Systems and methods for sealing cored or perforated tissue using an inflatable balloon - Patents.com

Abstract

Systems and methods for sealing a tissue site can include coring tissue at the target site such that a tissue core is removed from the target site to create a core cavity in the target site, and sealing at least a portion of the target site.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to and the benefit of U.S. Patent Application No. 63 / 017,734, filed April 30, 2020, the entirety of which is incorporated herein by reference. [Background technology]

[0002] Tissue, such as lung tissue, may be perforated or portions may be removed. Removal of tissue may include, for example, surgery involving coring and removal of tissue specimens from the lung. However, problems may arise with cored or perforated tissue. Improvements are needed in the management of cored or perforated tissue, such as lung tissue. Summary of the Invention

[0003] It may be desirable to remove a core of tissue from a target tissue site, including, but not limited to, the lung, liver, pancreas, or gastrointestinal (GI) tract, where management of bleeding after core removal may be desired. The tissue core may have a predetermined (e.g., predefined) shape (e.g., cylindrical) and dimensions based on a core removal device. Such a core removal device may be used to core tissue cores of the same or substantially the same shape in a repeatable manner. Such core removal may be distinguished from other tissue removals, such as those using scissors or a scalpel, where the cut tissue does not have a predefined shape or dimensions.

[0004] Once cored, it may be desirable to seal the cored tissue. As described herein, it may be desirable to seal during the coring process, for example, to seal against blood and / or fluid flow at the core site, which may be caused by the coring operation itself. Additionally or alternatively, it may be desirable to seal after the tissue core and / or core removal device has been removed. Furthermore, sealing may occur at least once during the coring process and at least once after the tissue core and / or core removal device has been removed. As an illustrative example, the core removal site may be sealed during the coring process to restrict unwanted blood or fluid from entering the core removal site. The core removal site may then be sealed after the tissue core has been removed to restrict unwanted air from leaking through the core removal site, such as in the lungs. A variety of sealing operations may be used.

[0005] Systems and / or methods for sealing tissue are described herein. A method for sealing tissue at a core removal site can include coring tissue at the target site such that a tissue core is removed from the target site, thereby creating a core cavity at the target site. A sealing device can be positioned adjacent to the target site. The sealing device can seal at least a portion of the core cavity at the target site. The sealing device can be moved away (e.g., removed, separated, etc.) from the target site.

[0006] Systems and / or methods for sealing tissue are described herein. An exemplary method can include positioning a port to provide access to a target site. An exemplary method can include securing a fixation device to a surface of the target site through the port. An exemplary method can include positioning a sealing device adjacent to the target site through the port. An exemplary method can include causing the sealing device to seal the target site. An exemplary method can include positioning a filler material adjacent to the target site. The sealing device can minimize leakage of the filler material from the target site.

[0007] Systems and / or methods for sealing tissue are described herein. An exemplary method can include positioning a sealing device adjacent to a target site in the lung while the lung is compressed. An exemplary method can include causing the sealing device to seal the target site. An exemplary method can include positioning a filler material adjacent to the target site. The sealing device can minimize leakage of the filler material from the target site. An exemplary method can include moving (e.g., removing, separating, etc.) the sealing device away from the target site.

[0008] Systems and / or methods for sealing tissue are described herein. An exemplary method can include securing a fixation device to a surface of the target site. An exemplary method can include positioning the sealing device adjacent to the target site via fixation. An exemplary method can include causing the sealing device to seal the target site. An exemplary method can include positioning a filler material adjacent to the target site. The sealing device can minimize leakage of the filler material from the target site.

[0009] Systems and / or methods for sealing tissue are described herein. An exemplary method can include placing a fluid delivery device at a target site in the lung. An exemplary method can include placing a filler material at the target site. An exemplary method can include separating (e.g., removing, separating, etc.) the fluid delivery device from the target site.

[0010] The following drawings illustrate generally, by way of example, but not by way of limitation, various examples discussed in the present disclosure. [Brief explanation of the drawings]

[0011] [Figure 1] 1A-1C illustrate application of an exemplary system for sealing tissue. [Figure 2] 1A-1C illustrate application of an exemplary system for sealing tissue. [Figure 3]1 is a flow chart of an exemplary method for sealing tissue. [Figure 4] 1 is a flow chart of an exemplary method for sealing tissue. [Figure 5] 1 is a flow chart of an exemplary method for sealing tissue. [Figure 6] 1 is a flow chart of an exemplary method for sealing tissue. [Figure 7] 1 is a flow chart of an exemplary method for coring and sealing tissue. [Figure 8] 1A-C illustrate the application of an exemplary system for sealing tissue. [Figure 9] 1A and 1B illustrate the application of an exemplary system for sealing tissue. [Figure 10] 1A-C illustrate the application of an exemplary system for sealing tissue. [Figure 11] 1 illustrates a tissue excision device according to an embodiment of the present disclosure. [Figure 12] 2 is a cross-sectional view of the tissue excision device of FIG. 1. [Figure 13] 1 is a cross-sectional view of a tissue excision device according to an embodiment of the present disclosure. [Figure 14] 1 is a cross-sectional view of a tissue excision device according to an embodiment of the present disclosure. [Figure 15] 1A-1C illustrate exemplary anchors that may be used in a lesion removal method according to an embodiment of the present disclosure. [Figure 16] 1A-1C illustrate a series of dissection blades for use in a lesion removal method according to an embodiment of the present disclosure. [Figure 17] 1 illustrates a tissue expander suitable for use in a lesion removal method according to an embodiment of the present disclosure. [Figure 18] 1 is a flow chart of an exemplary method for coring and sealing tissue. DETAILED DESCRIPTION OF THE INVENTION

[0012] The present disclosure relates to systems and methods for treating tissue, such as cored, perforated, and / or removed tissue regions, although other tissues and sites may benefit from the disclosed systems and methods.

[0013] The present disclosure relates to methods and systems for core-removing tissue and sealing a core cavity created by removing the tissue core. Such methods can include disposing a filler material within the core cavity. The methods can include applying pressure to a portion of the core cavity, such as a wall defining the core cavity. The methods can include ablating a portion of the core cavity, such as a wall defining the core cavity. The methods can include closing the tissue cavity with a cavity closure device, such as a suture, a stapling device, an ultrasonic tissue sealing device, a bipolar radiofrequency sealing device, or any combination thereof. The methods can include disposing a cavity sealing material, such as a tissue graft, a hemostatic patch, a hemostatic agent, such as fibrin or thrombin, a bioadhesive material, such as Dermabond™, or any combination thereof, to close the tissue cavity.

[0014] The method includes: 1) placing a fixation device within the tissue cavity; 2) placing a tissue access port within the tissue cavity; 3) placing a tissue sealing device within the tissue cavity (with or without the tissue access port, with or without guidance from the fixation device); 4) causing the tissue sealing device to seal at least a portion of the tissue cavity; and 5) introducing a filler material into the tissue cavity (with or without a filler material delivery device, with or without preceding placement of the tissue sealing device within the tissue cavity, with or without removing the tissue sealing device after sealing at least a portion of the tissue cavity, and The method may include, in any combination or permutation, placing a cavity closure device adjacent to the tissue cavity (with or without a port), 6) placing a cavity sealing material adjacent to the tissue cavity (with or without being preceded by placing a tissue sealing device within the tissue cavity, with or without removing the tissue sealing device after sealing at least a portion of the tissue cavity, with or without being preceded by introducing a filler material into the tissue cavity), 7) placing the cavity closure device adjacent to the tissue, and 8) allowing the cavity closure device to close the tissue cavity (with or without being preceded by any combination or permutation of the above steps). As described herein, the methods can be used to core and / or seal tissue at a variety of target sites. While the lung is used as an example, it should not be so limited, as other target sites can be punctured or actively cored and benefit from the disclosed sealing methods.

[0015] The present disclosure relates to a method for delivering filler material, such as autologous blood, to a core site, which can be used to provide sealing and pneumostasis. By way of example, once a tissue specimen has been cored and removed from the lung, it may be necessary to seal the core site and provide pneumostasis. As a further example, air leak closure can be achieved in the same surgical session as the tissue removal.

[0016] Although autologous blood is described herein as an example, other filler materials and additives can be used. For example, absorbable gelatin foam (e.g., SURGIFOAM™), biological oxidized regenerated cellulose (ORC), fibrin / thrombin spray, and other hemostatic aids are available. As a further example, a patient may suffer from hemophilia, a rare disease in which blood does not clot normally. Other patients may be taking anticoagulants that may inhibit the formation of blood clots. For such patients, thrombin and / or fibrinogen can be added to the autologous blood sample to aid in clot formation in order to seal the cored cavity. Reactive polyethylene glycol (PEG), ammonium sulfate, ethanol, calcium chloride, or magnesium chloride can also be added to the blood sample to aid in clot formation. Another source of blood used to seal the cored cavity is donated blood from another person or a blood bank. Donated blood can be used with or without a coagulant, as described above.

[0017] Systems and / or methods for sealing tissue are described herein. An exemplary method can include placing a port to provide access to a target site. The target site can include biological tissue. The target site can include lung tissue. The target site can include cored tissue. The target site can include perforated tissue. Other sites can benefit from the disclosed methods.

[0018] An exemplary method can include anchoring a fixation device to a surface of the target site (e.g., via a port). Anchoring can be by any suitable structure that secures the device to the lung. An exemplary method can include positioning a sealing device adjacent to the target site (e.g., via a port). An exemplary method can include positioning the sealing device adjacent to the target site using the fixation device as a guide. The sealing device can include an inflatable balloon. The sealing device can include an inflatable balloon with an array of radio frequency (RF) electrodes configured to ablate and seal tissue. The sealing device can include an inflatable balloon configured to seal tissue using a thermal fluid. The sealing device can include an inflatable balloon catheter. The sealing device can include an access port with an array of RF electrodes configured to ablate and seal tissue. The sealing device can include at least one microwave ablation probe.

[0019] An exemplary method can include sealing the target site with a sealing device. Sealing the target site with the sealing device can include abutting at least a portion of the sealing device against a portion of the target site. An exemplary method can include disposing a filler material adjacent to the target site. An exemplary method can include disposing the filler material adjacent to the target site via a filler material delivery device, such as a catheter. The filler material can include autologous blood, donated blood, recirculated blood, hemostatic aids such as fibrin and / or thrombin, biological tissue adhesives such as Dermabond™, ORC, absorbable gelatin, or any combination thereof. The filler material can promote air leak closure. The filler material can further promote hemostasis. Other materials can be used. The sealing device can minimize leakage of the filler material from the target site.

[0020] As an illustrative example, the target site can include at least a portion of a lung. The lung can be compressed before placing the sealing device adjacent the target site. The lung can be ventilated while the sealing device seals the target site. The sealing device can be spaced (e.g., removed, detached, etc.) from the target site after the filler material is placed.

[0021] Sealing systems and / or methods are described herein. An exemplary method can include positioning a sealing device adjacent to a target site in a lung. The sealing device can be positioned adjacent to the target site while the lung is compressed, while the lung can be ventilated. An exemplary method can include having the sealing device seal the target site. An exemplary method can include positioning the sealing device adjacent to the target site using a fixation device as a guide. The sealing device can include an inflatable balloon. The sealing device can include an inflatable balloon with an array of RF electrodes configured to ablate and seal tissue. The sealing device can include an inflatable balloon configured to seal tissue using a thermal fluid. The sealing device can include an inflatable balloon catheter. The sealing device can include an access port with an array of RF electrodes configured to ablate and seal tissue. The sealing device can include at least one microwave ablation probe. An exemplary method can include positioning a filler material adjacent to the target site. An exemplary method can include positioning a filler material adjacent to the target site via a filler material delivery device, such as a catheter. The filling material can include autologous blood, donated blood, recirculated blood, hemostatic aids such as fibrin, thrombin, etc., tissue adhesives such as Dermabond™, ORC, absorbable gelatin, etc., or any combination thereof. The filling material can promote air leak closure. The filling material can further promote hemostasis. Other materials can be used. The sealing device can minimize leakage of the filling material from the target site.

[0022] Sealing systems and / or methods are described herein. An exemplary method can include placing a fluid delivery device at a target site in a lung. The sealing device can be positioned adjacent to the target site while the lung is compressed. The sealing device can be positioned adjacent to the target site while the lung is ventilated. An exemplary method can include placing a filler material at the target site. An exemplary method can include moving (e.g., removing, separating, etc.) the sealing device away from the target site.

[0023] The sealing device can include an inflatable balloon. The sealing device can include an inflatable balloon with an array of RF electrodes configured to ablate and seal tissue. The sealing device can include an inflatable balloon configured to seal tissue using a thermal fluid. The sealing device can include an inflatable balloon catheter. The sealing device can include an access port with an array of RF electrodes configured to ablate and seal tissue. The sealing device can include at least one microwave ablation probe. The systems and / or methods described herein can provide a seal with coagulated blood to achieve air leak closure. An exemplary method can include placing a filler material adjacent to the target site. An exemplary method can include placing the filler material adjacent to the target site via a filler material delivery device, such as a catheter. The filler material can include autologous blood, donated blood, recirculated blood, a hemostatic adjuvant such as fibrin or thrombin, a biological tissue adhesive such as Dermabond™, ORC, absorbable gelatin, or any combination thereof. The filler material can facilitate air leak closure. The filler material can further facilitate hemostasis. Other materials can be used. The sealing device can minimize leakage of the filler material from the target site.

[0024] The target site can include a cavity. The cavity can be closed, for example, after sealing. Closing the cavity can include using a biological tissue adhesive, such as Dermabond™, a tissue graft, a hemostatic sealing patch, staple closure, or sutures.

[0025] FIG. 1 illustrates a system 100. The system 100 may include a port, such as a chest port 102, configured to provide access via a channel to a portion of the body. It should be understood that various channels or ports may be used throughout the body, and the chest port 102 is shown as a non-limiting example. As an illustrative example, the chest port 102 is shown positioned adjacent a rib 106 to provide access to the patient's lungs 110. However, other locations may be used, and the chest port 102 (or other port) may not be necessary. A fixation device 104 may be anchored to tissue, such as the lungs 110. An exemplary fixation device is shown in FIG. 15 for illustrative purposes. However, any suitable device for anchoring to the target site 112 may be used. As shown, the fixation device 104 extends through the chest port 102 and through the pleura 108 to anchor to tissue within the lungs 110. The fixation device 104 may be anchored (e.g., releasably coupled) to tissue at the target site 112. The target site 112 can include a core site where a portion of lung tissue has been cored, perforated, or removed. The fixation device 104 can be placed at the target site 112 while the lung is inflated. However, other processes can be performed while the lung is compressed.

[0026] FIG. 2 illustrates an exemplary application of the sealing device 200. The sealing device 200 may comprise an inflatable balloon 202. Other sealing mechanisms may be used. The sealing device 200 may comprise and / or contact a balloon catheter. The balloon catheter may be a single-lumen balloon catheter. The balloon catheter may be a multi-lumen balloon catheter. The sealing device 200 may be positioned adjacent to the target site 112. As such, the sealing device 200 may seal the target site 112 to minimize leakage of fluid or material from the target site 112. As an example, a filler material 204 may be positioned at the target site 112 and sealed within the target site 112 by the sealing device 200. As an illustrative example, the inflatable balloon 202 may provide a seal while the lung 110 moves (e.g., expands and contracts). The sealing device 200 may be implemented when the lung 110 is inflated or compressed.

[0027] 3 shows a flow diagram of an exemplary method 300. At 302, a port can be positioned to provide access to a target site. A port (e.g., chest port 102 (FIG. 1)) can be positioned to provide access to the target site. A user can position the port to provide access to the target site. The target site can include biological tissue. The target site can include lung tissue. The target site can include cored tissue. The target site can include perforated tissue. The target site can include at least a portion of a lung.

[0028] The fixation device can be secured to the surface of the target site at 304. As an example, a user can secure the fixation device to the surface of the target site through a port.

[0029] At 306, a sealing device can be positioned adjacent to the target site, for example, via a port. The sealing device can include an inflatable balloon. The sealing device can include an inflatable balloon catheter. The lungs can be compressed before the sealing device is positioned adjacent to the target site. The lungs can be ventilated while the sealing device seals the target site.

[0030] The sealing device can be caused to seal against the target site at 308. Sealing the sealing device against the target site can include abutting at least a portion of the sealing device against a portion of the target site.

[0031] At 310, a filler material can be placed adjacent to the target site. The sealing device can minimize leakage of the filler material from the target site. The filler material can promote air leak closure. The filler material can include autologous blood. The sealing device can be spaced (e.g., removed, detached, etc.) from the target site after the filler material is placed.

[0032] 4 shows a flow chart of an exemplary method 400. At 402, a sealing device can be positioned adjacent to a target site in the lung while the lung is compressed. The target site can include lung tissue. The target site can include cored tissue. The target site can include perforated tissue. The sealing device can include an inflatable balloon. The sealing device can include an inflatable balloon catheter.

[0033] The sealing device can be caused to seal against the target site at 404. Sealing the sealing device against the target site can include abutting at least a portion of the sealing device against a portion of the target site.

[0034] At 406, a filler material can be positioned adjacent to the target site. The sealing device can minimize leakage of the filler material from the target site. The filler material can promote air leak closure. The filler material can include autologous blood. At 408, the sealing device can be spaced (e.g., removed, detached, etc.) from the target site.

[0035] 5 shows a flow diagram of an exemplary method 500. At 502, a fixation device can be fixed to a surface of a target site. The target site can include biological tissue. The target site can include lung tissue. The target site can include cored tissue. The target site can include perforated tissue. The target site can include at least a portion of a lung.

[0036] At 504, a sealing device can be positioned adjacent to the target site by fixation. The sealing device can include an inflatable balloon. The sealing device can include an inflatable balloon catheter. The lung can be compressed before the sealing device is positioned adjacent to the target site.

[0037] At 506, the sealing device can be caused to seal against the target site. Sealing the sealing device against the target site can include abutting at least a portion of the sealing device against a portion of the target site. The lungs can be ventilated while the sealing device seals against the target site.

[0038] At 508, a filler material can be placed adjacent to the target site. The sealing device can minimize leakage of the filler material from the target site. The filler material can facilitate air leak closure. The filler material can include autologous blood. The sealing device can be spaced (e.g., removed, detached, etc.) from the target site after the filler material is placed.

[0039] 6 shows a flow diagram of an exemplary method 600. At 602, a fluid delivery device can be positioned adjacent to or within a target site of the lung while the lung is compressed. The target site can include biological tissue. The target site can include lung tissue. The target site can include cored tissue. The target site can include perforated tissue. The target site can include at least a portion of the lung.

[0040] At 604, a filler material can be placed at the target site. The filler material can promote air leak closure. The filler material can include autologous blood.

[0041] At 606, the fluid delivery device can be spaced (e.g., removed, detached, etc.) from the target site. The lungs can be compressed before the fluid delivery device is positioned adjacent to the target site.

[0042] 7 shows a flow chart of an exemplary method. At 702, tissue at a target site can be cored such that a tissue core is removed from the target site, thereby creating a core cavity at the target site. Coring tissue at the target site can include transecting and sealing the tissue. Coring tissue at the target site can include positioning a tissue core removal device adjacent to the target tissue site. The tissue core removal device can include a first clamping element with a helical coil, a second clamping element positioned opposite at least a portion of the first clamping element, first and second electrodes configured to deliver radiofrequency energy to seal the tissue, and / or a cutting element configured to transect at least a portion of the sealed tissue. Other devices can also be used.

[0043] Coring tissue at the target site can include forming a tissue core using a tissue core removal device. The target site can be, for example, a tissue site such as a lung. At 704, a sealing device can be positioned adjacent to the target site. The sealing device can include an inflatable balloon. The sealing device can include an inflatable balloon catheter. At 706, the sealing device can be caused to seal at least a portion of a core cavity at the target site. Example sealing procedures are described herein and include, for example, filling material, ablation, mechanical pressure, energy emission (e.g., RF energy), and others. Causing the sealing device to seal at least a portion of the core cavity at the target site can include abutting at least a portion of the sealing device against a wall defining the core cavity. Causing the sealing device to seal at least a portion of the core cavity at the target site can include ablating a wall defining the core cavity. Causing the sealing device to seal at least a portion of the core cavity at the target site can include applying pressure to a wall defining the core cavity. Method 700 can further include disposing a filler material within the core cavity, where the sealing device minimizes leakage of the filler material from the core cavity. The filler material can include autologous blood. By way of example, the target site can include at least a portion of a lung, and the method can further include compressing the lung before disposing the sealing device adjacent the target site. By way of further example, the target site can include at least a portion of a lung, and method 700 can further include ventilating the lung while the sealing device seals the target site. At 708, the sealing device can be moved away (e.g., removed, separated, etc.) from the target site.

[0044] An exemplary system for performing one or more of the methods of the present disclosure can include a guiding anchor. An exemplary system can include a single-lumen balloon catheter. An exemplary system can include a multi-lumen balloon catheter. An exemplary system can include a core removal device. After core removal with the core removal device, an anchor can be introduced into the tissue cavity to gain access to the cored site, as shown in FIG. 1. The chest port can be removed, and the lung can be compressed. A balloon catheter can be inserted into the anchor. Once the balloon catheter enters the thoracic cavity, the balloon catheter can be inflated. The inflated balloon catheter can be moved forward, slightly pressing against the lung tissue. Autologous blood can be injected into the core site through the inflated balloon catheter. The inflated balloon catheter and autologous blood can be held in place for a predetermined time (e.g., one minute) to allow blood to clot at the core site, as shown in FIG. 2. Ventilation of the lung can be resumed. The inflated balloon catheter can be raised and lowered along with the lung while maintaining contact with the lung, retaining blood at the core site and promoting further clotting. The balloon catheter can be deflated. The balloon catheter and anchor can be removed after a predetermined time (e.g., 3 minutes, etc.) and the autologous blood can clot at the core site to provide air leak closure.

[0045] In one embodiment, an anchor and / or balloon catheter can be used to deposit autologous blood at the core site while the lung is compressed. The anchor and / or balloon catheter can be removed immediately after the autologous blood is delivered. The blood is allowed to clot in place for a predetermined period of time (e.g., 5 minutes) before resuming ventilation of the lung.

[0046] An exemplary system allows autologous blood to be delivered to the core site. Other filling materials can be used.

[0047] An exemplary system can allow the clotted blood to provide a seal to achieve air leak closure.

[0048] 8A-8C illustrate an exemplary application. As shown, once the target site has been excavated and the tissue core removed, it may be necessary to ablate the tissue walls of the cavity. To do so, the following ablation method can be used. For example, a rotating ablation probe can be used. FIG. 8A shows a cavity 812 excavated in tissue 810 with a cavity sheath 802 in place, holding the cavity open. A rotating probe 800 is then inserted into the cavity sheath, as shown in FIG. 8B. The probe 800 can include an energy source, such as an array of energy heads or a continuous energy strip. The energy can be microwave, RF, or other forms of power. Once the probe 800 is in place, the cavity sheath 802 can remain in place or be removed. Energy is then applied while the probe / energy head is rotated, applying continuous ablation radially to the cavity walls and underlying tissue 810, as shown in FIG. 8C.

[0049] 9A and 9B illustrate an exemplary application. As shown, a thermal balloon catheter can be used. For example, balloon catheter 900 can be placed into a cavity 912 formed in tissue 910, and the cavity sheath can be removed to expose cavity 912 requiring ablation, as shown in FIG. 9A. Balloon 900 can then be inflated with hot fluid or hot air / gas to ablate cavity wall tissue 910, as shown in FIG. 9B.

[0050] 8 and 9 show illustrative examples, other methods of ablation or energy delivery can be used to seal the tissue. For example, a shaped mesh catheter can be used. Thus, a catheter with a compressed mesh shape can be inserted into the cavity, and the cavity sheath is removed. The mesh can then be expanded, and suction can be applied to draw the tissue into contact with the mesh. Energy, for example, RF energy, can then be applied to ablate the cavity tissue wall.

[0051] 10A-10C illustrate an exemplary application. As shown, once the target site has been cored and the tissue core removed, it may be necessary to seal the cut tissue walls of the cavity. Therefore, the following exemplary procedure may be used. The device 1000 may include a fluid conduit 1001 and an inflatable, absorbent balloon 1002. As shown in FIGS. 10A and 10B, the balloon 1002 may be coated on the outside with an absorbable bioadhesive that seals against the tissue of the cored cavity after core removal. Once the deflated balloon 1002 is positioned at the desired location, it may be inflated with CO2 (or other fluid), for example, via the fluid conduit 1001, to press the bioadhesive against the tissue walls of the cored cavity and achieve a seal that prevents air leakage. The CO2-filled balloon 1002 may be pressurized to an appropriate pressure and left within the cored cavity, as shown in FIG. 10C.

[0052] A variety of methods, devices, and systems can be used to core or remove tissue.

[0053] A method for removing a tissue lesion can include introducing a tissue ablation device to a target tissue site, causing the tissue ablation device to ablate a core of tissue from the target tissue site, and removing the tissue core from the body. The tissue core can include at least a portion of the tissue lesion. The method can further include creating a core cavity at the target tissue site. The method can further include inserting a sleeve into the core cavity. The method can further include delivering radiofrequency energy through the core cavity. The method can further include delivering chemotherapy through the core cavity. The method can further include delivering microwave radiation through the core cavity. The method can further include delivering thermal energy through the core cavity. The method can further include delivering ultrasonic energy through the core cavity. The tissue ablation device can be configured to perform radiofrequency energy delivery. The tissue ablation device can be configured to perform mechanical transection. The tissue ablation device can include mechanical compression and radiofrequency energy delivery. The method can further include severing the tissue core from the target tissue site. By way of example, the means for severing the tissue core can include mechanical transection. As a further example, the means for effecting a core severance of the tissue can include delivery of radio frequency energy. The means for effecting a core severance of the tissue can include mechanical compression and delivery of radio frequency energy. The means for effecting a core severance of the tissue can include transection with an energized wire. Other devices can also be used.

[0054] A method for removing a core of tissue can include introducing a tissue ablation device to a target tissue site, causing the tissue ablation device to ablate a core of tissue from the target tissue site, and removing the core of tissue from the body. The method can further include creating a core cavity at the target tissue site. The method can further include inserting a sleeve into the core cavity. The method can further include delivering radiofrequency energy through the core cavity. The method can further include delivering chemotherapy through the core cavity. The method can further include delivering microwave radiation through the core cavity. The method can further include delivering thermal energy through the core cavity. The method can further include delivering ultrasonic energy through the core cavity. The tissue ablation device can be configured to perform radiofrequency energy delivery. The tissue ablation device can be configured to perform mechanical transection. The tissue ablation device can be configured to perform mechanical compression and radiofrequency energy delivery. The method can further include severing the core of tissue from the target tissue site. Means for performing tissue core severance can include mechanical transection. Means for performing tissue core severance can include delivery of radiofrequency energy. Means for effecting severance of the core of the tissue may include mechanical compression and delivery of radio frequency energy. Means for effecting severance of the core of the tissue may include transection by an energized wire.

[0055] A method for removing a core of tissue can include introducing a tissue ablation device to a target tissue site. The tissue ablation device can include one or more of a first clamping element including a helical coil and a first electrode, or a second clamping element including a second electrode. If a second clamping element is included, the second clamping element can be positioned opposite at least a portion of the first clamping element. The method can further include causing the tissue ablation device to ablate the core of tissue from the target tissue site and removing the core of tissue from the body. The method can further include creating a core cavity at the target tissue site. The method can further include inserting a sleeve into the core cavity. The method can further include delivering radiofrequency energy through the core cavity. The method can further include delivering chemotherapy through the core cavity. The method can further include delivering microwave radiation through the core cavity. The method can further include delivering thermal energy through the core cavity. The method can further include delivering ultrasonic energy through the core cavity. The tissue ablation device can be configured to ablate a core of tissue and includes delivering radiofrequency energy. The tissue excision device can be configured to excise a core of tissue and includes mechanical transection. The tissue excision device can be configured to excise a core of tissue and includes mechanical compression and delivery of radio frequency energy. The method can further include severing the core of tissue from the target tissue site. Means for effecting the tissue core severance can include mechanical transection. Means for effecting the tissue core severance can include delivery of radio frequency energy. Means for effecting the tissue core severance can include mechanical compression and delivery of radio frequency energy. Means for effecting the tissue core severance can include transection by an energized wire.

[0056] A method for sealing a body fluid duct can include puncturing a target tissue site including at least a portion of at least one target body fluid duct with a helical tissue sealing mechanism. The helical tissue sealing mechanism can include a helical puncturing element and a clamping element. The method can include causing the helical tissue sealing mechanism to apply mechanical compression to the at least one target body fluid duct and delivering energy to seal the at least one target body fluid duct. The helical puncturing element can include a clamping element. The mechanical compression can be applied between the helical puncturing element and the clamping element. The method can further include a second clamping element. The mechanical compression can be applied between the first clamping element and the second clamping element. The delivered energy can include monopolar radiofrequency energy. The delivered energy can include bipolar radiofrequency energy. The delivered energy can include thermal energy. The delivered energy can include ultrasonic energy.

[0057] A method for sealing a body fluid duct can include puncturing a target tissue site with a helical puncturing element, adjusting the pitch of the helical puncturing element to apply mechanical compression to the target tissue, and delivering energy to seal at least one body fluid duct in the target tissue. The helical puncturing element can include multiple tissue sealing electrodes. The delivered energy can include monopolar radiofrequency energy. The delivered energy can include bipolar radiofrequency energy. The delivered energy can include thermal energy. The delivered energy can include ultrasonic energy.

[0058] The tissue excision device includes a first clamping element having a helical coil, a second clamping element positioned opposite at least a portion of the first clamping element, first and second electrodes configured to deliver radiofrequency energy to seal the tissue, and a cutting element configured to transect at least a portion of the sealed tissue. The tissue excision device can further include a first actuator operable to actuate the first or second clamping element to apply mechanical compression to the tissue, and a second actuator operable to actuate the cutting element to transect the tissue. The helical coil can include an articulating first coil segment and a second coil segment. The first coil segment can include a generally planar open ring. The first coil segment can be helical and can have a zero pitch. The second coil segment can be helical and can have a non-zero pitch. The second coil segment can have a variable pitch. The first coil segment can be helical and have a first pitch, and the second coil segment can be helical and have a second pitch, where at least one of the first pitch and the second pitch can be variable. The first electrode can be comprised of at least a portion of the first clamping element. The second electrode can be comprised of at least a portion of the second clamping element. The helical coil can have a blunt tip. The first electrode and the second electrode can have matching or substantially matching surface profiles. At least a portion of the cutting element can have a sharpened edge. The cutting element can include at least one electrode configured to deliver radiofrequency energy. The cutting element can include an ultrasonic blade. The tissue excision device can further include a second cutting element configured to sever a core of tissue from the target tissue site. At least a portion of the second cutting element can have a sharpened edge. The second cutting element can include at least one electrode configured to deliver radiofrequency energy. The second cutting element can include an energized wire.The second cutting element may comprise a suture.The tissue excision device may further comprise an actuator operable to actuate the second cutting element to transect the tissue.

[0059] The tissue excision device can include a first clamping element having a helical coil disposed at a distal end thereof, a second clamping element positioned opposite at least a portion of the first clamping element, first and second electrodes configured to deliver radiofrequency energy to seal the tissue, and a cutting element configured to transect at least a portion of the sealed tissue. The tissue excision device can further include a first actuator operable to actuate the first or second clamping element to apply mechanical compression to the tissue, and a second actuator operable to actuate the cutting element to transect the tissue. The helical coil can include an articulating first coil segment and a second coil segment. The first coil segment can include a generally planar open ring. The first coil segment can be helical and can have a zero pitch. The second coil segment can be helical and can have a non-zero pitch. The second coil segment can have a variable pitch. The first coil segment can be helical and have a first pitch, and the second coil segment can be helical and have a second pitch, where at least one of the first pitch and the second pitch can be variable. The first electrode can be comprised of at least a portion of the helical coil. The first electrode can be comprised of at least a portion of the first clamping element. The second electrode can be comprised of at least a portion of the second clamping element. The helical coil can have a blunt tip. The first electrode and the second electrode can have matching or substantially matching surface profiles. At least a portion of the cutting element can have a sharpened edge. The cutting element can include at least one electrode configured to deliver radiofrequency energy. The cutting element can include an ultrasonic blade. The tissue excision device can further include a second cutting element configured to sever a core of tissue from the target tissue site. At least a portion of the second cutting element can have a sharpened edge.The second cutting element can include at least one electrode configured to deliver radiofrequency energy. The second cutting element can include an energized wire. The second cutting element can include a suture. The tissue excision device can further include an actuator operable to actuate the second cutting element to transect tissue.

[0060] The tissue excision device can include a first clamping element including a helical coil and a first electrode, and a second clamping element including a second electrode and positioned opposite at least a portion of the first clamping element. The first clamping element and the second clamping element can be configured to (a) deliver radiofrequency energy to seal the tissue, and (b) apply mechanical compression to transect the tissue. The tissue excision device can further include a first actuator operable to actuate the first clamping element or the second clamping element to apply mechanical compression to the tissue, and a second actuator operable to actuate the cutting element to transect the tissue. The helical coil can include an articulating first coil segment and a second coil segment. The first coil segment can include a generally planar open ring. The first coil segment can be helical and can have a zero pitch. The second coil segment can be helical and can have a non-zero pitch. The second coil segment can have a variable pitch. The first coil segment can be helical and have a first pitch, and the second coil segment can be helical and have a second pitch, where at least one of the first pitch and the second pitch can be variable. The first electrode can be comprised of at least a portion of the helical coil. The first electrode can be comprised of at least a portion of the first clamping element. The second electrode can be comprised of at least a portion of the second clamping element. The helical coil can have a blunt tip. The first electrode and the second electrode can have matching or substantially matching surface profiles. At least a portion of the cutting element can have a sharpened edge. The cutting element can include at least one electrode configured to deliver radiofrequency energy. The cutting element can include an ultrasonic blade. The tissue excision device can further include a second cutting element configured to sever a core of tissue from the target tissue site. At least a portion of the second cutting element can have a sharpened edge.The second cutting element can include at least one electrode configured to deliver radiofrequency energy. The second cutting element can include an energized wire. The second cutting element can include a suture. The tissue excision device can further include an actuator operable to actuate the second cutting element to transect tissue.

[0061] A surgical tool system for resecting tissue can include an end effector operable to cut and seal tissue, the end effector having first and second electrodes for sealing the tissue, and a generator configured to provide power to the end effector. The end effector can include a first clamping element having a helical coil, a second clamping element positioned opposite at least a portion of the first clamping element, first and second electrodes configured to deliver radiofrequency energy to seal the tissue, and a cutting element configured to transect at least a portion of the sealed tissue. The surgical tool system can further include a controller in communication with the generator, the controller configured to control the generator to deliver radiofrequency energy to the first and second electrodes of the end effector sufficient to seal the tissue based on at least one sensed operating state of the end effector. The controller can be configured to sense the presence of tissue at the end effector. The controller can be configured to sense the presence of tissue at the end effector based on measured impedance levels associated with the first electrode and the second electrode. The controller can be configured to sense an amount of force applied to at least one of the first clamping element or the second clamping element to detect the presence of tissue at the end effector. The controller can be configured to sense a position of the cutting element relative to at least one of the first clamping element or the second clamping element. The controller can be configured to control the generator to supply radio frequency energy to the end effector when the second actuator is actuated and no tissue is sensed at the end effector. The controller can be configured to control the generator to supply a continuous amount of radio frequency energy. The controller can be configured to control the generator to automatically increase or decrease the amount of radio frequency energy.The system may further include a first actuator operable to actuate the first clamping element or the second clamping element to apply mechanical compression to the tissue, and a second actuator operable to actuate the cutting element to transect the tissue. The helical coil may include an articulating first coil segment and a second coil segment, the first coil segment including a first electrode. The first coil segment may include a generally planar open ring. The first coil segment may be helical and may have a zero pitch. The second coil segment may be helical and may have a non-zero pitch. The second coil segment may have a variable pitch. The first coil segment may be helical and may have a first pitch, and the second coil segment may be helical and may have a second pitch, at least one of the first pitch and the second pitch may be variable. The first electrode may be comprised of at least a portion of the helical coil. The first electrode can comprise at least a portion of the first clamping element. The second electrode can comprise at least a portion of the second clamping element. The helical coil can comprise a blunt tip. The first electrode and the second electrode can have matching or substantially matching surface profiles. At least a portion of the cutting element can comprise a sharpened edge. The cutting element can include at least one electrode configured to deliver radiofrequency energy. The cutting element can include an ultrasonic blade. The tissue excision device can further comprise a second cutting element configured to sever a core of tissue from the target tissue site. At least a portion of the second cutting element can comprise a sharpened edge. The second cutting element can include at least one electrode configured to deliver radiofrequency energy. The second cutting element can include an energized wire. The second cutting element can include a suture. The tissue excision device can further comprise an actuator operable to actuate the second cutting element to transect tissue.

[0062] The tissue excision device may include a first clamping element comprising a helical coil, a second clamping element positioned opposite at least a portion of the first clamping element, first and second electrodes configured to deliver radiofrequency energy to seal the tissue, a first cutting element configured to transect at least a portion of the sealed tissue, a first ligating element and a second ligating element, and a second cutting element positioned between the first and second ligating elements. The tissue excision device may further include a first actuator operable to actuate the first or second clamping element to apply mechanical compression to the tissue, and a second actuator operable to actuate the cutting element to transect the tissue. The helical coil may include an articulating first coil segment and a second coil segment. The first coil segment may include a generally planar open ring. The first coil segment may be helical and may have a zero pitch. The second coil segment can be helical and can have a non-zero pitch. The second coil segment can have a variable pitch. The first coil segment can be helical and can have a first pitch, and the second coil segment can be helical and can have a second pitch, where at least one of the first pitch and the second pitch can be variable. The first electrode can be comprised of at least a portion of the helical coil. The first electrode can be comprised of at least a portion of the first clamping element. The second electrode can be comprised of at least a portion of the second clamping element. The helical coil can have a blunt tip. The first electrode and the second electrode can have matching or substantially matching surface profiles. At least a portion of the cutting element can have a sharp edge. The cutting element can include at least one electrode configured to deliver radiofrequency energy. The cutting element can include an ultrasonic blade. The tissue excision device can further include a second cutting element configured to sever a core of tissue from the target tissue site.At least a portion of the second cutting element can include a sharp edge. The second cutting element can include at least one electrode configured to deliver radiofrequency energy. The second cutting element can include an energized wire. The second cutting element can include a suture. The tissue excision device can further include an actuator operable to actuate the second cutting element to transect tissue.

[0063] The tissue sealing mechanism may include a helical coil having a generally elliptical cross-section and a conical point disposed at a distal end, first and second helical tissue sealing surfaces provided by parallel planar surfaces of the helical coil, a first electrode disposed on the first helical tissue sealing surface, and a second electrode disposed on the second helical tissue sealing surface, the first and second electrodes configured to apply bipolar radiofrequency energy to seal tissue. The helical coil may include contiguous first and second coil segments. The helical coil may include a blunt tip. The first and second electrodes may have substantially matching surface profiles. The first and second helical tissue sealing surfaces may further include a plurality of electrodes configured to deliver bipolar radiofrequency energy.

[0064] 11-17 illustrate examples of devices that can be used to accomplish the core removal process as described herein. For example, the ablation devices of the present invention can include energy-based configurations capable of penetrating tissue toward a target lesion. In one embodiment shown in FIG. 11, the tissue ablation device 1100 includes an outer tube 1105 having a distal edge profile and an inner diameter IDouter. A coil 1110 is attached to the outer tube 1105, with the coil windings spaced apart from and facing the distal end of the outer tube 1105. The coil 1110 preferably has a slightly blunt tip 1115 that minimizes the possibility of penetrating blood vessels while providing sufficient sharpness to penetrate tissue such as the pleura and parenchyma. In some embodiments, the coil 1110 can take the form of a helix with a constant or variable pitch. The coil 1110 can also have a variable cross-sectional shape. The electrode 1130 can be disposed on the surface or embedded within the coil 1110.

[0065] 11, coil 1110 can include multiple articulating coil segments, such as coil segments 1120 and 1125. Coil segment 1120 can comprise a helical member with zero pitch, e.g., a generally planar open ring structure with an inner diameter ID coil and an outer diameter OD coil. Coil segment 1125 can comprise a helical structure with a constant or variable pitch and a constant or variable cross-sectional shape. In this embodiment, electrode 1130 can be disposed on a surface of coil segment 1120 or embedded therein.

[0066] A central tube 1200 can be provided having a distal end with an edge profile comprising one or more surface segments and having an outer diameter ODcentral and an inner diameter IDcentral. As shown in FIG. 12 , an electrode 1205 is disposed on or embedded within at least one of the surface segments. The central tube 1200 is slidably disposed within the outer tube 1105 and positioned such that the electrode 1205 faces and overlaps at least a portion of the electrode 1130. The space between the electrode 1205 and the electrode 1130 may be referred to as the tissue clamping zone. According to one aspect of the present disclosure, ODcentral > IDcoil and ODcoil > IDcentral. In some embodiments, ODcentral is approximately equal to ODcoil. Thus, the central tube 1200 can be advanced through the tissue clamping zone toward the coil 1110 so that the electrode 1205 abuts the electrode 1130.

[0067] The cutting tube 1300 may be slidably positioned within the central tube 1200. The distal end of the cutting tube 1300 is provided with a knife edge to facilitate cutting of tissue.

[0068] To enable tissue resection, the resection device 1100 is inserted into tissue, and the outer tube 1105 can be advanced a predetermined distance toward the target. The coil segment 1125 can allow the device to penetrate tissue in a manner similar to a cork screw. As the coil segment 1125 penetrates the tissue, any tubing in its path can either move into the planar coil segment 1120 or be pushed out of the coil 1110 for subsequent turns. The coil tip 1115 can be blunt enough to minimize the possibility of penetrating a blood vessel, while remaining sharp enough to penetrate certain tissues, such as the lung pleura and parenchyma. The central tube 1200 can then be advanced a predetermined distance toward the target. Any tubing positioned in the tissue clamping zone is clamped between the electrode 1130 and the electrode 1205. The tubing can then be sealed by applying bipolar energy to the electrode 1130 and the electrode 1205. Once the vessel is sealed, the cutting tube 1300 can be advanced to core tissue to the depth reached by the outer tube 1105. The sealing and cutting process can be repeated to create a core of the desired size.

[0069] According to one aspect of the present disclosure, the ablation device can be further configured to incise the target lesion and seal the tissue adjacent to the incision point. To facilitate the incision and sealing, the central tube 1200 is provided with a ligating snare 1230, first and second ligating electrodes 1215 and 1220, and a cutting snare 1225, as shown in FIG. 13 . As used herein, the term “snare” refers to a flexible line, such as a string or wire. The inner wall surface of the central tube 1200 can include an upper circumferential groove path 1212 and a lower circumferential groove path 1214 disposed adjacent the distal end. The first ligating electrode 1215 and the second ligating electrode 1220 can be positioned on the inner wall of the central tube 1200 with the lower circumferential groove 1214 between them. The upper channel path 1212 can be positioned axially above the ligating electrodes 1215 and 1220 .

[0070] A ligating snare 1230 can be positioned within the lower circumferential groove 1214 and extend axially through the central tube 1200 and along the outer wall surface to a snare actuation mechanism (not shown). A cutting snare 1225 can be positioned within the upper circumferential groove 1212 and extend axially through the central tube 1200 and along the outer wall surface to a snare actuation mechanism (not shown). The outer surface of the central tube 1200 can be provided with a plurality of axially extending groove channels that accommodate the cutting snare 1225 and ligating snare 1230 and communicate with the upper and lower circumferential groove channels 1212, 1214. Additionally, electrode leads for the ligating electrodes 1215 and 1220 can extend to an energy source via the axially extending groove channels.

[0071] In operation, this embodiment of the resection device can remove and seal the tissue core. The cutting tube 1300 can be retracted to expose the ligation snare 1230, which is preferably made of a flexible line such as a suture. The ligation snare 1230 can engage tissue to hook it and pull it against the inner wall surface between the first ligation electrode 1215 and the second ligation electrode 1220. Bipolar energy can then be applied to the first electrode 1215 and the second electrode 1220 to seal, i.e., cauterize, the tissue. Once sealed, the cutting tube 1300 can be further retracted to expose the cutting snare 1225, which can be activated to cut the tissue core upstream of the point where the tissue was sealed (the ligation point). In some embodiments, the cutting snare 1225 has a smaller diameter than the ligating snare 1230. The smaller the diameter, the easier it is to slice tissue. Thus, the resection device 1100 according to this embodiment can both create a tissue core and disengage the core from the surrounding tissue.

[0072] In an alternative embodiment, the resection device of the present disclosure can include a single snare positioned between the ligating electrodes to both ligate and cut tissue. In this embodiment, the single snare can first pull the tissue against the interior wall surface of the central tube 1200 between the ligating electrodes 1215 and 1220. Bipolar energy can then be applied to the first electrode 1215 and the second electrode 1220 to seal, i.e., cauterize, the tissue. Once sealed, the snare can be further pulled to cut the tissue core.

[0073] In yet another embodiment, cutting and sealing can be performed without the use of electrodes. In this embodiment, the ligation snare 1230 can include a set of knots 1235 and 1240 that tighten under load, as shown, for example, in FIG. 14 . Ligation is performed by retracting the cutting tube 1300 to expose the ligation snare 1230 and activating the ligation snare 1230, which captures tissue as the ligation knot tightens. Once tissue is captured, the cutting tube 1300 can be further retracted to expose the cutting snare 1225, which can then be activated to cut the tissue core upstream of the point where the tissue was captured.

[0074] The present disclosure also contemplates methods and systems for removing tissue lesions, such as lung lesions, using an ablation device. The method generally includes immobilizing the lesion targeted for removal, creating a channel in the tissue leading to the target lesion, creating a tissue core containing the immobilized lesion, ligating the tissue core and sealing the surrounding tissue, and removing the tissue core containing the lesion from the channel.

[0075] Anchoring can be achieved by any suitable structure for securing the device to the lung. Once the lesion is secured, a channel can be created to facilitate insertion of the ablation device 1100. The channel can be created by making an incision in the lung area and inserting a tissue expander and port into the incision. A tissue core containing the secured lesion can be created. In accordance with the present disclosure, the ablation device 1100 can be used to create the tissue core, ligate the tissue core, seal the tissue core, and sever it from the surrounding tissue, as described above. The tissue core can then be removed from the channel. As an example, a cavity port can be inserted into the channel to facilitate subsequent treatment of the target lesion site with energy-based tumor removal, such as chemotherapy and / or radiation. As a further example, a cavity port can be positioned around the tissue ablation device. The cavity port can remain in place or can be removed when the device is removed from the tissue site.

[0076] The anchor shown in FIG. 15 may be suitable for use in performing the methods of removing tissue lesions described herein. The anchor may include an outer tube 1422 having edges sharp enough to puncture chest cavity tissue and lungs without causing undue trauma, and an inner tube 1424 disposed within the outer tube 1422. One or more tines or fingers 1420 formed or pre-formed from a shape-memory material, such as Nitinol, may be attached to the end of the inner tube 1424. The outer tube 1422 may be retractably disposed over the inner tube 1424, and when the outer tube 1422 is retracted, the tines 1420 may assume a preformed shape as shown. In accordance with the present disclosure, the outer tube 1422 may be retracted after puncturing the lung lesion, thereby allowing the tines 1420 to engage the lung lesion. Other suitable anchors may include coil and suction-based structures.

[0077] The dissecting blade shown in FIG. 16 is suitable for use in performing the methods of removing tissue lesions described herein. Once the anchor 1400 is in place, it may be preferable to make a small incision or cut to facilitate insertion of a chest wall tissue expander. The dissecting blade 1605 can be used to make a wider incision. The dissecting blade 1605 may be sequential. The dissecting blade 1605 may include a central opening that can allow the dissecting blade 1605 to be advanced coaxially along the anchor needle 1405 to make a wider incision in the chest wall, with each successive blade being larger than the previous blade, thereby increasing the width of the incision.

[0078] The tissue expander shown in FIG. 17 may be suitable for use in performing the methods of removing tissue lesions described herein. The tissue expander may include any suitable device for creating a channel in organic tissue. In one exemplary embodiment, the tissue expander assembly includes a single cylindrical rod with a rounded end 1510 or a cylindrical rod with a rounded end and a rigid sleeve configuration 1515. Successive tissue expanders may be advanced coaxially along the anchor needle to create a tissue pathway or channel in the chest wall, with each successive expander being larger than the previous expander, thereby increasing the diameter of the channel. Once the final expander with the rigid sleeve is deployed, the inner rod 1505 may be removed, leaving the rigid sleeve in the intercostal space between the ribs, creating a direct passage to the lung pleura.

[0079] Any tissue ablation device capable of penetrating lung tissue and creating a tissue core containing a target lesion may be suitable for use in performing the methods of removing tissue lesions described herein, with tissue ablation device 1100 described herein above being preferred.

[0080] Upon removal of the tissue ablation device 1100, a small channel within the lung where the targeted lesion was removed may exist. This channel may be utilized to introduce energy-based ablation devices and / or localized chemotherapy, depending on the results of the tissue diagnosis. Thus, the disclosed methods and systems may be utilized to ensure that not only is an effective biopsy performed, but that complete removal of the lesion is achieved with minimal removal of healthy lung tissue.

[0081] 18 shows a flow chart of an exemplary method. At 1802, tissue at a target site can be cored such that a tissue core is removed from the target site, thereby creating a core cavity at the target site. Coring the tissue at the target site can include transecting and sealing the tissue. Coring the tissue at the target site can include positioning a tissue core removal device adjacent to the target tissue site. The tissue core removal device can include a first clamping element with a helical coil, a second clamping element positioned opposite at least a portion of the first clamping element, first and second electrodes configured to deliver radiofrequency energy to seal the tissue, and / or a cutting element configured to transect at least a portion of the sealed tissue. Other devices can also be used.

[0082] At 1804, a port can be deployed to provide access to the target site. A port (e.g., chest port 102 (FIG. 1)) can be deployed to provide access to the target site. A user can deploy the port to provide access to the target site. The target site can include biological tissue. The target site can include lung tissue. The target site can include cored tissue. The target site can include perforated tissue. The target site can include at least a portion of a lung.

[0083] The fixation device can be secured to the surface of the target site at 1806. As an example, a user can secure the fixation device to the surface of the target site through a port.

[0084] At 1808, a sealing device can be positioned adjacent to the target site, for example, via a port. The sealing device can include an inflatable balloon. The sealing device can include an inflatable balloon catheter. The lungs can be compressed before the sealing device is positioned adjacent to the target site. The lungs can be ventilated while the sealing device seals the target site.

[0085] At 1810, the sealing device can be caused to seal against the target site. Sealing the sealing device against the target site can include abutting at least a portion of the sealing device against a portion of the target site.

[0086] The present disclosure includes at least the following aspects.

[0087] Aspect 1. A method of sealing tissue at a target site, the method including: positioning a sealing device within a cavity at the target site of tissue, the sealing device comprising an inflatable balloon; inflating the balloon with a fluid such that at least a portion of the inflated balloon abuts a wall of the cavity to seal at least a portion of the cavity; and moving the sealing device away from the target site.

[0088] Embodiment 2. The method of embodiment 1, wherein the target site comprises lung tissue.

[0089] Embodiment 3. The method of embodiment 1 or 2, wherein the fluid has a temperature sufficient to ablate at least a portion of the wall of the cavity.

[0090] Embodiment 4. The method of any one of embodiments 1-3, wherein the cavity comprises cored tissue having a measurable radius, and the balloon is inflated based on the radius.

[0091] Embodiment 5. The method of any one of embodiments 1-4, wherein the target site comprises at least a portion of a lung, and the method further comprises compressing the lung prior to placing the sealing device within the cavity.

[0092] Embodiment 6. The method of any one of embodiments 1-5, wherein the target site comprises at least a portion of a lung, and the method further comprises ventilating the lung while the sealing device seals the target site.

[0093] Embodiment 7. The method of any one of embodiments 1-6, wherein the bioadhesive is disposed on a surface of the balloon, and when the balloon is inflated, the bioadhesive contacts the wall of the cavity.

[0094] Embodiment 8. The method of any one of embodiments 1-7, wherein the balloon is configured to deliver RF energy to at least a portion of a wall of the cavity.

[0095] Embodiment 9. The method of any one of embodiments 1-8, further comprising deflating the balloon to remove it from the cavity.

[0096] Aspect 10. A method of sealing tissue at a target site, the method comprising: positioning a cavity sheath adjacent to a tissue cavity to minimize compression of the tissue cavity; positioning a sealing device within the tissue cavity, the sealing device comprising an inflatable balloon; removing the cavity sheath from the tissue cavity such that the inflatable balloon remains positioned within the tissue cavity; and inflating the balloon with a fluid such that at least a portion of the inflated balloon abuts a wall of the tissue cavity to seal at least a portion of the tissue cavity.

[0097] Embodiment 11. The method of embodiment 10, wherein the tissue cavity is formed in the lung.

[0098] Embodiment 12. The method of embodiment 10 or 11, wherein the tissue cavity comprises cored tissue.

[0099] Embodiment 13. The method of any one of embodiments 10-12, wherein the fluid has a temperature sufficient to ablate at least a portion of a wall of the tissue cavity.

[0100] Embodiment 14. The method of any one of embodiments 10-13, wherein the tissue cavity comprises cored tissue having a measurable radius, and the balloon is inflated based on the radius.

[0101] Embodiment 15. The method of any one of embodiments 10-14, wherein the tissue cavity is disposed within a lung, and the method further comprises compressing the lung prior to disposing the sealing device within the tissue cavity.

[0102] Embodiment 16. The method of any one of embodiments 10-15, wherein the tissue cavity is disposed within a lung, and the method further comprises ventilating the lung while the sealing device seals the tissue cavity.

[0103] Embodiment 17. The method of any one of embodiments 10-16, further comprising deflating the balloon to remove it from the tissue cavity.

[0104] Embodiment 18. The method of any one of embodiments 10-17, wherein a bioadhesive is disposed on a surface of the balloon, and when the balloon is inflated, the bioadhesive contacts the wall of the cavity.

[0105] Embodiment 19. The method of any one of embodiments 10-18, wherein the balloon is configured to deliver RF energy to at least a portion of a wall of the cavity.

[0106] Embodiment 20. The method of any one of embodiments 10-19, further comprising removing the sealing device from the tissue cavity.

[0107] Aspect 21. A sealing device for sealing a tissue cavity, comprising: a balloon catheter configured to extend an inflatable balloon into the tissue cavity; and a fluid source in fluid communication with the inflatable balloon and configured to fill the balloon with fluid to inflate the balloon to a controlled radius.

[0108] Embodiment 22. The sealing device of embodiment 21, wherein the tissue cavity is formed within a lung.

[0109]

[0023] Aspect 23. The sealing device of Aspect 21 or 22, wherein the tissue cavity comprises cored tissue having a measurable radius, and the balloon is inflated based on the measurable radius.

[0110] Embodiment 24. The sealing device of any one of embodiments 21-23, wherein the fluid has a temperature sufficient to ablate at least a portion of a wall of the tissue cavity.

[0111] Embodiment 25. The sealing device of any one of embodiments 21-24, wherein the bioadhesive is disposed on a surface of the balloon, and when the balloon is inflated, the bioadhesive contacts the wall of the cavity.

[0112] Embodiment 26. The sealing device of any one of embodiments 21-25, wherein the balloon is configured to deliver RF energy to at least a portion of a wall of the cavity.

[0113] While what has been shown and described is believed to be the most practical and preferred embodiment, it will be apparent that deviations from the specific designs and methods described and illustrated may be suggested to those skilled in the art and may be used without departing from the spirit and scope of the present invention. For example, systems, devices, and methods for removing lesions from the lungs are described herein. Those skilled in the art will appreciate that the devices and methods described herein are not limited to the lungs and can be used for tissue ablation and lesion removal in other areas of the body. The present invention is not limited to the specific configurations described and illustrated, but should be constructed to cohere with all modifications that may fall within the scope of the appended claims.

Claims

1. a sealing device (200) configured to be positioned adjacent a core cavity of a target site, the sealing device (200) including a portion configured to be positioned adjacent the target site and seal at least a portion of the core cavity; a fixation device, the distal end of the fixation device configured to fixate to a surface of the target site; a tube included in the sealing device (200) configured to introduce a filler material into the core cavity after the sealing device (200) seals at least a portion of the core cavity; the filling material includes autologous blood that clots in a predetermined amount of time; the sealing device is configured to be held in place with the fixation device for the predetermined time period for clotting the autologous blood at the target site; the sealing device is configured to isolate from the target site after the predetermined time. system.

2. the core cavity is formed in the lung; the sealing device comprises an inflatable balloon disposed adjacent to the core cavity, the inflatable balloon configured to rise and fall with the lung and seal against the lung during lung movement; The system of claim 1 .

3. The system described in claim 1, wherein the sealing device is configured to be inserted into the core cavity by the fixing device.

4. The system of claim 3 , wherein the sealing device and fixation device are configured to be removed from the target site after a predetermined time.

5. The system of claim 1 , wherein the filling material further comprises at least one selected from the group consisting of donated blood, recirculated blood, and hemostatic adjuvants.

6. The system of claim 1 , further comprising a tissue excision device configured to excise a core of tissue from the target site to form the core cavity.

7. 7. The system of claim 6, comprising a first actuator operable to actuate one or more clamping elements to apply mechanical compression to tissue, and a second actuator operable to actuate a cutting element to transect tissue.

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