distal to the distal annular rim 18-4 of the injection cannula 18.

[0032]

[0044] Referring to Figures 8 to 11, a system 100 for preparing a sealant delivery device 10 for use in lung access procedures is shown. More specifically, system 100 is used to mix various chemicals, which, when mixed together, yield the first sealant component 24 and the second sealant component 26 of the multi-component sealant shown in Figure 4. 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 comprises a chamber 30 for the first component, a chamber 32 for the second component, and a first actuator 28 having a first piston 34 and a second piston 36. However, as shown in Figure 4, initially (for example, when delivered from the manufacturer), the chamber 30 for the first component does not yet contain the prepared first sealant component 24, and the chamber 32 for the second component does not yet contain the prepared second sealant component 26. Rather, referring to Figure 11, the chamber 30 for the first component initially contains component 24-1 of the powder or solution of the first sealant component 24 of the multicomponent sealant, and the chamber 32 for the second component initially contains component 26-1 of the powder or solution of the second sealant component 26 of the multicomponent sealant. Each solution used herein to form component 24-1 and / or component 26-1 is a combination of solute and solvent, and may include, for example, a suspension or a hydrogel.

[0034]

[0046] Referring to Figures 8 to 11, the second pair of syringes 120 includes a second actuator 128, a storage tank 130 for a first component having a first transfer port 130-1, and a storage tank 132 for a second component 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 link member that extends perpendicularly between the third piston 134 and the fourth piston 136 and connects to each of them, facilitating the simultaneous movement of the third piston 134 and the fourth piston 136 as the handle 138 is pushed in or retracted. The third piston 134 is in the form of a plunger located in the first component reservoir 130, and the fourth piston 136 is in the form of a plunger located in the second component reservoir 132. The first component reservoir 130 is initially a multi-component sealed The first sealing component 24 of the material contains liquid component 24-2, and the storage tank 132 of the second component initially contains liquid component 26-2 of the second sealing component 26 of the multi-component sealing material. The liquid components 24-2 and / or liquid components 26-2 used herein may be water or some other liquid, or may contain water.

[0036]

[0048] The coupling mechanism 122 has a first coupling end 40-1 and a second coupling end 140-2. The first coupling end 40-1 is configured to be releasably connected to a first pair of syringes 20, and the second coupling end 140-2 is configured to be releasably connected to a second pair of syringes 120. Referring particularly to Figures 9 and 11, the coupling mechanism 122 includes a first input port 22-1 and a second input port 22-2 at the first coupling end 40-1, and ports 122-1 and 122-2 at the second coupling end 140-2. A first passage 150-1 further included in the coupling mechanism 122 is in fluid communication with ports 22-1 and 122-1 and extends between them. Similarly, a second passage 150-2 included in the coupling mechanism 122 is in fluid communication with ports 22-2 and 122-2 and extends between them.

[0037]

[0049] The pair of connectors 42-1 and 42-2 can form a screw-type or snap-type 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 and 144-2 can form a screw-type or snap-type 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 releasably connectable to the coupling mechanism 122. Alternatively, the pair of connectors 42-1, 2-2 may be included as part of the coupling mechanism 122 and 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 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 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] Referring to Figures 8 to 11, the first coupling end 40-1 of the coupling mechanism 122 includes a first snap latch 146-1 and a second snap latch 146-2. The chamber 30 of the first component of the first pair of syringes 20 (more specifically, connector 42-1) includes a first snap catch 148-1 configured to releasably engage with the first snap latch 146-1 of the coupling mechanism 122. Similarly, the chamber 32 of the second component of the first pair of syringes 20 (more specifically, connector 42-2) includes a second snap catch 148-2 configured to releasably engage with the second snap latch 146-2 of the coupling mechanism 122.

[0041]

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

[0042]

[0054] Referring to Figures 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 port 30-1 of the first component 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 port 32-1 of the second component of the first pair of syringes 20.

[0043]

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

[0044]

[0056] Therefore, by alternately operating the second actuator 128 and the first actuator 28, for example by alternately pushing them, the second pair of syringes 120 and the first pair of syringes 20 are configured to alternately move any contents from the first component storage tank 130 and the second component storage tank 132 to the first component chamber 30 and the second component chamber 32, respectively, and to move any contents from the first component chamber 30 and the second component chamber 32 to the first component storage tank 130 and the second component storage tank 132, respectively. For example, a first pair of syringes 20 and a second pair of syringes 120 may be configured to simultaneously (A) hydrate a powder or solution component 24-1 into a liquid component 24-2 so as to form a first sealing component 24 of a multi-component sealing material that, when fully hydrated, is present in the chamber 30 of the first component of the first pair of syringes 20 (see also Figure 4), and (B) hydrate a powder or solution component 26-1 into a liquid component 26-2 so as to form a second sealing component 26 of a multi-component sealing material that, when fully hydrated, is present in the chamber 32 of the second component of the second pair of syringes 20, as shown in Figure 4.

[0045]

[0057] For example, in the first pushing 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 which transports the powder or solution component 24-1 of the first sealant component 24, and at the same time move the liquid component 26-2 of the second sealant component 26 through the second passage 150-2 into the second component chamber 32 which transports the powder or solution component 26-1 of the second sealant component 26. Subsequently, a first push of the first actuator 28 causes the first piston 34 and the second piston 36 to simultaneously move the contents of the first component chamber 30 and the contents of the second component chamber 32 of the first pair of syringes 20 into the first component storage tank 130 and the second component storage tank 132 of the second pair of syringes 120, respectively. Then, a second push of the second actuator 128 causes the third piston 134 and the fourth piston 136 to simultaneously move the contents of the first component storage tank 130 and the contents of the second component storage tank 132 of the second pair of syringes 120 into the first component chamber 30 and the second component chamber 32 of the first pair of syringes 20, respectively. This process may be repeated as necessary to ensure proper hydration of component 24-1 of the powder or solution with the liquid component 24-2 in order to form the first sealing component 24 of the multi-component sealing material, and to ensure proper hydration of component 26-1 of the powder or solution with the liquid component 26-2 in order to form the second sealing component 26 of the multi-component sealing material.

[0046]

[0058] When hydration / mixing is complete, the first sealing component 24 is present in the first component chamber 30 of the first pair of syringes 20, and the second sealing component 26 is present in the second component chamber 32. As described above with reference to Figures 1 to 7, the coupling mechanism 122 may be separated from the first pair of syringes 20, then the manifold 22 may be coupled to the first pair of syringes 20, and then the injection needle assembly 14 is connected via the manifold 22. It can be coupled to the first pair of syringes 20 to form a sealant dispensing 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 to 7, and a manifold 22 may be formed by connecting a Y connector 39 to the coupling mechanism 122, and then the injection needle assembly 14 may be connected to the first pair of syringes 20 via the manifold 22 to form a sealant dispensing device 10.

[0048]

[0060] Note that a kit can be formed by combining the (assembled or disassembled) sealant dispenser 10 shown in Figure 1 and / or Figure 2 with the pair of connectors 144-1 and 144-2 and the second pair of syringes 120 shown in Figure 9.

[0049]

[0061] Figure 12 is a flowchart showing a method in which the following steps may be performed sequentially to prepare a occlusive dressing dispenser 10 for use in lung access procedures, and more specifically, to prepare a pair of syringes 20 for the occlusive dressing dispenser 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 operated sequentially (i.e., alternately) to hydrate the powder or solution component 24-1 with the liquid component 24-2 to form the first sealing component 24 of the multi-component sealing material, and simultaneously to hydrate the powder or solution component 26-1 with the liquid component 26-2 to form the second sealing component 26 of the multi-component sealing material.

[0051]

[0064] The step of sequentially operating the first pair of syringes 20 and the second pair of syringes 120 can be performed by alternately pushing 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 storage tank 130 and the second component storage tank 132 into the first component chamber 30 and the second component chamber 32, respectively, and moving any contents of the first component chamber 30 and the second component chamber 32 into the first component storage tank 130 and the second component storage tank 132, respectively.

[0052]

[0065] When fully hydrated, the first sealing component 24 of the multi-component sealant is present in the first component chamber 30 of the first pair of syringes 20, and the second sealing component 26 of the multi-component sealant is present in the second component chamber 32 of the first pair of syringes 20. To achieve this, desired amounts of the first sealing component 24 and the second sealing component 26 are moved into the first pair of syringes 20 by pushing the second actuator 128 of the second pair of syringes 120 until the desired amounts are moved 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 injection needle assembly 14 is connected to the first pair of syringes 20, for example via a manifold 22 (see Figure 1), as described above with reference to Figures 1 to 7, to form a sealant delivery device 10, at which point it is ready to perform lung treatment to assist in the prevention of pneumothorax.

[0055]

[0068] Step S of the method using the prepared sealant dispensing device 10 as described above In steps 200-S206, an elongated, hollow stylet 48 is inserted into the patient to create an access pathway, and while the access pathway is being created, actuators 28 of a pair of syringes 20 may be pushed in to deliver a multi-component sealant from multiple side ports 52 into the access pathway being created in the subcutaneous tissue, pleural layer, pleural space, and / or lung parenchyma.

[0056]

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

[0070] The above invention, in one embodiment, is associated with a sealant delivery device for lung access procedures, particularly for the prevention of pneumothorax. The sealant delivery device includes a sealant applicator device and a needle assembly. The sealant applicator device may be configured to deliver each of the first sealant component and the second sealant component of a multi-component sealant separately. 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 may be configured to be detachably connected to the sealant applicator device. The elongated hollow stylet may be configured to facilitate (prepare) 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 and a distal portion. The distal portion has a closed distal end and a plurality of side ports proximal to the closed distal end. The elongated, hollow stylet has side walls surrounding a lumen, and in the distal portion of the elongated, hollow stylet, multiple side ports extend radially from the lumen through the side walls. The multiple side ports are in fluid communication with at least one output port of a sealing applicator device.

[0057]

[0071] In some embodiments, the multiple lateral ports in the distal portion of the elongated hollow stylet comprise at least three lateral ports in the distal portion, arranged around the elongated hollow stylet.

[0058]

[0072] In some embodiments, the multiple lateral ports in the distal portion of the elongated hollow stylet include at least two lateral ports spaced apart in the longitudinal direction.

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

[0059]

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

[0060]

[0075] In any embodiment, the sealant applicator device may include a pair of syringes having actuators, a chamber for a first component which may be configured to transport a first sealant component of a multicomponent sealant, and a chamber for a second component which may be configured to transport a second sealant component of a multicomponent sealant. The actuators may include a first piston and a second piston. The first piston may be located in the chamber for the first component near the first sealant component, and the second piston may be located in the chamber for the second sealant component near the second sealant component. The manifold may include a first input port, a second input port, and at least one output port which is in fluid communication with the first input port and the second input port, respectively. The first input port is in fluid communication with the chamber for the first component, and the second input port is in fluid communication with the chamber for the second component.

[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. The single output port is elongated with a closed distal end. Multiple side ports at the distal end of the hollow stylet may be in fluid communication with each other.

[0062]

[0077] Optionally, the device may include an induction cannula having a cannular lumen and a distal annular rim. The cannular lumen may be configured to receive an elongated hollow stylet of the injection needle assembly, and when the elongated hollow stylet of the injection needle assembly is fully inserted into the cannular lumen of the induction cannula, the multiple side ports are positioned distal to the distal annular rim of the induction cannula.

[0063]

[0078] The above invention may also relate to a lung biopsy apparatus equipped with a sealing material delivery device, as described above.

[0079] In another embodiment, the above invention relates to a system for preparing a sealant delivery device for lung access procedures. 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 chamber for a first component having a port for a first component, and a chamber for a second component having a port for a second component. The first actuator may include a first piston and a second piston. The first piston is located in the chamber for the first component, and the second piston is located in the chamber for the second component. The chamber for the first component initially contains a first powder or solution component of the first sealant component of a multi-component sealant, and the chamber for the second component initially contains a second powder or solution component of the second sealant component of a multi-component sealant. The second pair of syringes may include a second actuator, a reservoir for a first component having a first transfer port, and a reservoir for a second component having a second transfer port. The second actuator may include a third piston and a fourth piston. The third piston is located in the reservoir for the first component, and the fourth piston is located in the reservoir for the second component. The reservoir for the first component initially contains the first liquid component of the first sealing component of the multi-component sealant, and the reservoir for the second component initially contains the second liquid component of the second sealing 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 be releasably connected to the first pair of syringes, and the second coupling end may be configured to be releasably connected to the second pair of syringes. The coupling mechanism may have a first passage and a second passage. The first passage may be configured to facilitate fluid communication between the first transfer port of the second pair of syringes and the port for the first component of the first pair of syringes, and the second passage may be configured to facilitate fluid communication between the second transfer port of the second pair of syringes and the port for the second component of the first pair of syringes.

[0064]

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

[0065]

[0081] In any embodiment of the system, the second pair of syringes may be configured such that a first press of the second actuator moves the first liquid component of the first sealant component into a chamber of the first component that transports the first powder or solution component of the first sealant component, and simultaneously moves the second liquid component of the second sealant component into a chamber of the second component that transports the second powder or solution component of the second sealant component.

[0066]

[0082] In any embodiment of the system, the first pair of syringes and the second pair of syringes move any contents of the first component reservoir and the second component reservoir into the first component chamber and the second component chamber, respectively, by alternately pushing the second actuator and the first actuator, and move any contents of the first component chamber and the second component chamber into the first component reservoir. It may be configured to alternately transfer the first component into a storage tank for the second component.

[0067]

[0083] In any embodiment of the system, the first pair of syringes and the second pair of syringes can be configured to hydrate the components of the first powder or solution with the first liquid component to form the first sealing component of the multicomponent seal, which, when fully hydrated, is located in the chamber of the first component of the first pair of syringes. Alternatively, the first pair of syringes and the second pair of syringes can be configured to hydrate the components of the second powder or solution with the second liquid component to form the second sealing component of the multicomponent seal, which, when fully hydrated, is located in the chamber of the second component of the first pair of syringes.

[0068]

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

[0069]

[0085] In any embodiment of the system, the system may optionally include a needle assembly having a hub and an elongated hollow stylet extending distally from the hub. The hub may be configured to be detachably connected to a sealant applicator device. The elongated hollow stylet may be configured to facilitate fluid communication with the ports of a first component and a second component 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 a plurality of side ports proximal to the closed distal end. The elongated hollow stylet may have side walls surrounding a lumen, and in the distal portion of the elongated hollow stylet, the plurality of side ports extend radially from the lumen through the side walls. The plurality of side ports are configured to communicate fluidly with the ports of a first component and a second component of the sealant applicator device.

[0070]

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

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

[0071]

[0088] The above invention relates in another embodiment to a method for preparing a sealant delivery device for use in lung access procedures. The method comprises the steps of: preparing a first pair of syringes comprising a first actuator, a chamber for a first component having a port for a first component, and a chamber for a second component having a port for a second component, wherein the first actuator comprises a first piston and a second piston, the first piston may be located in the chamber for the first component, the second piston may be located in the chamber for the second component, the chamber for the first component contains a first powder or solution component of the first sealant component of a multicomponent sealant, and the chamber for the second component contains a second powder or solution component of the second sealant component of a multicomponent sealant; and preparing a second pair of syringes comprising a second actuator, a reservoir for a first component having a first transfer port, and a reservoir for a second component having a second transfer port, wherein the second actuator The steps include: preparing a second pair of syringes, wherein the ethanol includes a third piston and a fourth piston, the third piston can be placed in a reservoir of a first component, and the fourth piston can be placed in a reservoir of a second component, the reservoir of the first component containing the first liquid component of the first sealing component of the multicomponent sealing material, and the reservoir of the second component containing the second liquid component of the second sealing component of the multicomponent sealing material; and preparing a coupling mechanism having a first coupling end and a second coupling end. The present invention includes the step of providing a coupling mechanism having a first coupling end which may be releasably connectable to a first pair of syringes, a second coupling end which may be releasably connectable to a second pair of syringes, wherein the coupling mechanism has a first passage and a second passage, the first passage which facilitates fluid communication between a first transfer port of the second pair of syringes and a port for a first component of the first pair of syringes, and the second passage which facilitates fluid communication between a second transfer port of the second pair of syringes and a port for a second component of the first pair of syringes.

[0072]

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

[0073]

[0090] In any embodiment of the method, the method may include the steps of connecting a first pair of syringes to a second pair of syringes by a coupling mechanism, and moving the first liquid component of the first sealing component from the reservoir of the first component into the chamber of the first component that transports the first powder or solution component of the first sealing component, by pushing a second actuator of the second pair of syringes, and simultaneously moving the second liquid component of the second sealing component from the reservoir of the second component into the chamber of the second component that transports the second powder or solution component of the second sealing component.

[0074]

[0091] In any embodiment of the method, the method includes the steps of connecting a first pair of syringes to a second pair of syringes by a coupling mechanism, and sequentially operating the first pair of syringes and the second pair of syringes to hydrate a component of a first powder or solution with a first liquid component to form a first sealing component of a multi-component seal, wherein the first sealing component of the multi-component seal is located in the chamber of the first component of the first pair of syringes when fully hydrated, and simultaneously with the sequential operation of the first pair of syringes and the second pair of syringes, the first pair of syringes and the second pair of syringes operate to hydrate a component of a second powder or solution with a second liquid component to form a second sealing component of the multi-component seal, wherein the second sealing component of the multi-component seal is located in the chamber of the second component of the first pair of syringes when fully hydrated.

[0075]

[0092] In some embodiments of the method, the method includes the steps of alternately pressing a second actuator of a second pair of syringes and a first actuator of a 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 moving 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 embodiments of the method, the method may include the steps of separating the coupling mechanism from a first pair of syringes and coupling the injection needle assembly to the first pair of syringes.

[0077]

[0094] This invention has been described with reference to at least one embodiment, but may be further modified within the spirit and scope of this disclosure. Therefore, this application describes the above invention, This application is intended to cover any variations, uses, or modifications that utilize the general principles thereof. Furthermore, this application is intended to cover any such deviations from this disclosure as falling within the scope of the appended claims, within the scope of known or common practice in the art relating to this invention.

Claims

1. A system for preparing a sealant delivery device used in lung access procedures, The sealing material dispensing device comprises a first pair of syringes, each of which comprises a first actuator, a chamber for a first component having a port for a first component, and a chamber for a second component having a port for a second component, the first actuator comprises a first piston and a second piston, the first piston being located in the chamber for the first component, the second piston being located in the chamber for the second component, the chamber for the first component initially containing a first powder or solution component of the first sealing material component of the multi-component sealing material, and the chamber for the second component initially containing a second powder or solution component of the second sealing material component of the multi-component sealing material. A second pair of syringes comprising a second actuator, a reservoir for a first component having a first transfer port, and a reservoir for a second component having a second transfer port, wherein the second actuator comprises a third piston and a fourth piston, the third piston being located in the reservoir for the first component, the fourth piston being located in the reservoir for the second component, the reservoir for the first component initially containing the first liquid component of the first sealing component of the multi-component sealant, and the reservoir for the second component initially containing the second liquid component of the second sealing component of the multi-component sealant, A coupling mechanism having a first coupling end and a second coupling end, wherein the first coupling end is configured to be releasably connected to the first pair of syringes, and the second coupling end is configured to be releasably connected to the second pair of syringes, the coupling mechanism having a first passage and a second passage, wherein the first passage is configured to facilitate fluid communication between the first transfer port of the second pair of syringes and the port of the first component of the first pair of syringes, and the second passage is configured to facilitate fluid communication between the second transfer port of the second pair of syringes and the port of the second component of the first pair of syringes, The first pair of syringes and the second pair of syringes alternately push the second actuator and the first actuator, thereby discharging the first component into the reservoir and the front The device comprises a coupling mechanism configured to alternately move any contents of the storage tank for the second component to the chamber for the first component and the chamber for the second component, respectively, and move any contents of the chamber for the first component and the chamber for the second component to the storage tank for the first component and the storage tank for the second component, respectively. A system in which the first pair of syringes are connected to a needle assembly via the coupling mechanism and Y-connector.

2. The system according to claim 1, A system in which the first actuator of the first pair of syringes is configured to move the first piston and the second piston simultaneously, and the second actuator of the second pair of syringes is configured to move the third piston and the fourth piston simultaneously.

3. A system according to claim 1 or 2, A system in which the second pair of syringes are configured to move the first liquid component of the first sealing component into the chamber of the first component which transports the first powder or solution component of the first sealing component, by a first push of the second actuator, and simultaneously move the second liquid component of the second sealing component into the chamber of the second component which transports the second powder or solution component of the second sealing component.

4. A system according to any one of claims 1 to 3, A system in which the second actuator and the first actuator are alternately pressed until the respective powder or solution components are completely hydrated by the respective liquid components.

5. A system according to any one of claims 1 to 4, The first pair of syringes and the second pair of syringes are configured to hydrate the components of the first powder or solution with the first liquid component to form the first sealing component of the multi-component sealing material, and when the first sealing component of the multi-component sealing material is fully hydrated, it is present in the chamber of the first component of the first pair of syringes. A system in which the first pair of syringes and the second pair of syringes are configured to hydrate the second powder or solution component with the second liquid component to form the second sealing component of the multi-component sealing material, the second sealing component of the multi-component sealing material being present in the chamber of the second component of the first pair of syringes when fully hydrated.

6. A system according to any one of claims 1 to 5, The first coupling end of the coupling mechanism includes a first snap latch and a second snap latch, and the second coupling end of the coupling mechanism includes a third snap latch and a fourth snap latch, and the system is A first snap catch associated with the chamber of the first component of the first pair of syringes, configured to engage releasably with the first snap latch of the coupling mechanism, A second snap catch associated with the chamber of the second component of the first pair of syringes, configured to engage releasably with the second snap latch of the coupling mechanism, A third snap catch associated with the reservoir of the first component of the second pair of syringes is configured to engage releasably with the third snap latch of the coupling mechanism, A fourth snap catch associated with the reservoir of the second component of the second pair of syringes is configured to engage releasably with the fourth snap latch of the coupling mechanism. A system that further enhances this feature.

7. A system according to any one of claims 1 to 6, The injection needle assembly comprises a hub and an elongated hollow stylet extending distally from the hub, wherein the hub is configured to be removably connected to a sealant applicator device, the sealant applicator device comprising the first pair of syringes and the Y connector, and the elongated hollow stylet is configured to facilitate fluid communication between the port of the first component and the port of the second component of the sealant applicator device for receiving the multi-component sealant, the elongated hollow stylet A system comprising a hollow stylet having a proximal and distal portion, wherein the distal portion has a closed distal end and a plurality of side ports proximal to the closed distal end, the elongated hollow stylet having side walls surrounding a lumen, the plurality of side ports extending radially in the distal portion from the lumen through the side walls of the elongated hollow stylet, and the plurality of side ports being configured to be in fluid communication with the ports of the first component and the ports of the second component of the sealing applicator device.

8. A method for preparing a sealant delivery device for use in lung access procedures, A step of preparing a first pair of syringes comprising a first actuator, a chamber for a first component having a port for a first component, and a chamber for a second component having a port for a second component, wherein the first actuator comprises a first piston and a second piston, the first piston is located in the chamber for the first component, the second piston is located in the chamber for the second component, the chamber for the first component contains a first powder or solution component of the first sealing component of the multicomponent sealing material, and the chamber for the second component contains a second powder or solution component of the second sealing component of the multicomponent sealing material. A step of preparing a second pair of syringes comprising a second actuator, a reservoir for a first component having a first transfer port, and a reservoir for a second component having a second transfer port, wherein the second actuator comprises a third piston and a fourth piston, the third piston being located in the reservoir for the first component, the fourth piston being located in the reservoir for the second component, the reservoir for the first component containing the first liquid component of the first sealing component of the multi-component sealing material, and the reservoir for the second component containing the second liquid component of the second sealing component of the multi-component sealing material. A step of providing a coupling mechanism having a first coupling end and a second coupling end, wherein the first coupling end is releasably connectable to the first pair of syringes, the second coupling end is releasably connectable to the second pair of syringes, the coupling mechanism has a first passage and a second passage, the first passage facilitates fluid communication between the first transfer port of the second pair of syringes and the port of the first component of the first pair of syringes, and the second passage facilitates fluid communication between the second transfer port of the second pair of syringes and the port of the second component of the first pair of syringes, The steps of alternately pressing 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 storage tank and the second component storage tank into the first component chamber and the second component chamber, respectively, and alternately moving any contents of the first component chamber and the second component chamber into the first component storage tank and the second component storage tank, The steps include separating the coupling mechanism from the second pair of syringes, The steps include: connecting the injection needle assembly to the first pair of syringes via the coupling mechanism and the Y connector; A method that includes this.

9. The method according to claim 8, The coupling mechanism connects the first pair of syringes to the second pair of syringes, The steps include moving the first actuator of the first pair of syringes to move the first piston and the second piston simultaneously, The steps of moving the second actuator of the second pair of syringes to move the third piston and the fourth piston simultaneously, A method that includes them sequentially.

10. The method according to claim 8, The coupling mechanism connects the first pair of syringes to the second pair of syringes, The steps include: pushing the second actuator of the second pair of syringes to move the first liquid component of the first sealing material component from the storage tank of the first component into the chamber of the first component that transports the first powder or solution component of the first sealing material component, and simultaneously moving the second liquid component of the second sealing material component from the storage tank of the second component into the chamber of the second component that transports the second powder or solution component of the second sealing material component; A method that includes this.

11. The method according to claim 8, The coupling mechanism connects the first pair of syringes to the second pair of syringes, The steps include sequentially operating the first pair of syringes and the second pair of syringes to hydrate the components of the first powder or solution with the first liquid component to form the first sealing component of the multi-component sealing material, wherein the first sealing component of the multi-component sealing material is present in the chamber of the first component of the first pair of syringes when fully hydrated. A method wherein, simultaneously with the sequential operation of the first pair of syringes and the second pair of syringes, the first pair of syringes and the second pair of syringes operate to hydrate the second powder or solution component with the second liquid component to form the second sealing component of the multi-component sealing material, the second sealing component of the multi-component sealing material being present in the chamber of the second component of the first pair of syringes when fully hydrated.

12. A method according to any one of claims 9 to 11, A method of alternately pushing the second actuator of the second pair of syringes and the first actuator of the first pair of syringes until the respective powder or solution components are completely hydrated by the respective liquid components.

13. A method according to any one of claims 8 to 12, The injection needle assembly comprises a hub and an elongated hollow stylet extending distally from the hub, wherein the hub is configured to be detachably connected to a sealant applicator device, the sealant applicator device comprising the first pair of syringes and the Y-connector, and the elongated hollow stylet is configured to facilitate fluid communication with at least one output port of the sealant applicator device for receiving the multi-component sealant.

Images