Tissue ablation control system and method

Abstract

A method of removing tissue can include positioning a tissue excision device at a target tissue site, causing the tissue excision device to excise a core of tissue from the target tissue site, and removing the core of tissue from the body. Removing the core of tissue from the body creates a core cavity at the target tissue 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 / 035,913, filed June 8, 2020, and U.S. Patent Application No. 63 / 042,124, filed June 22, 2020, both of which are incorporated herein by reference in their entireties. [Background technology]

[0002] In certain cases, tissue may need to be removed from the body. One example is when cancerous or infected tissue is removed from the body as part of treatment. Cancer is not a single disease, but a collection of related diseases that can begin essentially anywhere in the body. What all types of cancer have in common is that once the body's cells begin to divide, they can grow rapidly without stopping and spread to surrounding tissues. Under normal circumstances, cells grow and divide to form new cells as needed by the body. When cells become damaged or old, they die and new cells replace the damaged or old cells. However, cancer inhibits this process. With cancer, cells become abnormal, cells that should die do not die, and new cells are formed when they are not needed. These new cells can reproduce or grow rapidly without stopping, forming growths called tumors.

[0003] Cancerous tumors are malignant, meaning they can spread or invade surrounding healthy tissue. Additionally, cancer cells can divide and travel to distant areas of the body via the blood or lymphatic system. Benign tumors, unlike malignant tumors, do not spread or invade surrounding tissue; however, they can grow large and cause damage. Both malignant and benign tumors can be removed or treated. Malignant tumors tend to recur. Benign tumors, on the other hand, can recur, but it is much less likely.

[0004] Cancer is a genetic disease caused by changes in genes that control how cells function, particularly how cells grow and divide. Genetic changes that cause cancer can be inherited or can occur over an individual's lifetime as a result of errors that occur when cells divide or due to DNA damage caused by exposure to certain environments, such as industrial / commercial chemicals or ultraviolet light. Genetic changes that can cause cancer tend to affect three types of genes: proto-oncogenes, which are involved in normal cell growth and division; tumor suppressor genes, which are also involved in controlling cell growth and division; and DNA repair genes, which, as the names suggest, are involved in repairing damaged DNA.

[0005] More than 100 different types of cancer have been identified. Cancer types may be named for the organ or tissue in which they originate (e.g., lung cancer) or for the type of cell that forms them (e.g., squamous cell carcinoma). Unfortunately, cancer is a leading cause of death both in the United States and worldwide. According to the World Health Organization, the number of new cancer cases is predicted to increase to 25 million per year over the next 20 years.

[0006] Lung cancer is one of the most common cancers today. According to the World Health Organization's World Cancer Report 2014, lung cancer affects 14 million people worldwide and causes 8.8 million deaths, making it the most common cause of cancer-related death in men and the second most common cause of cancer-related death in women. Lung cancer, or lung carcinoma, is a malignant lung tumor that can metastasize to adjacent tissues and organs if left untreated. The majority of lung cancers are caused by long-term smoking. However, approximately 10% to 15% of lung cancer cases are not tobacco-related. These non-tobacco cases are most often caused by a combination of genetic factors and exposure to certain environmental conditions, including radon gas, asbestos, passive smoking, other forms of air pollution, and other factors. Survival rates for lung cancer, as well as other forms of cancer, depend on early detection and treatment.

[0007] Improvements in tissue removal are needed. Summary of the Invention

[0008] It may be desirable to remove cores of tissue from other target tissue sites, including, but not limited to, the lung, liver, pancreas, or gastrointestinal (GI) tract, where management of bleeding after core removal may be desirable. The tissue cores 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.

[0009] The method can include removing a core of tissue from the tissue site. Such core removal can further include introducing a tissue excision device to the tissue site, creating a core of tissue using the tissue excision device, removing the core of tissue from the body to create a tissue cavity, and sealing the tissue cavity.

[0010] In certain embodiments, removing a tissue core from a tissue site can further include one or more of determining the location of the tissue lesion using one or more imaging modalities, navigating an instrument to a tissue site such as a tissue lesion (with and without image guidance), coupling (e.g., fixating) an instrument to the tissue lesion, gaining access to the tissue site (incising, introducing through a port / trocar, or directly accessing via an open procedure), introducing a tissue excision device to the tissue site (with and without using an anchor as a guide), creating a tissue core using the tissue excision device or severing the tissue core from the tissue site, removing the tissue core from the body (with and without leaving a hollow "access sleeve"), analyzing the tissue core sample (histology, ROSE, DNA sequencing, etc.), sealing the tissue cavity, removing some or all of the instrumentation, or closing the tissue access point.

[0011] In certain embodiments, removing a tissue core from a tissue site and subsequent diagnosis can further include one or more of determining the location of the tissue lesion using one or more imaging modalities, navigating an instrument to a tissue site such as a tissue lesion (with and without image guidance), coupling (e.g., fixating) an instrument to the tissue lesion, gaining access to the tissue site (incising, introducing through a port / trocar, or directly accessing via an open procedure), introducing a tissue excision device to the tissue site (with and without using an anchor as a guide), creating a tissue core using the tissue excision device or severing the tissue core from the tissue site, removing the tissue core from the body (with and without leaving a hollow "access sleeve"), analyzing the tissue core sample (histology, ROSE, DNA sequencing, etc.), sealing the tissue cavity, removing some or all of the instrumentation, or closing the tissue access point.

[0012] In certain aspects, removing a tissue core from a tissue site, and subsequent diagnosis and treatment management of a confirmed malignancy, can further include one or more of determining the location of the tissue lesion using one or more imaging modalities, navigating an instrument to the tissue lesion (with and without image guidance), coupling (e.g., fixating) an instrument to the tissue lesion, gaining access to the tissue site (incising, introducing through a port / trocar, or directly accessing via an open procedure), introducing a tissue excision device to the tissue site (with and without using an anchor as a guide), creating a tissue core using the tissue excision device or severing the tissue core from the tissue site, removing the tissue core from the body (with and without leaving a hollow "access sleeve"), analyzing the tissue core sample (histology, ROSE, DNA sequencing, etc.), performing treatment management of the tissue, such as benign or malignant tissue, sealing the tissue cavity, removing some or all of the instrumentation, and closing the tissue access point.

[0013] A method for core-removing tissue can include positioning a tissue excision device at a target tissue site, causing the tissue excision device to excise a core of tissue from the target tissue site, and removing the tissue core from the body, whereby a core cavity is created at the target tissue site. The tissue core comprises at least a portion of a tissue lesion. Excising the tissue core from the target tissue site can include mechanical transection. Excising the tissue core from the target tissue site can include delivery of radiofrequency energy. Excising the tissue core from the target tissue site can include mechanical compression and delivery of radiofrequency energy. Excising the tissue core from the target tissue site can include current-carrying wire transection. Excising the tissue core from the target tissue site can include one or more of mechanical compression, delivery of radiofrequency energy, delivery of microwave energy, delivery of ultrasonic energy, or current-carrying wire transection. Other excision devices and procedures can be used. The excision device can be configured to perform one or more of mechanical compression, delivery of radiofrequency energy, delivery of microwave energy, delivery of ultrasonic energy, or current-carrying wire transection.

[0014] The method of core-removing tissue may further include inserting a sleeve into the core cavity to support the walls of the core cavity. The method of core-removing tissue may further include delivering radiofrequency energy to at least a portion of the walls defining the core cavity. The method of core-removing tissue may further include delivering chemotherapy to at least a portion of the walls defining the core cavity. The method of core-removing tissue may further include delivering microwave energy to at least a portion of the walls defining the core cavity. The method of core-removing tissue may further include delivering thermal energy to at least a portion of the walls defining the core cavity. The method of core-removing tissue may further include delivering ultrasonic energy to at least a portion of the walls defining the core cavity.

[0015] The method of core removal of tissue can further include sealing the body fluid duct. Sealing the body fluid duct can minimize the flow of body fluid into the hollow core. Sealing can be performed using at least mechanical compression. Sealing can be performed using at least radio frequency energy. Sealing can be performed using at least microwave energy. Sealing can be performed using at least ultrasonic energy. Sealing can be performed using one or more of compression or delivery of energy such as radio frequency energy, microwave energy, ultrasonic energy, or thermal energy.

[0016] The present disclosure relates to systems, devices, and methods for performing lung lesion removal. Lung needle biopsy is typically performed when an abnormality is found on an imaging test, such as an X-ray or CAT scan. In lung needle biopsy, a fine needle is used to remove a sample of lung tissue, which is examined under a microscope to confirm the presence of abnormal cells. Histological diagnosis is difficult for small (less than 6 mm) and medium nodules (6 mm to 12 mm). CT-guided biopsies of peripheral lesions through the chest wall (80%) or by bronchoscopy (20%) require a needle of 0.001 cm or less. 2 ~0.002cm 2 Because only 10% of diagnostic tissue is available, cancer, if present, is successfully identified in only 60% of small and medium-sized nodules. Although bronchoscopy techniques and technologies continue to evolve, the accuracy, specificity, and sensitivity of biopsies will always be limited when dealing with small and medium-sized nodules in the periphery of the lung.

[0017] If the lesion is determined to be cancerous, a second procedure may be performed to remove the lesion, followed by follow-up with chemotherapy and / or radiation. The second procedure will most likely involve lung surgery. These procedures are usually performed through an incision between the ribs. Depending on the stage of the cancer, there are several possible procedures. Video-assisted thoracic surgery is a minimally invasive procedure for certain types of lung cancer. It is performed through small incisions using endoscopic techniques and is usually used to perform wedge resections of smaller lesions closer to the surface of the lung. In a wedge resection, part of a lobe is removed. In a sleeve resection, part of a large airway is removed, thereby preserving more lung function.

[0018] Once identified as suspicious for cancer, nodules deeper than 2–3 cm below the lung surface are difficult to locate and remove using laparoscopic or robotic lung-sparing techniques, despite preprocedural image-guided biopsy and localization. Therefore, surgeons perform thoracotomy or lobectomy to remove lung nodules 2–3 cm below the lung surface. Thoracotomy is an open procedure in which a portion of a lobe, an entire lobe, or the entire lung is removed. In pneumonectomy, the entire lung is removed. This type of surgery is clearly the most invasive. In lobectomy, an entire lung segment or lobe is removed, making it a less invasive approach than removing the entire lung. All thoracoscopic lung surgeries require trained and experienced thoracic surgeons, and the success of surgical outcomes depends on the surgeon's experience.

[0019] Both of these types of lung surgeries are major surgeries that can have complications depending on the extent of the surgery and the patient's overall health. In addition to the decreased lung function associated with either of these procedures, recovery can take weeks to months. Thoracotomy requires the ribs to be spread apart, increasing postoperative pain. Video-assisted thoracic surgery is less invasive, but can still require a significant recovery period. Additionally, once surgery is complete, complete treatment may require systemic chemotherapy and / or radiation therapy.

[0020] As mentioned above, fine-needle biopsies are not entirely diagnostic. The fine-needle biopsy procedure involves navigating a needle through three-dimensional space under two-dimensional imaging. Therefore, physicians may miss lesions. Even if physicians hit the correct target, the portion of the lesion removed through the needle may not contain cancerous cells or the cells necessary to assess the tumor's invasiveness. A needle biopsy removes enough tissue to create a smear on a slide. The disclosed device is designed to remove the entire lesion or a significant portion of it while minimizing the amount of healthy lung tissue removed. This has many advantages. First, the entire lesion can be examined to allow for a more accurate diagnosis without sampling error, loss of cellular packing, or deterioration of the overall structure. Second, because the entire lesion is removed, secondary procedures such as those described above may not be necessary. Third, energy-based tumor removal, such as local chemotherapy and / or radiation, can be introduced through the cavity created by the lesion removal.

[0021] In at least one embodiment, the present disclosure defines a method for removing a tissue lesion, the method comprising: attaching (e.g., immobilizing) the tissue lesion; creating a channel in tissue leading to the tissue lesion; creating a tissue core containing the tissue lesion; ligating the tissue core at a ligation point downstream of the tissue lesion; severing the tissue core from the tissue between the ligation point and the tissue lesion; and removing the tissue core from the channel.

[0022] According to an aspect of the present disclosure, a sleeve can be inserted into the channel before or after removing the tissue core. The sleeve can also be secured to the tissue. According to another aspect of the present disclosure, localized treatment can be administered through the sleeve.

[0023] In some embodiments, creating a tissue core involves cauterizing and cutting the tissue. Ligating the tissue can include cauterizing the tissue at specific locations known as ligation points. Cutting the tissue core can be performed with a snare, an energized wire, or any other device capable of slicing tissue.

[0024] In some embodiments, the tissue core is created by first sealing the blood vessels and then slicing the tissue to form the core.

[0025] 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]

[0026] [Figure 1] FIG. 1 illustrates an exemplary method according to the present disclosure. [Figure 2] FIG. 1 illustrates an exemplary method according to the present disclosure. [Figure 3] FIG. 1 illustrates an exemplary method according to the present disclosure. [Figure 4] FIG. 1 illustrates an exemplary method according to the present disclosure. [Figure 5] FIG. 1 shows a blade with an open channel. [Figure 6] FIG. 6 shows the distal tip of the blade of FIG. 5. [Figure 7] FIG. 10 shows the distal end of an air channel connected to a flexible or rigid tube. [Figure 8A] 1 illustrates an exemplary trocar. [Figure 8B] 1 illustrates an exemplary trocar. [Figure 9A] 1 illustrates an exemplary trocar. [Figure 9B] 1 illustrates an exemplary trocar. [Figure 10] 1 illustrates an exemplary trocar. [Figure 11] 1 illustrates a tissue excision device according to an embodiment of the present disclosure. [Figure 12] FIG. 12 is a cross-sectional view of the tissue excision device of FIG. [Figure 13] FIG. 1 is a cross-sectional view of a tissue excision device according to an embodiment of the present disclosure. [Figure 14]FIG. 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] FIG. 1 illustrates an exemplary workflow for tissue sample analysis. [Figure 19] 1A-1C illustrate application of an exemplary system for sealing tissue. [Figure 20] 1A-1C illustrate application of an exemplary system for sealing tissue. [Figure 21] 1A-C illustrate an exemplary system application for sealing tissue. [Figure 22] 1A-B illustrate an exemplary system application for sealing tissue. [Figure 23] 1A-C illustrate an exemplary system application for sealing tissue. [Figure 24] FIG. 1 illustrates an exemplary treatment system and method according to the present disclosure. [Figure 25] FIG. 1 illustrates an exemplary treatment system and method according to the present disclosure. [Figure 26] FIG. 1 illustrates an exemplary treatment system and method according to the present disclosure. [Figure 27] FIG. 1 illustrates an exemplary treatment system and method according to the present disclosure. [Figure 28] FIG. 1 illustrates an exemplary treatment system and method according to the present disclosure. [Figure 29] FIG. 1 illustrates an exemplary treatment system and method according to the present disclosure. [Figure 30] FIG. 1 illustrates an exemplary treatment system and method according to the present disclosure. [Figure 31] 1 is a flow diagram of an exemplary method according to the present disclosure. [Figure 32] 1A-1C illustrate an exemplary handle design according to the present disclosure. [Figure 33] 1 illustrates an exemplary rotational control assembly (e.g., a planetary gear assembly) according to the present disclosure. [Figure 34] FIG. 1 illustrates a linear translation control assembly according to the present disclosure. [Figure 35] FIG. 1 illustrates an anchor position monitor according to the present disclosure. [Figure 36] FIG. 1 illustrates an exemplary ligation and cutting system according to the present disclosure. [Figure 37A] FIG. 1 illustrates an exemplary method of the present disclosure. [Figure 37B] FIG. 1 illustrates an exemplary method of the present disclosure. [Figure 38] FIG. 1 illustrates an exemplary handle design of the present disclosure. [Figure 39] 1 illustrates a rotational control assembly according to the present disclosure. [Figure 40] 1 illustrates an exemplary clamp according to the present disclosure. [Figure 41] FIG. 1 illustrates an exemplary ligation and cutting system according to the present disclosure. [Figure 42] FIG. 1 shows an exemplary schematic and flow diagram according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0027] TECHNICAL FIELD The present disclosure relates to systems and methods for core removing tissue. A variety of tissues and sites can benefit from the disclosed systems and methods.

[0028] The tissue cores may have a predetermined (e.g., predefined) shape (e.g., cylindrical) and dimensions based on the core removal device. Such a core removal device may be used to repeatedly core tissue cores of the same or substantially the same shape. Such core removal may be distinguished from other tissue removal techniques, such as those using scissors or scalpels, in which the cut tissue does not have a predefined shape or dimensions.

[0029] 1 illustrates an exemplary method that may include removing a core of tissue from a tissue site. Such core removal may further include introducing a tissue excision device to the tissue site (102), cutting the tissue core, e.g., creating a tissue core using the tissue excision device (104), removing the tissue core from the body to create a tissue cavity (106), and sealing the tissue cavity (108).

[0030] As shown in FIG. 2, removing a core of tissue from a tissue site involves determining the location of the tissue lesion using one or more imaging modalities (202), navigating an instrument to the site (with and without image guidance) such as the tissue lesion (204), coupling (e.g., immobilizing) the instrument to the tissue lesion (206), gaining access to the tissue site (by incision, introduction through a port / trocar, or direct access via an open procedure) (208), and introducing a tissue resection device into the tissue site (using an anchor as a guide). The method may further include one or more of: using a tissue excision device (with and without the use of a tissue excision device) (210), creating a tissue core using a tissue excision device (212) or severing the tissue core from the tissue site (214), removing the tissue core from the body (with and without leaving a hollow "access sleeve") (216), analyzing the tissue core sample (histology, ROSE, DNA sequencing, etc.) (218), sealing the tissue cavity (220), removing some or all of the instrumentation (222), or closing the tissue access point (224).

[0031] As shown in FIG. 3 , removal of a tissue core from a tissue site and subsequent diagnosis involves determining the location of the tissue lesion using one or more imaging modalities (302), navigating an instrument to the site of such tissue lesion (with and without image guidance) (304), coupling (e.g., immobilizing) the instrument to the tissue lesion (306), gaining access to the tissue site (by incision, introduction through a port / trocar, or direct access via an open procedure) (308), introducing a tissue resection device to the tissue site (using anchors as guides and using The method may further include one or more of: using a tissue excision device (without the use of a tissue excision device) (310), creating a tissue core using a tissue excision device (312) or severing the tissue core from the tissue site, removing the tissue core from the body (with and without leaving a hollow "access sleeve") (314), analyzing the tissue core sample (histology, ROSE, DNA sequencing, etc.) (316), making a diagnosis based on at least the tissue core sample (318), sealing the tissue cavity (320), removing some or all of the instrumentation (322), or closing the tissue access point (324).

[0032] As shown in FIG. 4, removal of a core of tissue from a tissue site, and subsequent diagnosis and treatment management of a confirmed malignancy, involves determining the location of the tissue lesion using one or more imaging modalities (402), navigating an instrument to the site (with and without image guidance) such as the tissue lesion (404), coupling (e.g., immobilizing) the instrument to the tissue lesion (406), gaining access to the tissue site (by incision, introduction through a port / trocar, or direct access via an open procedure) (408), and introducing a tissue resection device into the tissue site (using anchors as guides). The method may further include one or more of: using a tissue excision device (with and without) (410), creating a tissue core or severing the tissue core from the tissue site (412), removing the tissue core from the body (with and without leaving a hollow "access sleeve") (414), analyzing the tissue core sample (histology, ROSE, DNA sequencing, etc.) (416), performing therapeutic management of the tissue, such as benign or malignant tissue (418), sealing the tissue cavity (420), removing some or all of the instrumentation (422), and closing the tissue access point (424).

[0033] The present disclosure relates to methods and systems for core removal of tissue. The method for core removal of tissue can include positioning a tissue excision device at a target tissue site, causing the tissue excision device to excise a core of tissue from the target tissue site, and removing the tissue core from the body. Removing the tissue core from the body can create a core cavity at the target tissue site. The tissue core can comprise at least a portion of a tissue lesion. Excising the tissue core from the target tissue site can include mechanical transection. Excising the tissue core from the target tissue site can include delivery of radiofrequency energy. Excising the tissue core from the target tissue site can include mechanical compression and delivery of radiofrequency energy. Excising the tissue core from the target tissue site can include transection with an energized wire. Excising the tissue core from the target tissue site can include one or more of mechanical compression, delivery of radiofrequency energy, delivery of microwave energy, delivery of ultrasonic energy, or transection with an energized wire. Other excision devices and procedures can be used. The ablation device can be configured to perform one or more of mechanical compression, delivery of radio frequency energy, delivery of microwave energy, delivery of ultrasonic energy, or transection with an energized wire.

[0034] 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.

[0035] 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, with or without an access opening; 5) placing a cavity sealing material adjacent to the tissue cavity (which may or may not be 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, and with or without introducing a filler material into the tissue cavity); 6) placing a cavity closure material adjacent to the tissue cavity (which may or may not be 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, and with or without introducing a filler material into the tissue cavity); 7) placing a cavity closure device adjacent to the tissue; and 8) allowing the cavity closure device to close the tissue cavity (which may or may not be 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.

[0036] Imaging system A variety of systems, devices, and apparatus can be used to locate a target site, such as a target tissue site, within the human body, including imaging systems such as computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), endoscopic, visual, electromagnetic, and / or x-ray.

[0037] CT In a conventional x-ray system, an x-ray beam is directed through an object, such as the human body, onto a flat radiographic film. The x-ray beam is selectively absorbed by structures within the object, such as bones within the human body. Because the exposure of the x-ray film is directly altered by the transmission of x-rays through the body (and inversely altered by absorption of x-rays), the image produced provides an accurate representation of any structures within the object that absorb the x-rays. As a result, x-rays are widely used for non-invasive examination of the interior of objects and are particularly useful in medical practice.

[0038] The images formed from x-rays are essentially shadows of structures within an object that absorb x-rays. As a result, the images formed on x-rays are only two-dimensional, and if multiple x-ray-absorbing structures are in the same shadow, information about some of these structures tends to be obscured. Furthermore, in medical applications, it is often very difficult to use conventional x-ray systems to examine parts of the body, such as the lungs, which, when inflated, consist mostly of air and do not absorb x-rays very well.

[0039] Many of the limitations of conventional x-ray systems can be circumvented by x-ray computed tomography, often referred to as CT, which, in particular, provides three-dimensional views and imaging of structures and features that would not be readily visible with conventional x-rays.

[0040] CT scanning equipment typically includes a computer, a large toroidal structure, and a platform movable along a longitudinal axis passing through the center of the toroidal structure. An x-ray source (not shown) and an array of x-ray detectors (not shown) are mounted within the toroidal structure. The x-ray source is oriented substantially along the longitudinal axis and is movable around the interior of the toroidal structure in a plane substantially perpendicular to the longitudinal axis. The x-ray detectors are mounted all around the toroidal structure in substantially the same plane as the x-ray source and are oriented along the longitudinal axis. To obtain a CT image, a patient is placed on the platform, which is inserted into the center of the toroidal structure. The x-ray source then rotates around the patient, continuously emitting x-rays, and the detectors sense the x-ray radiation that passes through the patient. Because the detectors are in the same plane as the x-ray source, the signal received by the detectors essentially relates to a slice through the patient's body, where the plane of the x-ray source and detector intersects the patient's body. The signals from the x-ray detector are then processed by a computer to produce an image of this slice, known in the art as an axial section.

[0041] As an example, x-rays can be emitted continuously over a full 360 degrees around the patient, and although multiple features can be observed, the overall approach will generally be the same.

[0042] While the patient remains stationary, the platform is moved along its longitudinal axis through the toroidal structure. During this movement, successive x-ray exposures are made of the portion of the patient where the CT is being performed. Because the table is moving during this process, the different x-ray exposures are exposures of different slices of the patient's body part being examined, and the image generated by the computer is a series of axial cross sections that show the patient's body part being examined in three dimensions. The spacing between adjacent CT sections depends on the minimum size of the feature to be detected. For highest resolution detection, the center-to-center spacing between adjacent sections should be less than 2 mm.

[0043] Due to the superior imaging capabilities of CT, the use of CT in medical imaging has grown rapidly in recent years with the advent of multislice CT. One application of medical CT is the detection and confirmation of cancer. However, the superior diagnostic information now available in CT axial sections, particularly that provided by multidetector CT (multiple slices acquired per gantry rotation), where the acquisition speed and volumetric resolution provide superior diagnostic value, allows for the detection of potential cancers at their earliest and most treatable stages. For example, the minimum detectable size of a potentially cancerous nodule in an axial section of the lung is approximately 2 mm (1 / 10 inch), a size that is potentially treatable and curable if detected.

[0044] In recent years, medical professionals have been able to diagnose lung cancer using computed tomography (CT) imaging systems. Radiologists can examine a series of these cross-sectional images to diagnose lung nodules. The radiologist's examination also determines whether these lung nodules are malignant or benign. If the radiologist confidently identifies a lung nodule as benign, further medical testing can be avoided.

[0045] To enable accurate diagnosis of pulmonary nodules with sizes on the order of the resolution of a CT scanner, it may be advantageous to combine CT scans with computer-aided diagnosis (CAD) schemes to assist the radiologist.

[0046] Procedures according to the present disclosure can be performed using CT guidance. CT is particularly well suited for solid organ interventions. CT fluoroscopy, which shows organ and device movement in real time, allows real-time tracking of the needle trajectory, allowing the physician to make appropriate adjustments. This advantage allows for shorter procedures with success rates comparable to or better than those using standard intermittent CT imaging.

[0047] A CT scan can be used to locate the target site for the anchor. The CT scan can be used to reconstruct the 3D positioning of the target site relative to fiducial markers on the patient's body. This reconstructed 3D image of the CT slices can be loaded into a system that helps a physician navigate the disclosed device through the patient's body and / or can help determine the best path for access.

[0048] The devices of the present disclosure can be fitted with accelerometers and / or gyroscopes that help determine the position of the instrument tip in 3D space at all times. By enabling communication between such devices of the present disclosure (adapted for 3D tracking) and CT software, the tip of the device of the present disclosure can be determined relative to the desired target spot. The software can help keep the device on a planned trajectory and help achieve optimal results.

[0049] Additionally or alternatively, CT scanning can be combined with other imaging modalities, such as ultrasound or electromagnetic tracking of the tip, to facilitate trajectory guidance of the devices of the present disclosure.

[0050] In one aspect of the present disclosure, a patient can be placed in a CT scanner and the nodule can be imaged. Using standard CT-guided interventional techniques commonly used in CT-guided lung biopsies, an anchoring needle can be advanced through the skin, chest wall, pleural cavity, and lung to the target tissue to be sampled. Once the distal end of the anchoring needle passes through the nodule or interstitial abnormality, an anchoring member composed of a shape-memory metal, such as nitinol, is advanced out of the distal end of the needle.

[0051] Ultrasound Ultrasound probes can be used to facilitate the detection and / or localization of target tissue sites. Ultrasound probes consist of a piezoelectric transducer that generates ultrasonic waves. These waves are reflected differently from tissue based on the mechanical and structural properties of various tissues. The reflected waves are then acquired through a receiver and interpreted to translate the properties and location of the tissue. By tracking the location of the ultrasound waves in 3D space, it is possible to generate a 3D map of the tissue imaged using ultrasound.

[0052] Alternatively or in addition to providing the location of a specific target tissue site, ultrasound can also distinguish tissue stiffness, which is extremely important since tumors are known to have different mechanical and elastic properties than the surrounding tissue. Thus, ultrasound may enable rapid detection and imaging of tumor sites in addition to providing details regarding the location, size, and other physical characteristics of the tumor site.

[0053] The ultrasound may be in the form of a probe that can be inserted into the pleural cavity or trajectory guided through the bronchial cavity. The probe may be in the form of a catheter configured to facilitate visualization. Such a catheter may be continuously rotated to obtain a full 360° ultrasound map as the catheter is advanced through the space (iVUS).

[0054] The tip has a lubricious coating that allows the operator to advance the ultrasound probe across the surface of the lung until the nodule is located. Once the nodule is located, suction can be activated around the periphery of the ultrasound probe so that the lung is aspirated into the scope / probe, thereby immobilizing the area and locking the probe in place. A needle can be advanced through the lung under ultrasound guidance (e.g., by an operating room) to access the nodule.

[0055] MRI / Magnetic Detection MRI, or magnetic resonance imaging, uses a high-flux electromagnet to vibrate polar molecules, thereby imaging their arrangement. The most ubiquitous polar molecule is water, which is present in human tissue. The water content of normal tissue is different from that of tumor tissue. For example, tumors usually have a sophisticated blood supply and drainage compared to normal tissue. This can be used to visualize the target tissue site. Depending on the characteristics of the target tissue, a contrast agent can be added to enhance the resolution of the imaging technique. The contrast agent may have a high dipole moment or contain a component that responds to changes in the surrounding magnetic field through movement, emission, or vibration.

[0056] Endoscopy Endoscopes can be used to facilitate visualization of target tissue sites. With regard to the lungs in particular, endoscopes can be used within the chest, thereby eliminating the need for large thoracotomy incisions. Thoracoscopy is the use of a specialized viewing instrument, usually a rigid endoscope, introduced through a thoracostomy, or small opening placed between the ribs. Once the endoscope is positioned within the space surrounding the lungs, known as the pleural cavity, additional thoracostomy openings can be created to introduce additional instruments. Additional instruments include grasping instruments, cutting instruments, and / or cutting staplers, such as the Ethicon Endosurgery Endo GIA 45mm Stapler. Using endoscopes and other instruments, a "triangulation" technique is utilized, where, for example, an endoscope is used to visualize the grasping instrument introduced from one direction and the stapler introduced from another direction, as the tissue is cut with the stapler and removed through one of the ports.

[0057] Vision Visual imaging can be performed using the following modalities: laser Doppler perfusion imaging (LDPI), laser speckle contrast imaging (LSCI), tissue viability imaging (TiVi), photoacoustic imaging (PAI), optical coherence tomography (OCT), infrared-based imaging, and optical cameras.

[0058] A wide range of visualization techniques can be used to detect and image target tissue sites. These techniques employ a specific wavelength range or combination of wavelengths to achieve definitive results. Depending on the wavelength range used by the source, the penetration depth can vary, and thus the target tissue site can be imaged noninvasively. The light (radiation source) can be a handheld probe used to scan the patient's body from the outside, similar to an ultrasound probe, for visualization or detection of the target tissue site. Alternatively, the light source can be mounted on a probe and orbitally guided through the patient's body to a point close enough to visualize the target tissue site. Such a probe can be advanced along the trachea and through the thoracic cavity to detect or visualize target tissue within the lungs.

[0059] These imaging techniques may be combined with other imaging modalities, such as ultrasound, electrical detection, etc., to enhance resolution.

[0060] Additionally, external agents such as contrast agents, nanoparticles, fluorescent agents, etc. can be administered to enhance the resolution or detection capabilities of visual imaging techniques.

[0061] Electromagnetic / potential / impedance The electromagnetic probe can be used to visualize the target tissue site.

[0062] Electromagnetic induction probes can also be used to remotely control trajectory guidance to a target tissue site.

[0063] Probes capable of detecting differences in zeta potential change as they are orbited through tissue can be used for the detection and visualization of target tissue sites.

[0064] Bioimpedance analysis involves measuring the response of organs or tissues to an applied electrical current. Bioimpedance parameters that can be recorded are resistance, reactance, and phase angle, and are determined for purposes of blood flow and body composition (e.g., water and fat content). However, there is physical evidence of the accumulation of at least the phase angle dimension of bioimpedance analysis criteria in body composition, as general health indicators and predictive tools tend to outgrow their commonly used stage. Phase angle is generally accepted to be an index of fluid flow, for example, cell membrane integrity and intracellular or extracellular spatial distribution at the cellular level. Ongoing research indicates that phase angle may also reflect other biological attributes.

[0065] Based on the Cole-Cole model and the Hanai method, a method for measuring extracellular fluid volume (ECV) and intracellular fluid volume (ICV) using a kind of bioimpedance frequency spectrum (BIS) has been proposed. Currently, multi-frequency bioimpedance analysis can provide information on the extracellular fluid volume and intracellular fluid volume in the whole or part of the health compartment.

[0066] The ability to recognize cancer cells using bioimpedance is well established in the biomedical literature. The usual method for measuring bioimpedance is by introducing the sample into a special chamber and applying an AC current to the sample while recording the voltage across the sample at each frequency. More modern methods rely on a matrix of electrodes that are connected to the human body and measure physiological and pathological changes. Several methods aim to locate and image tumor cells within the human body. Magnetic 13Another technique based on bioimpedance measures bioimpedance by magnetic induction. This technique consists of a single coil acting as both an electromagnetic source and receiver, typically operating in the 1 MHz to 10 MHz frequency range. When the coil is positioned in a fixed geometric relationship to a conductor, an alternating electric field within the coil generates eddy currents. Changes in bioimpedance induce changes in the eddy currents, which in turn induce changes in the magnetic field of these eddy currents. The coil acts as a receiver to detect such changes. Experiments using this technique have achieved 95% sensitivity and 69% specificity, distinguishing between 1% and 20% metastatic tumors. It is even better at distinguishing between tumors and normal tissue.

[0067] x-ray X-rays are electromagnetic radiation with high penetrating power. Differences in the fundamental properties of tissue result in differences in resistance to X-ray radiation. These properties of target tissue can be used to detect and visualize the target tissue site.

[0068] Fiducial markers constructed from an x-ray opaque material, such as lead, can be placed on the patient's body to aid in trajectory guidance to the target tissue and for trajectory planning.

[0069] Orbital Guidance System Various systems, devices, and apparatus can be used to guide instruments and / or devices to a target site, such as a target tissue site, within the human body, including, for example, Auris, robotic, CT / ultrasound fusion, electromagnetic guidance, fluoroscopy, and other guidance systems.

[0070] The tissue core removal system can include a tissue excision device with a helical coil electrode and a tracking device configured to determine the position of the helical coil electrode in three-dimensional space. The helical coil electrode can be configured to deliver energy to tissue. The helical coil electrode can be configured to determine electrical properties of the tissue. The tissue excision device can further include a first clamping element with the helical coil electrode, a second clamping element with a second electrode positioned opposite at least a portion of the first clamping element, and a cutting element configured to transecte the tissue. The tracking device can include one or more of an x-ray device, a computed tomography device, or a fluoroscopy device. Other devices and techniques can be used. The system can further include an anchor configured to guide movement of the helical coil electrode. The system can further include a non-invasive anchor configured to guide movement of the helical coil electrode. The system can further include operational logic configured to control movement of the helical coil electrode. The system can further include operational logic configured to determine a target trajectory of the helical coil electrode. The system may further comprise operational logic configured to determine an energy dosage to be provided by the helical coil electrode. The system may further comprise operational logic configured to determine an energy dosage to be provided to the helical coil electrode. The system may further comprise operational logic configured to receive position information indicative of a position of the helical coil electrode and determine a deviation from a target path or trajectory based at least on the position information. The system may further comprise operational logic configured to receive position information indicative of a position of the helical coil electrode and determine, based at least on the position information, to modulate energy delivered to the helical coil electrode. The system may further comprise operational logic configured to receive position information indicative of a position of the helical coil electrode and determine, based at least on the position information, a stopping point at which tissue ablation is intended to be performed.

[0071] A method for trajectory guiding a tissue ablation device may include placing the tissue ablation device within a patient's body, the tissue ablation device comprising a helical coil electrode, and determining a position of the helical coil electrode in three-dimensional space. The method may further include controlling movement of the helical coil electrode based at least on the determined position of the helical coil electrode. The method may further include determining a target trajectory for the helical coil electrode and determining a deviation from the target trajectory based at least on the determined position of the helical coil electrode. The method may further include determining an energy dosage to be provided by the helical coil electrode based at least on the determined position of the helical coil electrode. The method may further include determining an energy dosage to be provided to the helical coil electrode based at least on the determined position of the helical coil electrode. The method may further include determining an intended stopping point for performing tissue ablation based at least on the determined position of the helical coil electrode.

[0072] The trajectory guidance method and system may follow logic as depicted in FIG. 42 . As shown, the processing unit 4202 may communicate with a graphical user interface (GUI) 4204 to display a current device path 4206 and / or a desired trajectory 4208. The desired trajectory 4208 may be calculated based on a target location 4210 and an entry point. Other inputs may also be used. The entry point may be selected based on patient scan data 4212 or may be selected based on real-time device position feedback 4214. In addition, the real-time device position feedback 4214 may be used to determine the current path 4206 for device trajectory guidance. The target location 4210 may be selected through the GUI 4204 or may be input directly into the processing unit 4202 and may be based on the patient scan data 4212.

[0073] An example of a planned trajectory may be based on an anchor path as described herein. An example of real-time device position feedback may include the use of a trajectory guidance system as described herein.

[0074] A surgical instrument system for core-removing tissue from a target tissue site can include a tissue resection device configured to core tissue, the tissue resection device including a helical coil electrode and a cutting element configured to cooperate with the helical coil electrode to transect the tissue, a handle assembly configured to facilitate interaction between the tissue and the tissue resection device, and a tracking device configured to determine the position of the helical coil electrode in three-dimensional space.

[0075] Auris Auris is a system and tool for endoluminal robotic procedures that offers improved ergonomics, usability, and trajectory guidance. Endoscopy is a widely used minimally invasive technique for both imaging and delivering therapeutic agents to anatomical locations within the human body. Typically, a flexible endoscope is used to deliver tools to a surgical site within the body, for example, through a small incision or a natural body orifice (nose, anus, vagina, urinary tract, throat, etc.), where the procedure will be performed. The endoscope can have imaging, illumination, and steering capabilities at the distal end of a flexible shaft, which allows for trajectory guidance through non-linear lumens or pathways.

[0076] Auris typically uses a sheath with a lumen having a controllable and articulatable distal end, the sheath attached to a first robotic arm having at least three degrees of freedom (DOF), preferably six or more degrees of freedom (6 DOF). This embodiment also includes a flexible endoscope having a controllable and articulatable distal end, a light source and video capture unit at the distal end, and at least one working channel extending therethrough. The flexible endoscope is slidably disposed within the lumen of the sheath and attached to a second robotic arm having at least three degrees of freedom (DOF), preferably six or more degrees of freedom (6 DOF). The system further includes a first module and a second module operably coupled to the proximal ends of the sheath and the flexible endoscope, respectively. The modules are attached to the first and second robotic arms, thereby attaching the sheath and the flexible endoscope to the first and second robotic arms, respectively. The modules provide a mechanism for steering and manipulating the sheath and the flexible endoscope and receive power and other utilities from the robotic arms. The robotic arms are positioned so that the first module is distal to the second module and the proximal end of the sheath is distal to the proximal end of the flexible endoscope, and movement of the first and second robotic arms relative to each other and relative to the patient causes movement of the sheath relative to the flexible endoscope and either relative to the patient.

[0077] Robot / Electromagnetic Trajectory Guidance Robotically enabled medical systems can be used to perform a variety of medical procedures, including minimally invasive procedures such as laparoscopic procedures, and both percutaneous and non-invasive procedures such as endoscopic surgery.

[0078] Among endoscopic procedures, robotically operable medical systems can be used to perform bronchoscopies, ureteroscopies, gastroenteroscopies, and the like. During such procedures, a physician and / or a computer system can navigate a medical instrument through a patient's luminal network. The luminal network can include multiple branched lumens (e.g., the bronchial or renal network) or a single lumen (e.g., the gastrointestinal tract). The robotically operable medical system can include a trajectory guidance system that guides (or assists in guiding) the medical instrument through the luminal network. This trajectory guidance can be guided using mechanical means, such as that of Auris, or using electromagnets.

[0079] A robotic medical system can be used to perform minimally invasive percutaneous procedures. The method includes advancing a first alignment sensor through a patient lumen into a cavity. The first alignment sensor provides a position and orientation in free space in real time. The alignment sensor is manipulated until positioned near an object. A percutaneous opening is created in the patient with a surgical instrument, the surgical instrument including a second alignment sensor that provides a position and orientation of the surgical instrument in free space in real time. The surgical instrument is directed toward the object using data provided by both the first alignment sensor and the second alignment sensor.

[0080] The alignment sensor can be, for example, an anchor coupled to an EM sensor that operates in conjunction with an EM field generator and associated CT (or other) scan positioned around the patient to provide position and orientation information for the EM sensor within the patient's body. The alignment sensor is positioned through a cavity such as a device of the present disclosure and, together with a camera, is used to identify the location of the target tissue site. The alignment sensor provides a guidance mechanism for directing the percutaneous cut to access the target tissue site within the lung. Additionally, because a scope is already present at this point in the procedure, the working channel of the scope can be used to advance other tools to assist in the removal of the target tissue through the port created by the access device of the present disclosure.

[0081] Combination with CT / fluoroscopy and / or ultrasound In a conventional x-ray system, an x-ray beam is directed through an object, such as the human body, onto a flat radiographic film. The x-ray beam is selectively absorbed by structures within the object, such as bones within the human body. Because the exposure of the x-ray film is directly altered by the transmission of x-rays through the body (and inversely altered by absorption of x-rays), the image produced provides an accurate representation of any structures within the object that absorb the x-rays. As a result, x-rays are widely used for non-invasive examination of the interior of objects and are particularly useful in medical practice.

[0082] As an illustrative example, images formed from X-rays are effectively shadows of structures within an object that absorb X-rays. As a result, the images formed on the X-rays are only two-dimensional, and if multiple X-ray-absorbing structures are in the same shadow, information about some of these structures is likely to be obscured. Furthermore, in medical applications, it is often very difficult to use conventional X-ray systems to examine parts of the body, such as the lungs, which, when inflated, consist mostly of air and do not absorb X-rays very well.

[0083] Many of the limitations of conventional x-ray systems are circumvented by x-ray computed tomography, often referred to as CT, which, in particular, provides three-dimensional views and imaging of structures and features that would not be very visible with conventional x-rays.

[0084] Tracking and / or trajectory guidance of the disclosed ablation devices can be performed using CT guidance. CT is particularly well suited for solid organ interventions. CT fluoroscopy, which shows organ and device movement in real time, allows real-time tracking of the needle trajectory, allowing the physician to make appropriate adjustments. This advantage allows for shorter procedures with success rates comparable to or better than those achieved with standard intermittent CT imaging.

[0085] For example, a CT scan can be used to locate the target site for the anchor. The CT scan can be used to reconstruct the 3D positioning of the target site relative to fiducial markers on the patient's body. This reconstructed 3D image of the CT slices can be loaded into a system that helps the physician navigate the ablation device through the patient's body and / or can help determine the best path for access.

[0086] The ablation device can be fitted with accelerometers and / or gyroscopes to help determine the position of the instrument tip in 3D space at all times. By enabling communication between such an ablation device (adapted for 3D tracking) and CT software, the tip of the ablation device (e.g., a coil electrode) can be determined relative to the desired target spot. Arithmetic logic in the software (e.g., CT software) can be used to keep the device on a planned trajectory and help achieve optimal results.

[0087] Additionally or alternatively, CT scanning can be combined with other imaging modalities, such as ultrasound or electromagnetic tracking of the tip, to facilitate trajectory guidance of the ablation device. Other techniques may also be used alone or in combination.

[0088] As a further example, an ultrasound probe can be used to facilitate detection and / or localization of a target tissue site. The ultrasound probe can include a piezoelectric transducer that generates ultrasound waves. These ultrasound waves are reflected differently from various tissues based on the tissue's mechanical and structural properties. The reflected waves are then acquired through a receiver and interpreted to translate the tissue's properties and location. By tracking the location of the ultrasound waves in 3D space, it is possible to generate a 3D map of the tissue imaged using ultrasound.

[0089] Alternatively or in addition to providing the location of a specific target tissue site, ultrasound can also distinguish tissue stiffness, which can be important since tumors are known to have different mechanical and elastic properties than the surrounding tissue. Thus, ultrasound can enable rapid detection and imaging of tumor sites, in addition to providing details regarding the location, size, and other physical characteristics of the tumor site.

[0090] Systems and methods for navigating a probe to a location within a patient's body are described. The probe may comprise a needle, introducer, catheter, stylet, or sheath. Other probes may also be used. The method may include visualizing a three-dimensional image of a region of the patient's body. By way of example, the three-dimensional image of the region of the patient's body may be based on one or more of magnetic resonance imaging (MRI), computed tomography (CT), or ultrasound. Other imaging techniques may also be used. The method may include receiving a selection of a target location within the three-dimensional image of the region of the patient's body. By way of example, receiving the selection of the target location may be via interaction with a display device configured to output one or more of the visualization steps. Other inputs may also be used to make the selection. The method may include determining and visualizing a preferred path for the probe to follow from an external entry point on the patient's body to the target location. The preferred path may be determined by converting a selected point within a two-dimensional view of the three-dimensional image of the region of the patient's body into a line (e.g., a line of sight) through the three-dimensional image of the region of the patient's body. The method may further include pre-operatively calibrating the preferred path to compensate for anatomical shifts. Alternatively, or in addition, the method may further include calibrating the preferred path to compensate for shifts in the anatomical structures during the procedure. The method may include registering the three-dimensional image with the current actual position of the corresponding region of the patient's body. The method may include registering the current actual position of the probe with the three-dimensional image and the current actual position of the patient's body. The method may further include updating the registration of the three-dimensional image with the patient to compensate for shifts in the anatomical structures. The method may include visualizing the preferred path of the probe simultaneously with an indication of the current actual position of the probe in real time, such that the simultaneous visualization allows the user to align the current actual position of the probe with the preferred path. As an example, the indication of the current actual position of the probe may include the position of the probe in three-dimensional space.As a further example, the indication of the current actual position of the probe can include a projected extension of the probe in three-dimensional space. The method can include updating and visualizing the indication of the current actual position of the probe in real time as the probe is advanced to the target location. Additionally, audio or visual feedback output can be used to alert the user to information regarding proximity to the target location and / or to alert the user to information regarding proximity to critical anatomical structures.

[0091] The procedures of the present disclosure can be performed using CT guidance. CT is particularly well suited for solid organ interventions. CT fluoroscopy, which shows organ and device movement in real time, allows real-time tracking of the needle trajectory, allowing the physician to make appropriate adjustments. This advantage allows for shorter procedures with success rates comparable to or better than those using standard intermittent CT imaging.

[0092] A CT scan can be used to locate the target site for the anchor. The CT scan can be used to reconstruct the 3D positioning of the target site relative to fiducial markers on the patient's body. This reconstructed 3D image of the CT slices can be loaded into a system that helps a physician navigate the disclosed device through the patient's body and / or can help determine the best path for access.

[0093] The devices of the present disclosure can be fitted with accelerometers and / or gyroscopes that help determine the position of the instrument tip in 3D space at all times. By enabling communication between such devices of the present disclosure (adapted for 3D tracking) and CT software, the tip of the device of the present disclosure can be determined relative to the desired target spot. The software can help keep the device on a planned trajectory and help achieve optimal results.

[0094] Additionally, CT scanning can be combined with other imaging modalities, such as ultrasound or electromagnetic tracking of the tip, to facilitate trajectory guidance of the devices of the present disclosure.

[0095] In one embodiment of the present invention, a patient can be placed in a CT scanner and the nodule can be imaged. Using standard CT-guided interventional techniques commonly used in CT-guided lung biopsies, an anchoring needle can be advanced through the skin, chest wall, pleural cavity, and lung to the target tissue to be sampled. Once the distal end of the anchoring needle passes through the nodule or interstitial abnormality, an anchoring member composed of a shape-memory metal, such as nitinol, can be advanced to exit the distal end of the needle.

[0096] Fluoroscopy Fluoroscopy, like CT scanners, uses lower doses of radiation to minimize adverse effects on the patient.

[0097] Magnetic resonance imaging or radio frequency based trajectory guidance Magnetic resonance imaging (MRI), which can exploit the interaction between magnetic fields and nuclear spins to form two- or three-dimensional images, is widely used, particularly in the field of medical diagnostics, because it offers many advantages over other imaging techniques for imaging soft tissue, does not require ionizing radiation, and is typically non-invasive.

[0098] For example, during MRI, the patient's body is placed in a strong, uniform magnetic field B0, the direction of which defines the axis (usually the z-axis) of the coordinate system to which the measurements relate. Depending on the field strength, the magnetic field B0 induces different energy levels in the individual nuclear spins, which can be excited (spin resonance) by the application of an alternating electromagnetic field (RF field) of a defined frequency (the so-called Larmor frequency or MR frequency). From a macroscopic perspective, the distribution of the individual nuclear spins generates an overall magnetization that can be deflected from equilibrium by the application of an electromagnetic pulse (RF pulse) of an appropriate frequency. The corresponding magnetic field B1 of this RF pulse extends perpendicular to the z-axis, resulting in the magnetization precessing around the z-axis. The precession describes the surface of a cone whose opening angle is called the flip angle. The magnitude of the flip angle depends on the strength and duration of the applied electromagnetic pulse. In the example of a so-called 90-degree pulse, the magnetization is deflected transversely from the z-axis (flip angle 90 degrees).

[0099] After the RF pulse ends, the magnetization relaxes back to its original equilibrium state, with the z-direction magnetization reestablishing with a first time constant T1 (the spin-lattice or longitudinal relaxation time) and the magnetization perpendicular to the z-direction relaxing with a second, shorter time constant T2 (the spin-spin or transverse relaxation time). Transverse magnetization and its changes can be detected by a receiving RF antenna (coil array) located within the examination volume of the magnetic resonance examination system and oriented so that magnetization changes are measured perpendicular to the z-axis. The decay of transverse magnetization is accompanied by dephasing that occurs after RF excitation, caused by local magnetic field inhomogeneities that facilitate a transition from an ordered state with the same signal phase to a state in which all phase angles are uniformly distributed. Dephasing can be compensated for by a refocusing RF pulse (e.g., a 180-degree pulse). This generates an echo signal (spin echo) in the receiving coil.

[0100] To achieve spatial resolution in an imaged subject, such as a patient, constant magnetic field gradients extending along three principal axes are superimposed on a uniform magnetic field B0, resulting in a linear spatial dependence of the spin resonance frequency. The signals picked up by the receiving antenna (coil array) contain components of different frequencies that may relate to different locations within the body. The signal data acquired through the receiving coils corresponds to the spatial frequency domain of the wave vector of the magnetic resonance signal and is called k-space data. The k-space data typically includes multiple lines acquired with different phase encodings. Each line is digitized by collecting multiple samples. The k-space data set is converted into an MR image by Fourier transformation.

[0101] Transverse magnetization also dephases in the presence of a constant magnetic field gradient. This process can be reversed by appropriate gradient reversal to form a so-called gradient echo, similar to the formation of an RF-induced (spin) echo. However, in the case of a gradient echo, in contrast to an RF-refocused (spin) echo, the effects of main field inhomogeneities, chemical polarization, and other off-resonance effects are not refocused.

[0102] To enhance spatial resolution, certain elements (nuclei) can be used that provide higher contrast when excited by a magnetic field gradient. Real-time visualization of anchors or ablation devices may be achieved if the body of the respective device is made of such a material.

[0103] Vision Visual imaging can be implemented using at least the following exemplary modalities: laser Doppler perfusion imaging (LDPI), laser speckle contrast imaging (LSCI), tissue viability imaging (TiVi), photoacoustic imaging (PAI), optical coherence tomography (OCT), infrared-based imaging, and / or optical cameras.

[0104] A wide range of visualization techniques can be used to detect and image target tissue sites. These techniques employ a specific wavelength range or combination of wavelengths to achieve definitive results. Depending on the wavelength range used by the source, the penetration depth can vary, and thus the target tissue site can be imaged noninvasively. The light (radiation source) can be a handheld probe used to scan the patient's body from the outside, similar to an ultrasound probe, for visualization or detection of the target tissue site. Alternatively, the light source can be mounted on a probe and orbitally guided through the patient's body to a point close enough to visualize the target tissue site. Such a probe can be advanced along the trachea and through the thoracic cavity to detect or visualize target tissue within the lungs.

[0105] These imaging techniques may be combined with other imaging modalities, such as ultrasound, electrical detection, etc., to enhance resolution.

[0106] Additionally or alternatively, external agents such as contrast agents, nanoparticles, fluorescent agents, etc. may be administered to enhance the resolution or detectability of visual imaging techniques.

[0107] An example of the use of an optical camera is the use of an endoscope. Endoscopes can be used to facilitate visualization of target tissue sites. With regard to the lungs in particular, endoscopes can be used within the chest, thereby eliminating the need for a large thoracotomy incision. Thoracoscopy is the use of a specialized viewing instrument, usually a rigid endoscope, introduced through a thoracostomy, or small hole placed between the ribs. Once the endoscope is positioned within the space surrounding the lungs, known as the pleural cavity, additional thoracostomy holes can be created to introduce additional instruments. Additional instruments include grasping instruments, cutting instruments, and / or cutting staplers, such as the Ethicon Endosurgery Endo GIA 45mm Stapler. Using endoscopes and other instruments, a "triangulation" technique is utilized, where, for example, an endoscope is used to view the grasping instrument introduced from one direction and the stapler introduced from another direction, as the tissue is cut with the stapler and removed through one of the ports.

[0108] anchor Various anchoring devices can be used. A needle can be anchored to guide a core removal device. Non-invasive anchoring can be used. For example, the needle can be advanced to the desired target site through the use of real-time or virtual image-guided procedures. The advancement process can be performed directly by a human hand, manually by a human using a robotic arm, or autonomously robotically guided per digital 2D or 3D images. Once the desired position is achieved, nitinol fingers can engage the target tissue.

[0109] Fixation needle for guiding one or more devices Many medical procedures are performed through small channels formed within a patient's tissue. These procedures are minimally invasive. An anchor is typically inserted early in the procedure to form a channel that extends from outside the patient to a target within the patient. One exemplary such anchor may extend from the surface of the patient's skin to the target. As a further example, later in the procedure, this initial insertion can be expanded to accommodate other medical devices required for the procedure.

[0110] Additionally, local applications such as biopsies, thermal ablations, or local injections of therapeutic substances are currently performed in conjunction with imaging modalities such as ultrasound, x-ray, fluoroscopy, CT scans, MRI, vision, and optical imaging. As an example, in the use of x-ray emitting devices, x-ray energy passes through the patient's body and impinges differentially on a fluoroscopic screen, exciting fluorescent materials such as calcium tungstate and producing a screen representation of the body and anchors. The anchors are visualized on the fluoroscope as they enter the patient on the display of the medical device. The anchors may appear on the screen because they do not allow the energy to pass through (i.e., they may be opaque).

[0111] These imaging modalities allow visualization of the anchor and target area to safely orient and move the target relative to the target point. Additionally, these visualization modalities also allow proper positioning and / or repositioning of the anchor.

[0112] non-invasive fixation In certain cases, it may not be necessary to core tissue to access the target site. Examples of such cases may include growing cancers where access has been established through a previous biopsy procedure, or superficial target locations. In such cases, it may be possible to have a non-invasive anchor that helps guide the device along the desired trajectory.

[0113] The non-invasive anchor can be located on a patient's body surface, such as the skin, and can provide guidance for the device. The device can be inserted through the non-invasive anchor or from a location adjacent to the anchor. Guidance for the device to be guided to the target site can be provided through any of the following means: mechanical guidance (cannula), imaging and trajectory guidance techniques listed above, sensors mounted on the device or anchor itself, or a combination thereof.

[0114] In one embodiment, the anchor can be positioned on the surface of the patient's body and include a ring with an embedded sensor. As the ablation device is inserted through the ring, the sensor on the anchor tracks the ablation device's position in 3D space. As an example, the sensor on the anchor can interact with a sensor on the ablation device to improve accuracy or resolution. Some examples of sensors include, but are not limited to, electromagnetic sensors, photodiode sensors, optical sensors, IR sensors, magnetic sensors, FET sensors, and eddy current sensors.

[0115] In one aspect, the anchor can include a hard stop that limits the freedom of movement of the resection device. Once deployed, the anchor can act as a guide for insertion and advancement of the resection device. Advancement of the resection device may not require any imaging or monitoring, and may rely on the anchor's hard stop to advance and position the device at the target location and position. As a further example, the anchor can have sensors positioned along the body of the anchor. Once deployed, the sensors can monitor and provide feedback regarding the advancement and position of the resection device. While reference is made to resection devices, other devices, such as sealing devices and fluid delivery devices, may be used in the same or similar manner.

[0116] Various processes and mechanisms may be used to guide the anchor to a target location (such as a tissue location where core removal may be desired). As one example, the anchor may be placed in the target lesion using CT techniques similar to guided needle biopsy. Other systems, such as imaging systems, e.g., ultrasound, x-ray, etc., may also be used.

[0117] As a further example, a larger sheath needle may be placed at the target location using CT techniques similar to guided needle biopsy until the distal tip of the sheath needle touches or is adjacent to the target lesion. An anchor may then be inserted through the sheath needle to be placed at the target location (e.g., lesion). The sheath needle may then be removed. Other systems, such as imaging systems, e.g., ultrasound, X-ray, etc., may also be used.

[0118] As a further example, a position sensor may be positioned at or adjacent to the tip of the anchor and configured to scan a target location (e.g., a lung) and generate a 3D location of the target location (e.g., a lesion). The anchor may be guided to the target lesion based on the sensor location.

[0119] As a further example, a position sensor may be disposed on a larger sheath needle and configured to scan a target location (e.g., a lung) and generate a 3D location of the target location (e.g., a lesion). The sheath needle may be guided until the distal tip contacts the target location (e.g., a lesion). An anchor may then be inserted through the sheath needle to be positioned at the target lesion. The sheath needle may then be removed.

[0120] As a further example, a location sensor may be placed at the end of the anchor, and the Auris or other equivalent system may be used to place the location sensor through the airway to the target lesion. The anchor may be guided to the lesion based on the location of the two sensors.

[0121] As a further example, a location sensor may be placed at the tip of a larger sheath needle, and the Auris or other equivalent system may be used to place the location sensor through the airway to the target lesion. The sheath needle may be guided based on the location of the two sensors until the distal tip touches the lesion. An anchor may then be inserted through the sheath needle to be placed at the target lesion. The sheath needle may then be removed.

[0122] Tissue site access Various systems, devices, and apparatus can be used to provide or assist access to a target site, such as a target tissue site, within the human body. For example, chest incision blades, deployable access ports, tissue dilation, trocars, and / or open incisions can be used.

[0123] Chest Wall Incision Blade Once the anchor is positioned and deployed at the target location, it is necessary to break the vacuum in the intrapleural space to access the thoracic cavity through the chest wall without puncturing the lung. The thoracic incision blade can be designed with an open channel next to the central hole, which allows the blade to advance and cut through the chest wall tissue along the anchor. The open channel can be used to allow air to be introduced into the pleural cavity when the first layer of the pleural cavity is penetrated. The intrapleural vacuum can be lost, and the lung can then be lowered to minimize the potential for damage to the pulmonary pleura.

[0124] FIG. 5 shows a blade 500 having an open channel 502. The open channel 502 may be an air channel and may be connected at a distal end 506 to the sharp distal tip 504 of the blade to allow air to flow continuously to the distal tip 504 of the blade 500 (see, e.g., FIG. 6). FIG. 6 shows the distal tip 504 of the blade of FIG. 5. The proximal end 508 of the open channel 502 may be connected to a rigid or flexible tube 510. Air may enter the open channel 502 by ambient pressure or by higher pressurized air (see, e.g., FIG. 7). FIG. 7 shows the proximal end 508 of the open channel 502 connected to a flexible or rigid tube 510.

[0125] Cavity Access Sleeve After coring and cutting the target tissue, and before removing the core removal device with the target tissue therein, a cavity access sleeve can be placed on the outer diameter of the core removal device shaft to maintain access to the location where the target tissue was removed. Re-access to the location may be desirable for post-core removal treatment, such as adding a tissue location marking device for later surgery, cavity sealing, cavity ablation, drug delivery, or local chemotherapy. Without placing a cavity access sleeve before removing the core removal device, re-accessing the location of the removed target tissue can be difficult in organs with a lot of movement, such as the lung.

[0126] Tissue expansion After the anchor is deployed at a target tissue location in an organ, such as a target lesion in a human lung, to prevent removal of healthy tissue between the organ surface and the target tissue, the tissue may be expanded to allow for subsequent insertion of a core removal device that removes only the target tissue. Expansion may be achieved as follows.

[0127] A rigid rod having a central lumen may be advanced over the anchor until the distal end of the rod reaches the target tissue. The rigid rod may have a diameter that increases from a small diameter to a large diameter.

[0128] The expandable rod may be advanced over the anchor until the distal end of the expandable rod reaches the target tissue, at which point the distal end of the rod may be expanded to a desired diameter.

[0129] The balloon catheter in a compressed state may be advanced over the anchor. Once the distal end of the balloon catheter reaches the target site, the balloon can be expanded to open up the tissue. The balloon may have a shape similar to an angioplasty balloon or may be configured with square corners at the distal end. The body of the balloon may also have features such as a corrugated balloon to minimize tissue slippage along the balloon as it expands.

[0130] trocar Access to the target tissue site can be achieved via a trocar. Exemplary trocars 800, 900, and 1000 are shown in FIGS. 8-10. The trocar can include a trocar channel (e.g., trocar channel 802 in FIG. 8B and / or trocar channel 902 in FIG. 9B). The trocar channel can be used to allow air to be introduced into the pleural cavity when the first layer of the pleural cavity is penetrated. The intrapleural vacuum can be lost, and the lung can be lowered to minimize the possibility of damage to the lung pleura. Once the lesion is successfully located, a fixation device can be used to stabilize the target tissue lesion. A tissue core removal device can be introduced directly to the target lesion location using the trocar, or under direct visualization with or without a guide anchor, to perform tissue resection.

[0131] incision Access to the target tissue site can be achieved through an open incision. For the lungs specifically, a thoracotomy can be performed, which involves creating a 300-450 mm (12-18 inch) incision in the chest wall, dividing or dissecting the major back muscles to move them out of the way, partially removing the ribs, and placing a rib spreader to provide intrathoracic access for the operating surgeon. The advantage of a thoracotomy is that the surgeon has excellent access to the intrathoracic structures, allowing them to directly see and feel the lungs and other structures. Once the lesion is successfully located, fixation devices (e.g., as described above) can be used to stabilize the target tissue lesion. A tissue core removal device can be introduced directly to the target lesion location using an endoscope or under direct visualization with or without a guide anchor, and tissue resection can be performed.

[0132] Tissue core removal A variety of methods, devices, and systems can be used to core or remove tissue.

[0133] A method for removing a tissue lesion can include introducing a tissue excision device to a target tissue site, causing the tissue excision device to excise 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 excision device can be configured to perform radiofrequency energy delivery. The tissue excision device can be configured to perform mechanical transection. The tissue excision 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.

[0134] A method for removing a core of tissue can include introducing a tissue excision device to a target tissue site, causing the tissue excision device to excise 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 excision device can be configured to perform radiofrequency energy delivery. The tissue excision device can be configured to perform mechanical transection. The tissue excision 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.

[0135] A method for removing a core of tissue can include introducing a tissue excision device into a target tissue site. The tissue excision 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 excision device to excise 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 excision device can be configured to excise the 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.

[0136] 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.

[0137] 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.

[0138] 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.

[0139] 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 the tissue.

[0140] 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 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 have 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 the tissue.

[0141] 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.

[0142] 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.

[0143] 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.

[0144] 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 can be 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 tissues 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.

[0145] 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.

[0146] 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 can be disposed on or embedded within at least one of the surface segments. The central tube 1200 can be 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 can be approximately equal to ODcoil. Thus, the central tube 1200 can be advanced through the tissue clamping zone toward the coil 1110 such that the electrode 1205 abuts the electrode 1130.

[0147] The cutting tube 1300 may be slidably disposed within the central tube 1200. The distal end of the cutting tube 1300 may be provided with a knife edge to facilitate cutting of tissue.

[0148] 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 tubes 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 tubes positioned in the tissue clamping zone are clamped between the electrodes 1130 and 1205. The tubes can then be sealed by applying bipolar energy to the electrodes 1130 and 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.

[0149] According to one aspect of the present disclosure, the resection 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 can be provided with a ligating snare 1230, a first ligating electrode 1215 and a second ligating electrode 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 disposed 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 .

[0150] 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.

[0151] 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 can preferably be 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.

[0152] In an alternative embodiment, the resection device of the present disclosure can be provided with 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.

[0153] 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 can be 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.

[0154] 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.

[0155] Anchoring can be achieved by any suitable structure that secures 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. According to the present disclosure, the ablation device 1100 can be used to create a 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.

[0156] 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.

[0157] 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.

[0158] The tissue expander shown in FIG. 17 can be suitable for use in performing the methods of removing tissue lesions described herein. The tissue expander can 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 can 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 can be removed, leaving the rigid sleeve in the intercostal space between the ribs, creating a direct passage to the lung pleura.

[0159] Any tissue resection 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. The tissue resection device 1100 described herein above is preferred.

[0160] Upon removal of the tissue ablation device 1100, a small channel within the lung where the target lesion was removed may exist. This channel may be utilized to introduce an energy-based ablation device and / or local 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.

[0161] generator The electrical energy applied by the devices of the present disclosure can be transmitted to the device by a generator. The electrical energy can be in the form of radio frequency ("RF") energy. Upon application, the electrosurgical instrument can transmit RF energy through tissue, which causes ionic agitation or friction, in effect, resistive heating, thereby increasing the temperature of the tissue. The formation of a sharp boundary between the affected and surrounding tissue allows the surgeon to operate with a high level of precision and control without sacrificing adjacent, untargeted tissue. The low operating temperature of RF energy is useful for removing, shrinking, or shaping soft tissue while simultaneously sealing blood vessels.

[0162] The presently disclosed device is designed to work with any commercially available bipolar energy generator, such as an Enseal generator or a Bovie generator. The presently disclosed device can interface with a "brand-agnostic" generator adapter, allowing device operation regardless of the proprietary brand of generator used to deliver radiofrequency energy. In exemplary embodiments, the adapter can automatically identify, or manually identify with user assistance, the specific generator product connected to any of the presently disclosed devices. The generator adapter can modify, adjust, or change the generator's output (which may have subtle differences in characteristics depending on the specific generator used) to ensure optimal tissue sealing using the presently disclosed tissue core removal device. The generator provides radiofrequency power to drive the presently disclosed devices, such as electrosurgical core removal instruments used during open or laparoscopic surgery to cut and seal vessels and cut, grasp, and dissect tissue. The generator features adaptive tissue technology, which delivers intelligent energy for greater precision and efficiency.

[0163] Sample analysis Various systems, devices, processes, and apparatus can be used to analyze samples, such as core-removed tissue samples. For example, histology, DNA sequencing, rapid on-site evaluation (ROSE), or a combination thereof can be used. The core-removal methods described provide large tissue samples. Following removal of a core of tissue from the site of interest, the specimen can be analyzed for diagnostic purposes using any of the methods described below, independently or in combination.

[0164] Figure 18 shows an exemplary workflow 1800 for tissue sample analysis. As shown in Figure 18, tissue sample analysis can further include one or more of removing a core tissue (1802) and determining whether the removed core tissue is suitable (1804) or unsuitable / non-diagnostic (1806). If suitable, the removed tissue core can be analyzed using a specified analytical technique (1808). If unsuitable, the workflow can perform additional passes (1810) and the cycle can continue starting from step 1802.

[0165] Rapid On-Site Evaluation (ROSE) Rapid on-site evaluation (ROSE) is a method for rapid, real-time testing of samples at hand. The use of ROSE during lung lesion biopsy sampling has been suggested to improve diagnostic yield. Reported benefits of ROSE include a reduction in the number of biopsies performed, lower procedural risks, and improved accuracy rates. Isolated tissue cores can be analyzed using the ROSE technique. ROSE can be used to check sample adequacy and establish a preliminary diagnosis by performing rapid staining in the bronchoscopy suite or operating room, along with evaluation by a cytopathologist or trained cytotechnologist.

[0166] histology Morphological evaluation of core tissue samples can be performed by routine hematoxylin and eosin (H&E) staining, thereby allowing interpretation of the biopsy.

[0167] immunohistochemistry The majority of neoplasms arising from the lung or pleura are initially diagnosed based on histologic evaluation of tissue biopsies. While most diagnoses can be determined by morphology alone, immunohistochemistry can be a valuable diagnostic tool in the workup of problematic cases. Core tissue samples can also be analyzed using immunohistochemistry. This can help distinguish between lung adenocarcinoma and squamous cell carcinoma (SqCC), between lung adenocarcinoma and malignant mesothelioma (MM), between primary and metastatic cancers, and between small cell lung cancer (SCLC) and carcinoid tumors.

[0168] electron microscope Core-removed tissue samples can be evaluated using electron microscopy, which can be used to visualize structural details of cancer cells, which can provide clues to the exact type of cancer.

[0169] Flow cytometry Flow cytometry is used to detect the presence of tumor markers, such as antigens, on the surface of cells. This can be used to aid in the diagnosis of cancer. Isolated tissue cores can be analyzed using flow cytometry.

[0170] Image cytometry DNA image cytometry (DNA-ICM) has attracted attention due to its diagnostic advantages, including objectivity, convenience, and a high positive rate, in the diagnosis of various malignant cancer types. Therefore, this technique has been successfully used for lung biopsies. Isolated tissue cores can be analyzed using image cytometry.

[0171] polymerase chain reaction (PCR) Isolated tissue cores can be analyzed using PCR, which can be used to look for certain changes in genes or chromosomes, which can aid in the detection and diagnosis of genetic conditions or diseases such as cancer.

[0172] Gene expression microarray Isolated tissue cores can be analyzed using gene expression microarrays. Microarray-based techniques are ideal methods for studying the effects and interactions of multiple genes in cancer.

[0173] Fluorescence in situ hybridization (FISH) The isolated tissue cores can be analyzed using FISH techniques, which can be used to determine the location of a particular gene on a chromosome, how many copies of the gene are present, and identify any chromosomal abnormalities, which can be used to aid in the diagnosis of diseases such as cancer.

[0174] Gene sequencing Next-generation sequencing (NGS) is being rapidly implemented to help characterize cancer and guide treatment. It has previously been demonstrated that small lung biopsy samples yield DNA and RNA of sufficient quality to allow high-quality NGS analysis. Isolated tissue cores can be analyzed using NGS technology.

[0175] atomic force microscopy Isolated tissue cores can be analyzed using atomic force microscopy. Atomic force microscopy (AFM) allows for nanometer-scale investigation of cells and molecules. The physicochemical properties of living cells change as their physiological conditions change. Therefore, these physicochemical properties can reflect the complex physiological processes occurring within the cell. When cells undergo carcinogenesis and are stimulated by external stimuli, their morphology, elasticity, and adhesive properties can change. AFM can perform surface imaging and ultrastructural observation of living cells with atomic resolution under near-physiological conditions, collecting force spectroscopy information that allows for the study of cellular mechanical properties. Therefore, AFM has the potential to be used as a tool for the analysis and diagnosis of lung biopsy samples.

[0176] Surface-enhanced Raman spectroscopy Isolated tissue cores can be analyzed using surface-enhanced Raman spectroscopy. Because each macromolecule (lipid, protein, DNA, etc.) possesses unique fingerprint information regarding vibrational and rotational modes, Raman spectroscopy can characterize biomolecules. Therefore, Raman spectroscopy may be a promising tool for future cancer diagnosis. However, Raman spectroscopy suffers from low sensitivity in practical applications. Compared with conventional Raman spectroscopy, Raman scattering signals can be enhanced by 4 to 15 times using surface-enhanced Raman spectroscopy (SERS) technology. Research has shown that Raman enhancement can be achieved by utilizing silver nanospheres, gold nanospheres, and similar microparticles. In clinical detection, label-free SERS detection of tissue provides a rapid and easy method for distinguishing tumors from normal tissue. The difference in SERS spectra between lung cancer and normal tissue can potentially be used to diagnose lung cancer.

[0177] Sealing 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.

[0178] 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.

[0179] 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.

[0180] 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.

[0181] 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.

[0182] 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.

[0183] 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., biological 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.

[0184] 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.

[0185] 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.

[0186] 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.

[0187] FIG. 19 shows a system 1900. The system 1900 can include a port, such as a chest port 1902, configured to provide access via a channel to a body portion. It should be understood that various channels or ports can be used throughout the body, and the chest port 1902 is shown as a non-limiting example. As an illustrative example, the chest port 1902 is shown positioned adjacent a rib 1906 to provide access to the patient's lungs 1910. However, other locations may be used, and the chest port 1902 (or other port) may not be necessary. The fixation device 1904 can be secured to tissue, such as the lungs 1910. An exemplary fixation device is shown in FIG. 6 for illustrative purposes. However, any suitable device for fixation to the target site 1912 can be used. As shown, the fixation device 1904 extends through the pleura 1908 via the chest port 1902 and secures to tissue within the lungs 1910. The fixation device 1904 can be secured (e.g., releasably coupled) to tissue at the target site 1912. The target site 1912 can include a core site where a portion of lung tissue has been cored, perforated, or removed. The fixation device 1904 can be placed at the target site 1912 while the lung is inflated. However, other processes can be performed while the lung is compressed.

[0188] FIG. 20 shows an application of an exemplary sealing device 2000. The sealing device 2000 can include an inflatable balloon 2002. Other sealing mechanisms can be used. The sealing device 2000 can include and / or contact a balloon catheter. The balloon catheter can be a single-lumen balloon catheter. The balloon catheter can be a multi-lumen balloon catheter. The sealing device 2000 can be positioned adjacent to the target site 2012. As such, the sealing device 2000 can seal the target site 2012 to minimize leakage of fluid or material from the target site 2012. As an example, a filler material 2004 can be positioned at the target site 2012 and sealed within the target site 2012 by the sealing device 2000. As an illustrative example, the inflatable balloon 2002 can provide a seal while the lung 110 moves (e.g., expands and contracts). The sealing device 2000 can be implemented when the lung 2010 is inflated or compressed.

[0189] Examples of sealing procedures are described herein and include, for example, filling material, ablation, mechanical pressure, energy emission (e.g., RF energy), and others. Sealing at least a portion of the core cavity at the target site with the sealing device can include abutting at least a portion of the sealing device against a wall defining the core cavity. Sealing at least a portion of the core cavity at the target site with the sealing device can include ablating the wall defining the core cavity. Sealing at least a portion of the core cavity at the target site with the sealing device can include applying pressure to the wall defining the core cavity. The method can further include disposing a filling material within the core cavity, wherein the sealing device minimizes leakage of the filling material from the core cavity. The filling 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 to the target site. By way of further example, the target site can include at least a portion of a lung, and the method can further include ventilating the lung while the sealing device seals the target site.

[0190] 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. 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. Ventilation of the lung can be resumed. The inflated balloon catheter can be raised and lowered 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.

[0191] 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.

[0192] An exemplary system allows autologous blood to be delivered to the core site. Other filling materials can be used.

[0193] An exemplary system can allow the clotted blood to provide a seal to achieve air leak closure.

[0194] In one embodiment, a method and device are provided in which a plug or series of stitches is placed on a wire in a compressed configuration within the chest. When it is desired to seal the pleural cavity, the wire may be pulled back toward the operator, bringing the plug or stitches against the internal opening of the body space. The device can then be activated to insert the plug or stitches into the opening of the body space, causing the wire to break, thereby closing the hole and preventing fluid from leaking out or air from being sucked back in.

[0195] Polypeptide / protein-based adhesives, fibrin-based adhesives, gelatin-based adhesives, collagen-based adhesives, albumin-based adhesives, polysaccharide-based adhesives, chitosan-based adhesives, human blood-based adhesives, and animal-based adhesives, as well as synthetic and semi-synthetic adhesives (such as cyanoacrylates, polyethylene glycol hydrogels, urethane-based adhesives, and other synthetic adhesives). The fluid may fill the volume of the tube and may be heated using RF energy or a laser to a temperature above the temperature of the surrounding tissue sufficient to cauterize and seal the surrounding tissue. The combination of the fluid and RF seals the surrounding tissue.

[0196] A variety of methods, devices, and systems can be used to core or remove tissue.

[0197] treatment A variety of treatments can be performed.

[0198] 21-22 show illustrative examples, other methods of ablation or energy delivery may be used to seal the tissue. For example, a shaped mesh catheter may be used. Thus, a catheter having a folded mesh shape may be inserted into the cavity, and the cavity sheath may be removed. The mesh may then be expanded, and suction may be applied to pull the tissue into contact with the mesh. Energy, e.g., RF, may then be applied to ablate the cavity tissue wall.

[0199] Margin ablation An energy delivery device is introduced into the tissue cavity to deliver energy to eradicate the cancerous tissue. Once the target tissue has been cored and removed, the tissue walls of the cavity can be ablated. For example, any of the following ablation methods can be used:

[0200] Rotary Ablation Probe 21A-21C illustrate an exemplary application. As shown, once the target site has been hollowed out and the tissue core removed, it may be necessary to ablate the tissue wall of the cavity. To do so, the following ablation method can be used. For example, a rotating ablation probe can be used. FIG. 21A shows a hollowed-out cavity 2112 in tissue 2110 with a cavity sheath 2102 in place, holding the cavity open. A rotating probe 2100 can then be inserted into the cavity sheath 2102, as shown in FIG. 21B. The probe 2100 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 form of power. Once the probe 2100 is in place, the cavity sheath 2102 can remain in place or be removed. Energy can then be applied while rotating the probe / energy head to apply continuous radial ablation to the cavity walls and floor tissue 2110 as shown in Figure 21C.

[0201] Hot Balloon Catheter 22A and 22B show an exemplary application. As shown, a thermal balloon catheter can be used. For example, balloon catheter 2200 can be placed into a cavity 2212 formed in tissue 2210, and the cavity sheath can be removed to expose cavity 2212 requiring ablation, as shown in FIG. 22A. Balloon 2200 can then be inflated with hot fluid or hot air / gas to ablate cavity wall tissue 2210, as shown in FIG. 22B.

[0202] 23A-23C 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 2300 may include a fluid conduit 2301 and an inflatable, absorbent balloon 2302. As shown in FIGS. 23A and 23B, the balloon 2302 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 2302 is positioned at the desired location, it may be inflated with CO2 (or other fluid), for example, via the fluid conduit 2301, to press the bioadhesive against the tissue walls of the cored cavity and achieve a seal that prevents air leakage. The CO2-filled balloon 2302 may be pressurized to an appropriate pressure and left within the cored cavity.

[0203] Molded Mesh Catheter A catheter having a collapsed mesh configuration may be inserted into the cavity, and the cavity sheath may be removed. The mesh may then be expanded, and suction may be applied to draw tissue into contact with the mesh. Energy, e.g., RF, may then be applied to ablate the cavity tissue wall.

[0204] Microwave ablation Figure 24 shows an exemplary treatment system. A catheter probe 2402 including a microwave-emitting antenna 2404 can be inserted into a tissue cavity 2412 that has been cored from tissue 2410, as shown in Figure 24. The probe generates intense heat that ablates (e.g., destroys) the targeted tissue.

[0205] cryoablation Figure 25 shows an exemplary treatment system. A cryoablation probe 2502 can be inserted into a tissue cavity 2512 that has been cored from a target tissue 2510, as shown in Figure 25. The probe generates extremely low temperatures to ablate the target tissue 2510 within a cryoablation zone 2504.

[0206] Chemical ablation (chemoablation) To facilitate targeted cell damage, hypertonic saline gel, solid salt, and / or acetate gel can be implanted into the cavity.

[0207] Laser ablation (photoablation) A probe that emits a laser beam at a specific wavelength and pulse length can be inserted into the cavity, and the emitted laser beam can be used to kill targeted tissue within the cavity.

[0208] Ethanol ablation In this procedure, concentrated alcohol in liquid or gel form can be injected directly into the target cavity to damage the cells.

[0209] chemotherapy drugs At the cored site, administration of chemotherapeutic agents such as doxorubicin, fluorouracil, and / or cisplatin can be accomplished via direct injection of the agent into the cored tissue site.

[0210] FIG. 26 shows an exemplary treatment system. The method of drug / therapeutic agent delivery can be accomplished by placing a hollow sheath 2602 into a tissue cavity 2612 at the cored site of cored tissue 2610. A delivery probe 2604, including one or more lumens 2606 at its distal end, can then be inserted into the hollow sheath 2602. The delivery probe 2604 can exit a distal opening of the hollow sheath and extend into the cored tissue cavity. The desired therapeutic and / or diagnostic agent can then be delivered to the tissue through the delivery lumen 2606 via direct injection using a drug / therapeutic agent injection port with a plunger 2608, as shown in FIG. 26 , via the distal end of the delivery probe.

[0211] Figure 27 shows an exemplary treatment system. In some scenarios, a biodegradable plug 2702 can be placed across the cored site of the cored tissue 2710, following the addition of a drug / therapeutic agent to the cavity, as shown in Figure 27. That is, a drug 2704 can be delivered into the tissue cavity 2712 at the cored site of the cored tissue 2710. The plug 2702 can be secured in place using a biocompatible adhesive.

[0212] Chemotherapy drug-eluting particles Chemotherapeutic drug-eluting particles can be delivered to the cored tissue site, thereby facilitating controlled, sustained localized release of high concentrations of therapeutic agents through long-term administration. For example, doxorubicin can be encapsulated in nanoparticles to form micelles for targeted drug delivery. Furthermore, anticancer drugs can be vectorized using porous particles, such as mesoporous silica nanoparticles, and then delivered to the cored tissue site.

[0213] Co-delivery of siRNA and chemotherapy drugs Chemotherapeutic drugs and small interfering RNA (siRNA) can be co-delivered to cored tissue sites via direct injection to promote cancer cell death. Multidrug resistance in cancer cells can be suppressed using siRNA-based formulations to induce specific silencing of a wide range of gene targets. Delivering siRNA in combination with chemotherapeutic drugs can enhance the effectiveness of chemotherapy by overcoming cancer cell resistance mechanisms. For example, siRNA encapsulated in mesoporous silica nanoparticles can be co-delivered with doxorubicin to target cored tissue sites.

[0214] Biodegradable hydrogel-based controlled drug delivery 28 and 29 illustrate one exemplary treatment system and method. The method of hydrogel / plug delivery can be accomplished by placing a hollow sheath 2802 into the tissue cavity 2812 at the cored site 2810. A delivery plunger 2804, further comprising a delivery plunger sheath 2806 and containing a hydrogel 2807 at its distal end 2814, can then be inserted through the hollow sheath 2802 into the cored site 2812. The hydrogel 2807 can then be delivered into the cored site 2812 through the pushing mechanism of the delivery plunger 2802, as shown in FIGS. 28 and 29.

[0215] Photodynamic therapy (PDT) A combination of chemotherapy drug(s) and photodynamic therapy (PDT) can be delivered directly to the cored tissue site. PDT is a treatment modality that relies on photosensitizers and light to generate reactive oxygen species (ROS) to kill cancer cells.

[0216] Degradable polymer / scaffold systems FIG. 30 illustrates one exemplary treatment system. A polymer system containing a chemotherapy drug can be delivered to the cored tissue site 3012 of the cored tissue 3010 via direct implantation. A porous biodegradable polymer, such as a sponge or scaffold 3002, can be designed to carry a chemotherapy drug, such as cisplatin. These polymers degrade over time, thereby releasing the chemotherapy drug at a controlled rate within the target site. The superior biodegradability of a scaffold, such as a porous scaffold, supports the sustained release of the chemotherapy drug, overcoming the limitations of non-biodegradable systems that degrade after a specific period of time. The scaffold 3002 can be manufactured in a manner convenient for surgical delivery, as shown in FIG.

[0217] Hyperthermia of the cored tissue site Hyperthermia can be used to treat the desired cored tissue site. Using this technique, the cored tissue site can be exposed to temperatures higher than normal to promote selective destruction of abnormal cells, which minimizes side effects on healthy cells. For example, light-absorbing metal particles, such as gold nanoparticles or iron oxide microparticles, can be delivered to the cored tissue site. A short-pulse laser can then be applied to kill the cancer cells targeted by the metal particles.

[0218] Control System The present disclosure relates generally to electrosurgical systems configured to ablate a core of tissue from a tissue site. The present disclosure relates generally to electrosurgical methods that employ multiple energy modalities based on tissue parameters, for example, based on the type of tissue being treated, employing simultaneous energy modalities based on tissue impedance, and based on tissue parameters to optimize tissue core removal.

[0219] Depending on the specific instrument configuration and operating parameters, electrosurgical instruments can provide tissue cutting and hemostasis substantially simultaneously through the application of radio frequency energy, desirably minimizing patient trauma. With respect to the presently disclosed resection devices, tissue sealing can be achieved by clamping tissue between a helical coil and a corresponding circular ring (referred to as a first clamping element and a second clamping element) and delivering radio frequency energy to two RF electrodes (referred to as a first electrode element and a second electrode element) on the surfaces of the helical coil and the circular ring; and finally, cutting is typically achieved by a blade tip (or cutting element), which can be located at the distal end of the tissue core removal instrument. The presently disclosed devices can be configured for open surgical use, laparoscopic surgical procedures, or endoscopic surgical procedures, including robotic-assisted procedures.

[0220] Electrosurgical devices, which apply electrical energy to tissue to treat and / or destroy the tissue, are also finding increasingly widespread use in surgical procedures. Electrosurgical devices typically include a handpiece and an instrument having a distally attached end effector (e.g., one or more electrodes). The end effector can be positioned relative to the tissue so that electrical current can be introduced into the tissue. Electrosurgical devices can be configured for bipolar or monopolar operation. During bipolar operation, electrical current can be introduced into and returned from the tissue by the active and return electrodes of the end effector, respectively. During monopolar operation, electrical current can be introduced into the tissue by the active electrode of the end effector and returned through a return electrode (e.g., a grounding pad) separately located on the patient's body. Heat generated by electrical current flowing through the tissue can form a hemostatic seal within and / or between tissues and can thus be particularly useful, for example, for sealing blood vessels. The end effector of an electrosurgical device also includes a cutting member, which can be movable relative to the tissue and electrode to transect the tissue.

[0221] The electrical energy applied by the electrosurgical device can be transmitted to the instrument by a generator in communication with the handpiece. The electrical energy can be in the form of radio frequency ("RF") energy. RF energy is a form of electrical energy that can range in frequency from 200 kilohertz (kHz) to 1 megahertz (MHz). Upon application, the electrosurgical device can transmit low-frequency RF energy through tissue, which causes ionic agitation or friction, or, in effect, resistive heating, thereby increasing the temperature of the tissue. The ability to form a sharp boundary between the affected tissue and the surrounding tissue allows the surgeon to operate with a high level of precision and control without sacrificing adjacent, untargeted tissue. The low operating temperature of RF energy can be useful for removing, shrinking, or shaping soft tissue while simultaneously sealing blood vessels. RF energy works particularly well on connective tissue, which is primarily composed of collagen and contracts when exposed to heat.

[0222] The RF energy can be within the frequency range specified in EN 60601-2-2:2009+AI 1:2011, Definition 201.3.218-HIGH FREQUENCY. For example, frequencies in monopolar RF applications are typically limited to less than 5 MHz. However, in bipolar RF applications, frequencies can be nearly arbitrary. Frequencies above 200 kHz can typically be used in monopolar applications to avoid unwanted nerve and muscle stimulation that would result from the use of low-frequency currents. Lower frequencies may be used in bipolar applications if a risk analysis indicates that the potential for neuromuscular stimulation has been mitigated to an acceptable level. Typically, frequencies above 5 MHz are not used to minimize problems associated with radiofrequency leakage current. However, higher frequencies can be used in bipolar applications. It is generally recognized that 10 mA is the lower threshold for thermal effects on tissue.

[0223] One challenge with using conventional medical devices is the inability to control and customize the power output depending on the type of tissue being treated by the device. It would be desirable to provide a surgical instrument configured to perform tissue core removal that overcomes some of the shortcomings of current instruments.

[0224] In one aspect, a surgical instrument for resecting a core of tissue can be provided, the surgical instrument comprising: a processor; and an end effector at a distal end of the surgical instrument, the end effector configured to interact with tissue, the end effector comprising first and second clamping elements, first and second electrode elements, a force sensor in communication with the processor and configured to measure a force applied to tissue located between the first and second clamping elements, and a temperature sensor in communication with the processor, the first and second electrode elements configured to receive radio frequency energy from a generator and deliver RF energy to tissue interposed between the first and second clamping elements to seal the tissue, the processor configured to determine a type of tissue interacting with the end effector based on a tissue coefficient of friction determined based on the force applied to the tissue by the end effector and a rate of heat generated by the end effector, and to dynamically control energy delivered to the first and second electrode elements based on the type of tissue interacting with the end effector. Specifically, the output power of a surgical instrument can be adjusted as a function of a desired impedance trajectory, where the impedance trajectory produces a desired tissue effect or outcome. In one embodiment, the RF power can be therapeutic, e.g., tissue treatment, or sub-therapeutic, e.g., sensing only. The RF power can be applied to the tissue, and the voltage and current, or representations of the voltage and current, are measured or estimated. Impedance can be calculated by determining the ratio of voltage to current.

[0225] In one aspect, the tissue coring instrument can include a controller and processing unit configured to optimize delivery of radio frequency energy for core removal of tissue by a) identifying the brand and / or model of the electrosurgical generator powering the device, b) directly adjusting the dynamics of RF energy delivery to the tissue to optimize tissue sealing, and / or c) communicating with the electrosurgical generator to affect generator operation. Identification of the generator connected to the device may be accomplished automatically by the controller or may be manually determined, identified, and / or selected by the user.

[0226] The controller may be integrated within the device or may comprise an external unit placed in line between the device and a corresponding electrosurgical generator. The controller may further comprise a unique connector combination to allow for "brand-agnostic" use of the device (i.e., the controller may comprise a modular connector system to ensure that the device is capable of ablating the tissue core regardless of the type of generator used).

[0227] The controller can affect energy delivery to the device through bidirectional communication between the corresponding electrosurgical generator and the device. Various operational settings for energy delivery and tissue sealing parameters may be transferred from the generator to the controller. Real-time tissue sensing parameters may additionally be transferred from the device to the generator.

[0228] Additionally, the controller and processing unit may serve other purposes, including providing an interface for connection of other devices or accessories, such as a display, that visualizes and communicates useful information to the user (e.g., tissue sealing progress, device positioning relative to the target tissue site, proper device positioning and orientation, relevant device diagnostic data and error reports, device misuse warnings, a trajectory guidance system for determining the device's position in 3D space and / or relative to anatomical landmarks obtained via various medical imaging modalities such as CT, MRI, and ultrasound, etc.).

[0229] In another embodiment, a custom generator configured to perform tissue coring can include a controller and processing unit integrated directly into the generator. This exemplary tissue coring electrosurgical generator can include an interface for connection of other devices or accessories, such as a display, to visualize and communicate useful information to a user (e.g., tissue seal progress, device positioning relative to the target tissue site, proper device positioning and orientation, relevant device diagnostic data and error reports, device misuse warnings, a trajectory guidance system for determining device position in 3D space and / or relative to anatomical landmarks obtained via various medical imaging modalities such as CT, MRI, and ultrasound, etc.).

[0230] For any of the exemplary surgical instruments configured to perform the resection of a core of tissue from a target tissue site as described above (i.e., a tissue core removal electrosurgical generator specifically configured to perform tissue core removal, an integrated controller within the tissue core resection device configured to affect RF energy delivery from the electrosurgical generator to optimize tissue sealing, or an external controller configured to affect RF energy delivery from the electrosurgical generator to the tissue core resection device), RF energy delivery to the tissue can be adjusted, controlled, influenced, or otherwise modified to achieve a desired tissue effect or outcome.

[0231] RF impedance is known to change during tissue heating and coagulation. RF impedance can be used as an indicator of tissue condition and, therefore, can be used to indicate the progression of a coagulation cycle, a tube sealing cycle, ablation, etc. If the power is modulated so that the RF impedance follows a particular desired course of impedance change, the extension of this change in RF impedance may be used to create a desired treatment cycle. The desired course of impedance may be predetermined based on the operating parameters of the instrument, or may be determined by surgeon selection or measurement of tissue parameters to set the course of the treatment. The course of impedance may determine one or more of the output power, output waveform or wave shape, energy mode or modality selection, or the point at which energy application to the tissue is terminated.

[0232] During tissue treatment, a parameterized tissue model can be fitted to the tissue. The parameters found in the model can be used to generate an optimal controller in real time and can be correlated to specific tissue properties. This application provides real-time optimization for the generator control system based on RF impedance and real-time tissue assessment.

[0233] These techniques can be used to model tissue in real time and develop controllers specific to particular tissue types in real time to maximize sealing and minimize tissue sticking and cycle time, and provide control of surgical instrument output based on tissue properties and tissue changes during sealing and cutting cycles.

[0234] The RF output can be configured to deliver electrosurgical energy to the tissue via at least one electrode configured to apply electrosurgical energy to the tissue; sensing circuitry configured to measure the impedance of the tissue; and a controller programmed to determine whether a tissue response has occurred as a function of the impedance value and a predetermined rise in impedance, generate a target impedance trajectory as a function of the measured impedance and a predetermined desired rate of change of impedance based on the determination of the tissue response, and drive the tissue impedance along the target impedance trajectory by adjusting the power level of the ultrasonic output stage to substantially match the tissue impedance to the corresponding target impedance value for at least a predetermined minimum period of time, wherein the tissue response corresponds to a boiling point of tissue fluids, and the target impedance trajectory includes a plurality of target impedance values ​​for each of a plurality of time steps.

[0235] 31 shows a schematic diagram and flowchart of a device 3100 that may be advanced to a target site, distinguish tumor tissue from normal tissue, and successfully treat or ablate the tumor tissue. The device 3100 may include a processing unit 3102 and an external display 3104 (e.g., a graphical user interface (GUI)). The processing unit 3102 may be configured to receive one or more inputs, including, for example, three-dimensional (3D) data 3106 from a patient scan and / or energy from an energy source 3108. The processing unit 3102 may be further configured to receive device positioning information 3110 and confirm (3112) the current location of the tissue. The processing unit 3102 may be further configured to confirm (3114) that the device 3100 is at the target location and transmit such confirmation to a tissue sensing unit 3116. The processing unit 3102 may be further configured to actuate (3118) the delivery of energy to the tissue site. When energy delivery is activated, the processing unit 3102 can be configured to provide automatic advancement 3120 of the device 3100 and provide new location information to the tissue sensing unit 3116. The processing unit 3102 can be configured to receive information from the tissue sensing unit 3116 and adjust 3122 the energy delivery accordingly. The processing unit 3102 can further be configured to provide instructions 3124 to apparatus components for ablating and / or cutting tissue.

[0236] In one aspect, a surgical instrument system for core-removing tissue from a target tissue site can include a tissue resection device configured to core tissue, the tissue resection device including a helical coil electrode and a cutting element configured to cooperate with the helical cryoelectrode for transection of tissue, and a handle assembly configured to facilitate interaction between the tissue and the tissue resection device.

[0237] In one aspect, a surgical instrument system for core-removing tissue from a target tissue site can include a tissue resection device configured to core tissue, the tissue resection device including a first clamping element including a helical coil and a first electrode, a second clamping element including a second electrode and positioned opposite at least a portion of the first clamping element, and a cutting element configured to transcribe the tissue, and a handle assembly configured to facilitate interaction between the tissue and at least one of the first clamping element, the second clamping element, or the cutting element.

[0238] The handle assembly can facilitate connecting at least one electrode, e.g., at least one of the first electrode and the second electrode, to a generator. The handle assembly can facilitate connecting at least one electrode, e.g., at least one of the first electrode and the second electrode, to a computing device. The handle assembly can facilitate connecting at least one electrode, e.g., at least one of the first electrode and the second electrode, to a robotic system. The handle assembly can be configured to automate advancement of the at least one electrode, e.g., at least one of the first electrode and the second electrode. The handle assembly can be configured to automate delivery of energy to the at least one electrode, e.g., at least one of the first electrode and the second electrode.

[0239] In one aspect, a surgical instrument system for core-removing tissue from a target tissue site can include a tissue resection device configured to core tissue, the tissue resection device including a helical coil electrode and a cutting element configured to cooperate with the helical cryoelectrode to transect tissue, and operational logic configured to automate the use of one or more functions of the tissue resection device.

[0240] In one aspect, a surgical instrument system for core-removing tissue from a target tissue site can include a tissue resection device configured to core tissue, the tissue resection device including a first clamping element having a helical coil and a first electrode, a second clamping element having a second electrode and positioned opposite at least a portion of the first clamping element, and a cutting element configured to transect the tissue; and operational logic configured to automate the use of one or more functions of the tissue resection device.

[0241] The operational logic can be configured to automate the advancement of at least one electrode, e.g., at least one of the first electrode and the second electrode. The operational logic can be configured to automate the delivery of energy to at least one electrode, e.g., at least one of the first electrode and the second electrode. The operational logic can be configured to determine an energy distribution provided via the tissue ablation device. The operational logic can be configured to receive one or more inputs related to the ablation device, e.g., one or more of the first clamping element, the second clamping element, or the cutting element. The operational logic can be located in a handle assembly associated with the tissue ablation device. The operational logic can be located in a generator in communication with the tissue ablation device.

[0242] Handle Design Sequence A tissue core removal device having a helical coil and anvil electrode is provided to track along the anchor to remove the target tissue. Once the core removal device is positioned over the anchor and contacts the tissue surface with the distal tip of the helical coil, the following series of steps can be performed to core the target tissue while simultaneously sealing the fluid conduit. An exemplary method 3700 including the sequence of operations is shown in FIGS. 37A and 37B for illustrative purposes. The method can include a core removal procedure initiation step 3702. For example, the core removal device can be positioned over the anchor. The method 3700 can further include one or more of the following steps:

[0243] In step 3704, the anchor can be placed at a depth of 3 cm to 5 cm (eg, using an insertion stop) based on the target tissue depth from the organ surface.

[0244] In step 3706, the anchor can be deployed and the insertion stopper can be removed.

[0245] In step 3708, a centering aid can be placed over the anchor.

[0246] In step 3710, the core removal device can be passed through the anchor until the core removal device coil is above the pleura and centered around the anchor.

[0247] In step 3712, the advance button may be actuated (eg, pressed).

[0248] In step 3714, the coil electrode may be rotated 5 / 4 times through the organ surface (e.g., the pleura of a lung). The first rotation of the coil electrode may engage the coil electrode into the tissue. If a helical coil electrode is used, fluid ducts that may be trapped in the helical portion of the helical coil may be moved to the flat portion of the helical coil.

[0249] An anvil electrode can be clamped against the coil electrode in step 3716. In some embodiments, tissue can be clamped between the helical coil and one or more anvil electrodes to a predetermined gap suitable for a vessel seal.

[0250] In step 3718, the controller can apply RF energy to one or more electrodes to cauterize tissue and seal any fluid conduits clamped between the electrodes. RF energy can be applied between the helical coil and the anvil electrode to effect a conduit seal between the electrodes.

[0251] In step 3720, a hold or wait period of approximately 10 seconds may begin.

[0252] In step 3722, a determination can be made as to whether a generator alert and / or command was received during the ablation.

[0253] If so, steps 3724-3730 may be initiated.

[0254] In step 3724, the alert button may be activated (eg, pressed or selected) to clear the alert.

[0255] In step 3726, one or more electrodes may be deactivated.

[0256] In step 3728, one or more anvil electrodes may be unclamped from one or more coil electrodes.

[0257] In step 3730, the coil electrode may be rotated counterclockwise 1 / 36th of a turn.

[0258] After completing steps 3724 through 3730, the method 3700 may return to step 3716.

[0259] If not, the process may proceed to step 3716 and proceed as described herein.

[0260] In step 3732, the advance button may be actuated (eg, pressed).

[0261] In step 3734, one or more electrodes may be deactivated and disconnected.

[0262] The blade tube may be rotated 1 / 2 turn to dissect the cored tissue from the surrounding tissue in step 3738. For example, the tissue core may be dissected via a mechanical blade tube.

[0263] In step 3740, the braided tube can be retracted and the coil electrode can be disconnected.

[0264] As shown, continuing from FIG. 37A to FIG. 37B, in step 3742, a determination can be made as to whether the anchor is engaged with the core removal device (i.e., indicating that the target tissue at a depth of at least 3 cm has been reached).

[0265] If not, then in step 3744 the coil electrode may be rotated 3 / 4 of a turn and the method 3700 may return to step 3716.

[0266] If so, the method 3700 may proceed to step 3746, where the advance button may be actuated (eg, pressed).

[0267] In step 3748, the cutting instrument can be fully retracted.

[0268] In step 3750, the ligature can be pulled and held under tension.

[0269] One or more electrodes can be activated in step 3752. RF energy can be applied between the second set of electrodes to seal any fluid conduits within the ligature loops and between the electrodes.

[0270] In step 3754, a hold or wait period of approximately 10 seconds may begin.

[0271] One or more electrodes can be deactivated in step 3756. The anvil electrode can be separated from the spiral electrode.

[0272] The cycle of rotating the helical coil, clamping the tissue between the electrodes, applying RF energy to seal the tube, incising the tissue core, and separating the anvil and helical electrodes can be repeated as necessary. Once the target tissue has been cored and is within the blade tube, the ligature can be deployed to compress the distal end of the target tissue between a second set of electrodes.

[0273] In step 3758, ligature tension can be maintained.

[0274] In step 3760, a cutting wire can be actuated to sever the cored tissue from the surrounding tissue. For example, a mechanical wire can be deployed to cut the target tissue proximal to the ligature wire.

[0275] In step 3762, the cavity port can be rotated downward in a clockwise direction until resistance is felt.

[0276] In step 3764, the cavity port can be rotated downward counterclockwise until resistance is felt.

[0277] The coil electrode may be rotated three-quarters of a turn counterclockwise in step 3766. For example, a helical coil may be rotated to disengage the helical coil from the surrounding tissue.

[0278] In step 3768, the core removal device may be removed along with the cored tissue (eg, the target tissue sample).

[0279] In step 3770, the anchor may be unlocked.

[0280] In step 3772, the anchor may be undeployed and removed from the core removal device.

[0281] In step 3774, the cored tissue may be removed from the anchor for subsequent tissue lab work.

[0282] In step 3776, the core removal procedure may be completed.

[0283] To reduce the number of manual steps required for a user to perform a tissue coring device, a handle mechanism must be incorporated to drive the sequence of steps described above. The mechanism is controlled through electrical hardware encapsulated within the device handle, which includes the core removal device gear mechanism, and firmware sequences installed within the generator (also referred to as the controller). The sequences can have different input modes, e.g., operator action, advance, alert, etc. The following is a concept for using the input modes to automate the procedure after tissue core removal.

[0284] Below is a description of the handle mechanism design and the step sequence controlled by the controller. The sequence shows, as an example, target tissue to be cored 3 cm below the organ surface.

[0285] A handle design 3200, for example, is shown in FIG. 32. As shown, the handle 3200 can be configured for a tissue coring device having a helical coil and anvil electrode and can include subordinate mechanisms (e.g., four) for automatic rotation, tissue clamping, device position control relative to the anchor, and ligation / cutting of the target tissue. As described above, once the core removal device is placed on the anchor and the distal tip of the helical coil makes contact with the tissue surface, the above sequence of steps is performed using a planetary gear system with three rotational states for rotation of the coil and mechanical blade, a clamping camshaft 3202 for tube sealing, an optical anchor position monitoring mechanism to identify when the cored target tissue is within the mechanical blade tube, and an integrated bidirectional pulley system 3204 for ligation / cutting of the cored target tissue. The handle 3200 may further comprise an automatic housing cap 3206, a solenoid 3208, a manual clutch wing 3210, an automatic handle housing 3212, a coil cam pin 3214, and a mechanical blade cam pin 3216. The following features are described in more detail below:

[0286] FIG. 33 illustrates one exemplary rotational control assembly 3300 (e.g., a planetary gear assembly). The rotational control assembly 3300 illustrated in FIG. 33 can be configured to control bidirectional rotation for the tissue coring coil and unidirectional rotation for the mechanical blade tube 3310 using one motor control, requiring the system to maintain two degrees of freedom. To initiate coil rotation and engage the coil within tissue, the motor 3302 can be rotated counterclockwise, engaging the coil unidirectional bearing 3316 in series with the motor shaft 3304. The planetary gear mechanism can then be activated, rotating the ring gear 3306 clockwise and engaging the jackshaft 3322. The jackshaft 3322 can then be rotated counterclockwise to engage the coil tube gear 3312 and rotate the coil a predetermined rotational distance. To initiate rotation of the mechanical blade tube 3310 to incise a tissue core, the motor 3302 can be rotated clockwise, the mechanical blade one-way bearing 3308 in series with the motor shaft 3304 can be engaged, and the planetary gear mechanism can be deactivated, allowing the mechanical blade tube 3310 to rotate a predetermined rotational distance. To initiate counterclockwise rotation of the coil to disengage it within the tissue, the manual clutch 3320 can be biased to the up position, and the cone clutch 3318 can be moved into contact with the planetary gear system. The motor 3302 can then be rotated counterclockwise, engaging the coil one-way bearing 3316 in series with the motor shaft 3304. The planetary gear mechanism can be activated, and the ring gear 3306 can be rotated counterclockwise and engaged with the jackshaft 3322. The jackshaft 3322 can then be rotated clockwise to engage the coil tube gear 3312 and rotate the coil a predetermined rotational distance.

[0287] FIG. 34 illustrates a linear translation control assembly 3400 in the form of a clamp camshaft and pin mechanism. The clamp camshaft and pin mechanism shown in FIG. 34 controls the linear translation of the mechanical blade tube (not shown) and coil tube 3408 for tissue engagement, vessel sealing, and incision. After rotating the helical coil a predetermined distance to engage the target tissue, a camshaft 3402 having a machined slot housed in a servo motor 3420 can be rotated clockwise. The coil cam pin 3404 then follows the cam path 3406, and the coil tube 3408 can be linearly translated to clamp tissue between the helical coil and the anvil electrode to a predetermined gap that may be suitable for vessel sealing. The servo motor 3420 can then be rotated clockwise, and the mechanical blade cam pin 3410 can follow the mechanical blade path 3412, and the mechanical blade tube (not shown) can be linearly translated to the incision position. At the end of the cycle, the servo motor 3420 can be rotated counterclockwise to separate the anvil electrode from the helix electrode and translate the mechanical blade tube out of the cutting position.

[0288] 35 shows an anchor position monitor 3500. The anchor position monitor 3500 may be an optical anchor position monitoring mechanism that can actively monitor the target core tissue location on the anchor relative to the tissue coring device through an optical sensor 3502 in series with the anchor. When the target tissue has been cored and is within the mechanical blade tube, a preset marking on the anchor will be in series with the optical sensor 3502 or optical sensing unit, alerting the system that the tissue coring device is in the optimal position. A solenoid 3504 may then be fired, engaging a spring-loaded anchor lock 3506 and locking the anchor position relative to the tissue coring device.

[0289] FIG. 36 illustrates an exemplary ligation and cutting system 3600. The ligation and cutting system 3600 can be a bidirectional pulley system that can control the deployment of the ligation and cutting machine line. Once the target tissue enters the blade tube as described with respect to FIGS. 33 and 34 , the servo motor 3602 can be rotated clockwise. The one-way bearing 3604 housed within the ligation pulley 3606 can then be engaged, deploying the ligation machine line, and the ligation claws 3608 can hold the line taut, clamping the distal end of the target tissue between the second set of electrodes. After the radio frequency energy between the second set of electrodes to seal the fluid conduit within the ligation loop is completed, the servo motor 3602 can be rotated counterclockwise, engaging the one-way bearing 3610 housed within the cutting pulley 3612, deploying the cutting machine line to cut the target tissue proximal to the ligation line.

[0290] FIG. 38 illustrates a handle design 3800 for a tissue coring device comprising a helical coil and one or more anvil electrodes, which may include multiple attachments to the tissue coring device for automated rotation, tissue clamping, and ligation / severing of targeted tissue. As described above, once the core removal device is positioned on the anchor and the distal tip of the helical coil contacts the tissue surface, the sequence of steps described above can be performed using two independent gear systems for coil and mechanical blade rotation, a clamp actuator plate, and two independent spring-loaded systems for ligation and severing. The handle design 3800 may include a mechanical blade gear set 3802, a mechanical blade stepper motor 3804, a coil stepper motor 3806, a spring-loaded cutting knob 3808, a spring-loaded ligation knob 3810, a clamp plate housing 3812, and a clamp linear actuator 3814. The following mechanisms are described in more detail below.

[0291] FIG. 39 shows a rotational control assembly 3900. The rotational control assembly 3900 can be an independent gear system configured to control bidirectional rotation for the tissue core removal coil and mechanical blade tube with two motor controls. To initiate clockwise rotation of the coil (i.e., to engage the coil into tissue), the coil stepper motor (e.g., coil stepper motor 3806 of FIG. 38) can be rotated counterclockwise and the coil gear system can be activated. The coil can then be allowed to rotate a predetermined rotational distance, and the fluid conduit captured in the helical portion of the helical coil is moved to the flat portion of the helical coil. To initiate rotation of the mechanical blade tube and incise the target tissue core, the blade stepper motor (e.g., mechanical blade stepper motor 3804 of FIG. 38) can be rotated and the blade tube gear system can be activated, allowing the mechanical blade tube to rotate a predetermined rotational distance. To initiate a counterclockwise rotation of the coil to disengage the coil into tissue, the coil stepper motor can be rotated clockwise and the coil gear system 3902 can be actuated, allowing the coil tube to rotate a predetermined rotational distance. The rotation control assembly 3900 can further comprise a cutting tool motor bracket 3904, a motor housing / handle 3906, a linear actuator clamp plate 3908, and a linear actuator frame 3910.

[0292] FIG. 40 illustrates an exemplary clamp 4000. A clamp solenoid plate controls the linear movement of the coil tube for tissue engagement and vessel sealing. After the helical coil is rotated clockwise a predetermined distance to engage the target tissue, a linear actuator 4002 housed on a carrier plate 4004 can be activated. The actuator arm can then be linearly translated to clamp the tissue between the helical coil and the anvil electrode to a predetermined gap suitable for vessel sealing. At the end of the RF energy cycle, the linear actuator can be deactivated, and the coil tube can be unclamped under gravity. The clamp 4000 further comprises a coil gear set 4006, a clamp plate housing 4008, and a linear actuator frame 4010.

[0293] 41 shows an exemplary ligating and cutting system 4100. Independent spring-loaded mechanisms for ligating and cutting can control the deployment of the ligating and cutting machine lines. Once the target tissue is within the blade tube, the ligating spring 4102 can be engaged (e.g., pressed down by the operator) and the pin can rotate clockwise. The ligating and cutting system can further include a ligating knob 4104, a spring base 4106, and a locking channel 4108. The spring-loaded pin can then be actuated, deploying the ligating machine line and holding it in tension to clamp the distal end of the target tissue between the second set of electrodes. After application of radio frequency energy between the second set of electrodes to seal the fluid conduit with the ligation loop is complete, the cutting spring may be engaged (e.g., by an operator) and the pin may be rotated clockwise, thereby actuating the spring-loaded pin and deploying the cutting machine line to cut the target tissue proximal to the ligation line.

[0294] The present disclosure includes at least the following aspects.

[0295] Aspect 1. A method for core-removing tissue from a target tissue site, comprising delivering a first energy modality to an end effector of a surgical instrument that interacts with tissue, the end effector comprising a first clamping element configured to core-remove tissue and comprising a helical coil and a first electrode, a second clamping element comprising a second electrode and positioned opposite at least a portion of the first clamping element, and a cutting element configured to perform tissue transection.

[0296] Aspect 2. The method of aspect 1, further comprising determining tissue parameters of the tissue interacting with the end effector and delivering a second energy modality to the end effector based on the determined tissue parameters, wherein the first energy modality is different from the second energy modality.

[0297] Aspect 3. The method of aspect 2, wherein the tissue parameter comprises tissue impedance.

[0298] Aspect 4. The method of aspect 3, further comprising calculating the tissue impedance based on an electrical parameter associated with the first energy modality.

[0299] Aspect 5. A method according to any one of aspects 2 to 4, further comprising controlling the first energy modality delivered to the end effector based on the tissue parameters as input, and selecting the second energy modality to be delivered by the end effector to interact with the tissue, wherein characteristics of the first energy modality and the second energy modality correspond to the type of interaction between the end effector and the tissue.

[0300] Aspect 6. A method for core-removing tissue from a target tissue site, the method comprising: delivering a first drive signal to an end effector of a surgical instrument that interacts with tissue, the end effector being configured to core tissue and comprising a first clamping element having a helical coil and a first electrode, a second clamping element having a second electrode and positioned opposite at least a portion of the first clamping element, and a cutting element configured to transcribe tissue; measuring a tissue parameter of the tissue interacting with the end effector; modulating delivery of the first drive signal based on the measured tissue parameter; and ceasing delivery of the first drive signal when an end parameter is met.

[0301] Aspect 7. The method of aspect 6, wherein the first drive signal is a radio frequency (RF) energy signal.

[0302] Aspect 8. The method of aspect 6 or 7, wherein the first drive signal is an ultrasonic energy signal.

[0303] Aspect 9. The method of any one of aspects 6-8, further comprising determining that the tissue is sealed based on at least one of an initial tissue impedance, an initial opening defined by the jaws of the end effector, a current tissue impedance, a rate of change of tissue impedance, ultrasonic energy delivered to the tissue, radio frequency (RF) energy delivered to the tissue, or transaction time.

[0304] Aspect 10. The method of any one of aspects 6 to 9, wherein the first drive signal includes a first energy signal, and modulating the delivery of the first energy signal based on the measured tissue impedance includes modifying the output power of a generator, modifying the output waveform of the generator, selecting a second energy signal to deliver to the surgical instrument, or modifying the termination parameters.

[0305] Aspect 11. The method of any one of aspects 6-10, further comprising ceasing delivery of the first drive signal when the tissue parameter meets or exceeds the tissue parameter threshold.

[0306] Aspect 12. The method of any one of aspects 6 to 11, wherein the first drive signal comprises a first energy signal, the amplitude of the first energy signal is a first amplitude, and the method further comprises delivering a second drive signal to tissue at a second amplitude different from the first amplitude.

[0307] Aspect 13. The method of aspect 12, wherein the first drive signal is a radio frequency (RF) energy signal and the second drive signal is an ultrasonic energy signal.

[0308] Aspect 14. The method of any one of Aspects 6 to 13, wherein measuring the tissue parameter comprises measuring a rate of change of the tissue parameter.

[0309] Embodiment 15. The method of any one of embodiments 6 to 14, further comprising determining a state of the tissue based on the measured tissue parameters.

[0310] Aspect 16. The method of aspect 15, wherein the condition of the tissue comprises coagulation, sealing, or cutting.

[0311] Aspect 17. The method of any one of aspects 6-16, wherein delivery of the first drive signal to the end effector is modulated to vary the tissue parameter according to a predetermined technique.

[0312] Aspect 18. The method of aspect 17, wherein the predetermined technique includes adjusting the tissue parameter according to a threshold value for the tissue parameter or a threshold rate of change for the tissue parameter.

[0313] Aspect 19. The method of any one of aspects 6 to 18, wherein the tissue parameter is based on a voltage measurement of radio frequency (RF) energy divided by a current measurement of the RF energy.

[0314] Aspect 20. The method of aspect 19, wherein the tissue parameter threshold corresponds to an ending impedance at which sealing is completed during coagulation of the tissue using RF energy.

[0315] Aspect 21. A surgical instrument system for core-removing tissue from a target tissue site, comprising: a tissue resection device configured to core-remove tissue, the tissue resection device comprising: a first clamping element having a helical coil and a first electrode; a second clamping element having a second electrode and positioned opposite at least a portion of the first clamping element; and a cutting element configured to transcribe tissue; a handle assembly having a trigger system configured to facilitate interaction between tissue and at least one of the first clamping element, the second clamping element, or the cutting element; and a generator configured to deliver energy to the tissue resection device.

[0316] Aspect 22. The system described in Aspect 21, further comprising a controller in communication with the generator, the controller configured to control the generator to provide high frequency energy to the first electrode and the second electrode of the tissue excision device sufficient to seal tissue based on at least one sensed operating state of the tissue excision device.

[0317] Aspect 23. The system of aspect 22, wherein the controller is configured to sense tissue interaction with the tissue excision device.

[0318] Aspect 24. The system described in Aspect 23, wherein the controller is configured to sense the interaction of tissue with the tissue excision device based on measured impedance levels associated with the first electrode and the second electrode.

[0319] Aspect 25. The system of Aspect 23 or 24, wherein the controller is configured to sense the amount of force applied to at least one of the first clamping element or the second clamping element to detect the interaction of tissue with the tissue excision device.

[0320] Aspect 26. The system of any one of aspects 22 to 25, wherein the controller is configured to sense the position of the cutting element relative to at least one of the first clamping element or the second clamping element of the tissue excision device.

[0321] Aspect 27. The system described in any one of aspects 22 to 26, wherein the controller is configured to control the generator to provide a continuous amount of high frequency energy.

[0322] Aspect 28. The system described in any one of aspects 22 to 27, wherein the controller is configured to control the generator to automatically provide an increase or decrease in the amount of high frequency energy.

[0323] Embodiment 29. The system of any one of embodiments 22 to 28, wherein the controller is configured to control the position of the first clamping element relative to the second clamping element.

[0324] Aspect 30. The system of any one of aspects 22 to 29, wherein the controller is configured to control the position of the cutting element relative to at least one of the first clamping element or the second clamping element of the tissue excision device.

[0325] Aspect 31. A system described in any one of aspects 22 to 30, wherein the tissue excision device and the generator are at least one of mechanically and electrically connected to the handle assembly.

[0326] Aspect 32. A method comprising: placing a core removal device over an anchor, the core removal device including a helical coil having a coil portion and a flat portion; rotating the helical coil of the core removal device to engage the helical coil with tissue so that a fluid tube captured between the coil portions is moved to the flat portion of the helical coil; clamping the tissue between the helical coil and at least two anvil electrodes of the core removal device; applying radio frequency (RF) energy between the helical coil and the anvil electrodes to create a tube seal between the electrodes; incising a tissue core via a mechanical blade tube of the core removal device; separating the electrodes from one another; and repeating the cycle of rotating the helical coil, clamping the tissue between the electrodes, applying RF to seal the tube, incising a tissue core, and separating the electrodes.

[0327] Aspect 33. The method of aspect 32, further comprising the steps of: once the target tissue has been cored into the blade tube, deploying a ligature to squeeze the distal end of the target tissue between a second set of electrodes; applying RF energy between the second set of electrodes to seal any fluid conduits within the ligature loop and between the electrodes; deploying a mechanical wire to cut the target tissue proximal to the ligature; rotating the helical coil to disengage the helical coil from surrounding tissue; and removing the core removal device along with the target tissue sample.

[0328] Aspect 34. A surgical instrument system for core-removing tissue from a target tissue site, comprising: a tissue resection device configured to core-remove tissue, the tissue resection device comprising: a first clamping element having a helical coil and a first electrode; a second clamping element having a second electrode and positioned opposite at least a portion of the first clamping element; and a cutting element configured to transcribe tissue; and a handle assembly configured to facilitate interaction between tissue and at least one of the first clamping element, the second clamping element, or the cutting element.

[0329] Aspect 35. The system described in Aspect 34, wherein the handle assembly facilitates connecting at least one of the first electrode and the second electrode to a generator.

[0330] Aspect 36. The system described in aspect 34 or 35, wherein the handle assembly facilitates connecting at least one of the first electrode and the second electrode to a computing device.

[0331] Aspect 37. The system described in any one of aspects 34 to 36, wherein the handle assembly facilitates connecting at least one of the first electrode and the second electrode to a robotic system.

[0332] Aspect 38. A system described in any one of aspects 34 to 37, wherein the handle assembly is configured to automate the advancement of at least one of the first electrode and the second electrode.

[0333] Aspect 39. A system described in any one of aspects 34 to 38, wherein the handle assembly is configured to automate the delivery of energy to at least one of the first electrode and the second electrode.

[0334] Aspect 40. A surgical instrument system for core-removing tissue from a target tissue site, comprising: a tissue resection device configured to core-remove tissue, the tissue resection device comprising: a first clamping element having a helical coil and a first electrode; a second clamping element having a second electrode and positioned opposite at least a portion of the first clamping element; and a cutting element configured to perform tissue transection; and operational logic configured to automate the use of one or more functions of the tissue resection device.

[0335] Aspect 41. The system described in Aspect 40, wherein the operational logic is configured to automate the advancement of at least one of the first electrode and the second electrode.

[0336] Aspect 42. The system of aspect 40 or 41, wherein the operational logic is configured to automate the delivery of energy to at least one of the first electrode and the second electrode.

[0337] Aspect 43. A system described in any one of aspects 40 to 42, wherein the operational logic is configured to determine the energy distribution provided via the tissue ablation device.

[0338] Aspect 44. The system of any one of aspects 40 to 43, wherein the operational logic is configured to receive one or more inputs related to one or more of the first clamping element, the second clamping element, or the cutting element.

[0339] Aspect 45. A system described in any one of aspects 40 to 44, wherein the operational logic is disposed within a handle assembly associated with the tissue resection device.

[0340] Aspect 46. A system described in any one of aspects 40 to 45, wherein the operational logic is located within a generator in communication with the tissue ablation device.

[0341] Aspect 47. A surgical instrument system for core-removing tissue from a target tissue site, comprising: a tissue resection device configured to core-remove tissue, the tissue resection device comprising a helical coil electrode and a cutting element configured to cooperate with the helical coil electrode to effect tissue transection; and a handle assembly configured to facilitate interaction between tissue and the tissue resection device.

[0342] Aspect 48. The system described in Aspect 47, wherein the handle assembly facilitates connecting the electrodes to the generator.

[0343] Aspect 49. The system described in aspect 47 or 48, wherein the handle assembly facilitates connecting the electrodes to a computing device.

[0344] Aspect 50. A system described in any one of aspects 47 to 49, wherein the handle assembly facilitates connecting the electrodes to a robotic system.

[0345] Aspect 51. A system described in any one of aspects 47 to 50, wherein the handle assembly is configured to automate the advancement of the electrode.

[0346] Aspect 52. A system described in any one of aspects 47 to 51, wherein the handle assembly is configured to automate the delivery of energy to the electrode.

[0347] Aspect 53. A surgical instrument system for core-removing tissue from a target tissue site, the system comprising: a tissue resection device configured to core-remove tissue, the tissue resection device comprising a helical coil electrode and a cutting element configured to cooperate with the helical coil electrode to perform tissue transection; and operational logic configured to automate the use of one or more functions of the tissue resection device.

[0348] Aspect 54. The system described in Aspect 53, wherein the operational logic is configured to automate the advancement of the electrode.

[0349] Aspect 55. The system described in aspect 53 or 54, wherein the operational logic is configured to automate the delivery of energy to the electrodes.

[0350] Aspect 56. A system described in any one of aspects 53 to 55, wherein the operational logic is configured to determine the energy distribution provided via the tissue ablation device.

[0351] Aspect 57. The system described in any one of aspects 53 to 56, wherein the operational logic is configured to receive one or more inputs related to the tissue excision device.

[0352] Aspect 58. A system described in any one of aspects 53 to 57, wherein the operational logic is located within a handle assembly associated with the tissue excision device.

[0353] Aspect 59. A system described in any one of aspects 53 to 58, wherein the operational logic is located within a generator in communication with the tissue ablation device.

[0354] While what has been shown and described is considered 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 rotational control assembly configured to rotate the helical coil within the target tissue of the patient; a linear actuator comprising an actuator arm configured to translate to clamp a portion of a target tissue between one or more electrodes and a helical coil, the one or more electrodes are configured to deliver radio frequency energy to seal a portion of the target tissue clamped between the one or more electrodes and the helical coil; a linear actuator configured to deactivate the one or more electrodes after delivering radio frequency energy to unclamp a portion of the target tissue between the one or more electrodes and the helical coil; a ligation and cutting system comprising a knob and a machine wire, the machine wire configured to capture a distal end of a target tissue to sever the distal end of the target tissue; Device.

2. The device of claim 1 , wherein the helical coil is attached to a distal end of an outer tube.

3. The device of claim 1 , wherein the one or more electrodes include a first electrode embedded in a surface segment of a central tube and a second electrode disposed on a segment of the helical coil.

4. The device of claim 3 , wherein the central tube is slidably disposed within the outer tube.

5. The device of claim 3 , further comprising a cutting tube configured to move within the central tube to sever the seal in the target tissue.

6. The device of claim 1 , further comprising an anchor configured to secure to the target tissue.

7. The device of claim 6 , wherein the helical coil is configured to track along the anchor toward the target tissue.

8. The apparatus of claim 1 , wherein the rotational control assembly is configured to allow bidirectional rotation of the helical coil.

9. 2. The apparatus of claim 1, wherein the rotational control assembly is configured to rotate the helical coil a predetermined rotational distance such that a fluid conduit is captured in a helical portion of the helical coil and is movable to a flat portion of the helical coil.

10. 10. The apparatus of claim 9, wherein the linear actuator is configured to activate after the rotational control assembly rotates the helical coil a predetermined distance.

11. a controller in communication with the generator, the controller further comprising a controller configured to control a generator to supply radio frequency energy to the electrodes to seal the target tissue clamped between one or more of the electrodes and the helical coil.

2. The apparatus of claim 1.

12. 5. The apparatus of claim 4, wherein the ligation and cutting system is configured to deploy the mechanical wire to sever a distal end of the target tissue when the target tissue is located within the outer tube.

13. The device of claim 1 , wherein the ligating and cutting system includes a spring actuated to expose the machine wire.

14. The device of claim 1 , configured such that the target tissue is removed from the patient after the distal end of the target tissue is severed.

15. The device of claim 1 , wherein the target tissue is pulmonary tissue.

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