System for sealing portions of the pleural layers together

Abstract

A system for sealing a portion of pleural layers together includes an electrical energy source and an electrocautery probe electrically coupled to the electrical energy source. The electrocautery probe has a cannula shaft portion, a distal piercing tip, and an intermediate portion between the cannula shaft portion and the distal piercing tip. The electrocautery probe is configured to generate heat. A protein source is coupled to the intermediate portion of the electrocautery probe, wherein the protein source has a protein that is denatured by heating.

Description

[0001] Cross-references to related applications

[0002] none. Technical Field

[0003] The present invention relates to lung access procedures, such as lung biopsy, and more particularly to a system for sealing together portions of pleural layers. Background Art

[0004] Pneumothorax is a problematic complication of the lung biopsy surgical procedure in which air or fluid is allowed to enter the pleural space due to puncture of the parietal and visceral pleura. Pneumothorax, especially pneumothorax requiring chest tube placement, is a significant problem for clinicians performing percutaneous lung biopsies and for patients undergoing percutaneous lung biopsies. The incidence of pneumothorax has been reported to be 9–54% in patients undergoing percutaneous lung biopsies, with an average of approximately 15%. On average, 6.6% of all percutaneous lung biopsies result in pneumothorax requiring chest tube placement, which results in a mean hospital stay of 2.7 days.

[0005] Factors that increase the risk of pneumothorax include increasing patient age, obstructive lung disease, increased depth of lesion, multiple pleural traverses, increased time for the entry needle to traverse the pleura, and traversal of fissures. Pneumothorax may occur during the procedure or immediately after the procedure, which is why a CT scan of the area is usually performed after the needle is removed. Other less common complications of percutaneous lung biopsy include hemoptysis (coughing up blood), hemothorax (a pleural effusion where blood accumulates in the pleural space), infection, and air embolism.

[0006] There is a need in the art for a system for sealing portions of pleural layers together. Summary of the invention

[0007] The present invention provides a system for sealing portions of pleural layers together.

[0008] In one form, the invention is directed to a system for sealing a portion of pleural layers together. The system includes an electrical energy source and an electrocautery probe electrically coupled to the electrical energy source. The electrocautery probe has a cannula shaft portion, a distal piercing tip, and an intermediate portion between the cannula shaft portion and the distal piercing tip. The electrocautery probe is configured to generate heat. A protein source is coupled to the intermediate portion of the electrocautery probe, wherein the protein source has a protein that is denatured by heating.

[0009] Another form of the present invention is directed to a system for sealing a portion of each pleural layer together. The system may include a fluid source, an electrical energy source, a grounding pad, and a monopolar electrocautery probe. The fluid source is configured to deliver a sealing fluid, wherein the sealing fluid is heat-activated. The grounding pad is electrically coupled to the electrical energy source. The monopolar electrocautery probe is electrically coupled to the electrical energy source. The monopolar electrocautery probe and the grounding pad cooperate to generate heat. The monopolar electrocautery probe has a cannula shaft portion, a distal piercing tip, and an expandable portion between the cannula shaft portion and the distal piercing tip. The cannula shaft portion has a cannula lumen coupled to the fluid source in fluid communication. The expandable portion is coupled to the fluid source in fluid communication via the cannula lumen. The expandable portion is configured to define a plurality of openings, and is configured so that a sealing fluid supplied by the fluid source leaves the expandable portion through the plurality of openings to a position outside the monopolar electrocautery probe.

[0010] One advantage of the present invention is that the system allows a physician to hermetically seal the pleural layers prior to performing a lung surgical procedure, such as a lung biopsy, thereby reducing the risk of pneumothorax during the procedure. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The above and other features and advantages of the present invention and their implementation will become more apparent, and the present invention will be better understood by referring to the following description of the embodiments of the present invention in conjunction with the accompanying drawings, in which:

[0012] Figure 1 is a diagrammatic representation of a system for sealing together a portion of pleural layers of a patient in accordance with one aspect of the present invention;

[0013] Figure 2 for Figure 1 A stereoscopic view of the system's monopolar electrocautery device;

[0014] Figure 3 for Figure 1 A block diagram of the system shown;

[0015] Figure 4 for Figure 2 A diagrammatic side view of a portion of a monopolar electrocautery device depicting a fluid source for delivering a sealing fluid to a cannula lumen of a monopolar electrocautery probe;

[0016] Figure 5 for Figure 2 A perspective view of a portion of a monopolar electrocautery probe of , wherein the expandable portion is in a collapsed state;

[0017] Figure 6 for Figure 2 A perspective view of a portion of a monopolar electrocautery probe of , wherein the expandable portion is in an expanded state;

[0018] Figure 7yes Figure 6 a side view of a portion of a monopolar electrocautery probe of , showing a dilation member representing each of a plurality of dilation members of an expandable portion, with the remaining individual members of the plurality of dilation members omitted for clarity;

[0019] Figure 8 for Figure 1-7 a perspective view of a variation of an embodiment including a coating on a middle portion of a monopolar electrocautery probe;

[0020] Fig. 9 depicts a cross-sectional view of a portion of a patient's chest wall and lung and shows an expandable portion of a monopolar electrocautery probe in an expanded state to assist in drawing the pleural layers together;

[0021] Fig. 10A and 10B Describes the use Figure 1 Flow chart of a method in which the system is used in a lung access procedure to help prevent a pneumothorax.

[0022] Corresponding reference numerals indicate corresponding parts throughout the several views.The exemplifications set forth herein illustrate at least one embodiment of the invention and such exemplifications should not be construed as limiting the scope of the invention in any way. DETAILED DESCRIPTION

[0023] Reference is now made to the accompanying drawings, in particular Figure 1 , shows an example schematic diagram of a system 10 for sealing a portion of each pleural layer during a lung surgery procedure performed on a patient 12. In this embodiment, the system 10 generally includes an electrical energy source 14, a monopolar electrocautery device 16, and a ground pad 18. The monopolar electrocautery device 16 includes a handpiece 20 connected to a monopolar electrocautery probe 22.

[0024] In this embodiment, the electrical energy source 14 may be an electrosurgical radio frequency (RF) generator. In this embodiment, the electrical energy source 14 includes a first RF output 14-1 and a second RF output 14-2.

[0025] The first RF output 14-1 of the electrical energy source 14 is electrically coupled to the monopolar electrocautery device 16 via a connector cable 24. The connector cable 24 may be, for example, a multi-conductor cable that includes electrical conductors for supplying control signals from the handpiece 20 to the electrical energy source 14 to control the electrical power output of the electrical energy source 14, and includes conductors (e.g., shielded cables, such as coaxial cables) for supplying electrical RF power signals to the monopolar electrocautery probe 22 of the monopolar electrocautery device 16. Thus, the monopolar electrocautery probe 22 is electrically coupled to the first RF output 14-1 of the electrical energy source 14 via the connector cable 24.

[0026] The second RF output 14-2 of the electrical energy source 14 is electrically coupled to the ground pad 18 via a ground path 26. As is known in the art, the ground pad 18 is configured to contact the patient 12. It is contemplated that the ground path 26 between the electrical energy source 14 and the ground pad 18 may be in the form of a shielded cable (e.g., a coaxial cable).

[0027] The monopolar electrocautery probe 22 and the ground pad 18 form an RF circuit 28, wherein the monopolar electrocautery probe 22 serves as a primary electrosurgical electrode and the ground pad 18 serves as a return electrode. The monopolar electrocautery probe 22 includes a cannula shaft portion 30, a distal piercing tip 32, and an intermediate portion 34 between the cannula shaft portion 30 and the distal piercing tip 32.

[0028] The monopolar electrocautery probe 22 and the ground pad 18 cooperate to generate heat when excited by radio frequency energy. More specifically, the electrical energy source 14 includes circuitry known in the art for generating an RF output signal having an RF frequency, for example, in the range of 1.0 megahertz (MHz) to 10.0 MHz. The RF output signal generated by the electrical energy source 14 is delivered to the monopolar electrocautery probe 22 and the ground pad 18 to produce a heating effect at the monopolar electrocautery probe 22. Optionally, the cannula shaft portion 30 of the monopolar electrocautery probe 22 may include a thermally and electrically insulating outer layer, such as plastic or ceramic, to reduce heat transfer from the periphery of the cannula shaft portion 30 to surrounding tissue.

[0029] Figure 2 A more detailed view of the monopolar electrocautery device 16 is shown, which optionally includes a guide cannula 36 that may be mounted coaxially with the monopolar electrocautery probe 22 along a longitudinal axis 38 . Figure 3 A functional block diagram of the system 10 is shown, including an electrical energy source 14 and a monopolar electrocautery device 16 having a handpiece 20 and a monopolar electrocautery probe 22. The guide cannula 36 may be made of a biocompatible metal, such as stainless steel, and may include an insulating layer, such as plastic or ceramic, on the inner sidewall of the guide cannula 36 to help reduce heat transfer from the periphery of the cannula shaft portion 30 to the guide cannula 36. Alternatively, the guide cannula 36 may be made of a non-conductive material, such as plastic or ceramic.

[0030] refer to Figure 2 and Figure 3, the handpiece 20 includes a housing 40, which optionally contains an expander driver 42 and a fluid source 44. The handpiece 20 includes a button 46 for actuating the expander driver 42 to deploy the monopolar electrocautery probe 22, which will be further explained below. The handpiece 20 also includes a button 48 for actuating the fluid source 44, which is used to supply a sealing fluid to the monopolar electrocautery probe 22. The handpiece 20 also includes a button 50 for actuating and controlling the operation of the electrical energy source 14 when supplying an RF output signal to the monopolar electrocautery probe 22.

[0031] In the present embodiment, the button 46 may be in the form of a slider member that is slidable along a slot 40-1 formed in the housing 40 of the handpiece 20. The button 46 is connected to the dilator driver 42. The dilator driver 42 may include a driver member 42-1, such as a push rod or a cable, that is mechanically connected to each of the button 46 and the distal piercing tip 32 of the monopolar electrocautery probe 22 and interposed therebetween.

[0032] Alternatively, expander driver 42 may be an electromechanical device, such as a motor or solenoid, having a linearly movable component mechanically connected to driver member 42 - 1 , with button 46 acting as a switch to electrically actuate the motor or solenoid of expander driver 42 .

[0033] The button 48 is connected to a fluid source 44 that carries a heat-activated sealing fluid. The fluid source 44 is coupled in fluid communication with the monopolar electrocautery probe 22, and in particular, the cannula shaft portion 30 has a cannula lumen 30-1 coupled in fluid communication with the fluid source 44. In other words, the fluid source 44 is configured to deliver the sealing fluid to the middle portion 34 of the monopolar electrocautery probe 22 through the cannula lumen 30-1 of the cannula shaft portion 30, wherein the sealing fluid can be heat-activated by applying heat supplied by the monopolar electrocautery probe 22.

[0034] See also Figure 4In the present embodiment, for example, the fluid source 44 is a protein source that carries proteins in fluid form, wherein the proteins are denatured and heat-activated by heating the monopolar electrocautery probe 22. In other words, the protein source contains a substance characterized by proteins in a non-denatured or non-heat-activated state. In the present embodiment, the fluid source 44 can be in the form of a syringe 44-1, which has a container 44-2 and a piston 44-3 slidably located in the container 44-2. The container 44-2 is configured as a chamber, the chamber contains a sealing fluid 52 (heat-activated), the sealing fluid 52 contains proteins, and the button 48 can be a plunger connected to the piston 44-3 of the syringe 44-1. The Luer fitting 54 is connected to the proximal end 30-2 of the sleeve shaft portion 30, wherein the Luer fitting 54 is in fluid communication with the sleeve lumen 30-1. The fluid source 44, such as a syringe 44-1, includes an output port 44-4 connected to the Luer fitting 54.

[0035] In addition, in the present embodiment, the sealing fluid 52 may be, for example, a solution containing proteins that can be denatured due to heat. More specifically, the sealing fluid 52 may be, for example, a protein-containing solution that includes, for example, 10 to 50% by weight of protein, and may optionally include, for example, 0.1-5.0% by weight of a cross-linking agent. The protein in the solution may be, for example, albumin. In an optional embodiment that includes a cross-linking agent, the cross-linking agent in the solution may be, for example, genipin.

[0036] As an alternative to providing the fluid source 44 in the form of a syringe, it is contemplated that the piston 44-3 of the fluid source 44 may be replaced with an electric or pneumatic pump, wherein the button 48 sends an electrical or pneumatic signal to operate the pump, thereby supplying the sealing fluid 52 to the middle portion 34 of the monopolar electrocautery probe 22 through the cannula lumen 30-1 of the cannula shaft portion 30.

[0037] Also refer to Figure 5 and Figure 6 The middle portion 34 of the monopolar electrocautery probe 22 is configured as an expandable portion 56 having a collapsed state 58 ( Figure 5 ) and expansion state 60( Figure 6 In particular, the collapsed state 58 of the expandable portion 56 is determined by the extended position of the distal piercing tip 32 relative to the cannula shaft portion 30 (see Figure 5 ), while the expanded state 60 of the expandable portion 56 is determined by the retracted position of the distal piercing tip 32 relative to the cannula shaft portion 30 (see Figure 6 ) is limited. See also Figure 2In the present embodiment, the state transition of the expandable portion 56 from the collapsed state 58 to the expanded state 60, and the state transition from the expanded state 60 to the collapsed state 60, can be achieved by sliding the button 46 along the slot 40-1 of the housing 40 of the handpiece 20. For example, sliding the button 46 along the slot 40-1 of the housing 40 in the proximal direction pulls the driver member 42-1 attached to the distal piercing tip 32 in the proximal direction, so that the distance between the distal piercing tip 32 and the sleeve shaft portion 30 at the middle portion 34 is reduced, thereby expanding the expandable portion 56. Optionally, the plurality of expansion members 62 of the expandable portion 56 can be formed of a memory material (e.g., nitinol) to facilitate the transition from the collapsed state 58 ( Figure 5 ) changes to the expansion state 60( Figure 6 ).

[0038] It is contemplated that in some embodiments, the plurality of expansion members 62 of the expandable portion 56 using a memory material, such as Nitinol, in combination with the guide sleeve 36, can be used as an alternative to the arrangement of the expander driver 42, the button 46, and the driver member 42-1 connected to the distal piercing tip 32. In such an alternative embodiment, the guide sleeve 36 can be slid distally over the expandable portion 56 to collapse the expandable portion 56 to a collapsed state 58, and the guide sleeve 36 can be slid proximally to expose the expandable portion 56 so that the expandable portion 56 expands to an expanded state 60 in a self-expanding manner.

[0039] The expandable portion 56 includes a plurality of expansion members 62 located in the middle portion 34. For example, in one embodiment, the plurality of expansion members 62 can be formed by a plurality of longitudinal cuts or slots formed around the circumference of the tubular portion of the monopolar electrocautery probe 22 to define the middle portion 34. In this case, the middle portion 34 can be formed of the same material as the cannula shaft portion 30 of the monopolar electrocautery probe 22 (e.g., a biocompatible metal such as stainless steel).

[0040] Alternatively, the middle portion 34 may be a separate tubular member having a plurality of longitudinal cuts or slots formed around the tubular portion of the middle portion 34, wherein the middle portion 34 is interposed between the cannula shaft portion 30 and the distal piercing tip 32 and is attached to each of the cannula shaft portion 30 and the distal piercing tip 32. In this case, the middle portion 34 may be formed of a different material than the cannula shaft portion 30 (e.g., a different biocompatible metal, such as nitinol).

[0041] The plurality of expansion members 62 extend longitudinally between the cannula shaft portion 30 and the distal piercing tip 32. In addition, the plurality of expansion members 62 form an annular periphery of the intermediate portion 34 between the cannula shaft portion 30 and the distal piercing tip 32.

[0042] The expandable portion 56 at the intermediate portion 34 is coupled in fluid communication with the fluid source 44 via the cannula lumen 30-1. Figure 6 , the expandable portion 56 is configured to define a plurality of openings 64, wherein each individual opening of the plurality of openings 64 is located between two adjacent members of the plurality of expansion members 62 around the periphery of the intermediate portion 34. In other words, a corresponding opening of the plurality of openings 64 is located between each pair of adjacent expansion members of the plurality of expansion members 62. Thus, the sealing fluid 52 supplied by the fluid source 44 (see also Figure 3 and Figure 4 ) exit the expandable portion 56 through the plurality of openings 64 to a location external to the monopolar electrocautery probe 22, such as at the pleural layer.

[0043] Figure 7 An example of an expansion member 62-1 is shown, which represents each expansion member in the plurality of expansion members 62, and the remaining expansion members in the plurality of expansion members 62 have been disengaged (removed) for clarity. Each expansion member in the plurality of expansion members 62 includes a proximal end 66, a distal end 68, and an articulation joint 70. The proximal end 66 is connected to the cannula shaft portion 30, and the distal end 68 is connected to the distal piercing tip 32. The articulation joint 70 is located halfway between the proximal end 66 and the distal end 68. The articulation joint 70 can be formed, for example, as a fold line 72 in the middle portion 34 (see Figure 5 ).

[0044] Reference again Figure 5 In the collapsed state 58, the diameter of the cannula shaft portion 30 and the diameter of the expandable portion 56 are substantially equal. Figure 6 In the expanded state 60, the diameter of the expandable portion 56 at its largest circumference, ie at the articulation joint 70, is larger than the diameter of the cannula shaft portion 30, for example, 2 to 4 times larger.

[0045] refer to Figure 8 As a variation of the aforementioned embodiment, a protein-containing coating 74 may be applied and formed (e.g., layered) on at least one of the intermediate portion 34 and the distal piercing tip 32. The coating 74 is configured to be heat-activatable and used as a protein source, which may serve as a substitute or supplement to the fluid source 44. The coating 74 may be formed in whole or in part from a protein-containing material (e.g., a collagen-containing material). The coating 74 may serve as a primary protein source, or alternatively may serve as a secondary protein source. As a secondary protein source, collagen may serve as a secondary protein of a primary protein source (e.g., a sealing fluid 52).

[0046] Although in the present embodiment, the coating 74 is applied to the intermediate portion 34 having the expandable portion 56 (which includes the plurality of expansion members 62), it is also contemplated that the coating 74 may alternatively be applied to the intermediate portion that does not include the expandable portion 56.

[0047] refer to Fig. 9 , depicting a portion of a patient's chest wall 80 and lung 82. Referring again to Figure 2 , the monopolar electrocautery probe 22, alone or in combination with the guide cannula 36, ​​can be used to form an access opening 84 to the interior of the lung 82. Specifically, the access opening 84 is formed between adjacent ribs 86-1, 86-2 in the rib cage of the chest wall 80 and extends through the parietal pleura 88, the pleural space 90, and the visceral pleura 92 to provide access to the interior of the lung 82. The parietal pleura 88 and the visceral pleura 92 are collectively referred to herein as the pleural layers 88, 92.

[0048] The monopolar electrocautery probe 22 is shown positioned in the access opening 84 with the expandable portion 56 of the intermediate portion 34 positioned distal to (and adjacent to) the visceral pleura 92, i.e., below the visceral pleura 92, and in the expanded state 60 (see also FIG. Figure 6 ). Using an imaging system, such as ultrasound imaging or X-ray imaging, the position of the expandable portion 56 of the monopolar electrocautery probe 22 can be determined and / or confirmed. Fig. 9 The expanded state 60 ( Figure 6 ) to help compress the pleural layers 88, 92 when the monopolar electrocautery probe 22 is pulled in a proximal direction toward the user.

[0049] Fig. 10A and 10B A flow chart depicting a method for lung access procedures to help prevent pneumothorax is provided. Further reference will be made to Figure 1-6 to describe the method and best understand the method.

[0050] In step S100, the monopolar electrocautery probe 22 is inserted through the access opening 84, either alone or in combination with the guide cannula 36, ​​with the expandable portion 56 of the middle portion 34 in the collapsed state 58 (see Figure 2 and Figure 5 ), the monopolar electrocautery probe 22 passes through the patient's pleural layers 88, 92 (see Fig. 9 ), the expandable portion 56 of the middle portion 34 is located distal to the visceral pleura 92.

[0051] In step S102, for example, by sliding the button 46 (see Figure 2 ) expands the expandable portion 56 of the monopolar electrocautery probe 22 to an expanded state 60 (see Figure 6 )).

[0052] In step S104, the monopolar electrocautery probe 22 is moved, i.e., pulled, in the proximal direction by the user so that the expandable portion 56 of the monopolar electrocautery probe 22 (in the expanded state 60; see also Figure 6 ) contacts and pulls the visceral pleura 92 so that it is firmly in contact with the parietal pleura 88, such as Fig. 9 shown.

[0053] In step S106, for example, by pressing button 50 (see Figure 2 ) to activate the electrical energy source 14, thereby heating the distal piercing tip 32 and the expandable portion 56 of the monopolar electrocautery probe 22.

[0054] In step S108, for example, by pressing the button 48 (see Figure 2 ) to activate the fluid source 44 to pass through the plurality of openings 64 (see Figure 6 ) to the tissue area surrounding the expandable portion 56 of step 104 (including the pleural layers 88, 92 (see Fig. 9 )) Supply heat activated sealing fluid 52 (see Figure 4 At this point, the pleural layers 88 , 92 are sealed together around the access opening 84 by heat activation of the sealing fluid 52 , as the pleural layers 88 , 92 were compressed by the previous proximal movement of the expandable portion 56 .

[0055] It is contemplated that steps S106 and S108 may be performed sequentially in the order presented above, or alternatively, may be performed simultaneously. As a further alternative, it is contemplated that the order in which steps S106 and S108 are performed may be reversed.

[0056] In step S110 , in embodiments where the introducer cannula 36 is included in step S100 , the introducer cannula 36 may be advanced distally along the access opening 84 and through the sealed portions of the pleural layers 88 , 92 .

[0057] In step S112, for example, by sliding the button 46 (see Figure 2 ) causes the expandable portion 56 of the monopolar electrocautery probe 22 to collapse to a collapsed state 58 (see also Figure 5 ), and the monopolar electrocautery probe 22 can be withdrawn from the access opening 84.

[0058] In alternative step S114, in an embodiment where the guide cannula 36 is not included in step S100, after the monopolar electrocautery probe 22 is withdrawn from the access opening 84, the guide cannula 36 can then be inserted into the access opening 84 and through the sealing portions of the pleural layers 88, 92 to maintain an access path to the lung 82.

[0059] After the introducer cannula 36 is positioned through the sealed portions of the pleural layers 88 , 92 , a lung surgical procedure, such as a lung biopsy, may be performed through the introducer cannula 36 .

[0060] While the primary embodiment described above utilizes a monopolar electrocautery probe 22, a ground pad 18, and an electrical energy source 14 in the form of a radio frequency (RF) generator, it is contemplated that the system may alternatively be configured to utilize a bipolar electrocautery probe having structural features as in the monopolar electrocautery probe 22 to facilitate localized delivery of heat-activated protein materials. Furthermore, it is contemplated that the electrocautery probe may take other forms, such as an electrocautery probe having an electrical heating element (DC or AC), having structural features as in the monopolar electrocautery probe 22 to facilitate localized delivery of heat-activated protein materials.

[0061] The following items are also relevant to the present invention:

[0062] In one form, the present invention relates to a system for sealing a portion of each pleural layer together. The system may include an electrical energy source, an electrocautery probe, and a protein source. The electrocautery probe is electrically coupled to the electrical energy source. The electrocautery probe may have a cannula shaft portion, a distal piercing tip, and an intermediate portion between the cannula shaft portion and the distal piercing tip, wherein the electrocautery probe is configured to generate heat. The protein source is coupled to the intermediate portion of the electrocautery probe. The protein source has a protein that is configured to be denatured or denatured by heating. In particular, the protein source includes a substance characterized by containing such a protein.

[0063] In some embodiments, the protein source can be a fluid source configured to deliver a supply of a sealed fluid comprising a protein, and the cannula shaft portion has a cannula lumen coupled in fluid communication with the fluid source. The intermediate portion can be an expandable portion coupled in fluid communication with the fluid source via the cannula lumen, wherein the expandable portion is configured to define a plurality of openings configured such that the sealed fluid supplied by the fluid source exits the expandable portion through the plurality of openings to a location outside the electrocautery probe.

[0064] In embodiments including an expandable portion, the expandable portion may be configured to have (to be in) an extended position and a retracted position, wherein the extended position defines a stowed state and the retracted position defines an expanded state. The expandable portion may include a plurality of expansion members, wherein a corresponding opening of the plurality of openings is located between each pair of adjacent expansion members of the plurality of expansion members.

[0065] In an embodiment according to the previous paragraph, each of the plurality of expansion members may include a proximal end, a distal end, and an articulation joint, wherein the proximal end is connected to the cannula shaft portion, the distal end is connected to the distal piercing tip, and the articulation joint is located between the proximal end and the distal end.

[0066] In embodiments including an expandable portion, the cannula shaft portion may have a first diameter and the expandable portion may have a second diameter, wherein in the collapsed state, the first diameter is substantially equal to the second diameter.

[0067] In embodiments including an expandable portion, the cannula shaft portion can have a first diameter in the expanded state and the expandable portion can be configured to have a maximum circumference having a second diameter, wherein the second diameter is greater than the first diameter.

[0068] In embodiments including a sealing fluid, the fluid source may be a syringe, and / or the sealing fluid may include albumin.

[0069] Optionally, in any of these embodiments, the protein source can include a coating comprising collagen, and / or the coating can be located on (eg, formed on) at least one of the intermediate portion and the distal piercing tip.

[0070] In one embodiment, for example, the middle portion can be an expandable portion, including a plurality of expansion members, and / or a plurality of expansion members can have a coating that is a protein source, the coating can be a heat-activated material including protein, and / or a plurality of expansion elements can be configured to have a collapsed state and an expanded state.

[0071] In an embodiment according to the preceding paragraph, the coating may comprise collagen.

[0072] In another form, the present invention relates to a system for sealing a portion of each pleural layer together, the system having a fluid source configured to deliver a sealing fluid, wherein the sealing fluid is heat-activatable. A system according to this embodiment may include an electrical energy source, a grounding pad electrically connected to the electrical energy source, and a monopolar electrocautery probe electrically connected to the electrical energy source, wherein the monopolar electrocautery probe and the grounding pad cooperate to generate heat. The monopolar electrocautery probe may have a cannula shaft portion, a distal piercing tip, and an expandable portion between the cannula shaft portion and the distal piercing tip. The cannula shaft portion has a cannula lumen connected to the fluid source fluid in communication. The expandable portion is connected to the fluid source fluid in communication via the cannula lumen. The expandable portion is configured to define a plurality of openings, and is configured so that the sealing fluid supplied by the fluid source leaves the expandable portion through the plurality of openings to a position outside the monopolar electrocautery probe.

[0073] In an embodiment according to the preceding paragraph, the expandable portion may be configured to have (be in) an extended position and a retracted position, wherein the extended position defines the retracted state and the retracted position defines the expanded state. The expandable portion may include a plurality of expansion members, wherein a corresponding opening of the plurality of openings is located between each pair of adjacent expansion members of the plurality of expansion members.

[0074] In some embodiments including an expandable portion having a plurality of expansion members, each expansion member of the plurality of expansion members can have a proximal end connected to the cannula shaft portion and a distal end connected to a distal piercing tip.

[0075] In some embodiments including an expandable portion having a plurality of expansion members, each of the plurality of expansion members may further include an articulated joint between a proximal end and a distal end, wherein the expanded state facilitates the flow of a sealing fluid between the plurality of fluid expansion members to a position outside the expandable portion.

[0076] In any of the embodiments including an expandable portion, the cannula shaft portion can have a first diameter and the expandable portion can have a second diameter, wherein in the collapsed state the first diameter is substantially equal to the second diameter.

[0077] In any of the embodiments including an expandable portion, in the expanded state, the cannula shaft portion can have a first diameter, the expandable member can have a maximum circumference, the maximum circumference can have a second diameter, wherein the second diameter is greater than the first diameter.

[0078] In any of the embodiments including an expandable portion, the expandable portion can be made of a biocompatible metal.

[0079] In any of the embodiments comprising a fluid source, the fluid source can be a syringe.

[0080] Optionally, in an embodiment according to the preceding paragraph, the system may further include a Luer fitting connected to the proximal end of the cannula shaft portion, wherein the Luer fitting is in fluid communication with the cannula lumen, and wherein the syringe is connected to the Luer fitting.

[0081] In any of the embodiments comprising a sealing fluid, the sealing fluid can comprise a protein.

[0082] Optionally, in any of the embodiments having an expandable portion, the system may include a coating that may be located on (e.g., formed on) at least one of the expandable portion and the distal piercing tip, and / or wherein the coating is a heat-activated material comprising a secondary protein.

[0083] As used herein, the term "substantially" and other degree words are relative modifiers intended to indicate a permissible deviation from the property so modified. These terms are not limited to the absolute value of the property it modifies, but rather possess more physical or functional properties than the opposite.

[0084] Although the present invention has been described with respect to at least one embodiment, the present invention may be further modified within the spirit and scope of the present disclosure. Therefore, the present application is intended to cover any variation, use or modification of the present invention using its general principles. In addition, the present application is intended to cover deviations from the present disclosure in known or common practice in the field to which the present invention belongs that fall within the limits of the appended claims.

Claims

1. A system for sealing together a portion of pleural layers, the system comprising: Electrical energy; an electrocautery probe electrically coupled to the electrical energy source, the electrocautery probe having a cannula shaft portion, a distal piercing tip, and an intermediate portion between the cannula shaft portion and the distal piercing tip, wherein the electrocautery probe is configured to generate heat; as well as A protein source connected to the middle portion of the electrocautery probe, the protein source being a fluid source, the fluid source being configured to deliver a supply of a sealed fluid having a protein denatured by heating, wherein the cannula shaft portion has a cannula lumen connected in fluid communication with the fluid source, and the middle portion is an expandable portion, the expandable portion being connected in fluid communication with the fluid source via the cannula lumen, wherein the expandable portion is configured to define a plurality of openings, and the sealed fluid supplied by the fluid source leaves the expandable portion through the plurality of openings to a position outside the electrocautery probe, wherein the expandable portion has an extended position and a retracted position, wherein the extended position defines a collapsed state, and the retracted position defines an expanded state, the expandable portion includes a plurality of expansion members, wherein a corresponding opening of the plurality of openings is located between each pair of adjacent expansion members of the plurality of expansion members, and wherein each of the plurality of expansion members includes a proximal end, a distal end, and an articulated joint, the proximal end being connected to the cannula shaft portion, the distal end being connected to the distal piercing tip, and the articulated joint being located between the proximal end and the distal end.

2. The system according to claim 1, wherein: The cannula shaft portion has a first diameter and the expandable portion has a second diameter, wherein in the collapsed state, the first diameter is substantially equal to the second diameter.

3. The system according to claim 1, wherein: In the expanded state, the cannula shaft portion has a first diameter and the expandable portion has a maximum circumference having a second diameter, wherein the second diameter is greater than the first diameter.

4. The system of claim 1, wherein the fluid source is a syringe, and wherein the sealing fluid comprises albumin.

5. The system of claim 1, wherein the protein source comprises a coating comprising collagen, the coating being formed on at least one of the intermediate portion and the distal piercing tip.

6. The system of claim 1, wherein the middle portion is an expandable portion comprising a plurality of expansion members, the plurality of expansion members having a coating as the source of the protein, the coating being a heat-activated material comprising the protein, the plurality of expansion members having a collapsed state and an expanded state.

7. The system of any one of claims 5 and 6, wherein the coating comprises collagen.

8. A system for sealing together a portion of pleural layers, the system comprising: a fluid source configured to deliver a sealing fluid, the sealing fluid being heat activated; Electrical energy; a ground pad electrically coupled to the electrical energy source; a monopolar electrocautery probe electrically coupled to the electrical energy source, wherein the monopolar electrocautery probe and the ground pad cooperate to generate heat, The monopolar electrocautery probe has a cannula shaft portion, a distal piercing tip, and an expandable portion between the cannula shaft portion and the distal piercing tip, the cannula shaft portion having a cannula lumen coupled in fluid communication with the fluid source, wherein: the expandable portion is coupled in fluid communication with the fluid source via the cannula lumen; The expandable portion is configured to define a plurality of openings, wherein a sealing fluid supplied by the fluid source exits the expandable portion through the plurality of openings to a location external to the monopolar electrocautery probe; and The expandable portion has an extended position and a retracted position, the extended position defining a stowed state, the retracted position defining an expanded state, the expandable portion comprising a plurality of expansion members, wherein: a corresponding opening of the plurality of openings being located between each pair of adjacent expansion members of the plurality of expansion members; Each of the plurality of dilation members has a proximal end connected to the cannula shaft portion and a distal end connected to the distal piercing tip; and Each of the plurality of expansion members further includes an articulated joint between a proximal end and a distal end, wherein the expanded state facilitates flow of a sealing fluid between the plurality of expansion members to a position external to the expandable portion.

9. The system according to claim 8, wherein: The cannula shaft portion has a first diameter and the expandable portion has a second diameter, wherein in the collapsed state, the first diameter is substantially equal to the second diameter.

10. The system according to claim 8, wherein: In the expanded state, the cannula shaft portion has a first diameter and the expandable portion has a maximum circumference having a second diameter, wherein the second diameter is greater than the first diameter.

11. The system according to claim 8, wherein: The expandable portion is made of biocompatible metal.

12. The system according to claim 8, wherein: The fluid source is a syringe.

13. The system of claim 12, further comprising a Luer fitting connected to the proximal end of the cannula shaft portion, the Luer fitting being in fluid communication with the cannula lumen, and wherein the syringe is connected to the Luer fitting.

14. The system according to claim 8, wherein: The sealing fluid includes a protein.

15. The system of claim 8, comprising a coating formed on at least one of the expandable portion and the distal piercing tip, the coating being a heat-activated material comprising a secondary protein.

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