Sealant injection needle assembly and sealant delivery device for lung access surgery

Abstract

The present invention relates to a sealant injection needle assembly, comprising a cannula assembly and a stylet assembly. The cannula assembly includes a cannula hub and a cannula having a first longitudinal sealant passage and a second longitudinal sealant passage. The first longitudinal sealant passage has a first proximal sealant port and a first distal sealant port. The second longitudinal sealant passage has a second proximal sealant port and a second distal sealant port. The stylet assembly has a stylet advancement hub and a stylet configured to longitudinally move within the cannula lumen. The stylet has a first stage position and a second stage position. The stylet has a first outer circumferential channel longitudinally spaced from a second outer circumferential channel, and the first outer circumferential channel and the second outer circumferential channel can be selectively and sequentially positioned in fluid communication with both the first distal sealant port and the second distal sealant port of the cannula.

Description

[0001] Cross - Reference to Related Applications

[0002] None. Technical Field

[0003] The present invention relates to a lung access procedure, such as a lung biopsy, and more particularly to a sealant injection needle assembly and a sealant delivery device for a lung access procedure to help prevent pneumothorax. Background Art

[0004] Pneumothorax is a problematic complication of a lung biopsy procedure, in which air or fluid is allowed to enter the pleural space due to penetration of the parietal and visceral pleura. Pneumothorax and especially pneumothorax that requires placement of a chest tube are important concerns for clinicians performing percutaneous lung biopsy and patients undergoing percutaneous lung biopsy. It has been reported that the incidence of pneumothorax in patients undergoing percutaneous lung biopsy is 9% - 54%, with an average of about 15%. On average, 6.6% of all percutaneous lung biopsies result in pneumothorax that requires placement of a chest tube, which results in an average hospital stay of 2.7 days.

[0005] Factors that increase the risk of pneumothorax include increased patient age, obstructive lung disease, increased lesion depth, multiple pleural penetrations, increased time of the access needle passing through the pleura, and laceration crossing. Pneumothorax may occur during or immediately after the procedure, which is why a CT scan of the area is typically performed after the needle is removed. Other less common complications of percutaneous lung biopsy include hemoptysis (coughing up blood), hemothorax (a pleural effusion in which blood accumulates in the pleural cavity), infection, and air embolism.

[0006] It is known to attempt to apply a sealant to an area near the patient's pleural layer to prevent pneumothorax. Such procedures typically require the use of a positioning imaging scan to position the device. However, sometimes the time required for the positioning imaging scan competes with the gelling time of the adhesive, and the user must remove the stylet and replace it with a new stylet to continue, which may move the needle reference and increase the procedure time.

[0007] There is a need in the art for a sealant injection needle assembly and a sealant delivery device having a multi-stage sealing ability for a lung access procedure to help prevent pneumothorax. Summary of the Invention

[0008] The present invention provides a sealant injection needle assembly and a sealant delivery device having a multi-stage sealing ability for a lung access procedure to help prevent pneumothorax.

[0009] In one form, the present invention is directed to a sealant injection needle assembly for use with a syringe-type applicator having a first sealant component chamber and a second sealant component chamber. The sealant injection needle assembly includes a cannula assembly and a stylet assembly. The cannula assembly has a cannula hub and a cannula. The cannula has an inner lumen and a distal end. The cannula hub is fixedly attached to the cannula. The cannula has a first longitudinal sealant passage and a second longitudinal sealant passage. The first longitudinal sealant passage has a first proximal sealant port and a first distal sealant port. The second longitudinal sealant passage has a second proximal sealant port and a second distal sealant port. The first proximal sealant port is configured to be in fluid communication with the first sealant component chamber, and the second proximal sealant port is configured to be in fluid communication with the second sealant component chamber. The stylet assembly has a stylet advancement hub and a stylet. The stylet advancement hub is fixedly attached to the stylet. The stylet is configured to longitudinally move within the inner lumen of the cannula. The stylet has a first stage position and a second stage position. The stylet has an outer surface including a first outer circumferential channel and a second outer circumferential channel. The first outer circumferential channel and the second outer circumferential channel are longitudinally spaced apart. When the stylet is in the first stage position, the first outer circumferential channel of the stylet is in fluid communication with both the first distal sealant port and the second distal sealant port of the cannula. When the stylet is in the second stage position, the second outer circumferential channel of the stylet is in fluid communication with both the first distal sealant port and the second distal sealant port of the cannula.

[0010] In another form, the present invention is directed to a sealant injection needle assembly for injecting a multi-component sealant. The sealant injection needle assembly includes a cannula having a proximal portion, a distal portion, a distal end, and a sidewall surrounding a lumen. The sidewall has a first longitudinal sealant passage and a second longitudinal sealant passage, wherein each of the first longitudinal sealant passage and the second longitudinal sealant passage extends from the proximal portion to the distal portion. The first longitudinal sealant passage has a first proximal sealant port and a first distal sealant port. The first proximal sealant port is configured to be in fluid communication with a first sealant component of the multi-component sealant. The first distal sealant port is located at the distal portion and is in fluid communication with the lumen of the cannula. The second longitudinal sealant passage has a second proximal sealant port and a second distal sealant port. The second proximal sealant port is configured to be in fluid communication with a second sealant component of the multi-component sealant. The second distal sealant port is located at the distal portion and is in fluid communication with the lumen of the cannula. A stylet is configured to longitudinally move within the lumen of the cannula between a first stage position and a second stage position. The stylet has an outer surface including a first outer circumferential channel and a second outer circumferential channel. The first outer circumferential channel and the second outer circumferential channel are longitudinally spaced apart. When the stylet is in the first stage position, each of the first distal sealant port and the second distal sealant port of the cannula is in fluid communication with a rear portion of the first outer circumferential channel of the stylet, and a front portion of the first outer circumferential channel of the stylet is positioned distal to the distal end of the cannula. When the stylet is in the second stage position, each of the first distal sealant port and the second distal sealant port of the cannula is in fluid communication with a rear portion of the second outer circumferential channel of the stylet, and a front portion of the second outer circumferential channel of the stylet is positioned distal to the distal end of the cannula.

[0011] In another form, the present invention is directed to a sealant delivery device for lung entry surgery to help prevent pneumothorax. The sealant delivery device includes a sealant applicator device, a cannula assembly, and a stylet assembly. The sealant applicator device has an actuator, a first sealant component chamber configured to carry a first sealant component of a multi-component sealant, and a second sealant component chamber configured to carry a second sealant component of the multi-component sealant. The first sealant component chamber has a first applicator port, and the second sealant component chamber has a second applicator port. The cannula assembly includes a cannula hub and a cannula having an inner lumen and a distal end. The cannula hub is fixedly attached to the cannula. The cannula is configured to have a first longitudinal sealant passage and a second longitudinal sealant passage. The first longitudinal sealant passage has a first proximal sealant port and a first distal sealant port. The second longitudinal sealant passage has a second proximal sealant port and a second distal sealant port. The first proximal sealant port is configured to be in fluid communication with the first applicator port of the first sealant component chamber of the sealant applicator device. The second proximal sealant port is configured to be in fluid communication with the second applicator port of the second sealant component chamber of the sealant applicator device. The stylet assembly has a stylet advancement hub, a stylet intermediate hub, and a stylet. The stylet intermediate hub is threadedly interposed between the cannula hub and the stylet advancement hub. The stylet advancement hub is fixedly attached to the stylet. The stylet is configured to move longitudinally within the inner lumen of the cannula. The stylet has a first stage position and a second stage position. The stylet has an outer surface including a first outer circumferential channel and a second outer circumferential channel. The first outer circumferential channel and the second outer circumferential channel are longitudinally spaced apart. When the stylet is in the first stage position, each of the first distal sealant port and the second distal sealant port of the cannula is in fluid communication with the first outer circumferential channel of the stylet, and a front portion of the first outer circumferential channel of the stylet is positioned distal to the distal end of the cannula. When the stylet is in the second stage position, each of the first distal sealant port and the second distal sealant port of the cannula is in fluid communication with the second outer circumferential channel of the stylet, and a front portion of the second outer circumferential channel of the stylet is positioned distal to the distal end of the cannula.

[0012] An advantage of the present invention is that the present invention reduces or eliminates the need to replace a used stylet or cannula due to premature curing of the sealant at the lung entry path during lung surgery by providing multi-stage sealing capabilities. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The above and other features and advantages of the present invention and the manner of obtaining them will become more apparent and the present invention will be better understood by referring to the following description of embodiments of the present invention in conjunction with the accompanying drawings, in which:

[0014] Figure 1Perspective view of a sealant delivery device for lung entry surgery according to one aspect of the present invention and including a safety member, which includes a sealant applicator device and a sealant injection needle assembly;

[0015] Figure 2 is Figure 1 exploded view of the sealant injection needle assembly of;

[0016] Figure 3 is Figure 1 enlarged perspective view of the seat portion of the sealant injection needle assembly of, with a quarter portion removed;

[0017] Figure 4 is along Figure 1 the line 4-4 of the Figure 1 enlarged cross-sectional view of the sealant injection needle assembly of, which shows the cannula assembly and the stylet assembly, and wherein the stylet is retracted and the safety member is removed;

[0018] Figure 5 shows Figure 4 enlarged cross-sectional view of the sealant injection needle assembly of, wherein the stylet is advanced to the first stage position;

[0019] Figure 6 shows Figure 4 and Figure 5 enlarged cross-sectional view of the sealant injection needle assembly of, wherein the stylet is further advanced to the second stage position;

[0020] Figure 7 is Figure 4 enlarged portion of the distal portion of the cannula and stylet depicted in;

[0021] Figure 8 is Figure 7 perspective view of a further enlarged portion of the cross-sectional portion of the enlarged portion of;

[0022] Figure 9 is Figures 1 - 8 perspective view of a further enlarged portion of the cross-sectional portion of the cannula of the cannula assembly of;

[0023] Figure 10 is Figure 1 and Figures 4 - 7 side view of the distal portion of the stylet of, which shows a first outer circumferential channel longitudinally separated from a second outer circumferential channel;

[0024] Figure 11 is Figure 1 and Figures 4 - 7 another side view of the distal portion of the stylet of, which is from Figure 10is depicted as being rotated 90 degrees directionally and shows a first outer circumferential channel longitudinally separated from a second outer circumferential channel; and

[0025] Figure 12 is of a seat portion of a sealant injection needle assembly according to one aspect of the present invention Figure 1 in an enlarged perspective view, where a portion of the stylet advancement seat is cut away to show a haptic feedback mechanism.

[0026] Corresponding reference numerals indicate corresponding parts in the several figures. The examples set forth herein illustrate at least one embodiment of the present invention, and such examples should not be construed as limiting the scope of the present invention in any way. DETAILED DESCRIPTION

[0027] Now referring to the drawings, and more particularly to Figure 1 , there is shown a sealant delivery device 10 for a lung entry procedure to help prevent pneumothorax. The sealant delivery device 10 includes a sealant applicator device 12 and a sealant injection needle assembly 14. The sealant applicator device 12 is fluidly connected to the sealant injection needle assembly 14 through a flexible tube 16 and a flexible tube 18.

[0028] The sealant applicator device 12 is a syringe-type applicator configured to separately carry each of a first sealant component 20 of a multi-component sealant and a second sealant component 22 of the multi-component sealant. When the first sealant component 20 is mixed with the second sealant component 22, the resulting chemical reaction forms a sealant gel (i.e., the multi-component sealant), which is adapted to form a seal area at the pleural layer of a patient and along an access tract leading to the pleural layer and the lung. The first sealant component 20 may include, for example, at least two N-hydroxysuccinimide (NHS) ester groups, and the second sealant component 22 may include, for example, at least two amine groups. For example, the first sealant component 20 may be a solution containing polyethylene glycol (PEG) succinimide succinate, while the second sealant component 22 may be a solution containing albumin and / or polyethyleneimine (PEI).

[0029] In the present embodiment, for example, the sealant applicator device 12 is in the form of a syringe-type applicator having a first sealant component chamber 24 and a second sealant component chamber 26. The first sealant component chamber 24 is configured to carry and contain the first sealant component 20 of the multi-component sealant. The second sealant component chamber 26 is configured to carry and contain the second sealant component 22 of the multi-component sealant. In the present embodiment, each of the first sealant component chamber 24 and the second sealant component chamber 26 may be, for example, in the form of a cylinder or in the form of a pair of cylindrical holes in a common body.

[0030] The first sealant component chamber 24 has a first applicator port 28. Also referring to Figure 2 , the first applicator port 28 is configured to be fluidly connected in a corresponding port in the sealant injection needle assembly 14 via the flexible tube 16.

[0031] Similarly, the second sealant component chamber 26 has a second applicator port 30. The second applicator port 30 is configured to be fluidly connected in a corresponding port in the sealant injection needle assembly 14 via the flexible tube 18.

[0032] The sealant applicator device 12 further includes an actuator 32. In the present embodiment, the actuator 32 of the sealant applicator device 12 includes a first piston 34, a second piston 36, and a plunger handle 38. The plunger handle 38 is in the form of a link member that extends perpendicularly between the first piston 34 and the second piston 36 and is connected to each of the first piston and the second piston. The first piston 34 is in the form of a plunger that can slide within the first sealant component chamber 24 and is proximal to the first sealant component 20 of the multi-component sealant. The second piston 36 is in the form of a plunger that can slide within the second sealant component chamber 26 and is proximal to the second sealant component 22 of the multi-component sealant.

[0033] The sealant injection needle assembly 14 includes a cannula assembly 40 and a stylet assembly 42. Optionally, the sealant injection needle assembly 14 may further include a safety member 44.

[0034] Referring to Figures 2 to 6 , the cannula assembly 40 has a cannula hub 46 and a cannula 48. The cannula hub 46 is fixedly connected to the cannula 48, for example, by a press fit or by overmolding. The cannula hub 46 has a hub body 46-1 and a male threaded portion 46-2, where the male threaded portion 46-2 extends proximally from the hub body 46-1.

[0035] Referring to Figures 1 to 3 , the cannula hub 46 has a first cannula hub port 50 and a second cannula hub port 52. The first cannula hub port 50 and the second cannula hub port 52 are configured, for example, as through-passages to facilitate fluid communication with the cannula 48. The first cannula hub port 50 has a tubular extension 50-1 and the second cannula hub port 52 has a tubular extension 52-1. In the present embodiment, for example, the tubular extension 50-1 and the tubular extension 52-1 extend from the hub body 46-1 in opposite directions.

[0036] Referring to Figure 1 and Figure 2, when the sealant injection needle assembly 14 is fully assembled, the tubular extension 50-1 of the first socket port 50 is connected via the flexible tube 16 to the first applicator port 28 of the first sealant component chamber 24 of the sealant applicator device 12 that carries the first sealant component 20 of the multi-component sealant via the flexible tube 16. Thus, the first socket port 50 facilitates fluid communication between the sealant injection needle assembly 14 and the first sealant component 20 of the multi-component sealant. Similarly, when the sealant injection needle assembly 14 is fully assembled, the tubular extension 52-1 of the second socket port 52 is connected via the flexible tube 18 to the second applicator port 30 of the second sealant component chamber 26 that carries the second sealant component 22 of the multi-component sealant. Thus, the second socket port 52 facilitates fluid communication of the sealant injection needle assembly 14 to facilitate fluid communication with the second sealant component 22 of the multi-component sealant.

[0037] Referring to Figures 3 to 6 , the cannula 48 has a proximal portion 54, a distal portion 56, a distal end 58, and a sidewall 60 surrounding the inner lumen 62 (see Figure 9 ). Also referring to Figures 7 to 9 , the sidewall 60 has a first longitudinal sealant passage 64 and a second longitudinal sealant passage 66. More particularly, in the present embodiment, the first longitudinal sealant passage 64 and the second longitudinal sealant passage 66 are located in the sidewall 60 of the cannula 48 and are surrounded by the sidewall of the cannula. Each of the first longitudinal sealant passage 64 and the second longitudinal sealant passage 66 extends from the proximal portion 54 to the distal portion 56. Further, in the present embodiment, as Figure 3 and Figures 7 - 9 best shown, the first longitudinal sealant passage 64 is configured as a pair of passages 64-1, 64-2, and similarly, the second longitudinal sealant passage 66 is configured as a pair of passages 66-1, 66-2.

[0038] Referring to Figures 3 to 9 , the first longitudinal sealant passage 64 has a first proximal sealant port 68 and a first distal sealant port 70. The first proximal sealant port 68 of the cannula 48 is fluidly connected to the first socket port 50 of the socket 46. In the present embodiment, the first proximal sealant port 68 is configured as an arcuate opening that fluidly connects each of the passages 64-1, 64-2 of the pair of passages 64-1, 64-2 of the first longitudinal sealant passage 64 together at the proximal portion 54, and as Figure 3 best shown, the arcuate opening fluidly connects the pair of passages 64-1, 64-2 to the first socket port 50 of the socket 46.

[0039] Thus, referring to Figures 1 to 3, a first proximal sealant port 68 is coupled to and in fluid communication with a first applicator port 28 of a first sealant component chamber 24 that carries a first sealant component 20 of a multi-component sealant via a first ferrule seat port 50 of a ferrule seat 46 and a flexible tube 16. Thus, the first proximal sealant port 68 of the first longitudinal sealant passage 64 of the ferrule 48 is configured to be in fluid communication with the first applicator port 28 of the first sealant component chamber 24 and with the first sealant component 20 of the multi-component sealant.

[0040] Referring Figure 7 and Figure 9 , a first distal sealant port 70 of the first longitudinal sealant passage 64 of the ferrule 48 is located at a distal portion 56 and is in fluid communication with the inner lumen 62 of the ferrule 48. More particularly, in this embodiment, also referring Figures 4 to 6 , the first distal sealant port 70 is located proximal to and adjacent to the distal end 58 of the ferrule 48. The first distal sealant port 70 is configured to connect arcuate channels of a pair of passages 64-1, 64-2 of the first longitudinal sealant passage 64 at the distal portion 56.

[0041] Referring Figures 3 to 9 , a second longitudinal sealant passage 66 has a second proximal sealant port 72 and a second distal sealant port 74. The second proximal sealant port 72 is fluidly coupled to a second ferrule seat port 52 of the ferrule seat 46. In this embodiment, the second proximal sealant port 72 is configured as an arcuate opening that fluidly connects each of a pair of passages 66-1, 66-2 of the second longitudinal sealant passage 66 together at a proximal portion 54, and as Figure 3 best shown, the arcuate opening fluidly connects the pair of passages 66-1, 66-2 to the second ferrule seat port 52 of the ferrule seat 46.

[0042] Thus, referring Figures 1 to 3 , the second proximal sealant port 72 is coupled to and in fluid communication with a second applicator port 30 of a second sealant component chamber 26 that carries a second sealant component 22 of the multi-component sealant via the second ferrule seat port 52 of the ferrule seat 46 and a flexible tube 18. Thus, the second proximal sealant port 72 of the second longitudinal sealant passage 66 is configured to be in fluid communication with the second applicator port 30 of the second sealant component chamber 26 and with the second sealant component 22 of the multi-component sealant.

[0043] Referring Figure 7 and Figure 9, the second distal sealant port 74 of the second longitudinal sealant passage 66 is located at the distal portion 56 and is in fluid communication with the lumen 62 of the cannula 48. More particularly, in the present embodiment, the second distal sealant port 74 is located proximal and adjacent to the distal end 58 of the cannula 48. The second distal sealant port 70 is configured to connect the arcuate channels of a pair of passages 64-1, 64-2 of the first longitudinal sealant passage 64 at the distal portion 56.

[0044] Referring to Figure 9 , each of the first distal sealant port 70 and the second distal sealant port 74 is located at the distal portion 56 of the cannula 48 and extends into the lumen 62 of the cannula 48. In the present embodiment, for example, the first distal sealant port 70 is diametrically opposed to the second distal sealant port 74 across the lumen 62 of the cannula 48. Referring to Figures 4 to 8 , each of the first distal sealant port 70 and the second distal sealant port 74 is configured to facilitate fluid communication between the first sealant component 20 and the second sealant component 22 of the multi-component sealant and the longitudinally positionable stylet 84 of the stylet assembly 42, as described in more detail below.

[0045] Referring to Figures 3 to 6 , the stylet assembly 42 includes a stylet advancement seat 80, a stylet intermediate seat 82, and a stylet 84.

[0046] The stylet advancement seat 80 is fixedly connected to the stylet 84, for example, by press fitting or by overmolding. The stylet advancement seat 80 has a seat body 80-1 and an internal female threaded portion 80-2 within the seat body 80-1. The seat body 80-1 is fixedly connected to the stylet 84, for example, by press fitting or by overmolding.

[0047] The stylet intermediate seat 82 is configured to be threadedly interposed between the cannula seat 46 and the stylet advancement seat 80 and threadedly coupled to each of the cannula seat and the stylet advancement seat. The stylet intermediate seat 82 has a seat body 82-1, a male threaded portion 82-2, and a female threaded portion 82-3. The male threaded portion 82-2 extends proximally from the seat body 82-1, for example, toward the stylet advancement seat 80. The female threaded portion 82-3 is located within the seat body 82-1. The male threaded portion 82-2 of the stylet intermediate seat 82 is configured to threadedly engage the female threaded portion 80-2 of the stylet advancement seat 80, and the female threaded portion 82-3 of the stylet intermediate seat 82 is configured to threadedly engage the male threaded portion 46-2 of the cannula seat 46. In other words, the female threaded portion 80-2 of the stylet advancement seat 80 is configured to threadedly engage the male threaded portion 82-2 of the stylet intermediate seat 82, and the male threaded portion 46-2 of the cannula seat 46 is configured to threadedly engage the female threaded portion 82-3 of the stylet intermediate seat 82.

[0048] The stylet assembly 42 can be threadedly connected to the cannula assembly 40, wherein the female threaded portion 82-3 of the stylet intermediate seat 82 can be partially or fully threadedly engaged with the male threaded portion 46-2 of the cannula seat 46, such as being screwed onto the male threaded portion of the cannula seat. In addition, the female threaded portion 80-2 of the stylet advancement seat 80 is adjustably and threadedly engaged with the male threaded portion 82-2 of the stylet intermediate seat 82.

[0049] By the user rotating the stylet advancement seat 80 relative to the stylet intermediate seat 82, the longitudinal position of the stylet advancement seat 80 and the stylet 84 can be adjusted relative to the stylet intermediate seat 82 and thus relative to the cannula assembly 40 (i.e., the cannula seat 46 and / or the cannula 48). More particularly, referring to Figures 4 to 6 , each of the female threaded portion 80-2 of the stylet advancement seat 80 and the male threaded portion 82-2 of the stylet intermediate seat 82 has a pitch of a first distance 86 to effect a rotational translation of a second distance 88 of the stylet advancement seat 80 and the stylet 84 relative to the stylet intermediate seat 82. Accordingly, the stylet 84 is configured to longitudinally move within the lumen 62 of the cannula 48 (see also Figures 7 - 9 ).

[0050] In the present embodiment, as Figures 4 to 6 best shown, the stylet 84 is an elongated solid member having a proximal portion 90 and a distal portion 92. The stylet advancement seat 80 is fixedly attached to the proximal portion 90 of the stylet 84. The distal portion 92 of the stylet 84 has a closed tip 94. Also referring to Figure 10 and Figure 11 , according to one aspect of the present invention, the stylet 84 has an outer surface 96 that includes a first outer circumferential channel 98 and a second outer circumferential channel 100, and the first outer circumferential channel and the second outer circumferential channel are located in the distal portion 92 of the stylet 84 proximal to the closed tip 94.

[0051] The first outer circumferential channel 98 extends longitudinally along the stylet 84 and is longitudinally spaced from the second outer circumferential channel 100, wherein a separation region 102 extends longitudinally between the first outer circumferential channel 98 and the second outer circumferential channel 100. The separation region 102 mechanically and fluidly separates the first outer circumferential channel 98 from the second outer circumferential channel 100. In the present embodiment, the first outer circumferential channel 98 is in the form of a first helical channel (e.g., having a slightly X-shaped shape along the stylet 84), and the second outer circumferential channel 100 is in the form of a second helical channel (e.g., having a slightly X-shaped shape along the stylet 84), and the separation region 102 extends longitudinally between the first helical channel and the second helical channel.

[0052] Referring again toFigures 4 to 6 , the female threaded portion 80-2 of the stylet advancement seat 80 has a pitch of a first distance 86 to effect a rotational translation of the stylet advancement seat 80 and the stylet 84 by a second distance 88 (see Figure 6 ). Accordingly, the female threaded portion 80-2 of the stylet advancement seat 80 is configured such that one full rotation of the stylet advancement seat 80 causes the stylet 84 to longitudinally move by the second distance 88 and, thus, causes each of the first outer circumferential channel 98 and the second outer circumferential channel 100 of the stylet 84 to longitudinally and simultaneously move by the second distance 88. In the present embodiment, the first distance 86 and the second distance 88 are equal and can be, for example, a distance in the range of 1.0 millimeter to 3 millimeters.

[0053] In the following description, with reference to Figures 4 to 7 , it is noted that: the first outer circumferential channel 98 is distal to the second outer circumferential channel 100 with respect to the distal direction 104 such that the first outer circumferential channel 98 will first be exposed distally beyond the distal end 58 of the cannula 48 before the second outer circumferential channel 100 is exposed distally beyond the distal end 58 of the cannula 48, so as to define two consecutive operating levels.

[0054] More particularly, with reference to Figure 5 and Figure 6 , the stylet 84 has a first level position 106 and a second level position 108.

[0055] With reference to Figure 5 , and further with reference to Figure 7 , 8 , 10 and 11, when the stylet 84 is in the first level position 106, as Figure 5 shown, each of the first distal sealant port 70 and the second distal sealant port 74 of the cannula 48, i.e., both of them, is in fluid communication with the rear portion 98-1 of the first outer circumferential channel 98 of the stylet 84, and the front portion 98-2 of the first outer circumferential channel 98 of the stylet 84 is positioned distally of the distal end 58 of the cannula 48. In other words, when the stylet 84 is in the first level position 106, the first outer circumferential channel 98 of the stylet 84 is in fluid communication with both the first distal sealant port 70 and the second distal sealant port 74 of the cannula 48.

[0056] Accordingly, also again with reference to Figure 1, in the case where the stylet 84 is in the first stage position 106, the first actuation (e.g., partial depression) of the plunger handle 38 of the sealant applicator device 12 causes the first sealant component 20 and the second sealant component 22 to be transported to the first outer circumferential channel 98 of the stylet 84, wherein the first outer circumferential channel 98 facilitates the mixing of the first sealant component 20 and the second sealant component 22 in the first outer circumferential channel 98 to form a multi-component sealant, and the mixed multi-component sealant is then transported from the front portion 98-2 of the first outer circumferential channel 98 of the stylet 84 into the patient's body.

[0057] Referring to Figure 6 , and further referring to Figure 7 、 8 、10 and 11, when the stylet 84 is in the second stage position 108, as Figure 6 shown, each of the first distal sealant port 70 and the second distal sealant port 74 of the cannula 48 is in fluid communication with the rear portion 100-1 of the second outer circumferential channel 100 of the stylet 84, and the front portion 100-2 of the second outer circumferential channel 100 of the stylet 84 is positioned distally of the distal end 58 of the cannula 48. In other words, when the stylet 84 is in the second stage position 108, the second outer circumferential channel 100 of the stylet 84 is in fluid communication with both the first distal sealant port 70 and the second distal sealant port 74 of the cannula 48.

[0058] Therefore, also referring again to Figure 1 , in the case where the stylet 84 is in the second stage position 108, the second actuation (e.g., second partial depression) of the plunger handle 38 of the sealant applicator device 12 causes the first sealant component 20 and the second sealant component 22 to be transported through the stylet 84 to the second outer circumferential channel 100 of the stylet 84, wherein the second outer circumferential channel 100 facilitates the mixing of the first sealant component 20 and the second sealant component 22 in the second outer circumferential channel 100 to form a multi-component sealant, and the mixed multi-component sealant is then transported from the front portion 100-2 of the second outer circumferential channel 100 of the stylet 84 into the patient's body.

[0059] Now referring to Figure 12, the stylet advancement seat 80 and the stylet intermediate seat 82 are configured to provide haptic feedback to the user for each rotation of the stylet advancement seat 80 relative to the stylet intermediate seat 82. More particularly, the stylet advancement seat 80 and the stylet intermediate seat 82, when combined, include a haptic feedback mechanism 110 that is configured to provide haptic feedback to the user for each rotational translation of the second distance 88 of the stylet 84. The haptic feedback mechanism 110 can include, for example, a plurality of stoppers 112 and a cantilever member 114. The plurality of stoppers 112 can be, for example, a set of linearly arranged and spaced notches in the male threaded portion 82-2 of the stylet intermediate seat 82. The cantilever member 114 extends, for example, in the distal direction 104 from the seat body 80-1 of the stylet advancement seat 80 and has a cantilever finger 114-1-1 that extends downwardly toward the male threaded portion 82-2 of the stylet intermediate seat 82. The cantilever finger 114-1-1 is configured to contact and follow the male threaded portion 82-2 of the stylet intermediate seat 82, wherein the cantilever finger 114-1-1 is biased by the cantilever member 114 in the direction toward the male threaded portion 82-2 of the stylet intermediate seat 82. For each rotation of the stylet advancement seat 80 relative to the stylet intermediate seat 82, the cantilever finger 114-1 of the stylet advancement seat 80 follows the male threaded portion 82-2 of the stylet intermediate seat 82 to engage one of the plurality of stoppers 112 formed in the male threaded portion 82-2 of the stylet intermediate seat 82, thereby providing a haptic resistance detectable by the user. Thus, the user will know how far the stylet 84 has been advanced relative to the cannula assembly 40 by sensing the rotational resistance provided by the haptic feedback mechanism 110 for each full rotation of the stylet advancement seat 80 relative to the stylet intermediate seat 82.

[0060] Referring again to Figures 1 to 3 , optionally, the safety member 44 can be removably interposed between the stylet advancement seat 80 and the stylet intermediate seat 82. As Figure 3 best shown, the safety member 44 can be, for example, in the form of a spacer having a handle 44-1 and a through hole 44-2, the size of the through hole being designed to receive the male threaded portion 82-2 of the stylet intermediate seat 82. Alternatively, the safety member 44 can be in the form of a clamp received on the male threaded portion 82-2 of the stylet intermediate seat 82. The thickness of the safety member 44 is selected to space the seat body 80-1 of the stylet advancement seat 80 from the seat body 82-1 of the stylet intermediate seat 82.

[0061] Referring to Figure 1 , 3 , 4, and 7, when the safety member 44 is interposed between the stylet advancement seat 80 and the stylet intermediate seat 82, then both the first outer circumferential channel 98 and the second outer circumferential channel 100 of the stylet 84 are completely contained within the lumen 62 of the cannula 48 of the cannula assembly 40 (seeFigure 4 , 7 and 8), and thus the first distal port 70 and the second distal port 74 are not radially aligned with any part of the first outer circumferential channel 98 and the second outer circumferential channel 100 of the stylet 84. Thus, as Figure 1 shown, with the safety member 44 in place, no amount of the multi-component sealant can be delivered from the sealant injection needle assembly 14.

[0062] However, referring to Figure 4 , with the safety member 44 removed, the stylet advancement seat 80 can be rotated relative to the stylet intermediate seat 82 and the cannula assembly 40 to reposition the stylet 84 within the cannula 48, first to the first stage position 106 (see Figure 5 ), and then to the second stage position (see Figure 6 ). For example, further referring to Figure 12 , by rotating the stylet advancement seat 80 to a first stop affected by the tactile feedback mechanism 110, the stylet 84 is then positioned in the first stage position 106 (see Figure 5 ), and each of the first distal sealant port 70 and the second distal sealant port 74 of the cannula 48, i.e., both, are in fluid communication with the rear 98-1 of the first outer circumferential channel 98 of the stylet 84, and the front 98-2 of the first outer circumferential channel 98 of the stylet 84 is positioned distal to the distal end 58 of the cannula 48. Thus, at this time, again referring to Figure 1 , a first actuation (e.g., partial depression) of the plunger handle 38 of the sealant applicator device 12 having the stylet 84 causes the first sealant component 20 and the second sealant component 22 to be delivered to the first outer circumferential channel 98 of the stylet 84, wherein the first outer circumferential channel 98 facilitates mixing of the first sealant component 20 and the second sealant component 22 in the first outer circumferential channel 98 to form a multi-component sealant, and the mixed multi-component sealant is then delivered from the front 98-2 of the first outer circumferential channel 98 of the stylet 84 into the patient's body.

[0063] Once the first sealant component 20 and the second sealant component 22 are mixed in the first outer circumferential channel 98, the multi-component sealant begins to cure. Thus, if there is a delay in the lung surgery, for example due to imaging or device repositioning, it is possible that the first outer circumferential channel 98 may become unavailable due to the cured multi-component sealant in the channel. However, advantageously, according to one aspect of the present invention, if further delivery of the sealant is required, the stylet advancement seat 80 is rotated to the next stop under the influence of the tactile feedback mechanism 110 (see Figure 12 ), wherein the stylet 84 is then positioned in the second stage position 108 (see Figure 6 ) to provide a new delivery channel.

[0064] For example, when the stylet 84 is in the second stage position 108, as Figure 6 shown, each of the first distal sealant port 70 and the second distal sealant port 74 of the cannula 48 is in fluid communication with the rear portion 100-1 of the second outer circumferential channel 100 of the stylet 84, and the front portion 100-2 of the second outer circumferential channel 100 of the stylet 84 is positioned distal to the distal end 58 of the cannula 48, wherein the second outer circumferential channel 100 facilitates the mixing of the first sealant component 20 and the second sealant component 22 in the second outer circumferential channel 100 to form a multi-component sealant, and the thus mixed multi-component sealant is delivered from the front portion 100-2 of the second outer circumferential channel 100 of the stylet 84 into the patient's body.

[0065] In the embodiments described herein, the stylet 84 is described as having two spaced-apart outer circumferential channels, e.g., including a first outer circumferential channel 98 and a second outer circumferential channel 100 of the stylet 84 (see, e.g., Figure 10 and Figure 11 ). However, those skilled in the art will recognize that by simply modifying the available thread lengths of the female threaded portion 80-2 of the stylet advancement seat 80 and / or the male threaded portion 82-2 of the stylet intermediate seat 82 (see, e.g., Figures 4 - 6 ), the number of spaced-apart outer circumferential channels (i.e., spaced-apart helical lines) of the stylet 84 can be increased to three, four, or more, in order to define additional stages of positioning the stylet 84, and thus additional stages of delivering the multi-component sealant to the access passage leading to the patient's lungs.

[0066] The following items are also related to the present invention.

[0067] In one form, the present invention relates to a sealant injection needle assembly for use with a syringe-type applicator having a first sealant component chamber and a second sealant component chamber. The sealant injection needle assembly includes a cannula assembly and a stylet assembly. The cannula assembly may have a cannula hub and a cannula. The cannula may have an inner lumen and a distal end. The cannula hub is fixedly attached to the cannula. The cannula may have a first longitudinal sealant passage and a second longitudinal sealant passage. The first longitudinal sealant passage may have a first proximal sealant port and a first distal sealant port. The second longitudinal sealant passage may have a second proximal sealant port and a second distal sealant port. The first proximal sealant port may be configured to be in fluid communication with the first sealant component chamber, and the second proximal sealant port may be configured to be in fluid communication with the second sealant component chamber. The stylet assembly may have a stylet advancement hub and a stylet. The stylet advancement hub is fixedly attached to the stylet. The stylet may be configured to longitudinally move within the inner lumen of the cannula. The stylet may have a first stage position and a second stage position. The stylet may have an outer surface including a first outer circumferential channel and a second outer circumferential channel. The first outer circumferential channel and the second outer circumferential channel are longitudinally spaced apart. The stylet assembly may be configured such that when the stylet is in the first stage position, the first outer circumferential channel of the stylet is in fluid communication with both the first distal sealant port and the second distal sealant port of the cannula, and when the stylet is in the second stage position, the second outer circumferential channel of the stylet is in fluid communication with both the first distal sealant port and the second distal sealant port of the cannula.

[0068] In any embodiment, the first outer circumferential channel may be a first helical channel and the second outer circumferential channel may be a second helical channel. A separation region extends longitudinally between the first helical channel and the second helical channel.

[0069] In any embodiment, the stylet assembly may be configured such that when the stylet is in the first stage position, a front portion of the first outer circumferential channel of the stylet is distal to the distal end of the cannula and a rear portion of the first outer circumferential channel of the stylet is in fluid communication with both the first distal sealant port and the second distal sealant port of the cannula.

[0070] In any embodiment, the stylet assembly may be configured such that when the stylet is in the second stage position, a front portion of the second outer circumferential channel of the stylet is distal to the distal end of the cannula and a rear portion of the second outer circumferential channel of the stylet is in fluid communication with both the first distal sealant port and the second distal sealant port of the cannula.

[0071] In some embodiments, the cannula may include a proximal portion, a distal portion having a distal end, and a sidewall surrounding a lumen, wherein a first longitudinal sealant passage and a second longitudinal sealant passage are located in the sidewall of the cannula. Each of the first longitudinal sealant passage and the second longitudinal sealant passage may be configured to extend from the proximal portion to the distal portion.

[0072] In any embodiment, each of a first distal sealant port and a second distal sealant port of the cannula may be located at the distal portion of the cannula and configured to extend into the lumen of the cannula.

[0073] In some embodiments, the first distal sealant port may be diametrically opposed to the second distal sealant port across the lumen of the cannula.

[0074] In some embodiments, the stylet may be an elongate solid member having a proximal portion and a distal portion. A stylet advancement seat may be fixedly attached to the proximal portion. The distal portion may have a closed tip. A first outer circumferential channel and a second outer circumferential channel are located in the distal portion proximal to the closed tip.

[0075] In some embodiments, a stylet intermediate seat may be threadedly coupled to each of the stylet advancement seat and the cannula seat.

[0076] In any embodiment having a stylet intermediate seat, the stylet intermediate seat may have a first male threaded portion and a first female threaded portion. The stylet advancement seat may have a second female threaded portion configured to threadedly engage the first male threaded portion of the stylet intermediate seat. The cannula seat may have a second male threaded portion configured to threadedly engage the first female threaded portion of the stylet intermediate seat.

[0077] In the embodiments of the previous paragraph, the second female threaded portion of the stylet advancement seat may have a pitch of a first distance, (configured) to effect a rotational translation of the stylet advancement seat and the stylet by a second distance, and wherein the sealant injection needle is configured such that a rotation of the stylet advancement seat by a full turn causes each of the first outer circumferential channel and the second outer circumferential channel of the stylet to longitudinally move by the second distance. In some embodiments, optionally, the first distance and the second distance are equal.

[0078] In any embodiment having a stylet intermediate seat, optionally, the sealant injection needle assembly may include a safety member that may be removably interposed between the stylet advancement seat and the stylet intermediate seat.

[0079] In any embodiment having a stylet intermediate seat, optionally, the sealant injection needle assembly can be configured such that the stylet advancement seat and the stylet intermediate seat, when combined, include a haptic feedback mechanism configured to provide haptic feedback to the user for each rotation and translation of the stylet by a second distance.

[0080] The invention also relates to an assembly including the sealant injection needle assembly as described above, for lung entry procedures (to help prevent pneumothorax), and in particular to a lung entry assembly including the sealant injection needle assembly as described above.

[0081] In another form, the invention relates to a sealant injection needle assembly for injecting a multi-component sealant. The sealant injection needle assembly can include a cannula having a proximal portion, a distal portion, a distal end, and a sidewall surrounding a lumen. The sidewall can have a first longitudinal sealant passage and a second longitudinal sealant passage, wherein each of the first longitudinal sealant passage and the second longitudinal sealant passage extends from the proximal portion to the distal portion. The first longitudinal sealant passage can have a first proximal sealant port and a first distal sealant port. The first proximal sealant port can be configured to be in fluid communication with a first sealant component of the multi-component sealant. The first distal sealant port is located at the distal portion and is in fluid communication with the lumen of the cannula. The second longitudinal sealant passage can have a second proximal sealant port and a second distal sealant port. The second proximal sealant port can be configured to be in fluid communication with a second sealant component of the multi-component sealant. The second distal sealant port is located at the distal portion and is in fluid communication with the lumen of the cannula. The stylet can be configured to longitudinally move within the lumen of the cannula between a first stage position and a second stage position. The stylet can have an outer surface that can include a first outer circumferential channel and a second outer circumferential channel. The first outer circumferential channel and the second outer circumferential channel are longitudinally spaced apart. The stylet (sealant injection needle assembly) is configured such that, when the stylet is in the first stage position, each of the first distal sealant port and the second distal sealant port of the cannula is in fluid communication with the rear portion of the first outer circumferential channel of the stylet, and the front portion of the first outer circumferential channel of the stylet is positioned distally of the distal end of the cannula. Additionally, the stylet (sealant injection needle assembly) is configured such that, when the stylet is in the second stage position, each of the first distal sealant port and the second distal sealant port of the cannula is in fluid communication with the rear portion of the second outer circumferential channel of the stylet, and the front portion of the second outer circumferential channel of the stylet is positioned distally of the distal end of the cannula.

[0082] In the embodiment of the previous paragraph, the sealant injection needle assembly can include a cannula seat fixedly connected to the cannula, a stylet advancement seat fixedly connected to the stylet, and a stylet intermediate seat coupled to each of the stylet advancement seat and the cannula seat.

[0083] In embodiments including a stylet intermediate seat, the stylet intermediate seat may have a first male thread portion and a first female thread portion. The stylet advancement seat may have a second female thread portion configured to threadedly engage the first male thread portion of the stylet intermediate seat. The cannula seat may have a second male thread portion configured to threadedly engage the first female thread portion of the stylet intermediate seat. The second female thread portion of the stylet advancement seat may have a pitch of a first distance, (configured) to effect a second distance of rotational translation of the stylet advancement seat and the stylet, and may be configured such that a full rotation of the stylet advancement seat causes each of the first outer circumferential channel and the second outer circumferential channel of the stylet to longitudinally move a second distance.

[0084] In embodiments including a stylet intermediate seat, the stylet advancement seat and the stylet intermediate seat, in combination, may include a haptic feedback mechanism configured to provide haptic feedback to a user for each second distance of rotational translation of the stylet.

[0085] In embodiments including a stylet intermediate seat, optionally, the sealant injection needle assembly may include a safety member removably interposed between the stylet advancement seat and the stylet intermediate seat.

[0086] The sealant injection needle assembly for injecting a multi-component sealant as described above may have the features of paragraphs

[0065] to

[0084] above and / or may be used for lung entry procedures and / or be included in a lung entry assembly.

[0087] In another form, the present invention relates to a sealant delivery device for lung entry surgery to help prevent pneumothorax. The sealant delivery device can include a sealant applicator device, a cannula assembly, and a stylet assembly. The sealant applicator device can have an actuator, a first sealant component chamber configured to carry a first sealant component of a multi-component sealant, and a second sealant component chamber configured to carry a second sealant component of the multi-component sealant. The first sealant component chamber can have a first applicator port, and the second sealant component chamber can have a second applicator port. The cannula assembly can include a cannula hub and a cannula that can have an inner lumen and a distal end. The cannula hub can be fixedly attached to the cannula. The cannula can be configured to have a first longitudinal sealant passage and a second longitudinal sealant passage. The first longitudinal sealant passage can have a first proximal sealant port and a first distal sealant port. The second longitudinal sealant passage can have a second proximal sealant port and a second distal sealant port. The first proximal sealant port can be configured to be in fluid communication with the first applicator port of the first sealant component chamber of the sealant applicator device. The second proximal sealant port can be configured to be in fluid communication with the second applicator port of the second sealant component chamber of the sealant applicator device. The stylet assembly can have a stylet advancement hub, a stylet intermediate hub, and a stylet. The stylet intermediate hub can be threadedly interposed between the cannula hub and the stylet advancement hub. The stylet advancement hub can be fixedly attached to the stylet. The stylet can be configured to longitudinally move within the inner lumen of the cannula. The stylet can have a first stage position and a second stage position. The stylet has an outer surface that can include a first outer circumferential channel and a second outer circumferential channel. The first outer circumferential channel and the second outer circumferential channel are longitudinally spaced apart. The stylet assembly (sealant delivery device) can be configured such that when the stylet is in the first stage position, each of the first distal sealant port and the second distal sealant port of the cannula is in fluid communication with the first outer circumferential channel of the stylet and the front portion of the first outer circumferential channel of the stylet is positioned distal to the distal end of the cannula, and when the stylet is in the second stage position, each of the first distal sealant port and the second distal sealant port of the cannula is in fluid communication with the second outer circumferential channel of the stylet, and the front portion of the second outer circumferential channel of the stylet is positioned distal to the distal end of the cannula.

[0088] In the embodiment of the previous paragraph, the stylet intermediate seat may have a first male threaded portion and a first female threaded portion. The stylet advancement seat may have a second female threaded portion configured to threadedly engage the first male threaded portion of the stylet intermediate seat. The cannula seat may have a second male threaded portion configured to threadedly engage the first female threaded portion of the stylet intermediate seat. The second female threaded portion of the stylet advancement seat may have a pitch of a first distance, (configured) to effect a second distance of rotational translation of the stylet advancement seat and the stylet, and may be configured such that one full rotation of the stylet advancement seat causes each of the first outer circumferential channel and the second outer circumferential channel of the stylet to longitudinally move a second distance.

[0089] Optionally, the stylet advancement seat and the stylet intermediate seat in combination may include a haptic feedback mechanism configured to provide haptic feedback to a user for each second distance of rotational translation of the stylet.

[0090] Optionally, the sealant delivery device may include a safety member removably interposed between the stylet advancement seat and the stylet intermediate seat.

[0091] The sealant injection delivery device as described above may have the features of the sealant injection needle assembly as described above and / or may be included in the lung entry assembly.

[0092] Although the invention has been described for at least one embodiment, the invention may be further modified within the spirit and scope of the present disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the invention using its general principles. Moreover, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and fall within the limits of the appended claims.

Claims

1. A sealant injection needle assembly for use with a syringe-type applicator having a first sealant component chamber and a second sealant component chamber, the sealant injection needle assembly comprises: a cannula assembly having a cannula hub and a cannula, the cannula having an inner lumen and a distal end, the cannula hub being fixedly connected to the cannula, the cannula having a first longitudinal sealant passage and a second longitudinal sealant passage, the first longitudinal sealant passage having a first proximal sealant port and a first distal sealant port, the second longitudinal sealant passage having a second proximal sealant port and a second distal sealant port, the first proximal sealant port being configured to be in fluid communication with the first sealant component chamber, and the second proximal sealant port being configured to be in fluid communication with the second sealant component chamber; and a stylet assembly having a stylet advancement hub and a stylet, the stylet advancement hub being fixedly connected to the stylet, the stylet being configured to longitudinally move within the inner lumen of the cannula, the stylet having a first stage position and a second stage position, the stylet having an outer surface including a first outer circumferential channel and a second outer circumferential channel, the first outer circumferential channel and the second outer circumferential channel having a slightly X-shaped shape along the stylet, wherein the first outer circumferential channel and the second outer circumferential channel are longitudinally spaced apart, wherein: when the stylet is in the first stage position, the first outer circumferential channel of the stylet is in fluid communication with both the first distal sealant port and the second distal sealant port of the cannula; and when the stylet is in the second stage position, the second outer circumferential channel of the stylet is in fluid communication with both the first distal sealant port and the second distal sealant port of the cannula.

2. The sealant injection needle assembly according to claim 1, wherein, the first outer circumferential channel is a first helical channel, and the second outer circumferential channel is a second helical channel, and the sealant injection needle assembly further includes a separation region longitudinally extending between the first helical channel and the second helical channel.

3. The sealant injection needle assembly according to any one of claims 1 to 2, wherein, when the stylet is in the first stage position, the front portion of the first outer circumferential channel of the stylet is distal to the distal end of the cannula and the rear portion of the first outer circumferential channel of the stylet is in fluid communication with both the first distal sealant port and the second distal sealant port of the cannula.

4. The sealant injection needle assembly according to any one of claims 1 to 2, wherein, when the stylet is in the second stage position, the front portion of the second outer circumferential channel of the stylet is distal to the distal end of the cannula and the rear portion of the second outer circumferential channel of the stylet is in fluid communication with both the first distal sealant port and the second distal sealant port of the cannula.

5. The sealant injection needle assembly according to any one of claims 1 to 2, wherein, the cannula includes a proximal portion, a distal portion having the distal end, and a sidewall surrounding the lumen, wherein the first longitudinal sealant passage and the second longitudinal sealant passage are located in the sidewall of the cannula, and wherein each of the first longitudinal sealant passage and the second longitudinal sealant passage extends from the proximal portion to the distal portion.

6. The sealant injection needle assembly according to claim 5, wherein, each of the first distal sealant port and the second distal sealant port is located at the distal portion of the cannula and extends into the lumen of the cannula.

7. The sealant injection needle assembly according to any one of claims 1 to 2, wherein, the first distal sealant port and the second distal sealant port are diametrically opposed across the lumen of the cannula.

8. The sealant injection needle assembly according to any one of claims 1 to 2, wherein, the stylet is an elongated solid member having a proximal portion and a distal portion, the stylet advancement seat is fixedly attached to the proximal portion, the distal portion has a closed tip, and the first outer circumferential channel and the second outer circumferential channel are located in the distal portion proximal to the closed tip.

9. The sealant injection needle assembly according to any one of claims 1 to 2, wherein, the sealant injection needle assembly includes a stylet intermediate seat threadedly coupled to each of the stylet advancement seat and the cannula seat.

10. The sealant injection needle assembly according to claim 9, wherein: the stylet intermediate seat has a first male thread portion and a first female thread portion; the stylet advancement seat has a second female thread portion configured to threadedly engage the first male thread portion of the stylet intermediate seat; and the cannula seat has a second male thread portion configured to threadedly engage the first female thread portion of the stylet intermediate seat.

11. The sealant injection needle assembly according to claim 10, wherein, the second female thread portion of the stylet advancement seat has a pitch of a first distance to effect a rotational translation of the stylet advancement seat and the stylet by a second distance, and is configured such that a full rotation of the stylet advancement seat causes each of the first outer circumferential channel and the second outer circumferential channel of the stylet to longitudinally move the second distance, and wherein the first distance and the second distance are equal.

12. The sealant injection needle assembly according to claim 9, wherein, the sealant injection needle assembly further includes a safety member removably interposed between the stylet advancement seat and the stylet intermediate seat.

13. The sealant injection needle assembly according to claim 11, wherein, The stylet advancement seat and the stylet intermediate seat include a haptic feedback mechanism when combined, and the haptic feedback mechanism is configured to provide haptic feedback to the user for each rotation and translation of the second distance of the stylet.

14. A sealant injection needle assembly for injecting a multi-component sealant, the sealant injection needle assembly comprising: a cannula having a proximal portion, a distal portion, a distal end, and a sidewall surrounding a lumen, the sidewall having a first longitudinal sealant passage and a second longitudinal sealant passage, wherein each of the first longitudinal sealant passage and the second longitudinal sealant passage extends from the proximal portion to the distal portion, wherein: the first longitudinal sealant passage has a first proximal sealant port and a first distal sealant port, the first proximal sealant port being configured to be in fluid communication with a first sealant component of the multi-component sealant, the first distal sealant port being located at the distal portion and in fluid communication with the lumen of the cannula, and the second longitudinal sealant passage has a second proximal sealant port and a second distal sealant port, the second proximal sealant port being configured to be in fluid communication with a second sealant component of the multi-component sealant, the second distal sealant port being located at the distal portion and in fluid communication with the lumen of the cannula; and a stylet configured to longitudinally move between a first stage position and a second stage position within the lumen of the cannula, the stylet having an outer surface including a first outer circumferential channel and a second outer circumferential channel, the first outer circumferential channel and the second outer circumferential channel having a slightly X-shaped shape along the stylet, wherein the first outer circumferential channel and the second outer circumferential channel are longitudinally spaced apart, and wherein: when the stylet is in the first stage position, each of the first distal sealant port and the second distal sealant port of the cannula is in fluid communication with a rear portion of the first outer circumferential channel of the stylet, and a front portion of the first outer circumferential channel of the stylet is positioned distal to the distal end of the cannula, and when the stylet is in the second stage position, each of the first distal sealant port and the second distal sealant port of the cannula is in fluid communication with a rear portion of the second outer circumferential channel of the stylet, and a front portion of the second outer circumferential channel of the stylet is positioned distal to the distal end of the cannula.

15. The sealant injection needle assembly according to claim 14, wherein, the sealant injection needle assembly comprises: a cannula seat fixedly connected to the cannula; a stylet advancement seat fixedly connected to the stylet; and a stylet intermediate seat coupled to each of the stylet advancement seat and the cannula seat.

16. The sealant injection needle assembly according to claim 15, wherein: the stylet intermediate seat has a first male threaded portion and a first female threaded portion; The stylet advancement seat has a second female thread portion configured to threadedly engage the first male thread portion of the stylet intermediate seat; and The cannula seat has a second male thread portion configured to threadedly engage the first female thread portion of the stylet intermediate seat, wherein: The second female thread portion of the stylet advancement seat has a pitch of a first distance to effect a second distance of rotational translation of the stylet advancement seat and the stylet, and the second female thread portion is configured such that one full rotation of the stylet advancement seat causes each of the first outer circumferential channel and the second outer circumferential channel of the stylet to longitudinally move the second distance.

17. The sealant injection needle assembly according to claim 16, wherein, The stylet advancement seat and the stylet intermediate seat in combination include a haptic feedback mechanism configured to provide haptic feedback to a user for each second distance of rotational translation of the stylet.

18. The sealant injection needle assembly according to any one of claims 15 to 17, wherein, The sealant injection needle assembly further includes a safety member removably interposed between the stylet advancement seat and the stylet intermediate seat.

19. A sealant delivery device for use in lung entry procedures to help prevent pneumothorax, the sealant delivery device comprising: A sealant applicator device having: an actuator; a first sealant component chamber configured to carry a first sealant component of a multi-component sealant; And a second sealant component chamber configured to carry a second sealant component of the multi-component sealant, the first sealant component chamber having a first applicator port and the second sealant component chamber having a second applicator port; A cannula assembly including a cannula seat and a cannula having a lumen and a distal end, the cannula seat fixedly attached to the cannula, the cannula configured to have a first longitudinal sealant passage and a second longitudinal sealant passage, the first longitudinal sealant passage having a first proximal sealant port and a first distal sealant port, the second longitudinal sealant passage having a second proximal sealant port and a second distal sealant port, the first proximal sealant port configured to be in fluid communication with the first applicator port of the first sealant component chamber of the sealant applicator device, and the second proximal sealant port configured to be in fluid communication with the second applicator port of the second sealant component chamber of the sealant applicator device; and A stylet assembly having a stylet advancement seat, a stylet intermediate seat, and a stylet, wherein the stylet intermediate seat is threadedly interposed between the cannula seat and the stylet advancement seat, the stylet advancement seat is fixedly connected to the stylet, the stylet is configured to longitudinally move within the lumen of the cannula, the stylet has a first stage position and a second stage position, the stylet has an outer surface including a first outer circumferential channel and a second outer circumferential channel, the first outer circumferential channel and the second outer circumferential channel have a slightly X-shaped shape along the stylet, wherein the first outer circumferential channel and the second outer circumferential channel are longitudinally spaced apart, and wherein: When the stylet is in the first stage position, each of the first distal sealant ports and the second distal sealant ports of the cannula is in fluid communication with the first outer circumferential channel of the stylet, and a front portion of the first outer circumferential channel of the stylet is positioned distal to the distal end of the cannula, and When the stylet is in the second stage position, each of the first distal sealant ports and the second distal sealant ports of the cannula is in fluid communication with the second outer circumferential channel of the stylet, and a front portion of the second outer circumferential channel of the stylet is positioned distal to the distal end of the cannula.

20. The sealant delivery device according to claim 19, wherein, the stylet intermediate seat has a first male threaded portion and a first female threaded portion, the stylet advancement seat has a second female threaded portion configured to threadedly engage the first male threaded portion of the stylet intermediate seat, and the cannula seat has a second male threaded portion configured to threadedly engage the first female threaded portion of the stylet intermediate seat, and the second female threaded portion of the stylet advancement seat has a pitch of a first distance to effect a rotational translation of the stylet advancement seat and the stylet by a second distance, and the second female threaded portion is configured such that a rotation of the stylet advancement seat through a full turn causes each of the first outer circumferential channel and the second outer circumferential channel of the stylet to longitudinally move the second distance.

21. The sealant delivery device according to claim 20, wherein, the stylet advancement seat and the stylet intermediate seat in combination include a haptic feedback mechanism configured to provide haptic feedback to a user for each rotational translation of the stylet by the second distance.

22. The sealant delivery device according to any one of claims 19 to 21, wherein, the sealant delivery device further includes a safety member removably interposed between the stylet advancement seat and the stylet intermediate seat.

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