Tissue resection 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 and the benefit of U.S. Patent Application No. 63 / 035,913 filed on June 8, 2020 and U.S. Patent Application No. 63 / 042,124 filed on June 22, 2020, the entire contents of which are incorporated herein by reference in their entirety.

Background Art

[0002] In certain specific cases, it may be necessary to remove tissue from the body. As an example, cancerous or infected tissue may be removed from the body as part of treatment. Cancer is not a single disease, but a collection of related diseases that can essentially originate anywhere in the body. Common to all types of cancer is that once the body's cells begin to divide, they can proliferate rapidly without stopping and spread to surrounding tissues. Under normal circumstances, cells grow and divide to form new cells as the body needs. When cells are damaged or old, they die, and new cells replace the damaged or old cells. However, cancer disrupts this process. When afflicted 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 regenerate or proliferate rapidly without stopping, potentially forming growths called tumors.

[0003] Cancerous tumors are malignant, which means they can spread to or invade surrounding healthy tissue. Furthermore, cancer cells can divide and travel through the blood or lymphatic system to distant regions within the body. Benign tumors, unlike malignant tumors, do not spread to or invade surrounding tissues. However, they can grow large and cause damage. Both malignant and benign tumors can be removed or treated. Malignant tumors tend to recur. On the other hand, benign tumors may recur, but the possibility is much lower.

[0004] Cancer is a genetic disorder caused by changes in genes that control how cells function, particularly how they grow and divide. These cancer-causing genetic changes may be inherited, or they may develop over a person's lifetime as a result of errors during cell division, or due to DNA damage caused by exposure to certain environments, such as industrial / commercial chemicals or ultraviolet radiation. 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 regulating cell growth and division; and DNA repair genes, which, as their names suggest, are involved in repairing damaged DNA.

[0005] More than 100 different types of cancer have been identified. Cancer types can be named after the organ or tissue in which the cancer develops (e.g., lung cancer) or after the type of cells that formed it (e.g., squamous cell carcinoma). Unfortunately, cancer is a leading cause of death in both the United States and worldwide. According to the World Health Organization, the number of new cancer cases is projected 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, causing 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 carcinoma, is a malignant lung tumor that, if left untreated, can metastasize to adjacent tissues and organs. The majority of lung cancers are caused by long-term smoking. However, about 10% to 15% of lung cancer cases are not related to tobacco. These non-tobacco cases are almost always 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 are needed in the removal of tissue. [Overview of the project]

[0008] In cases where management of post-core removal bleeding is desirable, it may be desirable to remove tissue cores from other target tissue sites, including but not limited to the lungs, liver, pancreas, or gastrointestinal (GI) tract. Tissue cores may have a predetermined (e.g., pre-defined) shape (e.g., cylindrical) and dimensions based on a core removal device. Such core removal devices can be used to remove tissue cores of the same or substantially the same shape in a repeatable manner. Such core removal can be distinguished from other tissue removal methods, such as those using scissors or surgical scalpels, where the severed tissue does not have a pre-defined shape or dimensions.

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

[0010] In a particular embodiment, removing a tissue core from a tissue site may further include one or more of the following: locating a tissue lesion using one or more imaging modalities; traversing an instrument to a tissue site such as a tissue lesion (with and without image guidance); binding an instrument to a tissue lesion (e.g., by fixing it); gaining access to the tissue site (by incision, introduction through a port / trocar, or direct access via an opening procedure); introducing a tissue resection device into the tissue site (with and without using an anchor as a guide); creating or cutting a tissue core from a tissue site using a tissue resection device; removing the tissue core from the body (with and without leaving a cavity "access sleeve"); analyzing a tissue core sample (histology, ROSE, DNA sequencing, etc.); sealing a tissue cavity; removing some or all of the instruments; or closing a tissue access point.

[0011] In certain embodiments, removal of a tissue core from a tissue site and subsequent diagnosis may further include one or more of the following: locating a tissue lesion using one or more imaging modalities; traversing an instrument to a tissue site such as a tissue lesion (with and without image guidance); binding an instrument to a tissue lesion (e.g., by fixation); obtaining access to the tissue site (by incision, introduction through a port / trocar, or direct access via an opening procedure); introducing a tissue resection device into the tissue site (with and without using an anchor as a guide); creating or cutting a tissue core from a tissue site using a tissue resection device; removing the tissue core from the body (with and without leaving a cavity "access sleeve"); analyzing a tissue core sample (histology, ROSE, DNA sequencing, etc.); sealing a tissue cavity; removing some or all of the instruments; or closing a tissue access point.

[0012] In certain embodiments, the removal of a tissue core from a tissue site, subsequent diagnosis, and treatment management of confirmed malignancy may further include one or more of the following: locating a tissue lesion using one or more imaging modalities; trajectorying an instrument to the tissue lesion (with and without image guidance); binding an instrument to the tissue lesion (e.g., by fixation); obtaining access to the tissue site (by incision, introduction through a port / trocar, or direct access via an open procedure); introducing a tissue resection device to the tissue site (with and without using an anchor as a guide); creating or cutting a tissue core from a tissue site using a tissue resection device; removing the tissue core from the body (with and without leaving a cavity "access sleeve"); analyzing a tissue core sample (histology, ROSE, DNA sequencing, etc.); treatment management of the tissue, such as benign or malignant tissue; sealing a tissue cavity; removing some or all of the instruments; and closing a tissue access point.

[0013] A method for core removal of tissue may include placing a tissue resection device at a target tissue site, allowing the tissue resection device to resection the tissue core from the target tissue site, and removing the tissue core from the body, thereby creating a core cavity at the target tissue site. The tissue core contains at least a portion of the tissue lesion. Resection of the tissue core from the target tissue site may include mechanical dissection. Resection of the tissue core from the target tissue site may include delivery of radiofrequency energy. Resection of the tissue core from the target tissue site may include mechanical compression and delivery of radiofrequency energy. Resection of the tissue core from the target tissue site may include dissection with an energized wire. Resection of the tissue core from the target tissue site may include one or more of the following: mechanical compression, delivery of radiofrequency energy, delivery of microwave energy, delivery of ultrasonic energy, or dissection with an energized wire. Other resection devices and procedures may be used. The resection device may be configured to perform one or more of the following: mechanical compression, delivery of radiofrequency energy, delivery of microwave energy, delivery of ultrasonic energy, or dissection with an energized wire.

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

[0015] A method for removing tissue from a core may further include sealing the fluid ducts. By sealing the fluid ducts, the flow of fluids into the cavity core can be minimized. Sealing can be performed using at least mechanical compression. Sealing can be performed using at least high-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 compression or one or more of the following methods of energy delivery: high-frequency energy, microwave energy, ultrasonic energy, or thermal energy.

[0016] This disclosure relates to systems, devices, and methods for performing lung lesion removal. Lung needle biopsy is typically performed when abnormalities are found on imaging tests, such as X-ray or CAT scans. In lung needle biopsy, a fine needle is used to remove a sample of lung tissue, which is then examined under a microscope to confirm the presence of abnormal cells. Histological diagnosis is difficult for small nodules (less than 6 mm) and medium nodules (6 mm to 12 mm). CT-guided biopsy of peripheral lesions via the chest wall (80%) or bronchoscopy (20%) is performed with a clearance of 0.001 cm. 2 ~0.002cm 2 Because only diagnostic tissue is available, even when cancer is present, it can only be normally identified in 60% of small and medium nodules. Although bronchoscopy techniques and skills continue to evolve, the accuracy, specificity, and sensitivity of biopsies remain limited when dealing with small and medium nodules located around the lungs.

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

[0018] Nodules deeper than 2-3 cm from the lung surface, once identified as suspected cancerous, are difficult to locate and resect using laparoscopy or robotic lung-sparing techniques, despite pre-operative image-guided biopsy and localization. Therefore, surgeons perform thoracotomy or lobectomy to remove lung nodules 2-3 cm from the lung surface. Thoracotomy is an open surgical technique that removes part of a lobe, the entire lobe, or the entire lung. In pneumonectomy, the entire lung is removed. This type of surgery is clearly the most invasive. In lobectomy, the entire lung or the entire lobe is removed, making it a less invasive technique than removing the entire lung. All thoracoscopic lung surgery requires a trained and experienced thoracic surgeon, and the success of the surgery depends on the surgeon's experience.

[0019] All of these types of lung surgery are major surgeries that can have complications depending on the extent of the surgery and the patient's overall health. In addition to the decline in lung function associated with any of these procedures, recovery can take weeks to months. Open thoracotomy involves spreading the ribs, which increases postoperative pain. Video-assisted thoracic surgery is less invasive, but even so, a considerable recovery period may be required. Furthermore, once surgery is complete, systemic chemotherapy and / or radiation therapy may be necessary for complete treatment.

[0020] As mentioned above, fine-needle biopsy is not always fully helpful in diagnosis. Fine-needle biopsy procedures involve guiding a needle into three-dimensional space under two-dimensional imaging. Therefore, physicians may miss lesions. Also, even if the physician hits the correct target, the portion of the lesion removed through the needle may not contain cancerous cells or cells necessary to assess the invasiveness of the tumor. Needle biopsy removes enough tissue to create a smear on a slide. The device of this disclosure is designed to remove the entire lesion or a significant portion of it while minimizing the amount of healthy lung tissue removed. This has several advantages. First, the entire lesion can be examined to make a more accurate diagnosis without sampling errors, loss of cell fill, or deterioration of the overall structure. Second, because the entire lesion is removed, secondary procedures such as those mentioned above may not be necessary. Third, energy-based tumor resection, such as local chemotherapy and / or radiation, can be introduced through the cavity created by lesion removal.

[0021] In at least one embodiment, the disclosure defines a method for removing a tissue lesion, the method comprising binding to (e.g., fixing) the tissue lesion, creating channels within the tissue leading to the tissue lesion, creating a tissue core containing the tissue lesion, ligating the tissue core at a downstream ligation point of the tissue lesion, cutting the tissue core from the tissue between the ligation point and the tissue lesion, and removing the tissue core from the channels.

[0022] According to aspects of this disclosure, the sleeve can be inserted into the channel before or after the removal of the tissue core. The sleeve can also be fixed to the tissue. According to another aspect of this disclosure, local treatment can be performed through the sleeve.

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

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

[0025] The following drawings generally illustrate various examples discussed in the present disclosure by way of example, not by way of limitation. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] [Figure 1] FIG. 3 is a diagram illustrating an exemplary method according to the present disclosure. [Figure 2] FIG. 4 is a diagram illustrating an exemplary method according to the present disclosure. [Figure 3] FIG. 5 is a diagram illustrating an exemplary method according to the present disclosure. [Figure 4] FIG. 6 is a diagram illustrating an exemplary method according to the present disclosure. [Figure 5] FIG. 7 is a diagram illustrating a blade having an open channel. [Figure 6] FIG. 8 is a diagram illustrating the distal tip of the blade of FIG. 5. [Figure 7] FIG. 9 is a diagram illustrating the distal end of an air channel connected to a flexible or rigid tube. [Figure 8A] FIG. 10 is a diagram illustrating an exemplary trocar. [Figure 8B] FIG. 11 is a diagram illustrating an exemplary trocar. [Figure 9A] FIG. 12 is a diagram illustrating an exemplary trocar. [Figure 9B] FIG. 13 is a diagram illustrating an exemplary trocar. [Figure 10] FIG. 14 is a diagram illustrating an exemplary trocar. [Figure 11] FIG. 15 is a diagram illustrating a tissue excision device according to an embodiment of the present disclosure. [Figure 12] FIG. 16 is a cross-sectional view of the tissue excision device of FIG. 11. [Figure 13] FIG. 17 is a cross-sectional view of a tissue excision device according to an embodiment of the present disclosure. [Figure 14]This is a cross-sectional view of a tissue excision device according to one embodiment of the present disclosure. [Figure 15] This figure shows an exemplary anchor that can be used in a lesion removal method according to one embodiment of the present disclosure. [Figure 16] This figure shows a series of cutting blades for use in a lesion removal method according to one embodiment of the present disclosure. [Figure 17] This figure shows a tissue expander suitable for use in a lesion removal method according to one embodiment of the present disclosure. [Figure 18] This diagram shows an example workflow for tissue sample analysis. [Figure 19] This figure illustrates the application of an example system for sealing an organization. [Figure 20] This figure illustrates the application of an example system for sealing an organization. [Figure 21] Figures A through C illustrate the application of an example system for sealing an organization. [Figure 22] Figures A and B illustrate the application of an example system for sealing tissue. [Figure 23] Figures A through C illustrate the application of an example system for sealing an organization. [Figure 24] This figure shows an example of a treatment system and method related to this disclosure. [Figure 25] This figure shows an example of a treatment system and method related to this disclosure. [Figure 26] This figure shows an example of a treatment system and method related to this disclosure. [Figure 27] This figure shows an example of a treatment system and method related to this disclosure. [Figure 28] This figure shows an example of a treatment system and method related to this disclosure. [Figure 29] This figure shows an example of a treatment system and method related to this disclosure. [Figure 30] This figure shows an example of a treatment system and method related to this disclosure. [Figure 31] This is a flowchart illustrating one example of the method relating to this disclosure. [Figure 32] This figure shows an example of a handle design relating to this disclosure. [Figure 33] This figure shows an example of a rotational control assembly (e.g., a planetary gear assembly) relating to the present disclosure. [Figure 34] This figure shows a linear translation control assembly related to the present disclosure. [Figure 35] This figure shows the anchor position monitor related to this disclosure. [Figure 36] This figure shows an example of a ligation and cutting system relating to this disclosure. [Figure 37A] This figure shows an example of the method described in this disclosure. [Figure 37B] This figure shows an example of the method described in this disclosure. [Figure 38] This figure shows an example of a handle design in this disclosure. [Figure 39] This figure shows the rotation control assembly related to this disclosure. [Figure 40] This figure shows an example of a clamp relating to this disclosure. [Figure 41] This figure shows an example of a ligation and cutting system relating to this disclosure. [Figure 42] This figure shows an example outline and flowchart relating to this disclosure. [Modes for carrying out the invention]

[0027] This disclosure relates to a system and method for core removal of an organization. Various organizations and parts may benefit from the disclosed system and method.

[0028] The tissue core may have a predetermined (e.g., pre-defined) shape (e.g., cylindrical) and dimensions based on a core removal device. Such a core removal device can be used to remove tissue cores of the same or substantially the same shape in a repeatable manner. Such core removal can be distinguished from other tissue removal methods, such as those using scissors or surgical scalpels, where the cut tissue does not have a predetermined shape or dimensions.

[0029] Figure 1 shows an exemplary method which may include removing the core of a tissue from a tissue site. Such core removal may further include introducing a tissue excision device into the tissue site (102), cutting the core of the tissue, for example, creating a tissue core using a 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 Figure 2, removing the tissue core from the tissue site involves: locating the tissue lesion using one or more imaging modalities (202); traversing the instrument to the site of the tissue lesion, etc. (with and without image guidance) (204); attaching the instrument to the tissue lesion (e.g., by fixing it) (206); gaining access to the tissue site (by incision, introduction through a port / trocar, or direct access via an open procedure) (208); and introducing the tissue resection device into the tissue site (using an anchor as a guide). This may further include one or more of the following: using and without using a tissue excision device (210), creating a tissue core using a tissue excision device (212) or cutting a tissue core from a tissue site (214), removing a tissue core from a body (with and without leaving a cavity “access sleeve”) (216), analyzing a tissue core sample (histology, ROSE, DNA sequencing, etc.) (218), sealing a tissue cavity (220), removing some or all of the instruments (222), or closing a tissue access point (224).

[0031] As shown in Figure 3, the removal of the tissue core from the tissue site and subsequent diagnosis involve: determining the location of the tissue lesion using one or more imaging modalities (302); trajectory guiding the instrument to the site of the tissue lesion, etc. (with and without image guidance) (304); binding the instrument to the tissue lesion (e.g., by fixing) (306); obtaining access to the tissue site (by incision, introduction through a port / trocar, or direct access via an open procedure) (308); and introducing the tissue resection device into the tissue site (using and using anchors as guides). This may further include one or more of the following: (without using) (310), creating a tissue core using a tissue excision device (312) or cutting the tissue core from a tissue site, removing the tissue core from the body (with and without leaving a cavity “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 instruments (322), or closing the tissue access point (324).

[0032] As shown in Figure 4, the removal of the tissue core from the tissue site, subsequent diagnosis, and treatment management of confirmed malignancy involve: determining the location of the tissue lesion using one or more imaging modalities (402); trajectory guiding the instrument to the site of the tissue lesion, etc. (with and without image guidance) (404); attaching the instrument to the tissue lesion (e.g., by fixation) (406); obtaining access to the tissue site (by incision, introduction through a port / trocar, or direct access via an open procedure) (408); and introducing the tissue resection device to the tissue site (using an anchor as a guide). This may further include one or more of the following: using or not using a tissue excision device (410), creating a tissue core or cutting a tissue core from a tissue site using a tissue excision device (412), removing a tissue core from a body (with or without leaving a cavity "access sleeve") (414), analyzing a tissue core sample (histology, ROSE, DNA sequencing, etc.) (416), managing the treatment of tissue such as benign or malignant tissue (418), sealing a tissue cavity (420), removing some or all of the instruments (422), and closing a tissue access point (424).

[0033] This disclosure relates to a method and system for core removal of tissue. A method for core removal of tissue may include placing a tissue resection device at a target tissue site, causing the tissue resection device to resection the core of the tissue from the target tissue site, and removing the core of the tissue from the body. Removing the core of the tissue from the body can create a core cavity at the target tissue site. The core of the tissue may include at least a portion of the tissue lesion. Resection of the core of the tissue from the target tissue site may include mechanical dissection. Resection of the core of the tissue from the target tissue site may include delivery of high-frequency energy. Resection of the core of the tissue from the target tissue site may include mechanical compression and delivery of high-frequency energy. Resection of the core of the tissue from the target tissue site may include dissection with an energized wire. Resection of the core of the tissue from the target tissue site may include one or more of the following: mechanical compression, delivery of high-frequency energy, delivery of microwave energy, delivery of ultrasonic energy, or dissection with an energized wire. Other resection devices and procedures may be used. The excision device can be configured to perform one or more of the following: mechanical compression, delivery of high-frequency energy, delivery of microwave energy, delivery of ultrasonic energy, or decompression by energized wire.

[0034] This disclosure relates to a method and system for core removal of tissue and sealing a core cavity created by removing the tissue core. Such a method may include placing a filling material into the core cavity. The method may include applying pressure to a portion of the core cavity, such as a wall defining the core cavity. The method may include dissolving a portion of the core cavity, such as a wall defining the core cavity. The method may 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 method may include placing 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 involves 1) placing a fixation device in the tissue cavity, 2) placing a tissue access port in the tissue cavity, 3) placing a tissue sealing device in the tissue cavity (with or without a tissue access port, with or without guidance from the fixation device), 4) sealing at least a portion of the tissue cavity with the tissue sealing device, and 5) introducing filler material into the tissue cavity (with or without a filler material delivery device, with or without placing the tissue sealing device in the tissue cavity first, with or without removing the tissue sealing device after sealing at least a portion of the tissue cavity, and tissue A The method may include any combination or permutation of the following steps: (with or without an access opening), 6) positioning a cavity sealing material adjacent to the tissue cavity (with or without prior positioning 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, with or without prior introduction of the filling material into the tissue cavity), 7) positioning a cavity closure device adjacent to the tissue, and 8) closing the tissue cavity with the cavity closure device (with or without prior any combination or permutation of the above steps). As described herein, the method can be used to core and / or seal tissue at a variety of target sites. Although the lung is used as an example, it should not be limited thereto, and other target sites may be punctured or actively cored and benefit from the disclosed sealing method.

[0036] Imaging system Various systems, devices, and apparatus can be used to locate target sites, such as target tissue areas within the human body. For example, imaging systems such as computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), endoscopy, vision, electromagnetic, and / or X-ray imaging can be used.

[0037] CT In conventional X-ray systems, an X-ray beam is directed through an object, such as the human body, onto a flat X-ray photographic film. The X-ray beam is selectively absorbed by structures within the object, such as bones. Since the exposure of the X-ray film changes directly due to the transmission of X-rays through the body (and conversely, due to X-ray absorption), the resulting image provides an accurate representation of any structure within the object that absorbed 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] Images formed from X-rays are essentially shadows of structures within objects that absorb X-rays. As a result, 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 unclear. Furthermore, in medical applications, it is often very difficult to examine parts of the body, such as the lungs, which are mostly air when expanded and do not absorb many X-rays, using conventional X-ray systems.

[0039] Many of the limitations of conventional X-ray systems can be overcome by X-ray computed tomography, often referred to as CT. In particular, CT provides a three-dimensional view and imaging of structures and features that are not easily visible with conventional X-rays.

[0040] A CT scanning system 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 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, the 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 passing through the patient. Because the detectors are in the same plane as the X-ray source, the signals received by the detectors are essentially related to slices passing through the patient's body where the planes of the X-ray source and detectors intersect with the patient's body. The signal from the X-ray detector is then processed by a computer to generate an image of this slice, known in the art as an axial cross-section.

[0041] For example, it is possible to continuously emit X-rays in a full 360 degrees around the patient, and numerous features can be observed, but the overall technique is generally the same.

[0042] While the patient remains still, the platform moves along the longitudinal axis through the toroidal structure. During this movement, X-ray exposures of the portion of the patient being CT scanned are continuously performed. As the table moves during this process, different X-ray exposures are exposures of different slices of the portion of the patient being examined, and the images generated by the computer are a series of axial cross-sections showing the portion of the patient's body being examined in three dimensions. The spacing between adjacent CT cross-sections depends on the minimum size of the features to be detected. For detection with the highest resolution, the spacing between the centers of adjacent cross-sections should be less than approximately 2 mm.

[0043] Due to its superior imaging capabilities, the use of CT in medical imaging has grown rapidly in recent years, particularly with the advent of multislice CT. One application of medical CT is the detection and confirmation of cancer. However, the diagnostically superior information currently available in the axial CT section, especially the information provided by multidetector CT (where multiple slices are acquired per rotation of the gantry) which offers superior acquisition speed and volumetric resolution, enables the detection of potential cancer at the earliest and most treatable stage. For example, the minimum detectable size of a potentially cancerous nodule in the axial section of the lung is approximately 2 mm (1 / 10 inch), which is 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 these series of cross-sectional images to diagnose lung nodules. The radiologist's examination also determines whether these lung nodules are malignant or benign. If the radiologist is confident that the lung nodule is benign, further medical examinations may be avoided.

[0045] To enable accurate diagnosis of pulmonary nodules with a size comparable to that of a CT scanner, it may be advantageous to assist radiologists by combining CT scans with computer-aided diagnosis (CAD) schemes.

[0046] The procedures described herein 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 for real-time tracking of the needle trajectory, enabling the physician to make appropriate adjustments. This advantage results in shorter procedures with success rates comparable to or better than those achieved with standard intermittent CT imaging.

[0047] CT scans can be used to locate the target site of an anchor. CT scans can be used to reconstruct the 3D positioning of the target site relative to reference markers on the patient's body. This reconstructed 3D image of the CT slice can be loaded into a system that helps a physician orbit the device of this disclosure through the patient's body and / or help determine the best route for access.

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

[0049] In addition 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 device of this disclosure.

[0050] In one embodiment of this disclosure, a patient can be positioned in a CT scanner and a nodule can be imaged. Using standard CT-guided intervention techniques commonly used in CT-guided lung biopsies, an anchor needle can be advanced through the skin, chest wall, pleural cavity, and lung to the target tissue to be sampled. As the distal end of the anchor needle passes through the nodule or interstitial abnormality, an anchor member made of a shape-memory metal such as nitinol is advanced so as to emerge from the distal end of the needle.

[0051] Ultrasound Ultrasound probes can be used to facilitate the detection and / or localization of target tissue sites. An ultrasound probe consists of a piezoelectric transducer that generates ultrasound waves. These ultrasound waves are reflected differently from tissues based on their mechanical and structural properties. The reflected waves are then acquired through a receiver and interpreted to transform 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.

[0052] In addition to providing the location of a specific target tissue site, ultrasound can also distinguish tissue stiffness. This is crucial because tumors are known to have different mechanical and elastic properties than surrounding tissues. Therefore, ultrasound can enable rapid detection and imaging of tumor sites, in addition to providing details about the location, size, and other physical properties of the tumor site.

[0053] Ultrasound can also be in the form of a probe that can be inserted into the pleural cavity or guided through the bronchial cavity. The probe can also be in the form of a catheter configured to facilitate visualization. Such a catheter can be continuously rotated to obtain a complete 360-degree ultrasound map as the catheter advances through space (iVUS).

[0054] The tip has a lubricating 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, the lung can be drawn into the scope / probe, thereby activating a suction device around the periphery of the ultrasound probe to fix the area and lock the probe in place. The needle can then 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 high-flux electromagnets 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 differs from that of tumor tissue. For example, tumors typically have a more sophisticated blood supply and drainage system compared to normal tissue. This can be used to visualize target tissue sites. Depending on the characteristics of the target tissue, contrast agents may be added to increase the resolution of the imaging technique. Contrast agents may contain components that have a high dipole moment or that respond to changes in the surrounding magnetic field through motion, emission, or vibration.

[0056] Endoscope Endoscopes can be used to facilitate the visualization of target tissue sites. In particular, with regard to the lungs, endoscopes can be used within the chest, thereby eliminating the need for a large thoracotomy. Thoracoscopy is the use of a special observation instrument, usually a rigid endoscope, which is introduced through a thoracic fistula, or small hole placed between the ribs. Once the endoscope is positioned within the space surrounding the lung, known as the pleural cavity, an additional thoracic fistula can be formed to introduce additional instruments. These additional instruments include grasping instruments, cutting instruments, and / or cutting staplers, such as the Ethicon Endosurgery Endo GIA 45mm stapler. Using the endoscope and other instruments, a “triangulation” technique is employed, where, for example, the endoscope is used to observe when a grasping instrument is brought in from one direction, a stapler from another, and the tissue is cut by 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 a combination of wavelengths to obtain definitive results. Depending on the wavelength range used by the source, the penetration depth can vary, thus allowing for non-invasive imaging of target tissue sites. 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 target tissue sites. Alternatively, the light source can be mounted on the probe and guided through the patient's body to a point close enough to visualize the target tissue site. Such a probe can be advanced through the pleural cavity along the trachea and used to detect or visualize target tissue within the lungs.

[0059] These imaging techniques can be combined with other imaging modalities such as ultrasound and electrical detection to improve resolution.

[0060] In addition, external agents such as contrast agents, nanoparticles, and fluorescent agents can be administered to enhance the resolution or detection capability of visual imaging techniques.

[0061] Electromagnetic / Electric Potential / Impedance Electromagnetic probes can be used to visualize target tissue sites.

[0062] Electromagnetic induction probes can also be used to remotely control the trajectory guidance of probes to target tissue sites.

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

[0064] Bioelectrical impedance analysis (PIAS) concerns the measurement of how an organ or tissue responds to an additional applied current. The bioelectrical impedance parameters that can be recorded are resistance, reactance, and phase angle, and are determined for purposes such as blood flow and body composition (water and fat content, etc.). However, given that common health indicators and predictive tools tend to go beyond the stage where they are commonly used, there is physical evidence for the accumulation of at least the phase angle dimension as a PIAS criterion in body composition. Phase angle is generally recognized as, for example, the integrity of the cell membrane and the fluid index in intracellular or extracellular spatial distribution at the cellular level. Ongoing research suggests that phase angle may also reflect other biological attributes.

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

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

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

[0068] Reference markers made of materials that do not transmit X-rays, such as lead, can be placed on a patient's body to assist in guiding the trajectory to target tissue and to perform trajectory planning.

[0069] Orbit guidance system Various systems, devices, and apparatus can be used to guide instruments and / or devices along a trajectory to a target site, such as a target tissue site within the human body. For example, trajectory guidance systems such as Auris, robots, CT / ultrasound fusion, electromagnetic trajectory guidance, and fluorescence fluoroscopy can be used.

[0070] A tissue core removal system may comprise a tissue resection device equipped 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 may be configured to deliver energy to the tissue. The helical coil electrode may be configured to determine the electrical properties of the tissue. The tissue resection device may further comprise a first clamping element equipped with a helical coil electrode, a second clamping element equipped with a second electrode and positioned opposite at least a portion of the first clamping element, and a cutting element configured to detach the tissue. The tracking device may comprise one or more of an X-ray device, a computed tomography device, or a fluoroscopy device. Other devices and techniques may be used. The system may further comprise an anchor configured to guide the movement of the helical coil electrode. The system may further comprise a non-invasive anchor configured to guide the movement of the helical coil electrode. The system may further comprise computational logic configured to control the movement of the helical coil electrode. The system may further comprise computational logic configured to determine the target trajectory of the helical coil electrode. The system may further include computational logic configured to determine the amount of energy supplied by the helical coil electrode. The system may further include computational logic configured to determine the amount of energy supplied to the helical coil electrode. The system may further include computational logic configured to receive positional information indicating the position of the helical coil electrode and, at least based on the positional information, determine a deviation from a target path or target trajectory. The system may further include computational logic configured to receive positional information indicating the position of the helical coil electrode and, at least based on the positional information, determine a stopping point where tissue resection is intended to be performed.

[0071] A method for guiding the trajectory of a tissue resection device includes positioning the tissue resection device within the patient's body, wherein the tissue resection device is equipped with a helical coil electrode, and determining the position of the helical coil electrode in three-dimensional space. The method may further include controlling the 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 of the helical coil electrode and determining deviations from the target trajectory based at least on the determined position of the helical coil electrode. The method may further include determining the amount of energy delivered by the helical coil electrode based at least on the determined position of the helical coil electrode. The method may further include determining the amount of energy delivered to the helical coil electrode based at least on the determined position of the helical coil electrode. The method may further include determining a stopping point where the tissue resection is intended to be performed, based at least on the determined position of the helical coil electrode.

[0072] The trajectory guidance method and system may follow the logic shown in Figure 42. As shown, the processing unit 4202 can communicate with the graphical user interface (GUI) 4204 to display the current device path 4206 and / or the desired trajectory 4208. The desired trajectory 4208 can be calculated based on the target location 4210 and the entry point. Other inputs may be used. The entry point may be selected based on patient scan data 4212 or based on real-time device position feedback 4214. In addition, real-time device position feedback 4214 can be used to determine the current path 4206 for device trajectory guidance. The target location 4210 may be selected through the GUI 4204, or it may be directly input to the processing unit 4202, or it may be based on 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 may include a tissue resection device configured to core-remove tissue, comprising a helical coil electrode and a cutting element configured to cooperate with the helical coil electrode for tissue detachment; 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 intraluminal robotic procedures that provides improved ergonomics, utility, and trajectory guidance. Endoscopy is a widely used minimally invasive technique for both imaging and delivery of therapeutic agents to anatomical locations within the human body. Typically, flexible endoscopes are used to deliver tools to surgical sites within the body, for example, through small incisions or natural openings of the body (nose, anus, vagina, urinary tract, throat, etc.), where the procedure is performed. The endoscope may have imaging, illumination, and maneuvering capabilities at the distal end of a flexible shaft that allows for trajectory guidance of non-linear lumens or pathways.

[0076] Auris typically uses a sheath with a lumen having a controllable and articulated distal end, the sheath being mounted on a first robotic arm having at least 3DOF, preferably 6DOF or more. This embodiment also includes a flexible endoscope having a controllable and articulated distal end, a light source and video capture unit located at the distal end, and at least one extending work channel. The flexible endoscope is slidably positioned within the lumen of the sheath and mounted on a second robotic arm having at least 3DOF, preferably 6DOF or more. Furthermore, it 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 mounted on the first and second robotic arms, thereby mounting the sheath and the flexible endoscope to the first and second robotic arms, respectively. The modules provide a mechanism for maneuvering and operating the sheath and the flexible endoscope and receive power and other utilities from the robotic arms. The robotic arms are positioned such 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. Movement of the first and second robotic arms relative to each other, and movement relative to the patient, causes movement of the sheath relative to the flexible endoscope, and movement relative to the patient.

[0077] Robot / Electromagnetic orbital induction Robot-operated medical systems can be used to perform a variety of medical procedures, including minimally invasive procedures such as laparoscopy, and both percutaneous and non-invasive procedures such as endoscopic surgery.

[0078] Among endoscopic procedures, robot-operated medical systems can be used to perform bronchoscopy, ureteroscopy, gastrointestinal endoscopy, and the like. During such procedures, a physician and / or a computer system can guide medical instruments through the patient's luminal network. The luminal network may include multiple branched lumens (e.g., the bronchial network or renal network) or a single lumen (e.g., the gastrointestinal tract). The robot-operated medical system may include a trajectory guidance system that guides (or assists in guiding) medical instruments through the luminal network. This trajectory guidance can be performed using mechanical means such as those of Auris, or using electromagnets.

[0079] For minimally invasive percutaneous procedures, a robot-operable medical system can be used. The method involves advancing a first alignment sensor into a cavity through the patient's lumen. The first alignment sensor provides real-time position and orientation in free space. The alignment sensor is operated until it is positioned near an object. A percutaneous opening is created in the patient using a surgical instrument, and the surgical instrument includes a second alignment sensor that provides real-time position and orientation of the surgical instrument in free space. The surgical instrument is directed towards the object using data provided by both the first and second alignment sensors.

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

[0081] CT / fluorescence fluoroscopy and / or combination with ultrasound In conventional X-ray systems, an X-ray beam is directed through an object, such as the human body, onto a flat X-ray photographic film. The X-ray beam is selectively absorbed by structures within the object, such as bones. Since the exposure of the X-ray film changes directly due to the transmission of X-rays through the body (and conversely, due to X-ray absorption), the resulting image provides an accurate representation of any structure within the object that absorbed 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, in effect, shadows of structures within objects that absorb X-rays. Consequently, 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 examine parts of the body, such as the lungs, which are mostly air when expanded and do not absorb many X-rays, using conventional X-ray systems.

[0083] Many of the limitations of conventional X-ray systems are overcome by X-ray computed tomography, often referred to as CT. In particular, CT provides a three-dimensional view and imaging of structures and features that are not easily visible with conventional X-rays.

[0084] Tracking and / or trajectory guidance of the resection device of this 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 for real-time tracking of the needle trajectory, enabling the physician to make appropriate adjustments. This advantage results in 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 of an anchor. A CT scan can be used to reconstruct the 3D positioning of the target site relative to reference markers on the patient's body. This reconstructed 3D image of the CT slice can be loaded into a system that helps physicians trajectory guide the resection device through the patient's body and / or help determine the best route for access.

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

[0087] In addition, or as an alternative, CT scans can be combined with other imaging modalities, such as ultrasound or electromagnetic tracking of the tip, to facilitate trajectory guidance of the resection device. Other techniques may be used alone or in combination.

[0088] As a further example, an ultrasound probe can be used to facilitate the detection and / or localization of a target tissue site. The ultrasound probe may be equipped with 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 transform 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] In addition to providing the location of a specific target tissue site, ultrasound can also distinguish tissue stiffness. This can be important because tumors are known to have different mechanical and elastic properties than surrounding tissues. Therefore, ultrasound can enable rapid detection and imaging of tumor sites, in addition to providing details about the location, size, and other physical properties of the tumor site.

[0090] A system and method for traversing a probe to a location within a patient's body is described. The probe may comprise a needle, introducer, catheter, stylet, or sheath. Other probes may be used. The method may include visualizing a three-dimensional image of a region of the patient's body. For example, the three-dimensional image of a 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 be used. The method may include receiving a selection of a target location within the above three-dimensional image of a region of the patient's body. For example, receiving a target location may be done via interaction with a display device configured to output one or more of the visualization steps. Selection may be made using other inputs. 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 in 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) passing through the three-dimensional image of the region of the patient's body. The method may further include calibrating the preferred path preoperatively to compensate for anatomical displacements. Alternatively, or in addition, the method may further include calibrating the preferred path to compensate for displacement of anatomical structures during surgery. The method may include aligning a 3D image to the current actual position of a corresponding region of the patient's body. The method may include aligning the current actual position of the probe to the current actual position of the 3D image and the patient's body. The method may further include updating the alignment of the 3D image to the patient to compensate for displacement of anatomical structures. The method may include visualizing the preferred path of the probe simultaneously with indicating the current actual position of the probe in real time, so that simultaneous visualization allows the user to align the current actual position of the probe with the preferred path. As an example, indicating the current actual position of the probe may include the position of the probe in 3D space.As a further example, indication of the probe's current actual position may include a projected extension of the probe in three-dimensional space. The method may include updating and visualizing the indication of the probe's current actual position in real time as the probe is advanced to the target location. In addition, auditory or visual feedback output may be used to alert the user about information regarding proximity to the target location and / or proximity to important anatomical structures.

[0091] The procedures described herein 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 for real-time tracking of the needle trajectory, enabling the physician to make appropriate adjustments. This advantage results in shorter procedures with success rates comparable to or better than those achieved with standard intermittent CT imaging.

[0092] CT scans can be used to locate the target site of an anchor. CT scans can be used to reconstruct the 3D positioning of the target site relative to reference markers on the patient's body. This reconstructed 3D image of the CT slice can be loaded into a system that helps a physician orbit the device of this disclosure through the patient's body and / or help determine the best route for access.

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

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

[0095] In one embodiment of the present invention, a patient can be placed in a CT scanner and a nodule can be imaged. Using standard CT-guided intervention techniques commonly used in CT-guided lung biopsies, an anchor 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 anchor needle passes through the nodule or interstitial abnormality, an anchor member made of a shape-memory metal such as nitinol can be advanced so as to emerge from the distal end of the needle.

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

[0097] Magnetic resonance imaging or radio frequency-based trajectory guidance Magnetic resonance imaging (MRI), which can utilize the interaction between a magnetic field and nuclear spins to form two-dimensional or three-dimensional images, is superior to other imaging methods in many ways for soft tissue imaging, does not require ionizing radiation, and is usually non-invasive, making it widely used, particularly in the field of medical diagnosis.

[0098] For example, during an MRI, the patient's body is placed in a strong, uniform magnetic field B0, the direction of which simultaneously defines the axis (usually the z-axis) of the coordinate system to which the measurement is related. The magnetic field B0 can be excited (spin-resonated) by the application of an alternating current electromagnetic field (RF field) of a defined frequency (the so-called Larmor frequency or MR frequency), and depending on the magnetic field strength, it produces different energy levels for individual nuclear spins. From a macroscopic perspective, the distribution of individual nuclear spins generates an overall magnetization that can be deflected from equilibrium by the application of an electromagnetic pulse (RF pulse) of the appropriate frequency. The corresponding magnetic field B1 of this RF pulse extends perpendicular to the z-axis, and as a result, the magnetization precesses around the z-axis. This precession traces the surface of a cone, where the angle of the aperture is called the flip angle. The magnitude of the flip angle depends on the intensity and duration of the applied electromagnetic pulse. In the example of a so-called 90-degree pulse, the magnetization is deflected from the z-axis to the cross-section (90-degree flip angle).

[0099] After the RF pulse ends, the magnetization relaxes and returns to its original equilibrium state. The magnetization in the z-direction is rebuilt with a first time constant T1 (spin lattice or longitudinal relaxation time), and the magnetization perpendicular to the z-direction relaxes with a second, shorter time constant T2 (spin-spin or transverse relaxation time). Transverse magnetization and its changes can be detected by a receiving RF antenna (coil array) positioned and oriented within the inspection volume of a magnetic resonance inspection system, such that the change in magnetization is measured perpendicular to the z-axis. The attenuation of transverse magnetization is accompanied by dephaser, which occurs after RF excitation caused by local magnetic field inhomogeneity that facilitates the transition from an ordered state with the same signal phase to a state where all phase angles are uniformly distributed. Dephaser 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 the imaged object, such as a patient being examined, a constant magnetic field gradient extending along three principal axes is superimposed on a uniform magnetic field B0, resulting in a linear spatial dependence of the spin resonance frequency. The signal picked up by the receiving antenna (coil array) contains components of different frequencies that may be associated with different locations within the body. The signal data obtained 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. k-space data typically includes multiple lines acquired with different phase encodings. Each line is digitized by collecting a large number of samples. The set of k-space data is converted into an MR image by a Fourier transform.

[0101] Transverse magnetization dephases even in the presence of a constant magnetic field gradient. This process can be reversed, similar to the formation of RF-induced (spin) echoes, by appropriate gradient reversal, which forms so-called gradient echoes. However, in the case of gradient echoes, in contrast to RF refocused (spin) echoes, the effects of principal magnetic field inhomogeneity, chemical shifts, and other off-resonance effects are not refocused.

[0102] To improve spatial resolution, certain elements (nuclei) that provide higher contrast when excited by a magnetic field gradient can be used. Real-time visualization of anchor or excision devices may be achieved if the body of each device is made of such 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 a combination of wavelengths to obtain definitive results. Depending on the wavelength range used by the source, the penetration depth can vary, thus allowing for non-invasive imaging of target tissue sites. 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 target tissue sites. Alternatively, the light source can be mounted on the probe and guided through the patient's body to a point close enough to visualize the target tissue site. Such a probe can be advanced through the pleural cavity along the trachea and used to detect or visualize target tissue within the lungs.

[0105] These imaging techniques can be combined with other imaging modalities such as ultrasound and electrical detection to improve resolution.

[0106] In addition, or as an alternative, external agents such as contrast agents, nanoparticles, and fluorescent agents may be administered to enhance the resolution or detection capability of the visual imaging technique.

[0107] An example of the use of optical cameras is the use of endoscopes. Endoscopes can be used to facilitate the visualization of target tissue sites. In particular with respect to the lungs, endoscopes can be used in the chest, thereby eliminating the need for a large thoracotomy incision. Thoracoscopy is the use of a special observation instrument, usually a rigid endoscope, which is introduced through a thoracic fistula, or small hole placed between the ribs. Once the endoscope is positioned in the space surrounding the lung, known as the pleural cavity, an additional thoracic fistula can be formed to introduce additional instruments. Additional instruments include grasping instruments, cutting instruments, and / or cutting staplers, for example, the Ethicon Endosurgery Endo GIA 45mm stapler. Using endoscopes and other instruments, a “triangulation” technique is employed, where, for example, the endoscope is used to observe when a grasping instrument is brought in from one direction, a stapler is brought in from another direction, and the tissue is cut by the stapler and removed through one of the ports.

[0108] anchor Various anchoring devices can be used. The needle can be fixed to guide the core removal device. Non-invasive fixation can be used. For example, the needle can be advanced to the desired target site via the use of real-time or virtual image-guided procedures. The advancement process may be performed directly by human hands, manually by a person using a robotic arm, or autonomously guided by a robot for each digital 2D or 3D image. Once the desired position is achieved, the Nitinol finger can be engaged with the target tissue.

[0109] Fixed needle for guiding one or more devices Many medical procedures are performed through small tubes formed within the patient's tissues. These procedures are minimally invasive. To form a tube extending from outside the patient to a target inside the patient, an anchor is typically inserted during the initial stages of the procedure. In one example, such an anchor may extend from the surface of the patient's skin to the target. In a further example, later in the procedure, this initial insertion can be expanded to accommodate other medical devices required for the procedure.

[0110] In addition, local applications such as biopsy, thermal excision, or local injection of therapeutic substances are currently performed in combination with imaging methods such as ultrasound, X-ray, fluoroscopy, CT scan, MRI, vision, and optics. For example, when using an X-ray emitting device, the X-ray energy passes through the patient's body and strikes the fluoroscopy screen in different ways, exciting fluorescent materials such as calcium tungstate and generating a screen display of the body and anchors. The anchors, upon entering the patient, are visualized on the X-ray fluoroscopy device's display. These anchors may appear on the screen because they do not allow energy to pass through (i.e., they may be non-transparent).

[0111] These imaging modalities enable the visualization of anchor and target regions, allowing for the safe orientation and movement of targets relative to their target points. Furthermore, these visualization modalities also enable the proper positioning and / or repositioning of anchors.

[0112] non-invasive fixation In certain cases, it may not be necessary to core-remove tissue to access the target site. Examples of such cases include growing cancers or surface target sites where access has been established through previous biopsy procedures. In such cases, it may be possible to have non-invasive anchors that help guide the device along the desired trajectory.

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

[0114] In one embodiment, the anchor may be positioned on the surface of the patient's body and comprise a ring with embedded sensors. As the excision device is inserted through the ring, the sensors on the anchor track the position of the excision device in 3D space. For example, the sensors on the anchor can interact with sensors on the excision 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 embodiment, the anchor may be equipped with a hard stop that restricts the freedom of movement of the excision device. When the anchor is deployed, it can act as a guide for the insertion and advancement of the excision device. The advancement of the excision device may not require any imaging or monitoring and may rely on the hard stop of the anchor to advance the device and position it at the target location and position. As a further example, the anchor may have a sensor positioned along the body of the anchor. When the anchor is deployed, the sensor can monitor the advancement and position of the excision device and provide feedback thereon. Although an excision device is referred to, 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 orbit the anchor to a target location (such as a tissue location where core removal is desired). For example, the anchor may be positioned in the target lesion using CT technology similar to that used in guided needle biopsy. Other systems, such as imaging systems, such as ultrasound or X-ray, may also be used.

[0117] As a further example, a larger sheath needle may be positioned at the target site using CT techniques similar to those used in 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 so that it is positioned at the target site (e.g., the lesion). The sheath needle can then be removed. Other systems, such as imaging systems, e.g., ultrasound, X-ray, etc., may 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., the lung) and generate a 3D position of the target location (e.g., a lesion). The anchor may be guided to the target lesion based on the sensor position.

[0119] As a further example, a position sensor may be positioned on a larger sheath needle and configured to scan a target location (e.g., the lung) and generate a 3D position of the target location (e.g., a lesion). The sheath needle may be guided until its 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 can then be removed.

[0120] As a further example, a position sensor may be placed at the end of the anchor, and the position sensor may be positioned at the target lesion through the airway using Auris or another equivalent system. The anchor may be guided to the lesion based on the locations of the two sensors.

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

[0122] Tissue site access Various systems, devices, and apparatus can be used to provide or assist access to target sites, such as target tissue sites within the human body. For example, chest wall 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, the vacuum in the intrapleural space needs to be broken to access the pleural cavity through the chest wall without causing puncture to the lung. The chest wall 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 punctured. The intrapleural vacuum may be lost, and therefore the lung may be lowered to minimize the potential for damage to the pleura.

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

[0125] Hollow access sleeve After core removal and dissection of target tissue, and before removing the core removal device containing the target tissue, a cavity access sleeve can be placed on the outer diameter of the core removal device shaft to maintain access to the site where the target tissue was removed. Re-access to this site may be desirable for post-core removal treatment, such as subsequent surgery, cavity sealing, cavity dissolution, drug delivery, or the addition of a tissue location marking device for local chemotherapy. If the cavity access sleeve is not placed before removing the core removal device, re-access to the site of the removed target tissue may be difficult in organs with large movements, such as the lungs.

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

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

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

[0129] A compressed balloon catheter may be advanced over an anchor. Once the distal end of the balloon catheter reaches the target site, the balloon can be expanded to spread the tissue. The balloon may have a shape similar to an angiogenic balloon, or it may be configured to have square corners at its distal end. The balloon body 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 Figures 8–10. The trocar may be equipped with a trocar channel (e.g., trocar channel 802 in Figure 8B and / or trocar channel 902 in Figure 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 may be lost, and therefore the lung may be descended to minimize the possibility of damage to the pulmonary pleura. Once the lesion is successfully located, the target tissue lesion can be stabilized using a fixation device. The tissue core removal device can be introduced directly to the location of the target lesion using a trocar or, with or without guide anchors, under direct visualization, and tissue resection can be performed.

[0131] incision Access to the target tissue site can be achieved by open incision. In particular, in the case of the lungs, thoracotomy can be performed, which involves making a 300mm-450mm (12-18 inch) incision in the chest wall, then dividing or cutting the major back muscles to move them out of the way, partially removing the ribs, and positioning a rib spreader to provide the surgeon performing the operation with intrathoracic access. The advantage of thoracotomy is that the surgeon has excellent access to the intrathoracic structures and can directly see and feel the lungs and other structures. Once the lesion is successfully located, the target tissue lesion can be stabilized using fixation devices (e.g., as described above). Tissue core removal devices can be directly introduced to the location of the target lesion using an endoscope or under direct visualization with or without guide anchors, and tissue resection can be performed.

[0132] Tissue core removal Tissue can be core-removed or removed using a variety of methods, devices, and systems.

[0133] A method for removing a tissue lesion may include introducing a tissue resection device into a target tissue site, causing the tissue resection device to resection the core of the tissue from the target tissue site, and removing the core of the tissue from the body. The core of the tissue may include at least a portion of the tissue lesion. The method may further include creating a core cavity in the target tissue site. The method may further include inserting a sleeve into the core cavity. The method may further include delivering radiofrequency energy through the core cavity. The method may further include delivering chemotherapy through the core cavity. The method may further include delivering microwave radiation through the core cavity. The method may further include delivering thermal energy through the core cavity. The method may further include delivering ultrasonic energy through the core cavity. The tissue resection device may be configured to deliver radiofrequency energy. The tissue resection device may be configured to perform mechanical dissection. The tissue resection device may include mechanical compression and radiofrequency energy delivery. The method may further include cutting the core of the tissue from the target tissue site. As an example, the means for cutting the core of the tissue may include mechanical dissection. As further examples, means for cutting the tissue core may include the delivery of high-frequency energy. Means for cutting the tissue core may include mechanical compression and the delivery of high-frequency energy. Means for cutting the tissue core may include disconnection by energized wire. Other devices may also be used.

[0134] A method for removing a tissue core may include introducing a tissue resection device into a target tissue site, causing the tissue resection device to resection the tissue core from the target tissue site, and removing the tissue core from the body. The method may further include creating a core cavity in the target tissue site. The method may further include inserting a sleeve into the core cavity. The method may further include delivering radiofrequency energy through the core cavity. The method may further include delivering chemotherapy through the core cavity. The method may further include delivering microwave radiation through the core cavity. The method may further include delivering thermal energy through the core cavity. The method may further include delivering ultrasonic energy through the core cavity. The tissue resection device may be configured to deliver radiofrequency energy. The tissue resection device may be configured to perform mechanical dissection. The tissue resection device may be configured to perform mechanical compression and radiofrequency energy delivery. The method may further include cutting the tissue core from a target tissue site. Means for cutting the tissue core may include mechanical dissection. Means for cutting the tissue core may include delivering radiofrequency energy. Means for cutting the tissue core may include mechanical compression and delivery of high-frequency energy. Means for cutting the tissue core may also include severance by energized wire.

[0135] A method for removing a tissue core may include introducing a tissue resection device into a target tissue site. The tissue resection device may comprise one or more of a first clamping element comprising a helical coil and a first electrode, or a second clamping element comprising a second electrode. If a second clamping element is included, the second clamping element may be positioned to face at least a portion of the first clamping element. The method may further include causing the tissue resection device to resection a tissue core from a target tissue site and removing the tissue core from the body. The method may further include creating a core cavity in the target tissue site. The method may further include inserting a sleeve into the core cavity. The method may further include delivering radiofrequency energy through the core cavity. The method may further include delivering chemotherapy through the core cavity. The method may further include delivering microwave radiation through the core cavity. The method may further include delivering thermal energy through the core cavity. The method may further include delivering ultrasonic energy through the core cavity. The tissue resection device may be configured to resection a tissue core and include the delivery of radiofrequency energy. A tissue excision device can be configured to excise the core of tissue and includes mechanical dissection. A tissue excision device can be configured to excise the core of tissue and includes mechanical compression and delivery of high-frequency energy. The method may further include cutting the core of tissue from a target tissue site. Means for cutting the core of tissue may include mechanical dissection. Means for cutting the core of tissue may include delivery of high-frequency energy. Means for cutting the core of tissue may include mechanical compression and delivery of high-frequency energy. Means for cutting the core of tissue may include dissection by energized wire.

[0136] A method for sealing a body fluid duct may include puncturing a target tissue site, including at least a portion of at least one target body fluid duct, using a helical tissue sealing mechanism. The helical tissue sealing mechanism may comprise a helical puncture element and a clamping element. The method may include applying mechanical compression to at least one target body fluid duct using the helical tissue sealing mechanism and delivering energy to seal at least one target body fluid duct. The helical puncture element may comprise a clamping element. Mechanical compression may be applied between the helical puncture element and the clamping element. The method may further include a second clamping element. Mechanical compression may be applied between the first clamping element and the second clamping element. The delivered energy may include unipolar high-frequency energy. The delivered energy may include bipolar high-frequency energy. The delivered energy may include thermal energy. The delivered energy may include ultrasonic energy.

[0137] A method for sealing a fluid duct may include puncturing a target tissue site with a helical puncture element, adjusting the pitch of the helical puncture element to apply mechanical compression to the target tissue, and delivering energy to seal at least one fluid duct in the target tissue. The helical puncture element may comprise multiple tissue sealing electrodes. The delivered energy may include unipolar high-frequency energy, bipolar high-frequency energy, thermal energy, or ultrasonic energy.

[0138] A tissue excision device comprises 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 high-frequency energy for sealing the tissue, and a cutting element configured to detach at least a portion of the sealed tissue. The tissue excision device may further comprise 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 detach the tissue. The helical coil may comprise an adjoining first coil segment and a second coil segment. The first coil segment may generally include a planar open ring. The first coil segment may be helical and may have 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, and at least one of the first pitch and the second pitch may be variable. The first electrode may consist of at least a portion of the first clamping element. The second electrode may consist of at least a portion of the second clamping element. The helical coil may have a blunt tip. The first and second electrodes may have matching or substantially matching surface profiles. At least a portion of the cutting element may have a sharp edge. The cutting element may include at least one electrode configured to deliver high-frequency energy. The cutting element may include an ultrasonic blade. The tissue excision device may further include a second cutting element configured to cut the core of the tissue from a target tissue site. At least a portion of the second cutting element may have a sharp edge. The second cutting element may include at least one electrode configured to deliver high-frequency energy. The second cutting element may include a current-carrying wire.The second cutting element may include a suture. The tissue excision device may further include an actuator that can actuate the second cutting element to sever the tissue.

[0139] A tissue excision device may comprise a first clamping element having a helical coil positioned at its distal end; a second clamping element positioned opposite at least a portion of the first clamping element; first and second electrodes configured to deliver high-frequency energy for sealing the tissue; and a cutting element configured to detach at least a portion of the sealed tissue. The tissue excision device may further comprise 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 detach the tissue. The helical coil may comprise an adjoining first coil segment and a second coil segment. The first coil segment may generally include a planar open ring. The first coil segment may be helical and may have 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, and at least one of the first pitch and the second pitch may be variable. The first electrode may consist of at least a portion of the helical coil. The first electrode may consist of at least a portion of the first clamping element. The second electrode may consist of at least a portion of the second clamping element. The helical coil may have a blunt tip. The first and second electrodes may have matching or substantially matching surface profiles. At least a portion of the cutting element may have a sharp edge. The cutting element may include at least one electrode configured to deliver high-frequency energy. The cutting element may include an ultrasonic blade. The tissue excision device may further include a second cutting element configured to cut the core of the tissue from a target tissue site. At least a portion of the second cutting element may have a sharp edge.The second cutting element may include at least one electrode configured to deliver high-frequency energy. The second cutting element may include a current-carrying wire. The second cutting element may include a suture. The tissue excision device may further include an actuator that can operate to actuate the second cutting element to sever the tissue.

[0140] A tissue excision device may comprise a first clamping element comprising a helical coil and a first electrode, and a second clamping element comprising a second electrode and positioned to face at least a portion of the first clamping element. The first and second clamping elements may be configured to (a) deliver high-frequency energy for sealing the tissue, and (b) apply mechanical compression for tissue separation. The tissue excision device may further comprise 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 a cutting element to separate the tissue. The helical coil may comprise an adjoining first coil segment and a second coil segment. The first coil segment may generally include a planar open ring. The first coil segment may be helical and may have 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, and at least one of the first pitch and the second pitch may be variable. The first electrode may consist of at least a portion of the helical coil. The first electrode may consist of at least a portion of the first clamping element. The second electrode may consist of at least a portion of the second clamping element. The helical coil may have a blunt tip. The first and second electrodes may have matching or substantially matching surface profiles. At least a portion of the cutting element may have a sharp edge. The cutting element may include at least one electrode configured to deliver high-frequency energy. The cutting element may include an ultrasonic blade. The tissue excision device may further include a second cutting element configured to cut the core of the tissue from a target tissue site. At least a portion of the second cutting element may have a sharp edge.The second cutting element may include at least one electrode configured to deliver high-frequency energy. The second cutting element may include a current-carrying wire. The second cutting element may include a suture. The tissue excision device may further include an actuator that can operate to actuate the second cutting element to sever the tissue.

[0141] A surgical instrument system for tissue excision may comprise an end effector operable to cut and seal tissue, the end effector having a first electrode and a second electrode for sealing tissue, and a generator configured to supply power to the end effector. The end effector may comprise 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 high-frequency energy for sealing tissue, and a cutting element configured to detach at least a portion of the sealed tissue. The surgical instrument system may further comprise a controller communicating with the generator, the controller configured to control the generator based on at least one sensed operating state of the end effector to supply sufficient high-frequency energy to the first and second electrodes of the end effector to seal tissue. The controller may be configured to sense the presence of tissue in the end effector. The controller can be configured to sense the presence of tissue in the end effector based on measured impedance levels associated with the first and second electrodes. The controller can be configured to sense the amount of force applied to at least one of the first or second clamping elements in order to sense the presence of tissue in the end effector. The controller can be configured to sense the position of the cutting element relative to at least one of the first or second clamping elements. The controller can be configured to control the generator to supply high-frequency energy to the end effector when the second actuator is activated and no tissue is sensed in the end effector. The controller can be configured to control the generator to supply a continuous amount of high-frequency energy. The controller can be configured to control the generator to automatically increase or decrease the amount of high-frequency energy.The system may further include a first actuator capable of operating to apply mechanical compression to tissue by acting on a first or second clamping element, and a second actuator capable of operating to detach tissue by acting on a cutting element. The helical coil may comprise a 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 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, with at least one of the first and second pitches being variable. The first electrode may consist of at least a portion of the helical coil. The first electrode may consist of at least a portion of the first clamping element. The second electrode may consist of at least a portion of the second clamping element. The helical coil may have a blunt tip. The first and second electrodes may have matching or substantially matching surface profiles. At least a portion of the cutting element may have a sharp edge. The cutting element may include at least one electrode configured to deliver high-frequency energy. The cutting element may include an ultrasonic blade. The tissue excision device may further include a second cutting element configured to cut the core of the tissue from a target tissue site. At least a portion of the second cutting element may have a sharp edge. The second cutting element may include at least one electrode configured to deliver high-frequency energy. The second cutting element may include a current-carrying wire. The second cutting element may include a suture. The tissue excision device may further include an actuator that can operate to actuate the second cutting element to sever the tissue.

[0142] A tissue excision device may comprise 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 high-frequency energy for sealing the tissue, a first cutting element configured to detach at least a portion of the sealed tissue, a first ligation element and a second ligation element, and a second cutting element positioned between the first and second ligation elements. The tissue excision device may further comprise 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 detach the tissue. The helical coil may comprise an adjoining first coil segment and a second coil segment. The first coil segment may generally include a planar open ring. The first coil segment may be helical and may have 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, with at least one of the first and second pitches being variable. The first electrode may consist of at least a portion of the helical coil. The first electrode may consist of at least a portion of the first clamping element. The second electrode may consist of at least a portion of the second clamping element. The helical coil may have a blunt tip. The first and second electrodes may have matching or substantially matching surface profiles. At least a portion of the cutting element may have a sharp edge. The cutting element may include at least one electrode configured to deliver high-frequency energy. The cutting element may include an ultrasonic blade. The tissue excision device may further include a second cutting element configured to cut the core of the tissue from a target tissue site.At least a portion of the second cutting element may have a sharp edge. The second cutting element may include at least one electrode configured to deliver high-frequency energy. The second cutting element may include a current-carrying wire. The second cutting element may include a suture. The tissue excision device may further include an actuator that can operate to actuate the second cutting element to sever the tissue.

[0143] The tissue sealing mechanism may comprise a helical coil having a generally elliptical cross-section and a cone point located at its distal end; a first helical tissue sealing surface and a second helical tissue sealing surface 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 high-frequency energy for sealing the tissue. The helical coil may comprise an adjoining first coil segment and a second coil segment. The helical coil may have a blunt tip. The first and second electrodes may have substantially matching surface profiles. The first and second helical tissue sealing surfaces may further comprise a plurality of electrodes configured to deliver bipolar high-frequency energy.

[0144] Figures 11 to 17 show examples of devices that can be used to achieve a core removal process as described herein. For example, the excision device of the present invention may have an energy-based configuration that can penetrate tissue toward a target lesion. In one embodiment shown in Figure 11, the tissue excision device 1100 comprises an outer tube 1105 which may have a distal edge profile and an inner diameter IDouter. A coil 1110 can be attached to the outer tube 1105, with the coil winding portion facing the distal end of the outer tube 1105 at a distance. Preferably, the coil 1110 has a slightly blunt tip 1115 that is sharp enough to penetrate tissue such as the pleura and parenchyma, while minimizing the possibility of penetrating blood vessels. In some embodiments, the coil 1110 may take the form of a helical with a constant or variable pitch. The coil 1110 may also have a variable cross-sectional shape. An electrode 1130 may be placed on the surface or embedded within the coil 1110.

[0145] In some embodiments, as shown in Figure 11, the coil 1110 may include a plurality of interconnected coil segments, for example, coil segments 1120 and 1125. The coil segment 1120 may comprise a generally planar open ring structure having a helical member with zero pitch, for example, an inner diameter ID coil and an outer diameter OD coil. The coil segment 1125 may comprise a helical structure with a constant or variable pitch and a constant or variable cross-sectional shape. In this embodiment, the electrode 1130 may be placed on the surface of the coil segment 1120 or embedded therein.

[0146] A central tube 1200 can be provided, having a distal end with a marginal profile comprising one or more surface segments, and having an outer diameter ODcentral and an inner diameter IDcentral. As shown in Figure 12, the electrode 1205 can be positioned in or embedded within at least one of the surface segments. The central tube 1200 can be slidably positioned within the outer tube 1105, and the electrode 1205 can be positioned to overlap and face 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 clamp zone. According to one aspect of this disclosure, ODcentral > IDcoil and ODcoil > IDcentral. In some embodiments, ODcentral can be substantially equal to ODcoil. Thus, the central tube 1200 can advance toward the coil 1110 through the tissue clamp zone so that the electrode 1205 abuts against the electrode 1130.

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

[0148] To enable tissue resection, the resection device 1100 is inserted into the 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 the tissue in a manner similar to a cork screw. As the coil segment 1125 penetrates the tissue, the tube in its path can move to the planar coil segment 1120 or be pushed out of the coil 1110 for a subsequent turn. The coil tip 1115 can be made 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 tube placed in the tissue clamp zone is clamped between electrodes 1130 and 1205. The tube can then be sealed by applying bipolar energy to electrodes 1130 and 1205. Once the blood vessel is sealed, the cutting tube 1300 can advance to core the tissue to the depth reached by the outer tube 1105. By repeating the sealing and cutting process, a core of the desired size can be created.

[0149] According to one aspect of the present disclosure, the excision device may be further configured to incise a target lesion and seal the tissue adjacent to the incision. To facilitate incision and sealing, the central tube 1200 may be provided with a ligation snare 1230, a first ligation electrode 1215 and a second ligation electrode 1220, and a cutting snare 1225, as shown in Figure 13. As used herein, the term “snare” means a flexible line, e.g., string or wire. The inner wall surface of the central tube 1200 may include an upper circumferential groove route 1212 and a lower circumferential groove route 1214 positioned adjacent to the distal end. The first ligation electrode 1215 and the second ligation electrode 1220 may be positioned on the inner wall of the central tube 1200 such that the lower circumferential groove 1214 is between them. The upper groove path 1212 can be positioned axially above the ligation electrodes 1215 and 1220.

[0150] The ligation snare 1230 can be positioned in the lower circumferential groove 1214 and extends axially along the outer wall surface through the central tube 1200 to a snare operating mechanism (not shown). The cutting snare 1225 can be positioned in the upper circumferential groove 1212 and extends axially along the outer wall surface through the central tube 1200 to a snare operating mechanism (not shown). Multiple axially extending groove paths can be provided on the outer surface of the central tube 1200 to accommodate the cutting snare 1225 and the ligation snare 1230 and to communicate with the upper circumferential groove path 1212 and the lower circumferential groove path 1214. Furthermore, electrode leads for the ligation electrodes 1215 and 1220 can extend to an energy source via axially extending groove paths.

[0151] During operation, the excision device of this embodiment can remove and seal the tissue core. The cutting tube 1300 can be retracted to expose the ligation snare 1230, which is preferably made of a flexible line such as a suture. The ligation snare 1230 can engage with the tissue by hooking it and pulling it against the inner wall surface between the first ligation electrode 1215 and the second ligation electrode 1220. Then, bipolar energy can 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, and the cutting snare 1225 can be activated to cut the tissue core upstream of the point where the tissue was sealed (ligation point). In some embodiments, the cutting snare 1225 has a smaller diameter than the ligation snare 1230. A smaller diameter makes it easier to slice the tissue. Therefore, the excision 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 excision device of the present disclosure may be provided with a single snare positioned between ligation electrodes for both ligating and cutting tissue. In this embodiment, first, the single snare can pull the tissue against the inner wall surface of the central tube 1200 between the ligation electrodes 1215 and 1220. Next, bipolar energy is 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 may include a set of knots 1235 and 1240 that tighten under load, as shown, for example, in Figure 14. Ligation can be performed by retracting the cutting tube 1300 to expose the ligation snare 1230 and activating the ligation snare 1230 to capture tissue as the ligation knots tighten. Once tissue is captured, the cutting tube 1300 retracts further to expose the cutting snare 1225, and the cutting snare 1225 is activated to cut the tissue core upstream of the point where the tissue was captured.

[0154] Furthermore, this disclosure intends to provide a method and system for removing tissue lesions, such as lung lesions, using a resection device. The method generally includes fixing the lesion to be removed, creating a channel within the tissue leading to the target lesion, creating a tissue core containing the fixed lesion, ligating the tissue core and sealing the surrounding tissue, and removing the tissue core containing the lesion from the channel.

[0155] Fixation can be achieved by any suitable structure for fixing the device to the lung. Once the lesion is fixed, a channel can be created to facilitate the insertion of the resection device 1100. The channel can be created by making an incision in the lung region and inserting a tissue expander and a port into the incision. A tissue core containing the fixed lesion can be created. According to this disclosure, the resection device 1100 can be used to create a tissue core, ligate the tissue core, seal the tissue core, and cut 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 by tumor resection based on chemotherapy and / or energy such as radiation. As a further example, a cavity port can be positioned around the tissue resection device. When the device is removed from the tissue site, the cavity port may remain in place or may be removed.

[0156] The anchor shown in Figure 15 may be suitable for use when performing the method for removing tissue lesions described herein. The anchor may comprise an outer tube 1422 having edges sharp enough to puncture pleural tissue and lung without causing excessive damage, and an inner tube 1424 positioned within the outer tube 1422. One or more tines or fingers 1420 formed from or pre-molded 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 positioned above the inner tube 1424, and when the outer tube 1422 is retracted, the tines 1420 may take on a preformed shape as shown. According to this disclosure, the outer tube 1422 can be retracted after puncturing a lung lesion, thereby allowing the tines 1420 to engage with the lung lesion. Other suitable anchors may include coil and suction base structures.

[0157] The incision blade shown in Figure 16 is suitable for use when performing the method for 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 the insertion of a chest wall tissue expander. The incision blade 1605 can be used to make a wider incision. The incision blade 1605 may be continuous. The incision blade 1605 may include a central opening that allows the incision blade 1605 to advance coaxially along the anchor needle 1405 to make a wider incision in the chest wall, with each continuous blade being larger than the previous blade, thereby increasing the width of the incision.

[0158] The tissue expander shown in Figure 17 may be suitable for use when performing the method for removing tissue lesions described herein. The tissue expander may include any suitable device for creating a channel within organic tissue. In one exemplary embodiment, the tissue expander assembly includes a single cylindrical rod having a rounded end 1510 or a cylindrical rod having a rounded end and a rigid sleeve configuration 1515. Successive tissue expanders can advance coaxially along an anchor needle to create a tissue pathway or channel within 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 medial rod 1505 can be removed, leaving the rigid sleeve in the intercostal space between the ribs, creating a direct passage to the pulmonary pleura.

[0159] Any tissue resection device capable of penetrating lung tissue and creating a tissue core containing the target lesion may be suitable for use in carrying out the method for removing the tissue lesion described herein. The aforementioned tissue resection device 1100 is preferred herein.

[0160] Once the tissue resection device 1100 is removed, a small channel may be present in the lung from which the target lesion has been removed. This channel can be used to introduce an energy-based lysis device and / or local chemotherapy, depending on the results of the tissue diagnosis. Thus, the method and system of this disclosure can be used to ensure not only that an effective biopsy is performed, but also that the lesion is completely removed with minimal removal of healthy lung tissue.

[0161] Generator The electrical energy applied by the device of this 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 the RF energy through the tissue, which causes ionic agitation or friction, or in fact, resistance heating, thereby raising the temperature of the tissue. A clear boundary is formed between the affected tissue and the surrounding tissue, allowing the surgeon to perform surgery 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 devices of this disclosure are designed to work with any commercially available bipolar energy generator, such as an Enseal generator or a Bovie generator. The devices of this disclosure can be connected via an interface with a “brand-independent” generator adapter that enables device operation regardless of the proprietary brand of the generator used to deliver the high-frequency energy. In exemplary embodiments, the adapter can automatically identify a specific generator product to which any of the devices of this disclosure is connected, or can be manually identified with user assistance. The generator adapter can modify, adjust, or alter the generator output (which may have subtle characteristic differences depending on the specific generator used) to ensure optimal tissue sealing using the tissue core removal devices of this disclosure. The generator provides high-frequency power to drive the devices of this disclosure, such as electrosurgical core removal instruments used during open or laparoscopic surgery to cut and seal tubes and cut, grasp, and incise tissue. The generator has adaptive tissue technology that delivers intelligent energy for greater precision and efficiency.

[0163] Sample analysis Various systems, devices, processes, and instruments 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 method described provides a large tissue sample. Following the removal of the tissue core from the site of interest, the specimen can be analyzed for diagnostic purposes using any of the methods described below, either independently or in combination.

[0164] Figure 18 shows workflow 1800, an example of tissue sample analysis. As shown in Figure 18, tissue sample analysis may further include removing 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 may perform an additional pass (1810), and the cycle may continue starting from step 1802.

[0165] Rapid On-Site Evaluation (ROSE) Rapid on-site evaluation (ROSE) is a method for rapidly and in real time examining samples on hand. The use of ROSE during lung lesion biopsy sampling has been suggested to improve diagnostic rates. Reported benefits of ROSE include a reduction in the number of biopsies performed, lower procedural risk, and improved accuracy. The core of isolated tissue can be analyzed using the ROSE technique. Using ROSE, sample validity can be checked and a preliminary diagnosis established by performing rapid staining in the bronchoscopy 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-eosin (H&E) staining, which allows for the interpretation of biopsies.

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

[0168] Electron microscope Core-removed tissue samples can be evaluated using an electron microscope. Electron microscopy can be used to visualize structural details of cancer cells, providing 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. The core of isolated tissue can be analyzed using flow cytometry.

[0170] Image cytometry DNA imaging cytometry (DNA-ICM) is gaining attention in the diagnosis of various types of malignant cancer due to its diagnostic advantages, including objectivity, convenience, and high positive rates. Therefore, this technique is successfully used for lung biopsies. The core of the isolated tissue can be analyzed using imaging cytometry.

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

[0172] Gene expression microarrays The core of isolated tissue can be analyzed using gene expression microarrays. Microarray-based techniques are an ideal method for studying the effects and interactions of multiple genes in cancer.

[0173] Fluorescence in situ hybridization (FISH) The core of isolated tissue can be analyzed using FISH technology. FISH can be used to identify the location of specific genes on chromosomes, the number of copies of genes present, and any chromosomal abnormalities. This is 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 been previously demonstrated that small lung biopsy samples yield sufficient quality DNA and RNA, enabling high-quality NGS analysis. The core of isolated tissue can then be analyzed using NGS technology.

[0175] Atomic force microscopy The core of isolated tissue can be analyzed using atomic force microscopy. Atomic force microscopy (AFM) enables the investigation of cells and molecules at the nanometer scale. The physicochemical properties of living cells change when their physiological conditions change. Therefore, these physicochemical properties can reflect the complex physiological processes that occur within the cell. When cells are in the carcinogenic process and stimulated by external stimuli, their morphology, elasticity, and adhesion properties can change. AFM can perform surface imaging and ultrastructural observation of living cells with atomic resolution under near-physiological conditions, and collects force spectroscopic information that enables the study of the mechanical properties of cells. For this reason, AFM has the potential to be used as a tool for the analysis and diagnosis of lung biopsy samples.

[0176] Surface-enhanced Raman spectroscopy The core of isolated tissue can be analyzed using surface-enhanced Raman spectroscopy. Since each macromolecule (lipids, proteins, 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 to conventional Raman spectroscopy, the Raman scattering signal can be enhanced by approximately 4 to 15 times using surface-enhanced Raman spectroscopy (SERS) techniques. Studies have shown that the Raman enhancement effect can be obtained 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 This disclosure relates to a method for delivering a filling material, such as autologous blood, to a core site, which can be used to provide sealing and pneumostasis. For example, when a tissue specimen is core-removed and removed from the lung, it may be necessary to seal the core site and provide pneumostasis. In a further example, pneumostasis can be achieved in the same surgical session as the tissue removal.

[0178] This specification describes autologous blood as an example, but other fillers and additives can be used. For example, absorbable gelatin foam (e.g., SURGIFOAM®), biologically oxidized regenerated cellulose (ORC), and hemostatic aids such as fibrin / thrombin spray. As a further example, a patient may have a rare condition called hemophilia, in which the blood does not clot properly. Other patients may be taking anticoagulants that may inhibit the formation of blood clots. In such patients, thrombin and / or fibrinogen can be added to the autologous blood sample to help clot formation in order to seal the core-removed cavity. Reactive polyethylene glycol (PEG), ammonium sulfate, ethanol, calcium chloride, or magnesium chloride can also be added to the blood sample to help clot formation. Another source of blood used to seal the core-removed cavity is blood donation from another person or from a blood bank. Donation can be used with or without coagulants as described above.

[0179] Systems and / or methods for sealing tissue are described herein. Exemplary methods may include arranging a port to provide access to a target site. The target site may include biological tissue. The target site may include lung tissue. The target site may include core-removed tissue. The target site may include perforated tissue. Other sites may benefit from the methods disclosed.

[0180] Exemplary methods may include fixing the fixation device to the surface of the target site (e.g., via a port). Fixation can be performed by any suitable structure for fixing the device to the lung. Exemplary methods may include positioning the sealing device adjacent to the target site (e.g., via a port). Exemplary methods may include positioning the sealing device adjacent to the target site using the fixation device as a guide. The sealing device may comprise an inflatable balloon. The sealing device may comprise an inflatable balloon with an array of radio frequency (RF) electrodes configured to melt and seal tissue. The sealing device may comprise an inflatable balloon configured to seal tissue using a thermal fluid. The sealing device may comprise an inflatable balloon catheter. The sealing device may comprise an access port with an array of RF electrodes configured to melt and seal tissue. The sealing device may comprise at least one microwave ablation probe.

[0181] An exemplary method may include sealing the target site with a sealing device. Sealing the target site with a sealing device may include contacting at least a portion of the sealing device with a portion of the target site. An exemplary method may include placing the filler material adjacent to the target site. An exemplary method may include placing the filler material adjacent to the target site via a filler material delivery device such as a catheter. The filler material may include autologous blood, donated blood, recirculated blood, hemostatic agents such as fibrin and / or thrombin, biotissue adhesives such as Dermabond®, ORC, absorbable gelatin, or any combination thereof. The filler material may promote air leak closure. The filler material may further promote hemostasis. Other materials may be used. The sealing device may minimize leakage of the filler material from the target site.

[0182] As an illustrative example, the target site may include at least a portion of the lung. The lung can be compressed before the sealing device is placed adjacent to the target site. The lung can be ventilated while the sealing device is sealing the target site. The sealing device can be separated from the target site after the filling material has been placed (e.g., removed, separated, etc.).

[0183] Systems and / or methods for sealing are described herein. An exemplary method may include positioning a sealing device adjacent to a target site in the lung. The sealing device may be positioned adjacent to the target site while the lung is being compressed, but the lung can be ventilated. An exemplary method may include allowing the sealing device to seal the target site. An exemplary method may include positioning the sealing device adjacent to the target site using a fixation device as a guide. The sealing device may comprise an inflatable balloon. The sealing device may comprise an inflatable balloon with an array of RF electrodes configured to melt and seal tissue. The sealing device may comprise an inflatable balloon configured to seal tissue using a thermal fluid. The sealing device may comprise an inflatable balloon catheter. The sealing device may comprise an access port with an array of RF electrodes configured to melt and seal tissue. The sealing device may comprise at least one microwave ablation probe. An exemplary method may include positioning a filler material adjacent to the target site. An exemplary method may include positioning the filler material adjacent to the target site via a filler material delivery device, such as a catheter. The filling material may include autologous blood, donated blood, recirculated blood, hemostatic agents such as fibrin and thrombin, biotissue adhesives such as Dermabond®, ORC, and absorbable gelatin, or any combination thereof. The filling material can promote air leak closure. The filling material can further promote hemostasis. Other materials may be used. The sealing device can minimize leakage of the filling material from the target site.

[0184] Systems and / or methods for sealing are described herein. An exemplary method may include positioning a fluid delivery device at a target site in the lung. A sealing device may be positioned adjacent to the target site while the lung is being compressed. A sealing device may be positioned adjacent to the target site while the lung is being ventilated. An exemplary method may include positioning a filler material at the target site. An exemplary method may include separating the sealing device from the target site (e.g., removing, separating, etc.).

[0185] The sealing device may comprise an inflatable balloon. The sealing device may comprise an inflatable balloon comprising an array of RF electrodes configured to melt and seal tissue. The sealing device may comprise an inflatable balloon configured to seal tissue using a thermal fluid. The sealing device may comprise an inflatable balloon catheter. The sealing device may comprise an access port comprising an array of RF electrodes configured to melt and seal tissue. The sealing device may comprise at least one microwave ablation probe. The systems and / or methods described herein can achieve air leak closure by providing sealing with coagulated blood. An exemplary method may include placing a filler material adjacent to the target site. An exemplary method may include placing a filler material adjacent to the target site via a filler material delivery device such as a catheter. The filler material may include autologous blood, donated blood, recirculated blood, hemostatic adjuvants such as fibrin and thrombin, biotissue adhesives such as Dermabond®, ORC, and absorbable gelatin, or any combination thereof. The filler material may promote air leak closure. The filler material may further promote hemostasis. Other materials may be used. The sealing device can minimize leakage of the filler material from the target site.

[0186] The target site may include a cavity. The cavity can be closed, for example, after sealing. Closing the cavity may involve using bio-adhesives such as Dermabond®, tissue grafts, hemostatic sealing patches, staple closures, or sutures.

[0187] Figure 19 shows system 1900. System 1900 may include ports such as a chest port 1902 configured to provide access via channels to, for example, a part of the body. 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, a chest port 1902 is shown positioned adjacent to a rib 1906 to provide access to the patient's lung 1910. However, other sites may be used, and the chest port 1902 (or other ports) may not be necessary. An immobilization device 1904 can be fixed to tissue such as the lung 1910. An exemplary immobilization device is shown in Figure 6 for illustrative purposes. However, any suitable device can be used for immobilization to a target site 1912. As shown, the immobilization device 1904 extends through the pleura 1908 via the chest port 1902 and is fixed to tissue within the lung 1910. The immobilization device 1904 can be fixed (e.g., releasably coupled) to tissue at the target site 1912. The target site 1912 may include a portion of lung tissue from which a core has been removed, perforated, or removed. The fixation device 1904 can be placed on the target site 1912 while the lung is inflated. However, other processes can be performed while the lung is compressed.

[0188] Figure 20 shows an application of an exemplary sealing device 2000. The sealing device 2000 may comprise an inflatable balloon 2002. Other sealing mechanisms may be used. The sealing device 2000 may comprise and / or be in contact with a balloon catheter. The balloon catheter may be a single-lumen balloon catheter. The balloon catheter may be a multi-lumen balloon catheter. The sealing device 2000 may be positioned adjacent to the target site 2012. Thus, the sealing device 2000 can seal the target site 2012 to minimize the leakage of fluid or material from the target site 2012. As an example, a filler material 2004 may be placed in 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 sealing while the lung 110 is moving (e.g., inflating and deflating). The sealing device 2000 can be implemented when the lung 2010 is inflating or deflating.

[0189] Examples of sealing procedures are described herein and include, for example, filler material, melting, mechanical pressure, energy release (e.g., RF energy), and others. Sealing at least a portion of a core cavity in a target site with a sealing device may include contacting at least a portion of the sealing device with the wall defining the core cavity. Sealing at least a portion of a core cavity in a target site with a sealing device may include melting the wall defining the core cavity. Sealing at least a portion of a core cavity in a target site with a sealing device may include applying pressure to the wall defining the core cavity. The method may further include placing a filler material into the core cavity, and the sealing device may minimize leakage of the filler material from the core cavity. The filler material may include autologous blood. As an example, the target site may include at least a portion of the lung, and the method may further include compressing the lung before placing the sealing device adjacent to the target site. As a further example, the target site may include at least a portion of the lung, and the method may further include ventilating the lung while the sealing device seals the target site.

[0190] An exemplary system performing one or more of the methods of this disclosure may include a guide anchor. An exemplary system may include a single-lumen balloon catheter. An exemplary system may include a multi-lumen balloon catheter. An exemplary system may include a core removal device. After core removal by the core removal device, the anchor can be introduced into the tissue cavity to ensure access to the core removal site. The chest port can be removed and the lung can be compressed. The balloon catheter can be inserted into the anchor. Once the balloon catheter is in the pleural cavity, it can be inflated. The inflated balloon catheter can be moved forward and slightly pressed 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., 1 minute) to allow the blood to clot at the core site. Lung ventilation can be resumed. The inflated balloon catheter can be moved up and down with the lung while maintaining contact with the lung, allowing the blood to be held at the core site to promote further clotation. The balloon catheter can be deflated. The balloon catheter and anchor can be removed after a predetermined time (e.g., 3 minutes). The patient's own blood can coagulate at the core site, providing air leak closure.

[0191] In one embodiment, an anchor and / or balloon catheter can be used to deposit autologous blood at a core site while the lung is compressed. The anchor and / or balloon catheter can be removed immediately after the autologous blood has been delivered. The blood can be allowed to coagulate in place for a predetermined time (e.g., 5 minutes) before resuming lung ventilation.

[0192] An exemplary system can deliver the patient's own blood to the core site. Other filler materials can be used.

[0193] An exemplary system may allow the coagulated blood to provide a seal, thereby achieving air leak closure.

[0194] In one embodiment, a method and apparatus are provided in which a plug or a series of stitches are placed on a wire inside the chest in a compressed configuration. If it is desirable to seal the pleural cavity, the wire may be pulled back toward an operator, and the plug or stitches may be positioned opposite an internal opening in the body space. The apparatus can then be activated to insert the plug or stitches into the opening in the body space, causing the wire to break, thereby sealing the hole and preventing fluid leakage or air from being drawn 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 (cyanoacrylate, polyethylene glycol hydrogel, urethane-based adhesives, and other synthetic adhesives, etc.). The fluid may fill the volume of the tube and may be heated using RF energy or a laser to a temperature exceeding the temperature of the surrounding tissue, to a temperature sufficient to cauterize and seal the surrounding tissue. The combination of fluid and RF seals the surrounding tissue.

[0196] Various methods, apparatuses, and systems can be used to remove or eliminate the tissue core.

[0197] treatment Various treatments can be performed.

[0198] Figures 21 and 22 illustrate illustrative examples, but other methods of melting or energy release may be used to seal the tissue. For example, a molded 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, for example, RF, may then be applied to melt the cavity tissue wall.

[0199] Margin reduction Energy delivery devices are introduced into tissue cavities to deliver energy and eradicate cancerous tissue. Once the target tissue is core-removed and removed, the tissue walls of the cavities can be dissolved. For example, one of the following dissolution methods can be used.

[0200] Rotary melting probe Figures 21A to 21C illustrate exemplary applications. As shown, once the target site is hollowed out and the tissue core is removed, it may be necessary to ablate the tissue wall of the cavity. For this purpose, the following ablation methods can be used. For example, a rotational ablation probe can be used. Figure 21A shows a hollowed-out cavity 2112 within tissue 2110, with the cavity sheath 2102 in place and the cavity left open. Then, as shown in Figure 21B, a rotational probe 2100 can be inserted into the cavity sheath 2102. The probe 2100 may be equipped with an energy source such as an array of energy heads or a continuous energy strip. The energy can be in the form of microwaves, RF, or other output forms. Once the probe 2100 is in place, the cavity sheath 2102 can remain in place or be removed. Next, by applying energy while rotating the probe / energy head, continuous radial ablation can be applied to the cavity wall and bottom tissue 2110, as shown in Figure 21C.

[0201] Hot balloon catheter Figures 22A and 22B show exemplary applications. As illustrated, a thermal balloon catheter can be used. For example, the balloon catheter 2200 can be placed in a cavity 2212 formed within tissue 2210, and the cavity sheath can be removed to expose the cavity 2212 that needs to be melted, as shown in Figure 22A. The balloon 2200 can then be inflated with a thermal fluid or hot air / gas to melt the cavity wall tissue 2210, as shown in Figure 22B.

[0202] Figures 23A to 23C show exemplary applications. As illustrated, once the target site is hollowed out and the tissue core is removed, it may be necessary to seal the cut tissue wall of the cavity. Therefore, the following exemplary procedure can be used. The apparatus 2300 may comprise a fluid conduit 2301 and an inflatable absorbent balloon 2302. As shown in Figures 23A and 23B, the balloon 2302 can be coated on the outside with an absorbent bioadhesive to seal the tissue of the core-removed cavity after core removal. Once the deflated balloon 2302 can be positioned in the desired location, the balloon 2302 can be inflated with CO2 (or other fluid), for example, through the fluid conduit 2301, pressing the bioadhesive against the tissue wall of the core-removed cavity to achieve a seal that prevents air leakage. The CO2-filled balloon 2302 can be pressurized to an appropriate pressure and left inside the core-removed cavity.

[0203] Molded mesh catheter 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, such as RF, may then be applied to dissolve the cavity tissue wall.

[0204] microwave fusion Figure 24 shows an illustrative treatment system. A catheter probe 2402, including a microwave-emitting antenna 2404, can be inserted into a tissue cavity 2412 core-removed from tissue 2410, as shown in Figure 24. The probe generates high heat that melts (e.g., destroys) the target tissue.

[0205] Freezing and thawing Figure 25 shows an exemplary treatment system. The cryo-thaw probe 2502 can be inserted into the tissue cavity 2512 core removed from the target tissue 2510, as shown in Figure 25. The probe generates an extremely low temperature to thaw the target tissue 2510 within the cryo-thaw zone 2504.

[0206] Chemical ablation To promote damage to target cells, hypertonic saline gel, solid salt, and / or acetate gel can be implanted into the cavity.

[0207] Laser fusion (photofusion) A probe emitting a laser beam at a specific wavelength and pulse length can be inserted into the cavity. The emitted laser beam can be used to destroy target tissue within the cavity.

[0208] Ethanol dissolution 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 In the core-removed area, chemotherapeutic agents such as doxorubicin, fluorouracil, and / or cisplatin can be administered by direct injection of the drug into the core-removed tissue site.

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

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

[0212] Chemotherapy drug-eluting particles Chemotherapy drug-eluting particles can be delivered to core-removed tissue sites, thereby promoting controlled and 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 core-removed tissue sites.

[0213] Co-delivery of siRNA and chemotherapy drugs Chemotherapy drugs and small interfering RNAs (siRNAs) can be co-delivered to core-extracted 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 resistance mechanisms in cancer cells. For example, siRNA encapsulated in mesoporous silica nanoparticles can be co-delivered to target core sites together with doxorubicin.

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

[0215] Photodynamic therapy (PDT) A combination of chemotherapy drugs (sometimes multiple drugs) and photodynamic therapy (PDT) can be delivered directly to the core-removed tissue site. PDT is a therapeutic modality that relies on photosensitizers and light to generate reactive oxygen species (ROS) that kill cancer cells.

[0216] Biodegradable polymer / scaffold system Figure 30 shows an exemplary treatment system. A polymer system containing a chemotherapeutic agent can be delivered to the core-excised tissue site 3012 of the core-excised tissue 3010 via direct implantation. Porous biodegradable polymers, such as sponges or scaffolds 3002, can be designed to carry chemotherapeutic agents such as cisplatin. These polymers degrade over time, thereby releasing the chemotherapeutic agent at a controlled rate within the target site. The superior biodegradability of scaffolds, such as porous scaffolds, supports the sustained release of chemotherapeutic agents and overcomes the limitations of non-biodegradable systems that degrade after a specific period. Scaffolds 3002 can be manufactured in a manner convenient for surgical delivery, as shown in Figure 30.

[0217] Thermotherapy for tissue sites from which the core has been removed Hyperthermia can be used to treat desired core-removed tissue sites. Using this technique, core-removed tissue sites can be exposed to temperatures higher than normal to promote the selective destruction of abnormal cells, while minimizing side effects on healthy cells. For example, light-absorbing metal particles such as gold nanoparticles or iron oxide microparticles can be delivered to the core-removed tissue site. Then, by applying a short-pulse laser, cancer cells targeted by the metal particles can be killed.

[0218] control system This disclosure generally relates to an electrosurgical system configured to excise the core of tissue from a tissue site. This disclosure generally relates to an electrosurgical method for optimizing tissue core removal by employing multiple energy modalities based on tissue parameters, for example, based on the type of tissue being treated, and by employing simultaneous energy modalities based on tissue impedance and tissue parameters.

[0219] Depending on the specific instrument configuration and operating parameters, electrosurgical instruments can provide substantially simultaneous tissue cutting and hemostasis through the application of radiofrequency energy, preferably minimizing patient trauma. With respect to the excision device of this disclosure, the tissue sealing action can be achieved by clamping the tissue between a helical coil and a corresponding circular ring (referred to as a first clamping element and a second clamping element) and delivering radiofrequency 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, the cutting action is typically achieved by a blade tip (or cutting element). The element may be located at the distal end of the tissue core removal instrument. The device of this disclosure can be configured for open surgery use, laparoscopic surgery, or endoscopic surgery, including robot-assisted procedures.

[0220] Electrosurgical devices that apply electrical energy to tissue to treat and / or destroy it are also finding increasingly broad applications in surgical procedures. Electrosurgical devices typically include an instrument having a handpiece and distally mounted end-effectors (e.g., one or more electrodes). The end-effectors can be positioned relative to the tissue so that current can be introduced into the tissue. Electrosurgical devices can be configured to perform bipolar or unipolar operation. In bipolar operation, current can be introduced into and returned from the tissue by the active and return electrodes of the end-effectors, respectively. In unipolar operation, 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 positioned on the patient's body. The heat generated by the current flowing through the tissue can form a hemostatic seal within and / or between tissues, and thus may be particularly useful, for example, to seal blood vessels. The end-effectors of electrosurgical devices may also include cutting members that can be moved relative to the tissue and electrodes to sever the tissue.

[0221] The electrical energy applied by an electrosurgical device can be transmitted to the instrument by a generator that communicates 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 have a frequency range of 200 kilohertz (kHz) to 1 megahertz (MHz). When applied, the electrosurgical device can transmit low-frequency RF energy through the tissue, which causes ionic agitation or friction, or in fact, resistive heating, thereby raising the temperature of the tissue. Because a clear boundary can be formed between the affected tissue and the surrounding tissue, the surgeon can perform surgery 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 mainly composed of collagen and shrinks when in contact with heat.

[0222] The RF energy can be within the frequency range specified in EN 60601-2-2:2009+Al 1:2011, Definition 201.3.218-HIGH FREQUENCY. For example, the frequency in unipolar RF applications can typically be limited to less than 5 MHz. However, in bipolar RF applications, the frequency can be almost arbitrary. Frequencies above 200 kHz can typically be used in unipolar applications to avoid undesirable neuromuscular stimulation that may result from the use of low-frequency currents. Lower frequencies may be used in bipolar applications if risk analysis indicates that the possibility of neuromuscular stimulation has been reduced to an acceptable level. Frequencies above 5 MHz are generally not used to minimize problems associated with high-frequency 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 conventional medical devices is the inability to control and customize power output depending on the type of tissue being treated by the device. It is desirable to provide surgical instruments configured for tissue core removal that overcome some of the shortcomings of current instruments.

[0224] In one embodiment, a surgical instrument for excising the core of tissue can be provided, the surgical instrument comprising a processor and an end effector located at the distal end of the surgical instrument, the end effector being configured to interact with tissue, the end effector comprising a first clamp element and a second clamp element, a first electrode element and a second electrode element, a force sensor configured to communicate with the processor and measure the force applied to the tissue located between the first and second clamp elements, and a temperature sensor communicating with the processor, wherein the first and second electrode elements are configured to receive high-frequency energy from a generator and to deliver RF energy to the tissue interposed between the first and second clamp elements to seal the tissue, the processor being configured to determine the type of tissue interacting with the end effector based on the force applied to the tissue by the end effector and the rate of heat generated by the end effector, and to dynamically control the 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 output may be therapeutic, e.g., for tissue treatment, or less than therapeutic, e.g., for sensing only. The RF output may be applied to tissue, and the voltage and current, or a representation of the voltage and current, may be measured or estimated. The impedance may be calculated by determining the ratio of voltage to current.

[0225] In one embodiment, the tissue core removal instrument may comprise a controller and processing unit configured to optimize the delivery of radio frequency energy for tissue core removal by a) identifying the brand and / or model of an electrosurgical generator supplying power to 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 influence its operation. Identification of the device-connected generator may be achieved automatically by the controller or manually determined, identified, and / or selected by the user.

[0226] The controller may be integrated into the device, or it may be an external unit positioned in series between the device and the corresponding electrosurgical generator. The controller may further include a proprietary combination of connectors to enable "brand-independent" use of the device (i.e., the controller may include a modular connector system to ensure that the device can perform tissue core excision regardless of the type of generator used).

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

[0228] In addition, the controller and processing unit may serve other purposes, including providing an interface for connecting other devices or accessories such as displays, which visualize and communicate useful information to the user (e.g., progress of tissue sealing, device positioning relative to a target tissue site, appropriate device positioning and orientation, relevant device diagnostic data and error reporting, device misuse warnings, and trajectory guidance systems for determining the device position in 3D space and / or via various medical imaging modalities such as CT, MRI, and ultrasound).

[0229] In another embodiment, a custom generator configured to perform tissue core removal may include a controller and processing unit directly integrated into the generator. This exemplary tissue core removal electrosurgical generator may include an interface for connecting other devices or accessories, such as a display, to visualize and communicate useful information to the user, such as the progress of tissue sealing, device positioning relative to the target tissue site, appropriate device positioning and orientation, relevant device diagnostic data and error reporting, device misuse warnings, and a trajectory guidance system for determining the device position in 3D space and / or via various medical imaging modalities such as CT, MRI, and ultrasound.

[0230] For any exemplary surgical instrument configured to excise the core of tissue from a target tissue site as described above (i.e., a tissue core removal electrosurgical generator specifically configured to remove the core of tissue, an integrated controller within a tissue core removal device configured to influence RF energy delivery from the electrosurgical generator to optimize tissue sealing, or an external controller configured to influence RF energy delivery from the electrosurgical generator to the tissue core removal device), the RF energy delivery to the tissue may 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 state and therefore can be used to indicate the progress of coagulation cycles, tube sealing cycles, cuttings, etc. If the output is modulated so that the RF impedance follows a specific desired process of impedance change, the extension of this change in RF impedance may be used to form a desired treatment cycle. The desired process of impedance can be predetermined based on the operating parameters of the instrument to set the process of this procedure, or it can be determined by the surgeon's choice or by measurement of tissue parameters. The process of impedance can determine one or more of the following: output power, output waveform or waveform, energy mode or modality selection, or the point at which the application of energy to the tissue ends.

[0232] During tissue therapy, a parameterized tissue model can be fitted to the tissue. Parameters found within the model can be used to generate an optimal controller in real time and can also be correlated with specific tissue characteristics. This application provides real-time optimization for a generator control system based on RF impedance and real-time tissue evaluation.

[0233] These technologies can be used to model tissue in real time and develop controllers specific to particular tissue types in real time, maximizing sealing and minimizing tissue adhesion and cycle time. Furthermore, they provide control of the output of surgical instruments based on tissue properties and tissue changes during sealing and cutting cycles.

[0234] The RF output can be configured to supply electrosurgical energy to tissue via at least one electrode configured to apply electrosurgical energy to the tissue, a sensing circuit configured to measure the impedance of the tissue, and a controller programmed to drive the tissue impedance along the target impedance trajectory by determining whether a tissue response has occurred as a function of an impedance value and a predetermined rise in impedance, and based on the determination of the tissue response, generating a target impedance trajectory as a function of the measured impedance and a predetermined desired rate of change of impedance, and adjusting the output 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, wherein the tissue response corresponds to the boiling point of the tissue fluid, and the target impedance trajectory includes a plurality of target impedance values ​​for each of a plurality of time steps.

[0235] Figure 31 shows a schematic diagram and flowchart of device 3100, which would be able to advance to a target site, identify tumor tissue from normal tissue, and successfully treat or excise the tumor tissue. Device 3100 may comprise a processing unit 3102 and an external display 3104 (e.g., a graphical user interface (GUI)). 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. Processing unit 3102 may be further configured to receive device positioning information 3110 and confirm the current location of the tissue (3112). Processing unit 3102 may be further configured to confirm that device 3100 is at the target location (3114) and transmit such confirmation to a tissue sensing unit 3116. Processing unit 3102 may be further configured to activate the delivery of energy to the tissue site (3118). When energy delivery is activated, the processing unit 3102 may be configured to provide automatic advancement 3120 of device 3100 and provide new location information to the tissue sensing unit 3116. The processing unit 3102 may be configured to receive information from the tissue sensing unit 3116 and adjust energy delivery accordingly (3122). The processing unit 3102 may be further configured to provide instructions 3124 to device components for dissolving and / or excising tissue.

[0236] In one embodiment, a surgical instrument system for core-removing tissue from a target tissue site may comprise 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 a helical cryoelectrode for tissue detachment, and a handle assembly configured to facilitate interaction between the tissue and the tissue resection device.

[0237] In one embodiment, a surgical instrument system for core-removing tissue from a target tissue site may include a tissue resection device configured to core-remove tissue, comprising: a first clamping element having a helical coil and a first electrode; a second clamping element having a second electrode and positioned to face at least a portion of the first clamping element; and a cutting element configured to sever 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 the connection of at least one electrode, for example, at least one of a first electrode and a second electrode, to a generator. The handle assembly can facilitate the connection of at least one electrode, for example, at least one of a first electrode and a second electrode, to a computing device. The handle assembly can facilitate the connection of at least one electrode, for example, at least one of a first electrode and a second electrode, to a robotic system. The handle assembly can be configured to automate the forward movement of at least one electrode, for example, at least one of a first electrode and a second electrode. The handle assembly can be configured to automate the delivery of energy to at least one electrode, for example, at least one of a first electrode and a second electrode.

[0239] In one embodiment, a surgical instrument system for core-removing tissue from a target tissue site may comprise a tissue resection device configured to core-remove tissue, comprising a helical coil electrode and a cutting element configured to cooperate with a helical cryoelectrode for tissue detachment, and computational logic configured to automate the use of one or more functions of the tissue resection device.

[0240] In one embodiment, a surgical instrument system for core-removing tissue from a target tissue site includes 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 to face at least a portion of the first clamping element, and a cutting element configured to detach the tissue, and an arithmetic logic configured to automate the use of one or more functions of the tissue resection device.

[0241] The arithmetic logic can be configured to automate the advancement of at least one electrode, for example, at least one of a first electrode and a second electrode. The arithmetic logic can be configured to automate the delivery of energy to at least one electrode, for example, at least one of a first electrode and a second electrode. The arithmetic logic can be configured to determine the energy distribution delivered through the tissue excision device. The arithmetic logic can be configured to receive one or more inputs relating to the excision device, for example, one or more of a first clamp element, a second clamp element, or a cutting element. The arithmetic logic can be located within a handle assembly associated with the tissue excision device. The arithmetic logic can be located within a generator that communicates with the tissue excision device.

[0242] Handle design sequence A tissue core removal device having a helical coil and an anvil electrode is provided to track along an anchor to remove target tissue. Once the core removal device is positioned on the anchor and the distal tip of the helical coil is in contact with the tissue surface, a series of steps are performed to core the target tissue while simultaneously sealing the fluid channel. An exemplary method 3700, including the operation sequence, is shown for illustrative purposes in Figures 37A and 37B. The method may include a core removal procedure initiation step 3702. For example, the core removal device may be positioned on an anchor. Method 3700 may 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 based on the target tissue depth from the organ surface (for example, using an insertion stopper).

[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 over the anchor until the core removal device coil is above the pleura and centered around the anchor.

[0247] In step 3712, the advancement button can be actuated (for example, pressed).

[0248] In step 3714, the coil electrode can be rotated 5 / 4 turns through the organ surface (for example, the pleura of the lung). The first rotation of the coil electrode can engage the coil electrode into the tissue. When a helical coil electrode is used, a fluid duct that may be trapped in the helical portion of the helical coil can be moved to the flat portion of the helical coil.

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

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

[0251] In step 3720, a holding or waiting period of approximately 10 seconds can be initiated.

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

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

[0254] In step 3724, the warning can be dismissed by activating the warning button (for example, by pressing or selecting it).

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

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

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

[0258] After completing steps 3724-3730, method 3700 can return to step 3716.

[0259] If no receipt is received, the process may proceed to step 3716 and proceed as described herein.

[0260] In step 3732, the forward button can be activated (for example, pressed).

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

[0262] At step 3738, the blade tube can be rotated 1 / 2 turn to incise the cored tissue from the surrounding tissue. For example, the tissue core can be incised via the mechanical blade tube.

[0263] At step 3740, the blade tube can be retracted, and the coil electrode can be de-coupled.

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

[0265] If not locked, at step 3744, the coil electrode can be rotated 3 / 4 turn, and the method 3700 can return to step 3716.

[0266] If locked, the method 3700 can proceed to step 3746, where the advance button can be actuated (e.g., pressed).

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

[0268] At step 3750, the ligation suture can be pulled and held under tension.

[0269] At step 3752, one or more electrodes can be actuated. RF energy can be applied between the second set of electrodes to seal any fluid vessels within the ligation suture loop and between the electrodes.

[0270] At step 3754, a hold or wait period of about 10 seconds can be initiated.

[0271] At step 3756, the one or more electrodes can be deactivated. The anvil electrode can be separated from the helical electrode.

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

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

[0274] In step 3760, the cutting line can be activated to sever the core-removed tissue from the surrounding tissue. For example, the mechanical line can be deployed to sever the target tissue proximal to the ligation line.

[0275] In step 3762, the cavity port can be rotated clockwise downwards until resistance is felt.

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

[0277] In step 3766, the coil electrode can be rotated 3 / 4 counterclockwise. For example, a helical coil can be rotated so as to disengage it from the surrounding tissue.

[0278] In step 3768, the core removal device can be removed along with the core removed tissue (e.g., the target tissue sample).

[0279] In step 3770, the anchor can be released.

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

[0281] In step 3774, the core-removed tissue can be removed from the anchor for subsequent laboratory work on the tissue.

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

[0283] To reduce the number of manual steps required for a user to operate a tissue core removal device, a handle mechanism must be incorporated to drive the sequence of steps described above. The mechanism is controlled through electrical hardware enclosed within a device handle containing a core removal device gear mechanism, and a firmware sequence installed within a generator (also referred to as a controller). The sequence can have different input modes, such as operator action, forward, warning, etc. The following is a concept using these input modes to automate post-tissue core removal procedures.

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

[0285] A handle design 3200 is shown, for example, in Figure 32. As illustrated, the handle 3200 can be configured for a tissue core removal device having a helical coil and an anvil electrode, and may include dependent 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 positioned on the anchor and the distal tip of the helical coil is in contact with the tissue surface, the above-described series of steps are performed using a planetary gear system having three rotational states for rotating the coil and mechanical blade, a clamp camshaft 3202 for tube sealing, an optical anchor position monitoring mechanism for identifying when the core-removed target tissue is inside the mechanical blade tube, and an integrated bidirectional pulley system 3204 for ligation / cutting of the core-removed target tissue. The handle 3200 may further include 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 mechanisms are described in more detail below.

[0286] Figure 33 shows an exemplary rotation control assembly 3300 (e.g., a planetary gear assembly). The rotation control assembly 3300 shown in Figure 33 can be configured to control bidirectional rotation for the tissue core removal coil and unidirectional rotation for the mechanical blade tube 3310 using one motor control, requiring the system to maintain two degrees of freedom. To initialize the rotation of the coil and engage the coil with the tissue, the motor 3302 can be rotated counterclockwise, engaging the coil unidirectional bearing 3316 in series with the motor shaft 3304. Subsequently, the planetary gear mechanism can be actuated, rotating the ring gear 3306 clockwise and engaging it with the jack shaft 3322. Then, the jack shaft 3322 can be rotated counterclockwise to engage it with the coil tube gear 3312, allowing the coil to rotate by a predetermined rotational distance. To initialize the rotation of the mechanical blade tube 3310 for cutting the tissue core, the motor 3302 can be rotated clockwise, and the mechanical blade unidirectional 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 distance. To initialize the counterclockwise rotation of the coil and disengage the coil in the tissue, the manual clutch 3320 can be shifted to the upper position, and the conical clutch 3318 can be moved to contact the planetary gear system. Then, the motor 3302 can be rotated counterclockwise, and the coil unidirectional bearing 3316 in series with the motor shaft 3304 can be engaged. The planetary gear mechanism can be activated, and the ring gear 3306 can be rotated counterclockwise and engaged with the jack shaft 3322. Next, the jack shaft 3322 is rotated clockwise to engage with the coil tube gear 3312, allowing the coil to rotate by a predetermined distance.

[0287] Figure 34 shows a linear translation control assembly 3400 in the form of a clamp camshaft and pin mechanism. The clamp camshaft and pin mechanism shown in Figure 34 controls the linear translation of a mechanical blade tube (not shown) and a coil tube 3408 for tissue engagement, tube sealing, and incision. After the helical coil has been rotated a predetermined distance to engage with the target tissue, the camshaft 3402, which has a machined slot and is housed in a servo motor 3420, can be rotated clockwise. Subsequently, the coil cam pin 3404 can follow the cam path 3406, and the coil tube 3408 can be linearly translated to clamp the tissue between the helical coil and the anvil electrode to a predetermined gap that may be suitable for tube sealing. Then, the servo motor 3420 can 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 is rotated counterclockwise to separate the anvil electrode from the helical electrode and translate the mechanical blade tube out of the cutting position.

[0288] Figure 35 shows the anchor position monitor 3500. The anchor position monitor 3500 may be an optical anchor position monitoring mechanism that can actively monitor the location of the target core tissue on the anchor to the tissue core removal device through an optical sensor 3502 in series with the anchor. When the target tissue has been cored and is inside the mechanical blade tube, a pre-set marking on the anchor is in series with the optical sensor 3502 or optical sensing unit to warn the system that the tissue core removal device is in the optimal position. Then, a solenoid 3504 is fired and can engage with a spring-loaded anchor lock 3506 to lock the anchor position to the tissue core removal device.

[0289] Figure 36 shows 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 wires. As described with respect to Figures 33 and 34, once the target tissue enters the blade tube, the servo motor 3602 can be rotated clockwise. Then, the unidirectional bearing 3604 housed in the ligation pulley 3606 can be engaged, allowing the ligation machine wire to be deployed and the ligation claws 3608 to hold the line taut, thereby clamping the distal end of the target tissue between the second set of electrodes. After the high-frequency energy between the second set of electrodes to seal the fluid tube in the ligation loop is completed, the servo motor 3602 can be rotated counterclockwise, engaging the unidirectional bearing 3610 housed in the cutting pulley 3612, and deploying the cutting machine wire to cut the target tissue proximal to the ligation wire.

[0290] Figure 38 shows a handle design 3800 for a tissue core removal device comprising a helical coil and one or more anvil electrodes, and can be equipped with multiple attachments to the tissue core removal device for automatic rotation, tissue clamping, and ligation / cutting of target tissue. As described above, once the core removal device is positioned on an anchor and the distal tip of the helical coil is in contact with the tissue surface, the series of steps described above can be performed using two independent gear systems for the rotation of the coil and mechanical blade, a clamp actuator plate, and two independent spring load systems for ligation and cutting. The handle design 3800 can comprise 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 will be described in more detail below.

[0291] Figure 39 shows a rotation control assembly 3900. The rotation control assembly 3900 can be an independent gear system configured to control bidirectional rotation for a tissue core removal coil and a mechanical blade tube with two motor controls. To initialize the clockwise rotation of the coil (i.e., to engage the coil into the tissue), the coil stepper motor (e.g., coil stepper motor 3806 in Figure 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 tube, which is trapped in the helical portion of the helical coil, is moved to the flat portion of the helical coil. To initialize the rotation of the mechanical blade tube and to dissect the target tissue core, the blade stepper motor (e.g., mechanical blade stepper motor 3804 in Figure 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 initialize the counterclockwise rotation of the coil and disengage the coil into the tissue, the coil stepper motor can be rotated clockwise, the coil gear system 3902 can be put into operation, and the coil tube can be allowed to rotate by a predetermined rotational distance. The rotation control assembly 3900 may 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] Figure 40 shows an exemplary clamp 4000. The clamp solenoid plate controls the linear movement of the coil tube for tissue engagement and tube sealing. After the helical coil is rotated clockwise by a predetermined distance to engage with the target tissue, a linear actuator 4002 housed on the 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 into a predetermined gap suitable for tube sealing. At the end of the RF energy cycle, the linear actuator may be deactivated, and the coil tube may be released under gravity. The clamp 4000 further comprises a coil gear set 4006, a clamp plate housing 4008, and a linear actuator frame 4010.

[0293] Figure 41 shows an exemplary ligation and cutting system 4100. An independent spring load mechanism for ligation and cutting can control the deployment of the ligation and cutting machine wire. When the target tissue enters the blade tube, the ligation spring 4102 is engaged (e.g., pushed down by an operator), and the pin can rotate clockwise. The ligation and cutting system may further include a ligation knob 4104, a spring base 4106, and a locking path 4108. The spring-loaded pin can then be actuated to deploy the ligation machine wire, which can be held taut to clamp the distal end of the target tissue between a second set of electrodes. After the application of high-frequency energy to the electrodes of the second set for sealing the fluid tube with a ligation loop is complete, the cutting spring may be engaged (e.g., by the operator), and the pin may be rotated clockwise, thereby activating the spring-loaded pin and deploying the cutting machine line to cut the target tissue proximal to the ligation line.

[0294] This disclosure includes at least the following aspects:

[0295] Embodiment 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 the tissue, the end effector comprising a first clamping element configured to core-remove tissue and having a helical coil and a first electrode, a second clamping element having a second electrode and positioned to face at least a portion of the first clamping element, and a cutting element configured to detach the tissue.

[0296] Embodiment 2. The method according to Embodiment 1, further comprising determining the 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] Embodiment 3. The method according to Embodiment 2, wherein the tissue parameters include tissue impedance.

[0298] Embodiment 4. The method according to Embodiment 3, further comprising calculating the tissue impedance based on electrical parameters related to the first energy modality.

[0299] Embodiment 5. The method according to any one of Embodiments 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 the characteristics of the first and second energy modalities correspond to the type of interaction between the end effector and the tissue.

[0300] Embodiment 6. A method for core-removing tissue from a target tissue site, comprising: delivering a first drive signal to an end effector of a surgical instrument interacting with the tissue, the end effector comprising: a first clamping element configured to core-remove tissue and having a helical coil and a first electrode; a second clamping element having a second electrode and positioned to face at least a portion of the first clamping element; and a cutting element configured to detach the tissue; measuring tissue parameters of the tissue interacting with the end effector; modulating the delivery of the first drive signal based on the measured tissue parameters; and stopping the delivery of the first drive signal when termination parameters are met.

[0301] Embodiment 7. The method according to Embodiment 6, wherein the first drive signal is a radio frequency (RF) energy signal.

[0302] Embodiment 8. The method according to Embodiment 6 or 7, wherein the first drive signal is an ultrasonic energy signal.

[0303] Embodiment 9. The method according to any one of Embodiments 6 to 8, further comprising determining that the tissue is sealed based on at least one of the following: initial tissue impedance, initial opening defined by the jaw portion of the end effector, current tissue impedance, rate of change of tissue impedance, ultrasonic energy delivered to the tissue, radio frequency (RF) energy delivered to the tissue, or transaction time.

[0304] Embodiment 10. The method according to any one of Embodiments 6 to 9, wherein the first drive signal includes a first energy signal, and modulating the delivery of the first energy signal based on a 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 parameter.

[0305] Embodiment 11. The method according to any one of embodiments 6 to 10, further comprising stopping the delivery of the first drive signal when the tissue parameter satisfies or exceeds a threshold for the tissue parameter.

[0306] Embodiment 12. The method according to any one of embodiments 6 to 11, wherein the first drive signal includes 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 the tissue with a second amplitude different from the first amplitude.

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

[0308] Embodiment 14. The method according to any one of Embodiments 6 to 13, wherein measuring the tissue parameter includes measuring the rate of change of the tissue parameter.

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

[0310] Embodiment 16. The method according to Embodiment 15, wherein the state of the tissue includes coagulation, sealing, or cutting.

[0311] Embodiment 17. The method according to any one of Embodiments 6 to 16, wherein the delivery of the first drive signal to the end effector is modulated to change the tissue parameters according to a predetermined technique.

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

[0313] Embodiment 19. The method according to any one of Embodiments 6 to 18, wherein the tissue parameter is based on dividing the voltage measurement of the radio frequency (RF) energy by the current measurement of the RF energy.

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

[0315] Embodiment 21. A surgical instrument system for core-removing tissue from a target tissue site, comprising: a tissue resection device configured to core-remove tissue, comprising: a first clamping element having a helical coil and a first electrode; a second clamping element having a second electrode and positioned to face at least a portion of the first clamping element; and a cutting element configured to sever tissue; and a handle assembly with a trigger system, the handle assembly comprising: 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] Embodiment 22. The system according to Embodiment 21, further comprising a controller that communicates with the generator, the controller configured to control the generator to provide sufficient high-frequency energy to seal tissue to the first and second electrodes of the tissue excision device based on at least one sensed operating state of the tissue excision device.

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

[0318] Embodiment 24. The system according to Embodiment 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] Embodiment 25. The system according to Embodiment 23 or 24, wherein the controller is configured to sense the amount of force applied to at least one of the first clamp element or the second clamp element in order to detect the interaction of tissue with the tissue excision device.

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

[0321] Embodiment 27. The system according to any one of Embodiments 22 to 26, wherein the controller is configured to control the generator to provide a continuous amount of high-frequency energy.

[0322] Embodiment 28. The system according to any one of Embodiments 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 according to 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] Embodiment 30. The system according to any one of Embodiments 22 to 29, wherein the controller is configured to control the position of the cutting element relative to at least one of the first clamp element or the second clamp element of the tissue excision device.

[0325] Embodiment 31. The system according to any one of Embodiments 22 to 30, wherein the tissue excision device and the generator are connected to the handle assembly mechanically or electrically, at least in one way.

[0326] Embodiment 32. A method comprising arranging a core removal device on an anchor, wherein the core removal device includes 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 trapped 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 seal the tube between the electrodes; cutting the tissue core through the mechanical blade tube of the core removal device; separating the electrodes from each other; and repeating a cycle of rotating the helical coil, clamping the tissue between the electrodes, applying RF to seal the tube, cutting the tissue core, and separating the electrodes.

[0327] Embodiment 33. The method according to Embodiment 32, further comprising the steps of: deploying a ligation wire to constrict the distal end of the target tissue between a second set of electrodes once the target tissue has been core-removed and entered the blade tube; applying RF energy between the second set of electrodes to seal any fluid channels within the ligation wire loop and between the electrodes; deploying a mechanical wire to cut the target tissue proximal to the ligation wire; rotating the helical coil to disengage the helical coil from the surrounding tissue; and removing the core removal device together with the target tissue sample.

[0328] Embodiment 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 to face at least a portion of the first clamping element; and a cutting element configured to sever 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] Embodiment 35. The system according to Embodiment 34, wherein the handle assembly facilitates connecting at least one of the first electrode and the second electrode to the generator.

[0330] Embodiment 36. The system according to Embodiment 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] Embodiment 37. The system according to any one of embodiments 34 to 36, wherein the handle assembly facilitates connecting at least one of the first electrode and the second electrode to the robot system.

[0332] Embodiment 38. The system according to any one of embodiments 34 to 37, wherein the handle assembly is configured to automate the forward movement of at least one of the first electrode and the second electrode.

[0333] Embodiment 39. The system according to any one of embodiments 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] Embodiment 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 to face at least a portion of the first clamping element; and a cutting element configured to detach the tissue; and a system comprising: arithmetic logic configured to automate the use of one or more functions of the tissue resection device.

[0335] Embodiment 41. The system according to Embodiment 40, wherein the arithmetic logic is configured to automate the advancement of at least one of the first electrode and the second electrode.

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

[0337] Embodiment 43. The system according to any one of Embodiments 40 to 42, wherein the computational logic is configured to determine the energy distribution provided through the tissue excision device.

[0338] Embodiment 44. The system according to any one of Embodiments 40 to 43, wherein the arithmetic logic is configured to receive one or more inputs relating to one or more of the first clamping element, the second clamping element, or the cutting element.

[0339] Embodiment 45. The system according to any one of Embodiments 40 to 44, wherein the arithmetic logic is located within a handle assembly associated with the tissue excision device.

[0340] Embodiment 46. The system according to any one of Embodiments 40 to 45, wherein the arithmetic logic is located in a generator that communicates with the tissue excision device.

[0341] Embodiment 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 detach the tissue; and a handle assembly configured to facilitate interaction between the tissue and the tissue resection device.

[0342] Embodiment 48. The system according to Embodiment 47, wherein the handle assembly facilitates the connection of the electrodes to the generator.

[0343] Embodiment 49. The system according to Embodiment 47 or 48, wherein the handle assembly facilitates the connection of the electrodes to the computing device.

[0344] Embodiment 50. The system according to any one of Embodiments 47 to 49, wherein the handle assembly facilitates the connection of the electrodes to the robot system.

[0345] Embodiment 51. The system according to any one of Embodiments 47 to 50, wherein the handle assembly is configured to automate the forward movement of the electrode.

[0346] Embodiment 52. The system according to any one of Embodiments 47 to 51, wherein the handle assembly is configured to automate the delivery of energy to the electrodes.

[0347] Embodiment 53. 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 detach the tissue; and a system comprising: computational logic configured to automate the use of one or more functions of the tissue resection device.

[0348] Embodiment 54. The system according to Embodiment 53, wherein the arithmetic logic is configured to automate the advancement of the electrodes.

[0349] Embodiment 55. The system according to Embodiment 53 or 54, wherein the arithmetic logic is configured to automate the delivery of energy to the electrodes.

[0350] Embodiment 56. The system according to any one of Embodiments 53 to 55, wherein the computational logic is configured to determine the energy distribution provided through the tissue excision device.

[0351] Embodiment 57. The system according to any one of Embodiments 53 to 56, wherein the arithmetic logic is configured to receive one or more inputs relating to the tissue excision device.

[0352] Embodiment 58. The system according to any one of Embodiments 53 to 57, wherein the arithmetic logic is located within a handle assembly associated with the tissue excision device.

[0353] Embodiment 59. The system according to any one of Embodiments 53 to 58, wherein the arithmetic logic is located in a generator that communicates with the tissue excision device.

[0354] While the illustrations and descriptions represent what are considered to be the most practical and preferred embodiments, it will be apparent to those skilled in the art that deviations from the specific designs and methods described and illustrated may be suggested and used without departing from the spirit and scope of the invention. For example, systems, devices and methods for removing lesions from the lungs are described herein. Those skilled in the art will understand that the devices and methods described herein are not limited to the lungs but may be used for tissue resection and lesion removal in other areas of the body. The invention is not limited to the specific configurations described and illustrated and should be configured to be consistent with all modifications that may be included in the appended claims.

Claims

1. A tissue core removal device comprising: a helical coil including a first electrode; a central tube including a second electrode, wherein the second electrode is positioned opposite at least a portion of the first electrode; and a cutting tube configured to cut tissue; An anchor configured to be placed in the lung tissue of a patient and fixed to a target tissue, wherein the helical coil is positioned around the anchor such that the anchor is at its center, and is configured to move along the anchor toward the target tissue; A handle assembly configured to facilitate interaction between at least one of the helical coil, the central tube, or the cutting tube and the tissue, A rotational control assembly configured to rotate the helical coil within the target tissue of the patient; A linear actuator configured to clamp a portion of target tissue between the second electrode and the first electrode of the helical coil, The first electrode and the second electrode are configured to supply high-frequency energy to seal a portion of the target tissue clamped between the second electrode and the helical coil. A linear actuator configured to release a portion of the target tissue between the second electrode and the helical coil after the first electrode and the second electrode have supplied the high-frequency energy; An anchor lock configured to lock the position of the anchor relative to the tissue core removal device when the tissue core removal device is in a predetermined position relative to the target tissue; A ligation and cutting system comprising: a handle assembly having; a ligation and cutting system having a mechanical wire, wherein the mechanical wire is configured to grasp the distal end of a target tissue in order to cut the distal end of the target tissue; Device.

2. The apparatus according to claim 1, further comprising an outer tube, wherein the helical coil is coupled to the distal end of the outer tube.

3. The apparatus according to claim 1, wherein the first electrode is arranged on a planar segment of the helical coil, and the second electrode is embedded in the distal surface of the central tube.

4. The apparatus according to claim 3, further comprising an outer tube, wherein the central tube is slidably disposed within the outer tube.

5. The apparatus according to claim 3, wherein the cutting tube is configured to move within the central tube to cut the sealed portion of the target tissue.

6. The apparatus according to claim 1, wherein the rotation control assembly is configured to enable bidirectional rotation of the helical coil.

7. The apparatus according to claim 1, wherein the rotation control assembly is configured to rotate the helical coil by a predetermined rotational distance through the lung tissue such that a fluid tube in the lung tissue is captured by the helical portion of the helical coil and can move to the planar open ring of the helical coil.

8. The apparatus according to claim 7, wherein the linear actuator is configured to be activated after the rotation control assembly has rotated the helical coil a predetermined distance.

9. A controller that communicates with the generator, The controller further comprises a controller configured to control the generator to supply high-frequency energy to the first and second electrodes to seal the target tissue clamped between the second electrode and the helical coil. The apparatus according to claim 1.

10. The apparatus according to claim 4, wherein the ligation and cutting system is configured to unfold the mechanical wire and cut the distal end of the target tissue when the target tissue is located inside the outer tube.

11. The apparatus according to claim 1, wherein the ligation and cutting system includes a spring that operates to expose the mechanical wire from the cutting tube to the nearby tissue.

12. The apparatus according to claim 1, configured such that the target tissue is removed from the patient after the distal end of the target tissue has been severed.

13. The apparatus according to claim 1, wherein the target tissue is lung tissue.

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