KR20230117694A - Tissue ablation control system and method - Google Patents

Abstract

A method for removing tissue includes placing a tissue ablation device at a target tissue location, causing the tissue ablation device to ablate a core of tissue from the target tissue location, and removing the tissue core from a body; The step of removing the tissue core from the body creates a core cavity at the target tissue location.

Description

Tissue ablation control system and method

In some cases, tissue may need to be removed from the body. For example, cancerous or infected tissue may be removed from the body as part of treatment. Cancer is not a single disease, but rather a collection of related diseases that can originate essentially anywhere in the body. What is common among all types of cancer is that the body's cells do not stop and begin to divide, proliferating and potentially spreading to surrounding tissues. Normally, cells grow and divide to create new cells as required by the body, and when they are damaged or old they die and new cells replace the damaged or old cells, but cancer disrupts this process. With cancer, cells become abnormal, cells that should die do not and new cells form when they are not needed. These new cells regenerate or proliferate without stopping, forming growths called tumors.

Cancerous tumors are malignant, they spread or invade surrounding healthy tissue. In addition, cancer cells can separate and travel through the blood to distant areas in the body or to distant areas in the lymphatic system. Benign tumors, unlike malignant tumors, do not spread or invade surrounding tissue, but grow large and cause damage. Both malignant and benign tumors can be removed or treated. Malignant tumors tend to regrow, while benign tumors can, but are much less likely to regrow.

Cancer is a genetic disease in that it is caused by changes in the genes that control the way cells function, particularly how they grow and divide. Genetic changes that cause cancer can be inherited, or as a result of errors that occur as cells divide, or because of damage to DNA caused by some environmental exposures, such as industrial/commercial chemicals and ultraviolet light, throughout an individual's lifetime. can happen during Genetic alterations that cause cancer occur in three types of genes: proto-oncogenes, which are also involved in normal cell growth and division, and tumor suppressor genes, which are also involved in controlling cell growth and division. and, as the name implies, DNA repair genes involved in repairing damaged DNA.

More than 100 distinct types of cancer have been identified. Types of cancer may be named after the organ or tissue from which they originate, eg, lung cancer, or may be named after the type of cells that form them, eg, squamous cell carcinoma. Unfortunately, cancer is the leading cause of death both in the United States and worldwide. According to the World Health Organization, the number of new cancer cases will increase to 25 million per year over the next 20 years.

Today, lung cancer is one of the most common cancers. According to the World Health Organization's World Cancer Report 2014, lung cancer occurred in 14 million people worldwide and resulted in 8.8 million deaths, making it the most common cause of cancer-related death in men and the leading cause of cancer-related death in women. It made it the second most common cause of related deaths. Lung cancer or lung epithelial cancer is a malignant lung tumor that, if left untreated, metastasizes to neighboring tissues and organs. Although the majority of lung cancers are caused by long-term smoking, about 10 to 15 percent of lung cancers are not tobacco-related. These cases of non-smoking are most often caused by a combination of genetic factors and exposure to some environmental condition, including radon gas, asbestos, secondhand smoke, other types of air pollution, and other factors. The survival rate of lung cancer and other types of cancer depends on early detection and treatment.

Improvements in clearing tissue are desired.

This application claims the priority and 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, which are incorporated herein by reference. All are included here.

It may be desirable to remove a core of tissue from a target tissue location, including but not limited to lung, liver, pancreas, or gastrointestinal (GI) tract, for which it may be desirable to manage bleeding after coring. The core of the tissue may have a predefined (eg, predefined) shape (eg, cylindrical) and dimensions based on the coring mechanism. Such a coring mechanism can be used to core tissue cores of the same or substantially the same shape in a repeatable manner. Such coring can be distinguished from other tissue removal, such as with scissors or a scalpel, in which the cut tissue will not have a predefined shape or dimensions.

It may include removing the tissue core from the tissue location. Such coring may include introducing a tissue ablation device into a tissue location, using the tissue ablation device to create a core of tissue, removing the tissue core from the body to create a tissue cavity; and sealing the tissue cavity.

In some aspects, removing the core of tissue from the tissue location includes determining the location of the tissue lesion using one or more imaging modalities, navigating the instrument (with or without image guidance) into the tissue location, such as the tissue lesion. ( introducing the tissue ablation device into the tissue location (with or without the use of anchors as guides), using the tissue ablation device to create a core of tissue or cutting the tissue core from the tissue location, (cavity "access sleeve"). removing tissue cores from the body (with or without leaving), analyzing tissue core samples (tissue structure, ROSE, DNA sequencing, etc.), sealing tissue cavities, removing some or all instruments. It may further include one or more of the steps or steps of closing the tissue access point.

In some aspects, removing a core of tissue from a tissue location and subsequent diagnosis includes determining the location of a tissue lesion using one or more imaging modalities (with or without image guidance), tissue such as a tissue lesion (with or without image guidance). navigating the instrument into position, engaging (e.g., anchoring) the instrument to a tissue location, obtaining access to the tissue location (incision, introduction through a port/trocar, or direct access through an incision). introducing a tissue ablation device into the tissue location (with or without anchors as guides), creating a tissue core using the tissue ablation device or cutting the tissue core from the tissue location; removing the tissue core from the body (with or without leaving the cavity "access sleeve"), analyzing the tissue core sample (tissue structure, ROSE, DNA sequencing, etc.), sealing the tissue cavity, part or It may further include one or more of removing the entire instrument or closing the tissue access point.

In some aspects, the removal of a core of tissue from a tissue site, subsequent diagnosis and treatment management of an identified malignancy may include locating a tissue lesion using one or more imaging modalities (with an image guide or image navigating the instrument to a tissue location, such as a tissue lesion (without a guide), coupling (e.g., anchoring) the instrument to the tissue lesion, gaining access to the tissue location (via incision, port/trocar) direct access via introduction or lobotomy), introducing the tissue ablation device into the tissue location (with or without the use of anchors as a guide), using the tissue ablation device to create a tissue core or tissue core from the tissue location, removing the tissue core from the body (with or without leaving the cavity "access sleeve"), analyzing the tissue core sample (tissue structure, ROSE, DNA sequencing, etc.), positive or one or more of performing therapeutic management of the tissue, such as malignant tissue, sealing the tissue cavity, removing some or all of the instrument, and closing the tissue access point.

A method for coring tissue will include placing a tissue ablation device at a target tissue location, causing the tissue ablation device to ablate a core of tissue from the target tissue location, and removing the tissue core from the body. In addition, the step of removing the tissue core from the body creates a core cavity at the target tissue location. The tissue core includes at least a portion of the tissue lesion. Excising the core of tissue from the target tissue location may include mechanical transection. Abscising the core of tissue from the target tissue location may include delivery of radio frequency energy. Resecting the tissue core from the target tissue location may include mechanical compression and delivery of radio frequency energy. Excising the core of tissue from the target tissue location may include transverse cutting with an energized wire. Abscising the core of tissue from the target tissue location may include one or more of mechanical compression, delivery of radio frequency energy, delivery of microwave energy, delivery of ultrasonic energy, or transection with an energized wire. Other ablation devices and procedures may be used. The ablation device may be configured for one or more of mechanical compression, delivery of radio frequency energy, delivery of microwave energy, delivery of ultrasonic energy, or transverse cutting into an energized wire.

The method for coring tissue may further include inserting the sleeve into the core cavity to support a wall of the core cavity. The method for coring tissue may further include delivering radio frequency energy to at least a portion of a wall defining a core cavity. The method for coring tissue may further include delivering chemotherapy to at least a portion of a wall defining the core cavity. The method for coring tissue may further include delivering microwave energy to at least a portion of a wall defining the core cavity. The method for coring tissue may further include delivering thermal energy to at least a portion of a wall defining the core cavity. The method for coring tissue may further include delivering ultrasonic energy to at least a portion of a wall defining a core cavity.

The method for coring tissue may further include sealing a biological fluid vessel. It may include minimizing the flow of biological fluid into the core cavity. The sealing step can be effected using at least mechanical pressure. The sealing step can be effected using at least radio frequency energy. The sealing step can be effected using at least microwave energy. The sealing step can be effected using at least ultrasonic energy. The sealing step can be effected using one or more of compression or delivery of energy such as radio frequency, microwave, ultrasound, thermal energy.

The present disclosure relates to systems, apparatus and methods for performing pulmonary lesion removal. A lung needle biopsy is usually performed when abnormalities are found in imaging tests, such as X-rays or CAT scans. In a lung needle biopsy, a fine needle is used to remove a sample of lung tissue for examination under a microscope to determine the presence of abnormal cells. Histological diagnosis is challenging in small (<6 mm) and medium-sized (6-12 mm) nodules. CT-guided biopsy of peripheral lesions, either through the chest wall (80%) or by bronchoscope (20%) yields only 0.001-0.002 cm ² of diagnostic tissue, as such if cancer is present. It is successfully identified in only 60% of small and medium-sized nodules. Although bronchoscopy techniques and techniques continue to evolve, biopsy accuracy, specificity, and sensitivity will always be limited when dealing with small and medium-sized nodules in the periphery of the lung.

If the lesion is determined to be cancerous, a second procedure may be performed to remove the lesion, followed by chemotherapy and/or radiation. The second procedure is likely to involve lung surgery. This procedure is usually done through an incision between the ribs. There are several possible procedures depending on the condition of the cancer. Video-assisted chest surgery is a less invasive procedure for some types of lung cancer. It is performed through small incisions using an endoscopic approach and is usually used to perform wedge resections of smaller lesions close to the surface of the lungs. In a wedge resection, a portion of a lobe is removed. In sleeve resection, a portion of a large airway is removed thereby preserving more lung function.

Nodules deeper than 2-3 cm from the lung surface, when identified as suspected of cancer, are difficult to localize and resect using laparoscopic or robotic lung sparing techniques, despite pre-procedural image-guided biopsy and localization. Therefore, the surgeon performs a thoracotomy or lobectomy to remove lung nodules that are 2-3 cm from the lung surface. A thoracotomy is an open approach surgery in which part of a lobe, the entire lobe or the entire lung is removed. In pneumonectomy, the entire lung is removed. This type of surgery is obviously the most aggressive. In lobectomy, a lobe or entire section of the lung is removed and represents a less aggressive approach than removal of the entire lung. All thoracoscopic lung surgeries require trained and experienced thoracic surgeons, and the quality of surgical outcomes depends on surgical experience.

Any of these types of lung surgeries are major surgeries with possible complications depending on the size of the operation and overall health of the patient. In addition to the decline in lung function associated with any of these procedures, recovery can take weeks to months. With thoracotomy, enlargement of the ribs is required, which increases postoperative pain. Although video-assisted chest surgery is less invasive, there is still a significant recovery period. Additionally, once surgery is complete, complete cure may require systemic chemotherapy and/or radiation therapy.

As suggested above, it can be seen that fine needle biopsy is not exclusively diagnostic. The fine needle biopsy procedure involves guiding a needle in a three-dimensional space under two-dimensional imaging. Thus, the surgeon may miss the lesion or even when hitting the correct target, the section of the lesion removed via the needle may not contain cancerous cells or the cells required to assess the aggressiveness of the tumor. A needle biopsy removes enough tissue to create an indentation on a slide. Devices of the present disclosure are designed to remove entire lesions or a significant portion thereof, while minimizing the amount of healthy lung tissue removal. This offers several advantages. First, the entire lesion can be examined for a more accurate diagnosis without sampling errors, loss of cellular packing or confounding the overall architecture. Second, since the entire lesion is removed, the aforementioned secondary procedure may not be required. Third, energy-based tumor ablation, such as localized chemotherapy and/or radiation, can be introduced through the cavity created by the lesional ablation.

In at least one embodiment, the present disclosure provides a method comprising engaging (eg, anchoring) a tissue lesion; creating a channel in the tissue leading to the tissue lesion; creating a tissue core comprising tissue lesions; ligating the tissue core at a ligation point downstream from 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 channel.

According to aspects of the present disclosure, a sleeve may be inserted into the channel before or after removing the tissue core. The sleeve may also be anchored to tissue. According to another aspect of the present disclosure, localized treatment may be delivered through the sleeve.

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

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

The following drawings generally illustrate the various examples discussed in this disclosure by way of example, but not in a limiting manner.
1 shows an exemplary method according to the present disclosure.
2 shows an exemplary method according to the present disclosure.
3 shows an exemplary method according to the present disclosure.
4 shows an exemplary method according to the present disclosure.
5 illustrates a blade with an open channel.
6 illustrates the distal tip of the blade of FIG. 5;
7 illustrates the distal end of an air channel connected to a flexible or rigid tube.
8A-8B illustrate exemplary trocars.
9A-9B illustrate exemplary trocars.
10 illustrates an exemplary trocar.
11 illustrates a tissue ablation device according to an embodiment of the present disclosure.
12 illustrates a cross-sectional view of the tissue ablation device of FIG. 11 .
13 shows a cross-sectional view of a tissue ablation device according to an embodiment of the present disclosure.
14 shows a cross-sectional view of a tissue ablation device according to an embodiment of the present disclosure.
15 illustrates preferred anchors that may be used in a method for removing lesions according to one embodiment of the present disclosure.
16 shows a series of cutting blades for use in a method of removing a lesion, according to one embodiment of the present disclosure.
17 shows a tissue expander suitable for use in a method for removing a lesion according to one embodiment of the present disclosure.
18 depicts an exemplary workflow of tissue sample analysis.
19 illustrates an application of the exemplary system for sealing tissue.
20 illustrates an application of the exemplary system for sealing tissue.
21A, 21B and 21C illustrate applications of the exemplary system for sealing tissue.
22A and 22B illustrate applications of the exemplary system for sealing tissue.
23A, 23B and 23C illustrate applications of the exemplary system for sealing tissue.
24 illustrates exemplary treatment systems and methods according to the present disclosure.
25 illustrates exemplary treatment systems and methods according to the present disclosure.
26 illustrates exemplary treatment systems and methods according to the present disclosure.
27 illustrates exemplary treatment systems and methods according to the present disclosure.
28 illustrates exemplary treatment systems and methods according to the present disclosure.
29 illustrates exemplary treatment systems and methods according to the present disclosure.
30 illustrates exemplary treatment systems and methods according to the present disclosure.
31 illustrates a flow diagram of an example method according to this disclosure.
32 illustrates an exemplary handle design according to the present disclosure.
33 illustrates an exemplary rotation control assembly (eg, planetary gear assembly) according to the present disclosure.
34 illustrates a linear translation control assembly according to the present disclosure.
35 illustrates an anchor position monitor according to the present disclosure.
36 illustrates an exemplary ligation and cutting system according to the present disclosure.
37A-37B illustrate example methods according to the present disclosure.
38 illustrates an exemplary handle design of the present disclosure.
39 illustrates a rotation control assembly according to the present disclosure.
40 illustrates an exemplary clamp according to the present disclosure.
41 illustrates an exemplary ligation and cutting system according to the present disclosure.
42 illustrates an example, schematic diagram and flow diagram according to the present disclosure.

The present disclosure relates to systems and methods for coring tissue. A variety of organizations and locations can benefit from the disclosed systems and methods.

The core of the tissue may have a predefined (eg, predefined) shape (eg, cylindrical) and dimensions based on the coring mechanism. Such a coring mechanism can be used to core tissue cores of the same or substantially the same shape in a repeatable manner. Such coring can be distinguished from other tissue removal, such as with scissors or a scalpel, in which the cut tissue will not have a predefined shape or dimensions.

1 shows an exemplary method that may include removing a core of tissue from a tissue location. Such coring may include introducing a tissue ablation device into the tissue location (102), e.g., using the tissue ablation device to cut a core of tissue to create a core of tissue (104), removing the tissue core from the body. to create a tissue cavity ( 106 ) and seal the tissue cavity ( 108 ).

As illustrated in FIG. 2 , removing a core of tissue from a tissue location includes using one or more imaging modalities to determine the location of the tissue lesion 202 , (with or without an image guide) the tissue lesion. navigating the instrument to a tissue location (204), coupling (eg, anchoring) the instrument to a tissue lesion (206), obtaining access to the tissue location (through an incision, port/trocar), 208) introducing the tissue ablation device into the tissue location (with or without the use of an anchor as a guide) 210 using the tissue ablation device Creating a core or cutting the tissue core from the tissue location (214), removing the tissue core from the body (216) (with or without leaving the cavity "access sleeve"), analyzing the tissue core sample ( tissue structure, ROSE, DNA sequencing, etc.) (218), sealing the tissue cavity (220), removing some or all instruments (222), or closing the tissue access point (224). may further include.

As shown in FIG. 3, the removal of the tissue core from the tissue location and subsequent diagnosis includes the use of one or more imaging modalities to determine the location of the tissue lesion (302), (with an image guide or an image guide). navigating the instrument to a location such as a tissue lesion (304), coupling (e.g., anchoring) the instrument to the tissue lesion (306), obtaining access to the tissue location (incision, port/trocar ( introduction via a trocar or direct access via an incision) step 308, introduction of the tissue ablation device into the tissue location (with or without the use of an anchor as a guide) step 310, use of the tissue ablation device to create a tissue core (312) or cut the tissue core from the tissue location, remove the tissue core from the body (314) (with or without leaving the cavity "access sleeve"), tissue core sample analysis (tissue structure, ROSE, DNA sequencing, etc.) (316), diagnosis based on at least the tissue core sample (318), sealing the tissue cavity (320), removing some or all instruments. It may further include one or more of (322) or closing (324) the tissue access point.

As illustrated in FIG. 4 , removing the tissue core from the tissue site, subsequent diagnosis and management of treatment of an identified malignancy includes determining the location of the tissue lesion using one or more imaging modalities ( 402 ); navigating the instrument (with or without an image guide) to a tissue location, such as a tissue lesion (404), coupling (eg, anchoring) the instrument to the tissue lesion (406), providing access to the tissue location. acquiring (making an incision, introduction through a port/trocar, or direct access through an incision) 408, introducing the tissue ablation device into the tissue location (with or without anchors as a guide); 410, creating a core of tissue using a tissue ablation device or cutting the core of tissue from the tissue location 412, removing the core of tissue from the body (with or without leaving the cavity "access sleeve") (414) analyzing tissue core samples (tissue structure, ROSE, DNA sequencing, etc.) (416) performing therapeutic management of tissue such as benign or malignant tissue (418) sealing tissue cavities It may further include one or more of step 420, removing some or all of the instrument (422), closing the tissue access point (424).

The present disclosure relates to methods and systems for coring tissue. A method for coring tissue includes placing a tissue ablation device at a target tissue location; causing the tissue ablation device to ablate the core of the tissue from the target tissue location; and removing the tissue core from the body. Removing the tissue core from the body may create a core cavity at the target tissue location. A core of tissue may include at least a portion of a tissue lesion. Resecting the tissue core from the target tissue location may include mechanical transection. Abscising the core of tissue from the target tissue location may include delivery of radio frequency energy. Resecting the tissue core from the target tissue location may include mechanical compression and delivery of radio frequency energy. Excising the core of tissue from the target tissue location may include transverse cutting with an energized wire. Abscising the core of tissue from the target tissue location may include one or more of mechanical compression, delivery of radio frequency energy, delivery of microwave energy, delivery of ultrasonic energy, or transection with an energized wire. Other ablation devices and procedures may be used. The ablation device may be configured for one or more of mechanical compression, delivery of radio frequency energy, delivery of microwave energy, delivery of ultrasonic energy, or transverse cutting into an energized wire.

The present disclosure relates to a method and system for coring tissue and sealing a core cavity created by coring the tissue. Such a method may include disposing a filler into the core cavity. The method may include applying pressure to a portion of the core, such as a wall defining a core cavity. The method may include ablating a portion of the core cavity, such as a wall defining the core cavity. The method may include causing a cavity closure device, such as a suture thread, stapling device, ultrasonic tissue sealing device, bipolar radiofrequency sealing device, or any combination thereof to close the tissue cavity. The method may include closing the tissue cavity by placing a cavity sealing material such as cell implantation, a hemostatic patch, a hemostatic agent such as fibrin or thrombin, a biological adhesive such as Dermabond®, or any combination thereof.

The method includes 1) placing an anchoring device into the tissue cavity, 2) placing a tissue access port into the tissue cavity, 3) (with or without a tissue access port, with a guide from or from the anchoring device). positioning the tissue sealing device into the tissue cavity (without a filler delivery device), 4) allowing the tissue sealing device to seal at least a portion of the manipulation cavity, 5) placing the tissue sealing device (with or without a filler delivery device) With or without tissue access port, with or without tissue access port, with or without removal of the tissue sealing device after sealing at least a portion of the tissue cavity, with or without placement into the tissue cavity, into the manipulation cavity. step of introducing, 6) (with or without placement of the tissue sealing device into the tissue cavity, sealing at least a portion of the tissue cavity and then removing the tissue sealing device, with or without removing the filling material into the tissue cavity; 7) placing the cavity sealing material adjacent to the tissue cavity (with or without introduction); 7) placing the cavity closure device adjacent to the tissue; and 8) any combination or permutation of the above steps. any combination or permutation of the steps that cause the cavity closure device to close the tissue cavity (with or without progress). As described herein, the method may be used to core and/or seal tissue at various target locations. Although the lung is used as an example, it should not be limited thereto and other target locations may be drilled or actively corked and may benefit from the disclosed sealing method.

imaging system

A variety of systems, devices, and devices may be used to locate a target location, such as a target tissue location in a human body. For example, imaging systems such as computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), endoscopic, visual, electromagnetic and/or X-ray may be used.

CT

In a conventional x-ray system, a beam of x-rays is directed through an object such as a human body onto a flat x-ray photographic film. The beam of X-rays is selectively absorbed by structures in objects, such as bones in the human body. Since the exposure of an x-ray film varies directly with the transport of x-rays through the body (and inversely with absorption of x-rays), the image produced is an accurate indicator of any structure within the object that has absorbed the x-rays. provides As a result, X-rays have been widely used for non-invasive examination of the interior of objects and are particularly useful in medical practice.

Images formed from X-rays are basically shadows of structures in objects that absorb X-rays. As a result, the image formed on the X-rays is only two-dimensional, and when multiple X-ray absorbing structures lie in the same shadow, information about some of these structures is likely to be ambiguous. Also, for medical applications, it is often quite difficult to inspect body parts, such as the lungs, which when inflated using conventional x-ray systems are composed mostly of air and do not significantly absorb x-rays.

Many of the limitations of conventional X-ray systems can be circumvented by X-ray computed tomography, commonly referred to as CT. In particular, CT provides imaging of structures and features that are likely not very visible in three-dimensional views and conventional X-rays.

CT scanning facilities usually include a computer, a large annular structure and a platform movable along a longitudinal axis through the center of the annular structure. Mounted in the annular structure are an X-ray source (not shown) and an array of X-ray detectors (not shown). The X-ray source is movable around the interior of the annular structure in a plane substantially aimed at and substantially perpendicular to the longitudinal axis. An X-ray detector is mounted all around the circumference of the annular structure in substantially the same plane as the X-ray source and is aimed on the longitudinal axis. To acquire CT X-ray images, the patient is placed on a platform and the platform is inserted into the center of the annular structure. The X-ray source then rotates around the patient to continuously emit X-rays and a detector detects the X-ray radiation passing through the patient. Since the detectors are coplanar with the X-ray source, the signal they receive is inevitably related to a slice through the patient's body where the planes of the X-ray source and detector cross the body. The signals from the X-ray detector are then processed by a computer to create images of these slices, known in the art as axial sections.

For example, X-rays are continuously emitted for a full 360° around the patient and many features are observed, but the overall approach is generally the same.

While the patient is still, the platform is moved through the annular structure along the longitudinal axis. In the course of this movement, X-ray exposure is continuously made on the part of the patient on which CT is to be performed. As the table moves during this process, different X-ray exposures are exposures of different slices of the part of the patient being examined, and the computer-generated images are a series of axial sections showing the part of the patient's body being examined in three dimensions. am. The spacing between adjacent CT sections depends on the minimum size of the feature to be detected. For detection with the highest resolution, the center-to-center spacing between adjacent sections should be less than approximately 2 mm.

Due to the superior imaging capabilities of CT, the use of CT in medical imaging has grown rapidly in recent years due to the advent of multi-slice CT. One application of medical CT is the detection and confirmation of cancer. Diagnostically superior information is now available in the CT axial section, in particular by multi-detector CT (multiple slices acquired per single revolution of the gantry) whose acquisition speed and volume resolution provide good diagnostic value, but the fastest and It enables detection of latent cancer at the most treatable stage. For example, in an axial section of the lung, the minimum detectable size of a potentially cancerous nodule is about 2 mm (1/10 inch), which is a potentially treatable and reversible size if detected.

Recently, medical professionals have been able to diagnose lung cancer with the help of computed tomography (CT) imaging systems. A radiologist can diagnose lung nodules by examining these series of cross-sectional images. The radiologist's examination also diagnoses whether these lung nodules are malignant or benign. Further medical testing may be avoided if the radiologist confidently confirms that the lung nodule is benign.

It may be advantageous to assist radiologists by combining CT scans with computer-aided diagnostic (CAD) techniques to enable accurate diagnosis of lung nodules that have a size comparable to the resolution of CT scanners.

A procedure according to the present disclosure may be performed with a CT guide. CT is particularly suitable for solid organ interventions. With CT fluoroscopy, which shows the operation of organs and devices in real time, the trajectory of the needle can be tracked in real time, allowing the surgeon to make appropriate adjustments. These advantages can shorten the procedure with success rates equal to or better than standard intermittent CT imaging.

A CT scan can be used to locate a target location for an anchor. A CT scan can be used to reconstruct a 3D positioning of a target location relative to a fiducial marker on the patient's body. These reconstructed 3D images of CT slices can be loaded into a system that helps a physician navigate a device of the present disclosure through a patient's body and/or helps determine the best path for access.

Devices of the present disclosure may be fitted with accelerometers and/or gyroscopes that help determine the position of the instrument tip within 3D space at all times. By enabling communication between such a device of the present disclosure (fitted with 3D tracking) and the CT software, the tip of the device of the present disclosure can be determined with respect to the desired target spot. Software can help you stay on a planned trajectory and can help you achieve optimal results.

Additionally or alternatively, CT scans can be combined with other imaging modalities such as ultrasound or electromagnetic tracking of the tip to facilitate navigation of the device of the present disclosure.

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

ultrasonic wave

An ultrasound probe may be used to facilitate location and/or detection of a target tissue location. An ultrasonic probe consists of a piezoelectric transducer that generates ultrasonic waves. These ultrasound waves are reflected differently from various tissues based on their mechanical and structural properties. The reflected wavelengths are then acquired and interpreted via a receiver to translate the properties and location of the tissue. By tracking the position of ultrasound waves in 3D space, it is possible to create a 3D map of tissue imaged using ultrasound waves.

Alternatively or additionally to providing the location of specific target tissue locations, ultrasound can also differentiate tissue stiffness. This is of considerable importance as tumors are known to have different mechanical and elastic properties than their surrounding tissue. For this reason, ultrasound may enable imaging and rapid detection of tumor location, in addition to providing details on its location, size and other physical attributes.

Ultrasound can also be in the form of a probe that can be inserted into the pleural space or navigated through the bronchial space. The probe may be in the form of a catheter configured to facilitate visualization. Such a catheter can be continuously rotated to obtain a full 360 ultrasound map as the catheter navigates through the space (iVUS).

The tip has a smooth cover that allows the operator to run the ultrasound probe over the surface of the lung until the nodule is localized. Once the nodule is localized, a suction device around the ultrasound probe is actuated to suck the lung into the scope/probe, thus securing the area and locking the probe in place. The needle is advanced through the lungs under the guidance of ultrasound (eg, by means of an operating chamber) to access the nodule.

MRI/magnetic detection

MRI or magnetic resonance imaging requires the use of high flux electromagnets to vibrate polar molecules and thereby image the region of the polar molecules. The most common polar character is water in human tissues. The water content of normal tissue is different from that of tumor tissue. For example, tumors usually have an elaborate blood supply and drainage compared to normal tissue. This can be used to visualize the target tissue location. Depending on the target tissue properties, contrast agents may be added to enhance the resolution of the imaging modality. Contrast agents may include components that have a high dipole moment and respond to changes in the ambient magnetic field, either through motion, emission, or vibration.

Endoscope

An endoscope may be used to facilitate visualization of target tissue locations. For the lungs in particular, endoscopy can be used intrathoracically, thereby avoiding the need for large open thoracotomy. Thoracoscopy uses a specialized viewing instrument, usually a rigid endoscope inserted through a thoracotomy or a small hole placed between the ribs. When the endoscope is placed in the space surrounding the lungs known as the pleural space, an additional thoracic opening can be made to introduce additional instruments. Additional instruments include gripping instruments, cutting instruments, and/or cutting staplers such as the Ethicon Endosurgery Endo GIA 45 mm stapler. With endoscopes and other instruments, a "triangulation" technique is used where, for example, a gripping instrument is brought in from one side and a stapler is brought in from the other, and tissue is stapled and removed through one of the ports. used to see things

Visual

Visual imaging can be done using the following techniques: Laser Doppler perfusion imaging (LDPI), Laser speckle contrast imaging (LSCI), Tissue viability imaging (TiVi), Photoacoustic Imaging (PAI), Optical coherence tomography (OCT), Infrared based imaging, optical camera.

A wide range of visualization techniques are available for detection and imaging of target tissue locations. These techniques use several wavelength ranges or combinations of multiple wavelengths to produce deterministic results. Depending on the wavelength range used by the source, the depth of penetration can vary, thus making it possible to non-invasively image the target tissue location. The illumination (radiation source) may be a hand-held probe used to scan the patient's body from the outside, similar to an ultrasound probe, for visualization and detection of target tissue locations. Alternatively, a light source can be mounted on the probe and navigated through the patient's body to a point close enough to visualize the target tissue location. Such probes are advanced through the pleural cavity along the trachea and can be used to detect or visualize target tissue in the lungs.

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

Additionally, foreign materials such as contrast agents, nanoparticles, fluorescent agents, and the like may be imparted to improve resolution or detection capabilities of visible imaging techniques.

Electromagnetic/Electrical Potential/Impedance

An electromagnetic probe may be used to visualize the target tissue location.

Electromagnetic guide probes can also be used to remotely control navigation to a target tissue location.

Probes that can detect differences in zeta potential changes as they navigate through tissue can be used for detection and visualization of target tissue locations.

Bioimpedance analysis relates to the measurement of the response of an organ or tissue to an additionally applied current. Bioimpedance parameters that can be recorded are such as resistance, reactance, and phase angle, which are to be determined for purposes of blood flow and body composition (such as water or fat content). However, there is physical evidence of accumulation, at least the phase angle dimension of bioimpedance analysis measurements in body composition, as it is likely that general health status indices and predictive tools have exceeded those phases that are commonly used. It is generally known that the phase angle can be, for example, cell membrane integrity and fluidity index in intracellular or extracellular spatial distribution at the cellular level. Ongoing research shows that the phase angle may also reflect other biological properties.

Based on the Cole-Cole model and the Hanai method, a kind to be used for measuring ECV (extracellular liquid volume) and ICV (intracellular fluid body volume) using BIS (bio impedance frequency spectrum) Methods have been proposed. Now, multi-frequency bioimpedance analysis methods can provide some information about extracellular fluid and intracellular fluid volumes in whole or in part of the health sector.

The ability to recognize cancer cells using bioimpedance is well established in biomedical literature. A common method for measuring bioimpedance is by introducing the sample into a special chamber and applying an AC current through it while recording the voltage across the sample at each frequency. More modern methods rely on multi-electrode matrices that interface with the human body and measure physiological and pathological changes. Some of the methods aim to localize and image tumor cells inside the human body. Another technique measures bioimpedance by magnetic induction, based on magnetic bioimpedance. This technique consists of a single coil acting as both an electromagnetic source and a receiver that normally operates in the frequency range of 1-10 MHz. When a coil is placed in a fixed geometrical relationship to a conductor, an alternating electric field within the coil creates electrical eddy currents. A change in the bioimpedance induces a change in the eddy current and consequently a change in the magnetic field of that eddy current. The coil acts as a receiver to detect such changes. With this technique, the experiment achieved a sensitivity of 95%, a specificity of 69%, distinguishing between 1% and 20% metastatic tumors. Distinction between tumor and normal tissue was better.

X-ray

X-rays are electromagnetic radiation with a high penetrating ability. Differences in the basic properties of tissue include differences in resistance to X-ray radiation. This property of the target tissue can be used to detect and visualize the target tissue location.

Fiducial markers are composed of an X-ray opaque material, such as lead, and can be placed on the patient's body to aid navigation to target tissue and for trajectory planning.

navigation system

A variety of systems, devices and devices may be used to navigate instruments and/or devices to a target location, such as a target tissue location within a human body. For example, navigation systems such as Auris, robots, CT/ultrasound fusion, electromagnetic navigation, fluoroscopy, and the like may be used.

A tissue coring system can include a tissue ablation device that includes a spiral coil electrode and a tracking device that is configured to determine a location of the spiral coil electrode in three-dimensional space. The spiral coil electrode can be configured to deliver energy to tissue. The spiral coil electrode can be configured to determine the electrical properties of tissue. The tissue ablation device further comprises a first clamping element comprising a spiral coil electrode, a second clamping element comprising a second electrode and positioned opposite at least a portion of the first clamping element, and a cutting element configured for transverse cutting of tissue. can include The tracking device may include 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 can further include an anchor that can be configured to guide movement of the spiral coil electrode. The system may further include a non-invasive anchor configured to guide movement of the spiral coil electrode. The system may further include computing logic configured to control movement of the spiral coil electrode. The system may further include computing logic configured to determine a target trajectory of the spiral coil electrode. The system may further include computing logic configured to determine an energy dosage provided by the spiral coil electrode. The system may further include computing logic configured to determine an energy dose provided to the spiral coil electrode. The system may further include computing logic configured to receive positional information indicative of a position of the spiral coil electrode and to determine, based at least on the positional information, a target path or deviation from a target trajectory. The system may further include computing logic configured to receive location information indicating a location of the spiral coil electrode and to adjust and determine energy supplied to the spiral coil electrode based on at least the location information. The system may further include computing logic configured to receive positional information indicative of a position of the spiral coil electrode and to determine, based at least on the positional information, a stopping point at which tissue ablation is intended to be implemented.

A method of navigating a tissue ablation device may include disposing a tissue ablation device including a spiral coil electrode onto a patient's body and determining a location of the spiral coil electrode in a 3D space. The method may further include controlling movement of the spiral coil electrode based at least on the determined position of the spiral coil electrode. The method includes determining a target trajectory of a spiral coil electrode; The method may further include determining a deviation from the target trajectory based at least on the determined position of the spiral coil electrode. The method may further include determining an energy dose provided by the spiral coil electrode based at least on the determined position of the spiral coil electrode. The method may further include determining an energy dose provided to the spiral coil electrode based at least on the determined position of the spiral coil electrode. The method may further include determining a stopping point at which tissue ablation is intended to be implemented based on at least the determined position of the spiral coil electrode.

The navigation method and system may follow the logic as described in FIG. 42 . As shown, processing unit 4202 can communicate with a graphical user interface (GUI) 4204 to display a current device path 4206 and/or a desired trajectory 4208 . A desired trajectory 4208 can be calculated based on the target location 4210 and entry point. Other inputs may be used. The entry point may be selected based on patient scan data 4212 or may be selected based on real-time device position feedback 4214 . Additionally, real-time device location feedback 4214 can be used to determine a current route 4206 for device navigation. Target location 4210 may be selected via GUI 4204 or directly input into processing unit 4202 and may be based on patient scan data 4212 .

An example of a planned trajectory may be based on the anchor route described herein. An example of real-time device position feedback may include use of the navigation system described herein.

A surgical instrument system for coring tissue from a target tissue location is a tissue ablation device configured for coring tissue and comprising a spiral coil electrode, the device cooperating with the spiral coil electrode and the spiral coil electrode for transection of tissue. a cutting element configured to; a handle assembly configured to facilitate interaction between the tissue ablation device and tissue; and a tracking device configured to determine a location of the spiral coil electrode in three-dimensional space.

Auris

Auris is a system and tool for in-house robotic procedures that provides improved ergonomics, usability and navigation. Endoscopy is a widely used, minimally invasive technique for both imaging and delivering therapy to an anatomical location within the human body. Typically, flexible endoscopes are used to deliver instruments to surgical sites inside the body, eg, through small incisions or natural openings in the body (nose, anus, vagina, urinary, throat, etc.), where the procedure is performed. The endoscope may have imaging, illumination and steering capabilities at the distal end of a flexible shaft that allows for non-linear navigation of a lumen or pathway.

Auris usually utilizes a lumened sheath having a controllable, articulated distal end, which is attached to a first robotic arm having at least 3 DOFs, but preferably 6 or more DOFs. is fitted This embodiment also includes a flexible endoscope having a controllable and articulated distal end, a light source and video capture unit at the distal end, and at least one working channel extending. The flexible endoscope is slidably placed in the lumen of the sheath and has at least 3 DOF. However, it is preferably mounted on a second robot arm having 6 or more DOFs. A first and second module are further included, which are operably coupled to the flexible endoscope and the proximal end of the sheath, respectively. The module is mounted to the first and second robotic arms, thereby mounting the sheath and the flexible endoscope to the first and second robotic arms, respectively. The module provides the mechanics to steer and operate the sheath and flexible endoscope and receives power or other utility from the robotic arm. The robotic arm is 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 relative to the patient results in movement of the sheath relative to the flexible endoscope and respective movement relative to the patient.

Robotic/electromagnetic navigation

Robot-enabled medical systems may be used to perform a variety of medical procedures, including minimally invasive procedures such as laparoscopy procedures, and percutaneous, non-invasive procedures such as endoscopic procedures.

Among endoscopic procedures, robot-enabled medical incisions may be used to perform bronchoscopy, ureteroscopy, digestive tract examinations, and the like. During such procedures, the physician and/or computer system may navigate the medical instrument through the patient's luminal network. An intraluminal network may include multiple branched lumens (such as a bronchial network or renal network) or a single lumen (such as a gastrointestinal tract). A robot-enabled medical system may include a navigation system that guides (or assists in guiding) a medical instrument through an intraluminal network. Such navigation may be guided using mechanical means, such as Auris's or the use of electromagnets.

Among percutaneous procedures, robot-enabled medical systems may be used to perform minimally invasive surgery. The method includes advancing a first alignment sensor through a patient lumen and into the cavity. The first alignment sensor provides its position and orientation in free space in real time. The alignment sensor is manipulated until it is positioned adjacent to the object. A percutaneous opening is made in the patient with a surgical tool, wherein the surgical tool includes a second alignment sensor that provides position and orientation of the surgical tool in free space in real time. A surgical instrument may be directed towards an object using data provided by both the first and second alignment sensors.

An alignment sensor may, for example, be an anchor coupled with an EM sensor that works with an EM field generator placed around the patient and an associated CT (or other) scan to provide position and orientation information about the EM sensor within the patient's body. can An alignment sensor may be placed throughout the cavity, as with the devices of the present disclosure, and may be used in conjunction with a camera to identify target tissue locations. The alignment sensor may provide a guidance mechanism for targeting a percutaneous incision to access a target tissue location in the lung. Also, at this point in the procedure, as the scope is already present, the scope's working channel is utilized to advance other tools to aid in the removal of the target tissue through the port created by the access device of the present disclosure.

Combination with CT/Fluoroscopy and/or Ultrasound

In a conventional X-ray system, a beam of X-rays is directed through an object such as a human body onto a flat X-ray photographic film. The beam of X-rays is selectively absorbed by structures in the object, such as bones in the human body. Since the exposure of an X-ray film varies directly with the transmission of the X-rays through the body (and against the absorption of the X-rays), the resulting image is an accurate indication of any structure within the object that has absorbed the X-rays. provides As a result, X-rays have been widely used for non-invasive examination of the interior of objects and have been particularly useful in physician practice.

As an example, the image formed from the X-rays is actually a shadow of structures in the object that absorb the X-rays. As a result, the image formed on the X-rays is only two-dimensional, and when multiple X-ray absorbing structures lie in the same shadow, information about some of these structures is likely to be ambiguous. Also, for medical applications, it is quite difficult to inspect parts of the body, such as the lungs, which are composed mostly of air when inflated using conventional x-ray systems and do not significantly absorb x-rays.

Many of the limitations of conventional X-ray systems are circumvented by X-ray tomography, which is often referred to as CT. In particular, CT provides imaging and three-dimensional views of structures and features that are likely not very visible on conventional X-rays.

Tracking and/or navigation of the ablation device of the present disclosure may be performed with a CT guide. CT is particularly suitable for solid organ interventions. With CT fluoroscopy, which shows the operation of organs and devices in real time, the trajectory of the needle can be tracked in real time, allowing the surgeon to make appropriate adjustments. These advantages can shorten the procedure with success rates equal to or better than standard intermittent CT imaging.

A CT scan can be used, for example, to locate a target location for an anchor. A CT scan can be used to reconstruct a 3D positioning of a target location relative to fiducial markers on the patient's body. These reconstructed 3D images of the CT slice can be loaded into a system that helps the surgeon navigate the ablation device through the patient's body and/or helps determine the best route for access.

The ablation device may be fitted with an accelerometer and/or gyroscope to help determine the position of the instrument tip within 3D space at all times. (Fitted with 3D tracking) By enabling communication between such an ablation device and the CT software, the tip (eg, coil electrode) of the ablation device can be determined with respect to the desired target spot. Computing logic, such as software, can be used to maintain a planned trajectory and help achieve optimal results.

Additionally or alternatively, the CT scan may be combined with other imaging modalities such as ultrasound or electromagnetic tracking of the tip to facilitate navigation of the ablation device. Different techniques may be used singly or in combination.

As a further example, an ultrasound probe may be used to facilitate location and/or detection of a target tissue location. The ultrasonic probe may include a piezoelectric transducer that generates ultrasonic waves. These ultrasound waves are reflected differently from various tissues based on their mechanical and structural properties. The reflected wavelengths are acquired and interpreted by the receiver to translate the properties and location of the tissue. By tracking the position of ultrasound waves in 3D space, it is possible to create a 3D map of tissue imaged using ultrasound waves.

Alternatively or additionally to providing the location of specific target tissue locations, ultrasound can also differentiate tissue stiffness. This is of considerable importance as tumors are known to have different mechanical and elastic properties than their surrounding tissue. For this reason, ultrasound may enable imaging and rapid detection of tumor location, in addition to providing details on its location, size and other physical attributes.

A system and method for navigating a probe to a location within a patient's body is described. A probe may include 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. By way of 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) and computer tomography (CT) and ultrasound. Other imaging techniques may be used. The method may include receiving a selection of a target location within the three-dimensional image of a region of a patient's body. As an example, receiving the selection of the target location may be through interaction with a display device configured to output one or more of the visualizing steps. Other inputs may be used to validate selections. The method may include determining and visualizing a preferred path for the probe to lead from an external entry point on the patient's body to a target location. A preferred path may be determined by converting a selected point in a two-dimensional image of a three-dimensional image of a region of the patient's body into a line (eg, line of sight) through the three-dimensional image of the region of the patient's body. The method may further include calibrating the path first to compensate for shifts in the anatomy prior to surgery. Alternatively or additionally, the method may further include calibrating the path first to compensate for shifts in the anatomy during surgery. The method may include registering the three-dimensional image with the current actual location of the corresponding region of the patient's body. The method may include registering the current actual position of the probe with the three-dimensional image and the actual current position of the patient's body. The method may further include updating the registration of the three-dimensional image to the patient to correct for the shift in the anatomy. The method may include visualizing, in real time, a preferred path for the probe concurrently with an indication of a current actual position of the probe such that the concurrent visualization enables a user to align the current actual position of the probe with the preferred path. As an example, the indication of the current real position of the probe may include the position of the probe in 3D space. As a further example, an 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 an indicator of a current actual position of the probe in real time as the probe is advanced to the target location. Additionally, the output of audible or visual feedback may be used to warn a user about information about approaching a target location and/or about information about approaching an anatomical structure at risk.

The procedure of this disclosure can be performed with a CT guide. CT is particularly suitable for solid organ interventions. With CT fluoroscopy, which shows the operation of organs and devices in real time, the trajectory of the needle can be tracked in real time, allowing the surgeon to make appropriate adjustments. These advantages can shorten the procedure with success rates equal to or better than standard intermittent CT imaging.

A CT scan can be used to locate a target location for an anchor. A CT scan can be used to reconstruct a 3D positioning of a target location relative to fiducial markers on the patient's body. These reconstructed 3D images of CT slices can be loaded into a system that helps a physician navigate a device of the present disclosure through a patient's body and/or helps determine the best path for access.

Devices of the present disclosure may be fitted with accelerometers and/or gyroscopes that help determine the position of the instrument tip within 3D space at all times. By enabling communication between such a device of the present disclosure (fitted with 3D tracking) and the CT software, the tip of the device of the present disclosure can be determined with respect to the desired target spot. Software can help you stay on a planned trajectory and can help you achieve optimal results.

Additionally, CT scans can be combined with other imaging modalities, such as ultrasonic or electromagnetic tracking of the tip, to facilitate navigation of the device of the present disclosure.

In one embodiment of the present disclosure, the patient may be placed in a CT scanner and the nodules may be imaged. Using standard CT-guided intervention techniques commonly used for CT-guided biopsies of the lung, the anchor needle can be advanced through the skin, chest wall, pleural cavity, and lungs and into the target tissue to be sampled. When the distal end of the anchor needle passes through a nodule or interstitial abnormality, an anchoring member composed of a shape memory metal such as nitinol is advanced out of the distal end of the needle.

fluoroscopy

Fluoroscopy, similar to CT scanners, uses lower doses of radiation to minimize negative effects on the patient.

Magnetic resonance imaging or radio frequency based navigation

Magnetic resonance imaging (MRI) method can use the interaction between a magnetic field and nuclear spins to form a two-dimensional or three-dimensional image, is superior in many respects to other imaging methods for soft tissue imaging, and uses ionizing radiation It is not demanding and is usually not invasive, so it is particularly widely used in medical diagnostics.

For example, during MRI, the body of the patient to be examined is placed in a strong uniform magnetic field B0, the direction of which simultaneously defines the axis of the coordinate system to which the measurement is concerned (usually the z-axis). The magnetic field B0 has different energy levels for the individual nuclear spins, depending on the magnetic field strength that can be excited (spin resonance) by the application of an electromagnetic altering field (RF field) of a defined frequency (so-called Lamar frequency or MR frequency). cause From a macroscopic point of view, the distribution of individual nuclear spins produces an overall magnetization that can be deflected out of equilibrium by the application of electromagnetic pulses (RF pulses) of appropriate frequency, while the corresponding magnetic field (B1) of these RF pulses is z It extends perpendicular to the axis so that the magnetization performs a forward motion around the z-axis. The forward motion describes the surface of the cone, and the angle of its aperture is referred to as the flip angle. The magnitude of the flip angle depends on the duration and intensity of the applied electromagnetic pulse. In the example of the so-called 90° pulse, the magnetization is deflected from the z-axis to the transverse plane (flip angle 90°).

After the end of the RF pulse, the magnetization relaxes back to its original state of equilibrium, where the magnetization in the z-direction is again achieved with a first time constant T1 (spin lattice or longitudinal relaxation time), and in the z-direction The magnetization in the direction perpendicular to β relaxes with a shorter second time constant T2 (spin-spin or transverse relaxation time). The transversal magnetization and its fluctuations can be detected by means of receiving RF antennas (coil arrays) arranged and oriented within the examination volume of the magnetic resonance inspection system in such a way that the fluctuations in magnetization are measured in a direction perpendicular to the z-axis. there is. The decay of the transverse magnetization that occurs after RF excitation caused by local magnetic field non-uniformity, which facilitates the transition from an ordered state with equal signal phase to uniform distribution of all phase angles, can be accompanied by dephasing. Dephasing can be compensated for by refocusing RF pulses (eg, 180° pulses). This procedure creates an echo signal (spin echo) in the receiving coil.

In order to realize spatial resolution in the object being imaged, such as the patient to be examined, a constant magnetic field gradient extending along the three principal axes is superimposed on the uniform magnetic field B0, leading to a linear spatial dependence of the spin resonance frequency. The signal selected at the receiving antenna (coil array) then contains components of different frequencies that can be associated with different locations within the body. Signal data obtained through the receiving coil corresponds to the spatial frequency domain of the wavelength vector of the magnetic resonance signal and is referred to as k-space data. The k-space data usually includes multiple lines obtained with different phase encodings. Each line is digitized by collecting multiple samples. A set of k-space data is converted into an MR image by Fourier transformation.

Transversal magnetization also dephases in the presence of constant magnetic field gradients. This process can be reversed by an appropriate gradient reversal forming a so-called gradient echo, similar to the RF induced (spin) echo. However, in the case of gradient echo, the main field non-uniformity effect, chemical shift and other out-of-resonance effects are not refocused, as for RF refocusing (spin) echo.

To increase the spatial resolution, some elements (nuclei) can be used that give higher contrast when excited by a magnetic field gradient. If the body of each device is constructed from such a material, real-time visualization of the anchor or ablation device can be achieved.

visual material

Visual imaging can be done using the following techniques: Laser Doppler perfusion imaging (LDPI), Laser speckle contrast imaging (LSCI), Tissue viability imaging (TiVi), Photoacoustic Imaging (PAI), Optical coherence tomography (OCT), Infrared based imaging, optical camera.

A wide range of visualization techniques are available for detection and imaging of target tissue locations. These techniques use several wavelength ranges or combinations of multiple wavelengths to produce deterministic results. Depending on the wavelength range used by the source, the depth of penetration can vary, thus making it possible to non-invasively image the target tissue location. The illumination (radiation source) may be a passive probe used to scan the patient's body from the outside, similar to an ultrasound probe for visualization and detection of target tissue locations. Alternatively, a light source can be mounted on the probe and navigated through the patient's body to a point close enough to visualize the target tissue location. Such probes are advanced through the pleural cavity along the trachea and can be used to detect or visualize target tissue in the lungs.

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

Additionally or alternatively, extrinsic substances such as contrast agents, nanoparticles, fluorescent agents, and the like may be imparted to enhance the resolution or detection capabilities of the visible imaging technique.

An example of the use of an optical camera would be the use of an endoscope. An endoscope may be used to facilitate visualization of target tissue locations. For the lungs in particular, the endoscope can be used intrathoracically, thereby avoiding the need for a large open thoracotomy. Thoracoscopy uses a specialized viewing instrument, usually a rigid endoscope inserted through a thoracotomy or a small hole placed between the ribs. When the endoscope is placed in the space surrounding the lungs known as the pleural space, an additional thoracic opening can be made to introduce additional instruments. Additional instruments include gripping instruments, cutting instruments, and/or cutting staplers such as the Ethicon Endosurgery Endo GIA 45 mm stapler. With endoscopes and other instruments, a "triangulation" technique is used where, for example, a gripping instrument is brought in from one side and a stapler is brought in from the other, and tissue is stapled and removed through one of the ports. used to see things

anchoring

A variety of anchor devices may be used. The needles can be anchored to guide the coring device. Non-invasive anchoring may be used. For example, the needle can be advanced to a desired target position in real time or through the use of virtual image guidance procedures. The advancing procedure can be performed directly by human hand, or can be performed by a human using a robot arm manually, or can be automatically guided by a robot according to digital 2D or 3D images. When the desired position is achieved, the nitinol finger can be engaged into the target tissue.

Anchored needles for guiding one or more devices

Many medical procedures are undertaken through small tubes formed within the patient's tissue. These procedures are minimally invasive. To form a canal leading from the outside of the patient to a target within the patient, anchors are usually inserted at an early stage of the procedure. Such an exemplary anchor may lead from the patient's skin to the target. As a further example, later in the procedure, this initial insertion may be expanded to accommodate other medical devices needed for the procedure.

Additionally, localized applications such as biopsies, thermal ablation, or localized injection of therapeutic materials can be combined with imaging means such as ultrasound, X-rays, fluoroscopy, CT scans, MRIs, visual aids, optical data, etc. currently being performed For example, in the case of the use of an X-ray emitting device, the X-ray energy passes through the patient's body and otherwise affects a fluoroscopic screen that excites a luminescent material such as calcium tungstate to create a screen display of the body and anchors. generate The anchors are visualized on the fluoroscopy as they enter the patient on the display of the medical device. Anchors do not allow energy to pass through them (can be opaque), so they can appear on the screen.

This imaging technique allows visualization of the anchor and visualization of the target area to safely orient and move the target to the target point. Additionally, this visualization technique also allows for proper positioning and/or repositioning of anchors.

Non-invasive anchoring

In some cases, it may not be necessary to access the target location by coring the tissue. Examples of such cases may include a growing cancer or a superficial target location for which 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.

Non-invasive anchors can be placed on a patient's body surface, such as the skin, and provide guidance for the device. The device may be inserted through the anchor non-invasively or from a location adjacent to the anchor. Guidance for the device being navigated to the target location may be provided by means of a mechanical guide (cannula), the imaging and navigation techniques listed above, sensors mounted on the device or the anchor itself, or a combination thereof.

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

In one aspect, the anchors may include hard stops that limit freedom of movement relative to the ablation device. When deployed, the anchors may serve as guides for insertion and advancement of the ablation device. Advancement of the ablation device may require any imaging or monitoring and may rely on hard stops on anchors to advance and position the device at a target location and location. As a further example, an anchor may have sensors disposed along the body of the anchor. When the anchor is deployed, the sensors can monitor and provide feedback on the advancement and position of the ablation device. Although reference is made to an ablation device, other devices such as sealing devices and fluid delivery devices may be used in the same or similar manner.

A variety of processes and mechanisms can be used to navigate anchors to target locations (such as tissue locations that may require coring). For example, an anchor can be placed at the target lesion using CT techniques, similar to a guided needle biopsy. Other systems such as imaging systems may be used, such as ultrasound, X-rays, and the like.

As a further example, a larger sheath needle can be placed at the target location using CT techniques similar to a guided needle biopsy until the distill tip of the sheath needle touches or proximate the target lesion. An anchor can then be inserted through a sheath needle to be placed at a target location (eg, a lesion). The sheath needle can then be removed. Other systems such as imaging systems may be used, such as ultrasound, X-rays, and the like.

As a further example, a position sensor can be placed at or adjacent to the tip of an anchor and configured to scan a target location (eg lung) to create a 3D location of the target location (eg lesion). there is. An anchor may be guided to a target lesion based on the sensor location.

As a further example, a position sensor can be placed on a larger sheath needle and configured to scan a target location (eg, lung) to create a 3D location of the target location (eg, lesion). The sheath needle may be guided until the distal tip touches the target location (eg, lesion). An anchor can then be inserted through a sheath needle to be placed at the target lesion. The sheath needle can then be removed.

As a further example, a position sensor can be placed at the end of an anchor, and an Auris or other comparable system can be used to position the position sensor through the airway to a target lesion. An anchor can be guided to the lesion based on the position of the two sensors.

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

organization location access

A variety of systems, devices and devices may be used to provide or assist access to a target location on the human body, such as a target tissue location. For example, chest wall dissection blades, deployable access ports, tissue dilation, trocars, and/or open incisions may be used.

chest wall incision blade

When the anchor is positioned and deployed at the target location to access the chest cavity through the chest wall without causing perforation to the lung, it is necessary to break the vacuum of the intrapleural space. The chest wall cutting blade is designed with an open channel next to the central hole, which allows the blade to be advanced and cut through the chest wall tissue along the anchor. An open channel may be used to allow air to be introduced into the pleural space when the first layer of the pleural space is penetrated. The vacuum in the pleura disappears and thus the lungs shrink, minimizing the potential for damage to the lung pleura.

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

cavity access sleeve

After coring and cutting the target tissue, but prior to removing the coring device having the target tissue therein, a cavity access sleeve is placed on the outer diameter of the coring device shaft to maintain access to the location where the target tissue was removed. can Re-access to the site may be required after coring treatment, such as adding a marking device to the tissue site for later surgery, cavity sealing, cavity resection, drug delivery, or topical chemotherapy. Re-access to the ablated target tissue location without deploying the cavity access sleeve prior to removal of the coring device can be difficult for organs with high motion, such as the lungs.

organization expansion

After an anchor is placed at a target tissue location on an organ, such as a target lesion in a person's lungs, to free the target tissue and healthy tissue between the organ surfaces from being removed, the tissue is expanded so that subsequent insertion of the coring device can be performed on the target tissue. can be allowed to be removed. Expansion can be achieved as follows.

A rigid rod with a center hole can be advanced over the anchor until the distal end of the rod contacts the target tissue. Rigid rods can have diameters that increase from small to large.

The inflatable rod may be advanced over the anchor until the distal end of the inflatable rod contacts the target tissue. At this point, the distal end of the rod can be expanded to the required diameter.

A balloon catheter in a collapsed state can be advanced over an anchor. When the distal end of the balloon catheter touches the target tissue, the balloon may be inflated to expand the tissue. The balloon may have a shape similar to a balloon angioplasty balloon or may be configured to have square corners at the distal end. Additionally, the body of the balloon may have undulating balloon-like features to minimize tissue slip along the balloon as the balloon is inflated.

Trocar

Access to a target tissue location may be achieved through a trocar. Exemplary trocars 800, 900 and 1000 are shown in FIGS. 8-10. The trocar may include a trocar channel (eg, trocar channel 802 in FIG. 8B and/or trocar channel 902 in FIG. 9B ). The trocar channel may be used to allow air to be introduced into the pleural space when the first layer of the pleural space is penetrated. The vacuum in the pleura disappears, so the lungs can shrink, minimizing the potential for damage to the lung pleura. When the lesion is successfully located, an anchoring device may be used to stabilize the target tissue lesion. The tissue coring device may also be introduced directly into the location of the target lesion and perform tissue ablation, either with a trocar or under direct visualization with or without a guide anchor.

open incision

Access to a target tissue location may be achieved through an open incision. For the lungs in particular, a thoracotomy may be performed and consists of creating a 300 to 450 mm (12 to 18 inches) on the chest wall, isolating or incising the major back muscle to deflect the major back muscle, cutting of the ribs. Partial removal may lead to placement of a rib spreader to provide intrathoracic access to the surgeon. The advantage of thoracotomy is that the surgeon has good access to and sees the intrathoracic structures and directly and manually feels the lungs and other structures. Once the lesion is successfully located, the anchoring device (as above) can be used to stabilize the target tissue lesion. The tissue coring device may also be introduced directly into the location of the target lesion using an endoscope or under direct visualization with or without a guide anchor.

tissue coring

A variety of methods, devices and systems may be used to core or remove tissue.

A method for removing a tissue lesion includes introducing a tissue ablation device into a target tissue location; causing the tissue ablation device to ablate the core of the tissue from the target tissue location; and removing the tissue core from the body. The tissue core includes at least a portion of the tissue lesion. The method may further include creating a core cavity at the target tissue location. The method may further include inserting the sleeve into the core cavity. The method may further include passing the radio frequency energy through the core cavity. The method may further include delivering the chemotherapy through the core cavity. The method may further include delivering the microwave radiation through the core cavity. The method may further include transferring thermal energy through the core cavity. The method may further include passing ultrasonic energy through the core cavity. The tissue ablation device may be configured for delivery of radio frequency energy. The tissue ablation device may be configured for mechanical transection. A tissue ablation device may include mechanical compression and delivery of radio frequency energy. The method may further include cutting the core of the tissue away from the target tissue location. As an example, the means for cutting a core of tissue may include mechanical transection. As a further example, the means for cutting a core of tissue may include delivery of radio frequency energy. Means for cutting the tissue core may include mechanical compression and delivery of radio frequency energy. Means for cutting a core of tissue may include transverse cutting into an energized wire. Other devices may be used.

A method for removing a core of tissue includes introducing a tissue ablation device into a target tissue location; causing the tissue ablation device to ablate the core of the tissue from the target tissue location; and removing the tissue core from the body. The method may further include creating a core cavity at a target tissue location. The method may further include inserting the sleeve into the core cavity. The method may further include passing the radio frequency energy through the core cavity. The method may further include delivering the chemotherapy through the core cavity. The method may further include delivering the microwave radiation through the core cavity. The method may further include transferring thermal energy through the core cavity. The method may further include passing ultrasonic energy through the core cavity. The tissue ablation device may be configured for delivery of radio frequency energy. The tissue ablation device may be configured for mechanical transection. A tissue ablation device may include mechanical compression and delivery of radio frequency energy. The method may further include cutting the core of the tissue away from the target tissue location. As an example, the means for cutting a core of tissue may include mechanical transection. The means for cutting the tissue core may include the delivery of radio frequency energy. Means for cutting the tissue core may include mechanical compression and delivery of radio frequency energy. Means for cutting a core of tissue may include transverse cutting into an energized wire.

A method for removing a core of tissue may include introducing a tissue ablation device to a target tissue location. The tissue ablation device may include one or more of a first clamping element comprising a spiral 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 oppose at least part of the first clamping element. The method may further include causing the tissue ablation device to ablate the tissue core from the target tissue location and removing the tissue core from the body. The method may further include creating a core cavity at a target tissue location. The method may further include inserting the sleeve into the core cavity. The method may further include passing the radio frequency energy through the core cavity. The method may further include delivering the chemotherapy through the core cavity. The method may further include delivering the microwave radiation through the core cavity. The method may further include transferring thermal energy through the core cavity. The method may further include passing ultrasonic energy through the core cavity. A tissue ablation device may be configured to ablate a core of tissue and may include delivery of radio frequency energy. The tissue ablation device may be configured to resect a core of tissue and may include mechanical transection. A tissue ablation device may be configured to ablate a core of tissue and may include mechanical compression and delivery of radio frequency energy. The method may further include cutting the core of the tissue away from the target tissue location. Means for cutting the core of tissue may include mechanical transection. The means for cutting the tissue core may include the delivery of radio frequency energy. Means for cutting the tissue core may include delivery of radio frequency energy and mechanical compression. Means for cutting a core of tissue may include transverse cutting into an energized wire.

A method for sealing a biological fluid vessel can include penetrating a target tissue location comprising at least a portion of at least one biological fluid vessel with a helical tissue sealing mechanism. The spiral tissue sealing mechanism may include a spiral penetrating element and a clamping element. The method can include causing a helical tissue sealing mechanism to apply mechanical pressure to the at least one target biological fluid tube and transferring energy to seal the at least one target biological fluid tube. The spiral through element may comprise a clamping element. A mechanical pressure may be applied between the threaded penetrating element and the clamping element. The method may further include a second clamping element. Mechanical pressure can be applied between the first and second clamping elements. The energy delivered may include monopolar radio frequency energy. The energy delivered may include bipolar radio frequency energy. The energy transferred may include thermal energy. The energy delivered may include ultrasonic energy.

A method for sealing a biological fluid tube includes penetrating a target tissue location with a spiral penetrating element, adjusting a pitch of the spiral penetrating element to apply mechanical pressure to the target tissue, and transferring energy to at least one biological fluid. sealing the tube at the target tissue. The spiral penetrating element may include a plurality of tissue sealing electrodes. The energy delivered may include monopolar radio frequency energy. The energy delivered may include bipolar radio frequency energy. The energy transferred may include thermal energy. The energy delivered may include ultrasonic energy.

A tissue ablation device comprises a first clamping element comprising a helical coil, a second clamping element positioned opposite at least a portion of the first clamping element, first and second electrodes configured for delivery of radio frequency energy for sealing tissue. and a cutting element configured for transverse cutting of at least a portion of the sealed tissue. The tissue ablation device may further include a first actuator operable to drive the first or second clamping element to apply mechanical stress to tissue and a second actuator operable to drive the cutting element to transect tissue. The helical coil can include first and second adjacent coil segments. The first coil segment may comprise 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 have a first pitch, the second coil segment may be helical and have a second pitch, and at least one of the first and second pitches may be variable. The first electrode can be included as at least part of the first clamping element. The second electrode can be included as at least part of the second clamping element. The spiral coil may include 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 include a sharpened edge. The cutting element can include at least one electrode configured for delivery of radio frequency energy. The cutting element may include an ultrasonic blade. The tissue ablation device can include a second cutting element configured to cut a core of tissue from a target tissue location. At least a portion of the second cutting element may include a sharpened edge. The second cutting element can include at least one electrode configured for delivery of radio frequency energy. The second cutting element may include an energized wire. The second cutting element may include a suture. The tissue ablation device may further include an actuator operable to drive the second cutting element to transect tissue.

A tissue ablation device includes a first clamping element having a helical coil disposed at a distal end, a second clamping element disposed opposite at least a portion of the first clamping element, a first clamping element configured for delivery of radio frequency energy to seal tissue. and a second electrode and a cutting element configured for transverse cutting of at least a portion of the sealed tissue. The tissue ablation device may further include a first actuator operable to drive the first and second clamping elements to apply mechanical stress to tissue and a second actuator operable to drive the cutting element to cross-sever the tissue. The helical coil can include first and second contiguous coil segments. The first coil segment may comprise a generally planar open ring. The first coil segment may be helical and may have a pitch of zero. 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 and second pitches may be variable. The first electrode may be included as at least part of the helical coil. The first electrode can be contained by at least part of the first clamping element. The second electrode can be contained by at least part of the second clamping element. The helical coil may include 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 include a sharpened edge. The cutting element can include at least one electrode configured for delivery of radio frequency energy. The cutting element may include an ultrasonic blade. The tissue ablation device may further include a second cutting element configured to cut a core of tissue from a target tissue location. At least a portion of the second cutting element may include a sharpened edge. The second cutting element can include at least one electrode configured for delivery of radio frequency energy. The second cutting element may include an energized wire. The second cutting element may include a suture. The tissue ablation device may further include an actuator operable to drive the second cutting element to transect tissue.

The tissue ablation device can include a first clamping element comprising a spiral coil and a first electrode, a second clamping element comprising a second electrode and positioned opposite at least a portion of the first clamping element. The first and second clamping elements can be configured for (a) delivery of radio frequency energy to seal tissue and (b) application of mechanical pressure to cut tissue. The tissue ablation device may further include a first actuator operable to drive the first or second clamping element to apply mechanical stress to tissue and a second actuator operable to drive the cutting element to transect tissue. The helical coil can include first and second adjacent coil segments. The first coil may comprise 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 have a spiral shape, the second coil segment may have a spiral shape and may have a second pitch, and at least one of the first and second pitches may be variable. The first electrode may be encompassed by at least part of the helical coil. The first electrode can be contained by at least part of the first clamping element. The second electrode can be contained by at least part of the second clamping element. The helical coil may include 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 include a sharpened edge. The cutting element can include at least one electrode configured for delivery of radio frequency energy. The cutting element may include an ultrasonic blade. The tissue ablation device may further include a second cutting element configured to cut a core of tissue from a target tissue location. At least a portion of the second cutting element may include a sharpened edge. The second cutting element can include at least one electrode configured for delivery of radio frequency energy. The second cutting element may include an energized wire. The second cutting element may include a suture. The tissue ablation device may further include an actuator operable to drive the second cutting element to transect tissue.

A surgical instrument system for ablation of tissue may include an end effector operable to cut and seal tissue and a generator configured to provide power to the end effector having first and second electrodes for sealing tissue. The end effector includes a first clamping element comprising a helical coil, a second clamping element positioned opposite at least a portion of the first clamping element, first and second electrodes configured for delivery of radio frequency energy for sealing tissue, and and a cutting element configured for transverse cutting of at least a portion of the tissue to be sealed. The surgical instrument system further includes a controller in communication with the generator, the controller controlling the generator to generate radio frequency energy sufficient to seal tissue based on at least one sensed operating condition of the end effector. and to the second electrode. The controller may be configured to sense the presence of tissue at the end effector. The controller may be configured to sense the presence of tissue at the end effector based on the 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 and second clamping elements to detect the presence of tissue in the end effector. The controller may be configured to sense a position of the cutting element relative to at least one of the first and second clamping elements. The controller can be configured to control the generator to provide radio frequency energy at the end effector when the second actuator is actuated and no tissue is sensed at the end effector. The controller may be configured to control the generator to provide a continuous amount of radio frequency energy. The controller may be configured to control the generator to automatically provide an increase or decrease in the amount of radio frequency energy. The system may further include a first actuator operable to drive the first or second clamping element to apply mechanical pressure to tissue and a second actuator operable to drive the cutting element to cross-cut tissue. The helical coil may include first and second adjacent coil segments, the first coil segment including a first electrode. The first coil segment may comprise a generally planar open ring. The first coil segment may be helical and may have a pitch of zero. 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 have a first pitch, the second coil segment may be helical and may have a second pitch, and at least one of the first and second pitches may be variable. . The first electrode may be encompassed by at least part of the helical coil. The first electrode can be contained by at least part of the first clamping element. The second electrode can be contained by at least part of the second clamping element. The helical coil may include 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 include a sharpened edge. The cutting element can include at least one electrode configured for delivery of radio frequency energy. The cutting element may include an ultrasonic blade. The tissue ablation device may be configured to cut a core of tissue from a target tissue location. At least a portion of the second cutting element may include a sharpened edge. The second cutting element can include at least one electrode configured for delivery of radio frequency energy. The second cutting element may include an energized wire. The second cutting element may include a suture. The tissue ablation device may further include an actuator operable to drive the second cutting element to transect tissue.

A tissue ablation device includes a first clamping element comprising a helical coil, a second clamping element positioned opposite at least a portion of the first clamping element, first and second configured for delivery of radio frequency energy to seal tissue. and an electrode, a first cutting element configured for transverse cutting of at least a portion of sealed tissue, first and second ligating elements, and a second cutting element positioned between the first and second ligating elements. The tissue ablation device may further include a first actuator operable to drive the first or second clamping element to apply mechanical stress to tissue and a second actuator operable to drive the coating element to transect tissue. The helical coil can include first and second adjacent coil segments. The first coil segment may comprise 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 have a first pitch, the second coil segment may be helical and have a second pitch, and at least one of the first and second pitches may be variable. The first electrode may be encompassed by at least part of the helical coil. The first electrode can be contained by at least part of the first clamping element. The second electrode can be contained by at least part of the second clamping element. The helical coil may include 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 include a sharpened edge. The cutting element can include at least one electrode configured for delivery of radio frequency energy. The cutting element may include an ultrasonic blade. The tissue ablation device may further include a second cutting element configured to cut a core of tissue from a target tissue location. At least a portion of the second cutting element may include a sharpened edge. The second cutting element can include at least one electrode configured for delivery of radio frequency energy. The second cutting element may include an energized wire. The second cutting element may include a suture. The tissue ablation device may further include an actuator operable to drive the second cutting element to transect tissue.

The tissue sealing mechanism comprises a spiral coil having a generally obround cross-section and a tapered point disposed at a distal end, first and second spiral tissue sealing surfaces provided by parallel planar surfaces of the spiral coil, and a first spiral tissue. A first electrode disposed on the sealing surface and a second electrode disposed on the second spiral tissue sealing surface, the first and second electrodes configured to apply bipolar radio frequency energy to seal the tissue. The helical coil can include first and second adjacent coil segments. The helical coil may include a blunt tip. The first and second electrodes can have substantially matching surface profiles. The first and second spiral tissue sealing surfaces may further include a plurality of electrodes configured for delivery of bipolar radio frequency energy.

11-17 illustrate exemplary apparatus that may be used to effect a coring process, as described herein. For example, an ablation device of the present invention may include an energy-based array capable of penetrating tissue toward a target lesion. In one embodiment shown in FIG. 11 , tissue ablation device 1100 includes an outer tube 1105 , which may be provided with a distal edge profile and an inner diameter IDouter. Coil 1110 may be attached to outer tube 1105 , wherein the coil turns are spaced from and opposed to the distal end of outer tube 1105 . Coil 1110 preferably has a slightly blunt tip 1115 to minimize the possibility of penetrating blood vessels while being sharp enough to penetrate tissue such as pleura and parenchyma. In some embodiments, coil 1110 may take the form of a helix with a fixed or variable pitch. Coil 1110 may also have a variable cross-sectional geometry. Electrode 1130 may be disposed on a surface or embedded within coil 1110 .

In some embodiments, as illustrated in FIG. 11 , coil 1110 may include a plurality of adjacent coil segments, such as coil segments 1120 and 1125 . The coil segment 1120 may include a spiral member having a pitch of 0, for example, a generally planar open ring structure, and has an inner diameter IDcoil and an outer diameter ODcoil. Coil segments 1125 may include fixed or variable pitch helical structures and fixed or variable cross-sectional geometries. In such an embodiment, electrode 1130 may be disposed on a surface of coil segment 1120 or may be embedded in coil segment 1120 .

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

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

To enable tissue ablation, the ablation device 1100 can be inserted into the tissue and the outer tube 1105 can be advanced a predetermined distance towards the target. Coil segments 1125 may allow the device to penetrate tissue in a manner similar to a corkscrew. As coil segment 1125 penetrates tissue, any vessel in its path can be moved into planar coil segment 1120 or pushed away from coil 1100 for subsequent rotation. The coil tip 1115 can be made blunt enough to minimize the possibility of penetrating blood vessels, while still sharp enough to penetrate some tissues such as lung pleura and parenchyma. The central tube 1200 can then be advanced a predetermined distance towards the target. Any tube placed in the tissue clamping zone will be clamped between electrode 1130 and electrode 1205. The tube can then be sealed by application of anode energy to electrode 1130 and electrode 1205 . Once the vessel is sealed, the cutting tube 1300 can be advanced to core the tissue to the depth reached by the outer tube 1105. The sealing and cutting process can be repeated to create a core of the required size.

According to one aspect of the present disclosure, the ablation device may be further configured to incise a target lesion and seal tissue proximate to the incision site. As illustrated in FIG. 13 , in order to facilitate cutting and sealing, the central tube 1200 includes a ligation snare 1230, first and second ligation electrodes 1215 and 1220. ) and a cut snare 1225 may be provided. As used herein, the word “snare” refers to an elastic line, such as a string or wire. The inner wall surface of the central tube 1200 can include upper and lower circumferential groove paths 1212 and 1214 disposed proximate the distal end. The first and second ligation electrodes 1215 and 1220 are disposed on the inner wall of the central tube 1200 so that the lower circumferential groove 1214 may be between them. Upper groove path 1212 can be disposed axially over ligation electrodes 1215 and 1220.

A ligating snare 1230 is disposed in the lower circumferential groove 1214 and may extend through the central tube 1200 and axially along the outer wall surface to a snare drive mechanism (not shown). A cut snare 1225 may be disposed in the upper circumferential groove 1212 and extends through the center tube 1200 and axially along the outer wall surface to a snare drive mechanism (not shown). The outer surface of the center tube 1200 receives a cut snare 1225 and a ligature snare 1230 and is provided with a plurality of axially extending groove paths communicating with upper and lower circumferential groove paths 1212 and 1214. Additionally, the electrode leads to the ligation electrodes 1215 and 1220 may extend to the energy source through an axially extending groove path.

In operation, the ablation device of the present embodiments may separate and seal the tissue core. The cutting tube 1300 can be retracted to expose the ligating snare 1230, which is preferably made of an elastic line, eg, suture. The ligating snare 1230 can be engaged to latch onto tissue and pull the tissue against an inner wall surface between the first and second ligating electrodes 1215 and 1220 . Bipolar energy may then be applied to the first and second electrodes 1215 and 1220 to seal, ie hold, the tissue. Once sealed, the cutting tube 1300 can be further shortened to expose a cutting snare that can then be driven to cut the tissue core upstream from the point where the tissue is sealed (ligation point). In some embodiments, cut snare 1225 may have a smaller diameter than ligation snare 1230 . A smaller diameter facilitates tissue slicing. Thus, the ablation device 1100 according to the present embodiment can both create a tissue core and separate the core from surrounding tissue.

In an alternative embodiment, the ablation device 1100 of the present disclosure may be provided with a single snare disposed between the ligating electrodes that both ligate and cut tissue. In this embodiment, a single snare may first pull tissue against the inner wall surface of the central tube between the ligation electrodes 1215 and 1220. Bipolar energy may then be applied to the first and second electrodes 1215 and 1220 to seal, ie hold, the tissue. Once sealed, the snare is pulled further to cut through the tissue core.

In another embodiment, cutting and sealing can be performed without the use of electrodes. In such an embodiment, ligating snare 1230 may include a set of knots 1235 and 1240 tightened under load, as shown in FIG. 14, for example. Ligation may be performed by shortening the cutting tube 1300 to expose the ligating snare 1230 and actuating the ligating snare 1230 to snare the tissue as the ligating knot is tightened. Once the tissue is snareed, the cutting tube 1300 is further shortened to expose the cutting snare 1225, which can then be operated to cut the tissue core upstream from the point where the tissue is snareed.

The present disclosure contemplates methods and systems for using an ablation device to remove tissue lesions, such as lung lesions. The method generally involves anchoring a targeted lesion for ablation, creating a channel in the tissue leading to the target lesion, creating a tissue core containing the anchored lesion, ligating the tissue core and sealing the surrounding tissue. and removing the tissue core containing the target lesion from the channel.

Anchoring may be performed by any suitable structure for anchoring the device to the lung. Once the lesion is anchored, a channel can be created to facilitate insertion of the ablation device 1100 . A channel can be created by making an incision in the lung region and inserting a dilator and port into the incision. A tissue core containing anchored lesions can be created. According to the present disclosure, the ablation device 1100 can be used to create a tissue core, ligate the tissue core, seal the tissue core, and cut it from surrounding tissue as described above. The tissue core can then be removed from the channel. As an example, a cavity port may be inserted in the channel to facilitate subsequent treatment of the target lesion location through energy-based tumor removal, such as chemotherapy and/or radiation. As a further example, the cavity port can be placed around the tissue ablation device. When the device is removed from the tissue location, the cavity port may be left in place or removed.

The anchors shown in FIG. 15 may be suitable for use in performing the methods for removing tissue lesions described herein. The anchor may include an outer tube 1422 having edges sharp enough to penetrate the lungs and chest cavity tissue without excessive damage and an inner tube 1424 disposed within the outer tube 1422. One or more tines or fingers 1426 formed or preformed from a shape memory material, such as nitinol, may be attached to the end of inner tube 1424 . The outer tube 1422 is collapsibly disposed above the inner tube 1424 so that when the outer tube 1422 is shortened, the branch 1426 can assume its preformed form as shown. According to the present disclosure, the outer tube 1422 may be shortened after passing through the lung lesion thereby engaging the branch 1426 with the lung lesion. Other suitable anchors may include coil and suction based structures.

The cutting blade shown in FIG. 16 is suitable for use in performing the methods for removing tissue lesions described herein. Once anchor 1400 is in place, it may be desirable to create a small cut or incision to facilitate insertion of the chest wall tissue expander. A cutting blade 1605 can be used to make larger incisions. The cutting blade 1605 can be continuous. The cutting blades 1605 can include a central aperture that allows them to be advanced coaxially along the anchor needle 1405 to create a larger incision in the chest wall, with each successive blade being larger than the previous one, thereby reducing the length of the incision. width can be increased.

The tissue expander described in FIG. 17 may be suitable for use in performing the methods for removing tissue lesions described herein. A tissue expander may include any suitable device for creating channels in organic tissue. In one embodiment, the tissue expander assembly includes a single cylindrical rod with a rounded end (1510) or a cylindrical rod with a rigid sleeve arrangement (1515). Successive tissue dilators may be advanced coaxially along the anchor needle to create a tissue tube or channel in the chest wall, each successive dilator being larger than the previous dilator, thereby increasing the diameter of the channel. Once the final dilator with the rigid sleeve is deployed, the internal rod 1505 can be removed while the rigid sleeve remains in the intercostal space creating a direct passage to the lung pleura.

Any tissue ablation device capable of penetrating lung tissue and creating a tissue core comprising a target lesion may be suitable for use in performing the methods for ablating tissue lesions described herein. The tissue ablation device 1100 described above is preferred.

When the tissue ablation device 1100 is removed, there may be a small channel in the lung where the target lesion has been removed. Such channels may be used to introduce energy-based ablation devices and/or local chemotherapy depending on the results of tissue diagnosis. Thus, the methods and systems of the present disclosure can be used to ensure that effective biopsies are performed as well as achieve complete clearance of minimal lung tissue removal.

generator

Electrical energy applied to the device of the present disclosure may be transmitted to the device by a generator. Electrical energy may be in the form of radio frequency ("RF") energy. In applications, electrosurgical instruments transmit RF energy through tissue, which can cause ionic agitation or friction, in effect resistive heating, thereby increasing the temperature of the tissue. Because a sharp boundary is created between the affected tissue and surrounding tissue, the surgeon can operate with a high level of precision and control, without sacrificing untargeted surrounding tissue. The low operating temperature of the RF energy can be useful for ablating, shrinking or sculpting soft tissue while simultaneously sealing blood vessels.

Devices of the present disclosure may be designed to work with any commercially available bipolar energy generator, such as an Enseal generator or a Bovie generator. Devices of the present disclosure are capable of interfacing with generator adapters that are “brand agnostic” regardless of the trademark of the generator used to deliver the radio frequency energy. In a preferred embodiment, the adapter can automatically or manually with the user's assistance identify a specific generator product that is connected to any of the devices of the present disclosure. The generator adapter can modify, adjust or alter the output of the generator (which can have subtle differences in characteristics depending on the particular generator being used) to ensure optimal tissue sealing with the tissue coring device of the present disclosure. The generator provides radio frequency energy to drive a device of the present disclosure, such as an electrosurgical coring instrument used during an open or laparoscopic routine to cut and seal a tube and cut, grip, and dissect tissue. Generators have adaptive tissue technology, which delivers intelligent energy for greater accuracy and efficiency.

sample analysis

A variety of systems, devices, processes and instruments can be used to analyze samples such as cored tissue samples. For example, tissue histology, DNA sequences, rapid on site evaluation (ROSE), or combinations thereof may be used. The described coring method provides for large tissue samples. Following removal of the core of tissue from the location of interest, the specimen may be analyzed for diagnostic purposes using any of the methods described below, either independently or in combination.

18 depicts an exemplary workflow 1800 of tissue sample analysis. As illustrated in FIG. 18 , tissue sample analysis further includes one or more of removing core tissue 1802 and determining whether the removed core is appropriate 1804 or inappropriate/non-diagnostic 1806 . can do. If appropriate, the removed tissue cores may be analyzed using designated analysis techniques (1808). If inappropriate, the workflow may perform additional passes 1810, and the cycle may continue starting with step 1802.

Rapid on-site evaluation (ROSE)

Rapid on-site evaluation (ROSE) is an immediate, fast, real-time inspection method. The use of ROSE during lung lesion biopsy sampling has been proposed to improve diagnostic rates. Reported benefits of ROSE include reduced number of biopsies performed, lower procedural risk, and improved accuracy. Cores of the isolated tissue can be analyzed using the ROSE technique. With ROSE, a preliminary diagnosis can be established by confirming sample adequacy and performing a rapid stain in the bronchoscopy room or operating room with evaluation by a cytopathologist or trained cytology technician.

Histology

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

Immunohistochemistry

Most neoplasms arising from the lung or pleura are initially diagnosed based on histological evaluation of a tissue biopsy. Although most diagnoses can only be determined morphologically, immunohistochemistry can be a valuable diagnostic tool in a series of work-ups in problematic cases. Core tissue samples can also be analyzed using immunohistochemistry. These include lung adenocarcinoma and squamous cell carcinoma (SqCC), lung adeno-carcinoma, malignant mesothelioma (MM), primary and metastatic cancer and small cell lung cancer. It can help differentiate between carcinoma (SCLC) and carcinoid tumor.

electron microscope

Cored tissue can be evaluated using electron microscopy. Electron microscopy can be used to visualize structural details of cancer cells that provide clues to the exact type of cancer.

Flow cytometry

Flow cytometry can be 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. Cores of the isolated tissue can be analyzed using flow cytometry.

Image cytometry

DNA image cytometry (DNA-ICM) has attracted attention for its diagnostic advantages, including objectivity, convenience, and high positive rate, in diagnosing various malignant cancer types. Thus, the technique has been used successfully for lung biopsies. Cores of the isolated tissue were analyzed using image cytometry.

Polymerase Chain Reaction (PCR)

Cores of the isolated tissue can be analyzed using PCR. PCR can be used to look for some changes in genes or chromosomes, which can help find and diagnose genetic conditions or diseases such as cancer.

Gene expression microarrays

Cores of the isolated tissue can be analyzed using gene expression microarrays. Microarray-based technology is an ideal way to study the effects and interactions of multiple genes in the lung.

Fluorescent in situ hybridization (FISH)

Cores of the isolated tissue can be analyzed using FISH techniques. FISH can be used to identify where a particular gene is located on a chromosome, how many copies of the gene exist, and any chromosomal abnormalities. It can be used to help fight diseases such as cancer.

Genetic sequencing

Next-generation sequencing (NGS) is rapidly being implemented to characterize cancer and guide treatment. It has previously been demonstrated that small lung biopsy samples yield adequate quality DNA and RNA, allowing for high quality NGS analysis. Cores of the isolated tissue can be analyzed using NGS techniques.

atomic force microscope

Cores of the isolated tissue can be analyzed using atomic force microscopy. Atomic force microscopy (AFM) allows nanoscale investigation of cells and molecules. The physicochemical properties of living cells undergo changes when their physiological conditions are altered. These physiochemical properties may thus reflect complex physiological processes occurring in cells. When cells are in the process of carcinogenesis and stimulated by external stimuli, their morphology, elasticity and adhesive properties may change. AFM can perform surface imaging and ultrastructural observations of living cells at atomic resolution under ambient physiological conditions, and can collect force spectroscopy information that allows the study of mechanical properties of cells. For these reasons, AFM has the potential to be used as a tool for analysis and diagnosis of lung biopsy samples.

Surface enhanced Raman spectroscopy

Cores of the isolated tissue can be analyzed using surface-enhanced Raman spectroscopy. Raman spectroscopy can characterize biomolecules because each polymer (lipid, protein, DNA, etc.) has unique fingerprint information about vibration and rotation. Therefore, Raman spectroscopy may be a promising tool for cancer diagnosis in the future. Nevertheless, Raman spectroscopy has the drawback of low sensitivity in practical applications. Compared to conventional Raman spectroscopy, Raman scattering signals can be enhanced by 4-15 orders of magnitude using surface-enhanced Raman spectroscopy (SERS) techniques. Studies have shown that Raman enhancement effects can be obtained by using silver nanospheres, gold nanospheres and similar particles. In clinical detection, label-free SERS detection of tissues provides a quick and facile way to differentiate tumors from normal tissues. Differences in the SERS spectrum between lung cancer and normal tissue can potentially be used to detect lung cancer.

shilling

The present disclosure relates to a method for delivering a filler, such as autologous blood, to a core location that can be used to seal and provide pneumostasis. As an example, once the tissue sample is cored and removed from the lung, it may be necessary to seal the core location to provide airtightness. As a further example, airtightness can be achieved in the same surgical session as tissue removal.

Although autologous blood is described herein as an example, other fillers and additives may be used. For example, absorbable gelatin foam (eg, hemostatic adjuncts such as SURGIFOAM®, biological oxidatively regenerated cellulose (ORC), fibrin/thrombin spray, etc. As a further example, a patient may have a rare case of hemophilia in which his blood does not clot normally). Other patients may use blood thinners that inhibit blood clot formation For such patients, thrombin and/or fibrinogen are added to autologous blood samples to form clots to seal the coring cavity. Reactive polyethylene glycol (PEG), ammonium sulfate, ethanol, calcium chloride, magnesium chloride can be added to blood samples to aid in clot formation Other sources for blood to be used to seal the coring cavity are Blood donated from another person or from a blood bank The donated blood may be used with or without the coagulant described above.

Systems and/or methods for sealing tissue are described herein. An exemplary method may include deploying a port to provide access to a target location. A target location may include biological tissue. A target location may include lung tissue. The target location may include cored tissue. The target location may include perforated tissue. Other locations benefit from the disclosed methods.

An exemplary method may include anchoring an anchor device to a surface at a target location (eg, via a port). Anchoring may be performed by any suitable device for anchoring the device to the lung. An exemplary method may include placing a sealing device adjacent to a target location (eg, via a port). An exemplary method may include positioning a sealing device proximate to a target location using the anchoring device as a guide. The sealing device may include an inflatable balloon. The sealing device may include an inflatable balloon with an array of radio frequency (RF) electrodes configured to ablate and seal tissue. The sealing device may include an inflatable balloon configured to seal tissue using a thermal fluid. The sealing device may include an inflatable balloon catheter. The sealing device may include an access port with an array of RF electrodes configured to ablate and seal tissue. The sealing device may include at least one microwave ablation probe.

An exemplary method may include causing the sealing device to seal the target location. Causing the sealing device to seal the target location may include causing at least a portion of the sealing device to abut a portion of the target location. An exemplary method may include placing a filler material adjacent to a target location. Exemplary methods may include placing a filler material adjacent to a target location via a filler delivery device such as a catheter. Fillers may include autologous blood, donated blood, recirculated blood, hemostatic adducts such as fibrin and/or thrombin, biological tissue adhesives such as Dermabond®, ORC, absorbable gelatin, or combinations thereof. Fillers can promote tightness. Fillers may additionally promote hemostasis. Other materials may be used. The sealing device can minimize escape of the filling material from the target location.

As an example, the target location may include at least a portion of a lung. The lungs may be allowed to collapse prior to placing the sealing device proximate to the target location. The lungs may be allowed to ventilate while the sealing device seals the target location. The sealing device may be spaced (eg, removed, separated, etc.) from the target location after the filler material is placed.

Systems and/or methods for sealing are described herein. An exemplary method may include positioning a sealing device proximate to a target location in the lung. The sealing device may be placed adjacent to the target location during collapse of the lung. However, the lungs can be ventilated. An exemplary method may include causing the sealing device to seal the target location. An exemplary method may include positioning a sealing device adjacent to a target location using an anchoring device as a guide. The sealing device may include an inflatable balloon. The sealing device may include an inflatable balloon with an array of RF electrodes configured to ablate and seal tissue. The sealing device may include an inflatable balloon configured to seal tissue using a thermal fluid. The sealing device may include an inflatable balloon catheter. The sealing device may include an access port with an array of RF electrodes configured to ablate and seal tissue. The sealing device may include at least one microwave ablation probe. An exemplary method may include placing a filler material adjacent to a target location. Exemplary methods may include placing a filler material proximate to a target location via a filler delivery device such as a catheter. The filler may include autologous blood, donated blood, recirculated blood, hemostatic adducts such as fibrin, thrombin, biological tissue adhesives such as Dermabond®, ORC, absorbable gelatin, or any combination thereof. Fillers can promote tightness. Fillers may additionally promote hemostasis. Other materials may be used. The sealing device can minimize escape of the filling material from the target location.

Systems and/or methods for sealing are described herein. An exemplary method may include deploying a fluid delivery device to a target location in the lung. The sealing device may be placed adjacent to the target location during collapse of the lung. However, the sealing device may be placed adjacent to the target location when the lungs are ventilated. An exemplary method may include disposing a filler material to a target location. Exemplary methods may include spaced (eg, removed, separated, etc.) the sealing device from the target location.

The sealing device may include an inflatable balloon. The sealing device may include an inflatable balloon with an array of RF electrodes configured to ablate and seal tissue. The sealing device may include an inflatable balloon configured to seal tissue using a thermal fluid. The sealing device may include an inflatable balloon catheter. The sealing device may include an access port with an array of RF electrodes configured to ablate and seal tissue. The sealing device may include at least one microwave ablation probe. The systems and/or methods described herein may allow clotted blood to provide a seal to achieve airtightness. An exemplary method may include disposing a filler proximate to a target location. Exemplary methods may include placing a filler material proximate to a target location via a filler delivery device such as a catheter. Fillers may include autologous blood, donated blood, recirculated blood, hemostatic adducts such as fibrin, thrombin, biological tissue adhesives such as Dermabond®, absorbable gelatin, or any combination thereof. Fillers can promote tightness. Fillers may additionally promote hemostasis. Other materials may be used. The sealing device can minimize escape of the filler from the target location.

The target location may include a cavity. The cavity can be closed, for example after sealing. Closing the cavity can include using biological tissue adhesives such as Dermabond®, cell grafts, hemostatic sealing patches, staple closures, sutures, and the like.

19 shows an example system 1900. System 1900 may include a port, such as chest port 1902 configured to provide access to a body part through, for example, a channel. It should be understood that various channels or ports may be utilized throughout the body, and chest port 1902 is shown as a non-limiting example. As an example, a chest port 1902 is shown positioned adjacent to a rib 1906 to provide access to the patient's lungs 1910 . However, other locations may be used and the chest port 1902 (or other port) may not be required. Anchor device 1904 can be anchored to tissue such as lung 1910 . An exemplary anchor arrangement is shown in FIG. 15 for illustration purposes. However, any suitable device for anchoring to target location 1912 may be used. As shown, anchor device 1904 extends through pleura 1908 , through chest port 1902 , and anchors to tissue in lung 1910 . An anchor device 1904 can be anchored (eg, releasably coupled) to tissue at a target location 1912 . Target locations 1912 may include core locations where a portion of lung tissue has been cored, punctured, or removed. An anchor device 1904 can be positioned at a target location 1912 while the lungs are inflated. However, other processes may be performed while the lungs are collapsing.

20 shows an application of an exemplary sealing device 2000 . The sealing device 2000 may include an inflatable balloon 2002 . Other sealing mechanisms may be used. The sealing device 2000 may include and/or contact a balloon catheter. The balloon catheter may be a single lumen balloon catheter. The balloon catheter may be a multi-lumen balloon catheter. The sealing device 2000 may be disposed adjacent to the target location 2012 . In this way, the sealing device 2000 can seal the target position 2012 to minimize the separation of fluid or material from the target position 2012 . As an example, filler material 2004 can be placed at target location 112 and sealed at target location 2012 by sealing device 2000 . As an example, inflatable balloon 2002 can provide sealing while lung 2010 is in motion (eg, inflating and deflating). The sealing device 2000 may be implemented when the lung 2010 is inflated or collapsed.

Exemplary sealing procedures are described herein and may include, for example, fillers, ablation, mechanical pressure, energy release (eg, RF energy), and the like. Forcing the sealing device to seal at least a portion of the core cavity at the target location may include causing the at least portion of the sealing device to abut a wall defining the core cavity. Forcing the sealing device to seal at least a portion of the core cavity at the target location may include ablating a wall defining the core cavity. Forcing the sealing device to seal at least a portion of the core cavity at the target location may include applying pressure to a wall defining the core cavity. The method can include disposing a filler material into the core cavity, and the sealing device minimizes escape of the filler material from the core cavity. The filling material may contain autologous blood. As an example, the target location may include at least a portion of a lung, and the method may further include causing the lung to collapse prior to disposing the sealing device proximate to the target location. As a further example, the target location can include at least a portion of a lung, and the method can further include allowing the lung to vent while the sealing device seals the target location.

An exemplary system for implementing one or more of the methods of this disclosure may include guided anchors. 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 coring device. After coring by the coring device, anchors can be introduced into the tissue cavity to ensure access to the cored position. The chest port may be removed and the lung collapsed. A balloon catheter may be inserted over the anchor. If the balloon catheter is in the thoracic cavity, the balloon catheter may be inflated. The inflated balloon catheter can be moved forward and slightly pushed against lung tissue. Autologous blood may be infused into the core site via an inflated balloon catheter. The inflated balloon catheter and autologous blood may be held in place for a predetermined period of time (eg, 1 minute, etc.) to allow the blood to clot at the core location. The lungs may be allowed to resume ventilation. The inflated balloon catheter allows the lungs to move up and down while maintaining contact with the lungs so that the blood at the core location can continue to facilitate further clotting. The balloon catheter can be deflated. The balloon catheter and anchor may be removed after a predetermined period of time (eg, 3 minutes, etc.). Autologous blood can coagulate at the core location to provide airtightness.

In one embodiment, an anchor and/or balloon catheter may be used to deposit autologous blood at the core site as the lung collapses. The anchor and/or balloon catheter may be removed after autologous blood is delivered. The blood may be allowed to clot in situ for a predetermined period of time (eg, 5 minutes, etc.) before allowing the lungs to resume ventilation.

An example system may allow autologous blood to be delivered to the core site. Other fillers may be used.

Exemplary systems may allow clotted blood to provide a seal to achieve airtightness.

In one embodiment, a method and apparatus are provided whereby a plug or series of sutures are in a compressed configuration on a wire within the chest. If desired to seal the pleural space, the wire can be pulled towards the operator to bring the plug or suture against the internal opening of the body space. The device is then actuated to insert a plug or suture into the internal body space opening and the wire can be stripped, thereby plugging the hole and preventing fluid from leaking or air sucking back.

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, animal based adhesives and (cyanoacrylate polyethylene glycol hydrogels, synthetic and semi-synthetic adhesives, such as urethane-based adhesives and other synthetic adhesives. The fluid can fill the volume of the vessel and be heated with RF energy or laser to a temperature sufficient to cauterize and seal the surrounding tissue beyond its temperature. The combination of fluid and RF seals the surrounding tissue.

A variety of methods, devices, and systems may be used to core or remove tissue.

cure

A variety of treatments may be implemented.

21-22 show illustrative examples, however, other methods of ablation or energy release may be used to seal tissue. For example, a shaped mesh catheter may be used. Thus, a catheter having a collapsed mesh shape can be inserted into the cavity and the cavity sheath can be removed. The mesh can then be expanded and suction applied to pull the tissue into contact with the mesh. Energy, such as RF, can then be applied to remove the cavity tissue walls.

Margin ablation

introducing an energy delivery device into a tissue cavity and delivering energy to remove cancerous tissue. When the target tissue has been corroded and removed, the tissue walls of the cavity may be ablated. For example, any of the following ablation methods may be used.

rotational ablation probe

21a-21c show example applications. As shown, once the target location has been cored and tissue has been removed, it may be necessary to resect the tissue walls of the cavity. As such, the following ablation methods may be used. For example, a rotating ablation probe may be used. 21A shows a cored cavity 2112 in tissue 2110 and a cavity sheath 1202 in place to keep the cavity open. Rotating probe 2100 is then inserted into the cavity sheath as shown in FIG. 21B. The probe 2100 may be equipped with an energy source such as an array of energy heads or a continuous energy strip. Energy can be in the form of microwave, RF, or other outputs. With the probe 2100 in place, the cavity sheath 2102 can be left in place or removed. Then, while energy is applied, the probe/energy head can be rotated to provide radially continuous ablation on the wall of the cavity and the bottom tissue 2110 as shown in FIG. 21C .

hot balloon catheter

22a-22b show example applications. As shown, a hot balloon catheter may be used. For example, as shown in FIG. 22A , a balloon catheter 2200 can be placed into a cavity 2212 formed in tissue 2210 and the cavity sheath can be removed to expose the cavity 2212 that is desired to be ablated. there is. Balloon 2200 may then be inflated with hot fluid or hot air/gas to dislodge cavity wall texture 2210, as shown in FIG. 22B.

23A-23C show example applications. As shown, when the target location has been cored and the tissue core has been removed, it may be necessary to seal the tissue walls of the cut cavity. As such, the following example procedure may be used. Device 2300 can include a fluid conduit 2301 and an inflatable absorbable balloon 2302 . The balloon 2302 may, after coring, be coated on the outside with an absorbable bio-adhesive that will seal against the tissue of the cored cavity, as shown in FIGS. 23A-23B. When the deflated balloon 2302 can be placed in a desired position, the balloon 2302 is inflated with CO ₂ (or other fluid), eg, through a fluid conduit 2301, to form a cavity in which the bioadhesive is cored. can be pressed against the tissue wall of the tissue to achieve a seal to prevent air leaks. The balloon 2302 filled with CO ₂ can be pressurized to an appropriate pressure and remain within the cored cavity.

Shaped mesh catheter

A catheter having a collapsed mesh shape may be inserted into the cavity and the cavity sheath may be removed. The mesh is then inflated, and suction is applied to pull the tissue into contact with the mesh. Energy, such as RF, may then be applied to ablate the cavity tissue walls.

microwave ablation

24 illustrates an exemplary treatment system. A catheter probe 2402 that includes an antenna 2404 that emits microwaves can be inserted into a tissue cavity 2412 cored in tissue 2410, as illustrated in FIG. 24 . The probe produces intense heat capable of ablating (eg, destroying) the target tissue.

Cryoablation

25 illustrates an exemplary treatment system. A cryoablation probe 2502 may be inserted into a tissue cavity 2512 cored in a target tissue 2510, as shown in FIG. 25 . The probe may produce extremely cold temperatures to ablate the target tissue 2510 within the cryoablation zone 2504.

Chemical excision (chemoexcision)

Hypertonic saline gel, solid salt and/or acetic acid gel can be implanted into the cavity to promote target cell damage.

Laser ablation (optical ablation)

A probe that emits a laser beam at a specific wavelength and pulse length can be inserted into the cavity. The emitted laser beam may be used to kill target tissue within the cavity.

ethanol abstinence

In this procedure, concentrated alcohol in liquid or gel form is injected directly into the target cavity and can damage the cells.

chemotherapy drugs

At the cored site, administration of chemotherapeutic drugs such as doxorubicin, fluurauracil and/or cisplatin can be done through direct injection of the substance into the cored tissue site.

26 illustrates an exemplary treatment system. A method of drug/therapeutic delivery may be achieved by disposing the cavity sheath 2602 at a cored location of the cored tissue 2610 to the target tissue 2612 . Delivery probe 2604, which includes one or more lumens 2606 at its distal end, can then be inserted into cavity sheath 2602. The delivery probe 2604 can extend into the cored tissue cavity outside the distal opening of the cavity sheath. The desired therapeutic and/or diagnostic substance is then delivered to the target tissue via the distal end of the delivery probe via direct injection using the drug/treatment injection port with plunger 2608, as shown in FIG. 26, into the delivery lumen. (2606).

27 illustrates an exemplary treatment system. In some scenarios, a biodegradable plug 2702 may be placed over the cored location of the cored tissue 2710, as shown in FIG. 27, followed by the addition of a drug/therapeutic to the cavity. That is, the drug 2704 can be delivered to the tissue cavity 2712 at the cored location of the cored tissue 2710 . The plug 2702 can be secured in place using bio-glue.

Chemotherapy drug-eluting particles

Chemotherapeutic drug eluting particles can be delivered to a cored tissue location thereby facilitating controlled and sustained local area release of therapeutic agents at high concentrations with extended administration. For example, doxorubicin can be encapsulated into nanoparticles to form micelles for targeted drug delivery. Additionally, anti-cancer drugs can be vectorized and delivered to a cored tissue location using porous particles such as porous silicon dioxide nanoparticles.

Co-delivery of siRNA and chemotherapeutic drugs

Chemotherapeutic drugs and short interfering RNA (siRNA) can be co-delivered to cored tissue sites via direct injection to promote cancer cell death. Multi-drug resistance in cancer cells can be suppressed using siRNA-based formulations, leading to specific silencing of a wide range of genetic targets. Delivery of siRNA in combination with chemotherapeutic drugs can enhance the efficacy of chemotherapy through overcoming the resistance mechanisms of cancer cells. For example, siRNA encapsulated in porous silicon nanoparticles can be co-delivered with doxorubicin to a target core location.

Biodegradable hydrogel-based controlled drug delivery

28-29 illustrate exemplary treatment systems and methods. A method of hydrogel/plug delivery may be achieved by placing the cavity sheath 2802 into the tissue cavity 2812 at a cored position 2810 . Thereafter, the delivery plunger 2804, which further includes a delivery plunger sheath 2806 and includes a hydrogel 2806 at the distal end 2814, can be inserted through the cavity sheath 2802 into the cored position 2812. there is. The hydrogel 2806 can then be delivered to the cored position 2812 via the plunging mechanism of the delivery plunger 2802, as shown in FIGS. 28-29.

Photodynamic therapy (PDT)

A combination of chemotherapeutic drugs and photodynamic therapy (PDT) can be delivered directly to the cored tissue location. PDT is a treatment technique that relies on photosensitizers and light to kill cancer cells by generating reactive oxygen species (ROS).

Degradable polymer/scaffold system

30 illustrates an exemplary treatment system. The polymer system containing the chemotherapeutic drug may be delivered to the cored tissue location 3012 of the cored tissue 3010 via direct implantation. Porous biodegradable polymers 3002, such as sponges or scaffolds, can be designed to transport chemotherapeutic drugs such as cisplatin. These polymers degrade over time, thereby releasing the chemotherapeutic drug at a controlled rate within the targeted location. Excellent biodegradable scaffolds, such as porous scaffolds, support sustained release of chemotherapeutic drugs and overcome the limitations of non-biodegradable systems that degrade after a certain period of time. Scaffold 3002 can be fabricated in a manner convenient for surgical delivery, as shown in FIG. 30 .

Hyperthermia of cored tissue

Hyperthermia can be used to treat the desired cored tissue location. Tissues cored using this approach can be exposed to higher than normal temperatures to promote selective destruction of abnormal cells, which can minimize scale effects on healthy cells. For example, light absorbing metal particles such as gold nanoparticles or iron oxide microparticles can be delivered to the cored tissue site. Then, the targeted cancer cells together with the metal particles can be killed by applying a short pulse laser.

control system

The present disclosure relates generally to an electrosurgical system configured for ablation of a tissue core from a tissue location. The present disclosure generally relates to optimizing tissue coring based on, for example, the type of tissue being treated, using multiple energy modalities based on tissue parameters based on tissue impedance, and simultaneous energy modalities based on tissue parameters. It relates to an electrosurgical method for use.

Depending on the specific instrument configuration and surgical parameters, the electrosurgical instrument can provide substantially simultaneous cutting of tissue and hemostasis through the application of radiofrequency energy, thereby advantageously minimizing trauma to the patient. For the ablation device of the present disclosure, the tissue sealing operation clamps the tissue between the spiral coil and corresponding circular rings (referred to as first and second clamping elements), and directs radiofrequency energy onto the surface of the spiral coil and circular ring. It can be realized by passing to two RF electrodes (referred to as first and second electrode elements) and finally the cutting action is usually realized by the blade tip (or cutting element). The elements may be positioned at the distal end of the tissue coring instrument. Devices of the present disclosure may be configured for endoscopic surgical procedures, including open surgical use, laparoscopy or robot assisted procedures.

Electrosurgical devices for applying electrical energy to tissue to repair and/or destroy it are also finding increasingly wide applications in surgical procedures. Electrosurgical devices usually include a handpiece, an instrument having a distally mounted end effector (eg, one or more electrodes). The end effector can be positioned against tissue so that an electrical current can be introduced into the tissue. Electrosurgical devices can be configured for bipolar or unipolar operation. During bipolar operation, current can be introduced into and returned from tissue by the activation and return electrodes of the end effector, respectively. During unipolar operation, current can be introduced into the tissue by the activating electrode of the end effector and returned through a return electrode (eg, a ground pad) located separately on the patient's body. Heat generated by current flowing through tissue can form a hemostatic seal and thus can be particularly useful for sealing blood vessels, for example. The end effector of the electrosurgical device may also include a cutting member that may be movable relative to the tissue and the electrode to transect the tissue.

Electrical energy applied by the electrosurgical device may be transmitted to the instrument by a generator in communication with the hand piece. Electrical energy may be in the form of radio frequency ("RF") energy. RF energy can be in the form of electrical energy that can be in the frequency range of 200 kilohertz (kHz) to 1 megahertz (MHz). In applications, electrosurgical devices can transmit low-frequency RF energy through tissue, which causes ionic motion, friction, and, in effect, resistive heat, thereby increasing the temperature of the tissue. Because a sharp boundary is created between the affected tissue and surrounding tissue, the surgeon can operate with a high level of precision and control, without sacrificing untargeted surrounding tissue. The low operating temperature of the RF energy can be useful for sealing blood vessels while at the same time removing, shrinking or sculpting soft tissue. RF energy works particularly well on connective tissue, which primarily contains collagen and contracts when contacted by heat.

RF energy may be in the frequency range described in EN 60601-2-2:2009+Al 1 :2011, Definition 201.3.218-HIGH FREQUENCY. For example, in unipolar RF applications the frequency may normally be limited to less than 5 MHz. However, in bipolar RF applications, the frequency can be almost arbitrary. Frequencies above 200 kHz can be used for unipolar applications to avoid unwanted stimulation of nerves and muscles that would normally result from the use of low frequency currents. Lower frequencies may be used for bipolar applications if the risk analysis shows that the possibility of neuromuscular stimulation has been alleviated to an acceptable level. Usually, frequencies above 5 MHz are not used to minimize problems associated with high frequency leakage current. However, higher frequencies may be used for bipolar applications. It is generally recognized that 10 mA is a lower threshold for thermal effects on tissue.

One challenge with conventional medical devices is the inability to control and customize power output according to the type of tissue being treated by the device. It would be desirable to provide a surgical instrument configured for coring tissue that overcomes some of the drawbacks of current instruments.

In one aspect, a surgical instrument for resecting a core of tissue is provided, the surgical instrument comprising: a processor; an end effector at a distal end of the surgical instrument and configured to interact with tissue, the end effector including first and second clamping elements; first and second electrode elements; a force sensor configured to communicate with the processor and measure a force applied to tissue positioned between the first and second clamping elements; and a temperature sensor in communication with the processor, wherein the first and second electrode elements are configured to receive radio frequency energy from the generator and deliver the RF energy to tissue disposed between the first and second clamping elements to seal the tissue. and the processor determines the type of tissue interacting with the end effector based on the tissue friction coefficient, wherein the tissue friction coefficient is a rate of heat generated by the end effector and the force applied to the tissue by the end effector. ) and configured 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 the surgical instrument can be modulated as a function of the tissue effect or resultant desired impedance trajectory of which the impedance trajectory is desired. In one aspect, the RF output may be therapeutic, eg, tissue treatment, or sub-therapeutic, eg, sensing only. The RF output can be applied to tissue and a voltage and current or expression of voltage and current can be measured or estimated. Impedance can be calculated by determining the ratio of voltage to current.

In one aspect, a tissue coring instrument identifies a controller and a) the brand and/or model of the electrosurgical generator that powers the device, and b) directly adjusts the dynamics of RF energy delivery to the tissue to achieve tissue sealing. and/or c) a processing unit configured to optimize delivery of radio frequency energy for coring tissue by communicating with and influencing generator operation with the electrosurgical generator. Identification of the generator to which the device is connected may be accomplished automatically by the controller or may be manually determined, identified and/or selected by the user.

The controller may be integrated within the device or may include an external device disposed in-line between the device and a corresponding electrosurgical generator. The controller additionally includes a collection of proprietary connectors to enable "brand agnostic" use of the device (i.e., so that the device can perform ablation of a core of tissue regardless of the type of generator used, the controller may include modular connector systems).

The controller may affect the delivery of energy to the device through two-way communication between the corresponding electrosurgical generator and the device. Various operating settings for energy delivery and tissue sealing parameters can be transmitted from the generator to the controller. Real-time tissue sensing parameters may additionally be transmitted from the device to the generator.

Additionally, the controller and processing unit may serve other purposes, including (progress tissue sealing; determine device position relative to target tissue location; determine proper device positioning and orientation; report related device diagnostic data and errors; device misuse warning; CT; displays for communicating and visualizing useful information to the user (such as navigation systems for determining the location of devices in 3D space and/or for anatomical landmarks acquired through various medical imaging modalities such as MRI and ultrasound); and It includes providing interfaces for connection of other devices or accessories, such as

In another embodiment, a custom generator configured for tissue coring may include a processing unit and controller integrated directly into the generator. Such preferred tissue coring electrosurgical generators include (tissue sealing progress; device positioning relative to target tissue location; proper device positioning and orientation; associated device diagnostic data and error reporting; device misuse warnings; such as CT, MRI, and ultrasound). Other devices or accessories, such as displays for communicating and visualizing useful information to the user (such as navigation systems for determining the location of the device in 3D space and/or for anatomical landmarks acquired through various medical imaging modalities) It may include providing an interface for connection of

Any of the preferred surgical instruments configured for ablation of a core of tissue from a target tissue location as described above (i.e., a tissue coring electrical surgical generator specially configured for coring tissue, RF from an electrical surgical generator) For a controller integrated within the tissue core ablation device configured to affect energy delivery to optimize tissue sealing or an external controller configured to influence the delivery of RF energy from an electrosurgical generator to the tissue core ablation device), RF to tissue Energy delivery can be modified, controlled, influenced, or otherwise altered to achieve a desired tissue effect or result.

RF impedance is known to fluctuate during tissue heating and coagulation. RF impedance can be used as an indicator of tissue condition and thus can be used to indicate progression in coagulation cycles, vessel sealing cycles, cuttings, and the like. The extension of these fluctuations in RF impedance can be used to form the desired treatment cycle when the output is adjusted so that the RF impedance follows the specific, desired progression of fluctuations in impedance. The required progression of the impedance may be predetermined based on operating parameters of the instrument or determined by the surgeon's selection or measurement of tissue parameters, to set the treatment of this progression. The progression of the impedance can determine one or more of the output power, the output waveform or wave shape, the selection of a mode or aspect of energy, or the point at which the application of energy to tissue ends.

A parameterized tissue model may be fitted to the tissue during tissue treatment. Parameters found in the model can be used to create optimal controllers in real time and can also be correlated to specific tissue characteristics. The present application provides real-time optimization on generator control systems based on RF impedance and real-time tissue evaluation.

These techniques can be used to model tissue in real-time specific to a particular tissue type and develop a controller in real-time to maximize sealing, minimize sticking of tissue, and cycle time. Also provided is control of the output of the surgical instrument based on tissue characteristics and variations in tissue during sealing and cutting cycles.

The RF output includes at least one electrode configured to apply electrosurgical energy to tissue, a sensing circuit configured to measure an impedance of the tissue, and determining whether a tissue response has occurred as a function of a predetermined increase in impedance value and impedance - tissue response corresponds to the boiling point of tissue fluid; generating a target impedance trajectory as a function of a predetermined desired rate of change in impedance based on the measured impedance and the tissue response determination, the target impedance trajectory comprising a plurality of target impedance values for each of a plurality of time steps; and adjusting the output level of the ultrasound output stage to substantially match the tissue impedance to the corresponding target impedance value for at least a predetermined minimum period of time, thereby driving the tissue impedance along the target impedance trajectory to generate tissue electrosurgical energy through a controller programmed to drive the tissue impedance along the target impedance trajectory. It can be configured to supply.

31 shows a schematic and flow diagram of an apparatus 3100 that will be able to advance into a tissue location, discriminate neoplastic tissue from normal tissue, and successfully treat or excise the neoplastic tissue. Apparatus 3100 may include a processing unit 3102 and an external display 3104 (eg, 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 energy source 3108 . Processing unit 3102 can be configured to receive device positioning information 3110 and ascertain 3112 a current location of tissue. Processing unit 3102 can be further configured to confirm 3114 that device 3100 is at the target location and transmit such confirmation to tissue sensing unit 3116 . Processing unit 3102 may be further configured to activate 3118 delivery of energy to a tissue location. When energy transfer is activated, processing unit 3102 can be configured to provide automated advancement 3120 of device 3100 and provide new positional information to tissue sensing unit 3116 . Processing unit 3102 can be configured to receive information from tissue sensing unit 3116 and adjust 3122 energy delivery accordingly. Processing unit 3102 may be configured to provide instructions 3124 to an apparatus component for ablating and/or ablating tissue.

In one aspect, a surgical instrument system for coring tissue from a target tissue location includes a tissue ablation device configured for coring tissue, the device comprising a spiral coil electrode and a cutting configured to cooperate with the spiral coil electrode for transversal sectioning of tissue. contains elements; and a handle assembly configured to facilitate interaction between the tissue and the tissue ablation device.

In one aspect, a surgical instrument system for coring tissue from a target tissue location is a tissue ablation device configured for coring tissue, the device comprising: a first clamping element comprising a spiral coil and a first electrode; a second electrode; and a second clamping element positioned to at least partially oppose the first clamping element and a cutting element configured for transverse cutting of 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.

The handle assembly can facilitate connection of at least one electrode, such as at least one of the first electrode and the second electrode, to the generator. The handle assembly can facilitate connection of at least one electrode, such as at least one of the first electrode and the second electrode, to the computing device. The handle assembly can facilitate connection of at least one electrode, such as at least one of the first electrode and the second electrode, to the robotic system. The handle assembly may be configured to automate advancement of at least one electrode, such as at least one of the first electrode and the second electrode. The handle assembly can be configured to automate the transfer of energy to at least one electrode, such as at least one of the first electrode and the second electrode.

In one aspect, a surgical instrument system for coring tissue from a target tissue location comprises a tissue ablation device configured for coring tissue, the device comprising: a spiral coil electrode and a cutting configured to cooperate with the spiral coil electrode for transverse cutting of tissue. contains the element -; and computing logic configured to automate one or more functions of the tissue ablation device.

In one aspect, a surgical instrument system for coring tissue from a target tissue location is a tissue ablation device configured for coring tissue, the device comprising: a first clamping element comprising a spiral coil and a first electrode; a second electrode; and a second clamping element positioned to at least partially oppose the first clamping element and a cutting element configured for transverse cutting of tissue; and computing logic configured to automate one or more functions of the tissue ablation device.

Computing logic may be configured to automate advancement of at least one electrode, such as at least one of the first electrode and the second electrode. The computing logic may be configured to automate the transfer of energy to at least one electrode, such as at least one of the first electrode and the second electrode. Computing logic may be configured to determine the energy distribution provided through the tissue ablation device. The computing logic may be configured to receive one or more inputs relating to the ablation device, such as one or more of the first clamping element, the second clamping element, or the cutting element. Computing logic may be disposed in a handle assembly associated with the tissue ablation device. Computing logic may be placed in a generator that communicates with the tissue ablation device.

handle design sequence

Tissue coring devices with spiral coils and anvil electrodes are provided to track along anchors to remove target tissue. When the coring device is placed over the anchor and contacts the tissue surface with the distal tip of the helical coil, the following sequence of steps may be performed to core the target tissue while simultaneously sealing the fluid tube. An exemplary method 3700 involving co-located sequences is shown for illustration purposes in FIGS. 37A-37B. The method can include initiating a coring procedure step 3702 . For example, a coring device may be placed on an anchor. Method 3700 may further include one or more of the following steps.

At step 3704, an anchor may be placed at a depth of 3-5 cm (eg, using an insertion stopper), based on the targeted tissue depth from the organ surface.

At step 3706, anchors can be placed and insertion stoppers can be removed.

At step 3708, a center aid may be placed over the anchor.

At step 3710, the anchor may pass through the coring device until the coring device coil is over the pleura and centered on the anchor.

At step 3712, the forward button may be activated (eg, pressed).

At step 3714, the coil electrode may be rotated 5/4 of a turn through the tracheal surface (eg, the pleura of the lung). Initial rotation of the coil electrode may engage the coil electrode into tissue. When using a spiral coil electrode, the fluid tube that can be caught in the spiral section of the spiral coil can be moved to the flat portion of the spiral coil.

At step 3716, the anvil electrode may be clamped against the coil electrode. In some embodiments, tissue may be clamped between a helical coil and one or more anvil electrodes with a predetermined gap suitable for sealing a vessel.

At step 3718, the controller may apply RF energy to the one or more electrodes to cauterize the tissue and seal any fluid tubes clamped between the electrodes. RF energy may be applied between the helical coil anvil electrodes to effect tube sealing between the electrodes.

At step 3720, a hold or wait period of about ten (10) seconds may be initiated.

At step 3722, a determination may be made as to whether a generator alert and/or command was received during cauterization.

If "yes", steps 3724 - 3730 may be initiated.

At step 3724, an alert button may be activated (eg, pressed or selected) to clarify the alert.

At step 3726, one or more electrodes may be deactivated.

At step 3728, one or more anvil electrodes may be unclamped from one or more coil electrodes.

At step 3730, the coil electrode may be reversed 1/36th of a turn counterclockwise.

After completing steps 3824-3730, method 3700 may loop back to step 3716.

If no, the process may proceed to step 3716 and may proceed as described herein.

In step 3732 the go button may be activated (eg, pressed).

At step 3734, one or more electrodes may be deactivated and disconnected.

In step 3738, the blade tube is rotated 1/2 turn to dissect the cored tissue from the surrounding tissue. For example, tissue cores can be cut through mechanical blade tubes.

At step 3740, the blade tube may be shortened and the coil electrodes may be disconnected.

As shown, continuing from FIG. 37A to FIG. 37B , in step 3742 a determination may be made as to whether the anchor has been locked to the coring device (i.e., indicating that the targeted tissue at a depth of at least 3 cm has been reached). there is.

If no, at step 3744, the coil electrode may be rotated three quarters of a turn, and method 3700 may loop back to step 3716.

If yes, method 3700 can proceed to step 3746, where a go button can be activated (eg, pressed).

At step 3748, the cutting tool may be fully shortened.

At step 3750, the ligation line may be pulled and held taut in tension.

At step 3752, one or more electrodes may be activated. RF energy can be applied between the second set of electrodes to seal any fluid conduit within the ligating line loop and between the electrodes.

At step 3754, a hold or wait period of about ten (10) seconds may be initiated.

At step 3756, one or more electrodes may be deactivated. The anvil electrode can be separated from the spiral electrode.

The cycle of rotating the spiral coil, clamping the tissue between the electrodes, applying RF energy to seal the vessel, incising the tissue core, and separating the anvil and spiral electrodes can be repeated as desired. Once the target tissue is cored and within the blade tube, a ligation line may be placed to squeeze the distal end of the target tissue between the second set of electrodes.

At step 3758, ligation line tension may be maintained.

At step 3760, the cutting line may be actuated to cut the cored tissue from the surrounding tissue. For example, a mechanical line may be placed to cut the target tissue proximal to the ligation line.

At step 3762, the cavity port may be rotated clockwise and lowered until resistance is felt.

At step 3764, the cavity port may be rotated counterclockwise and lowered until resistance is felt.

At step 3766, the coil electrode may be rotated 3/4 turn counterclockwise. For example, the helical coil may be rotated to separate the helical coil from surrounding tissue.

At step 3768, the coring device may be removed with the cored tissue (eg, the target tissue sample).

At step 3770, the anchor may be unlocked.

At step 3772, the anchors may be undeployed and removed from the coring device.

At step 3774, the cored device may be removed from the anchor for subsequent tissue laboratory work.

At step 3776, the coring procedure may be completed.

It is necessary to include a handle mechanism for actuating the sequence of steps described above to reduce the number of manual steps a user needs to perform with the tissue coring device. The mechanism is controlled through a sequence of firmware installed in a generator (also referred to as a controller) and electrical hardware contained in a device handle with a coring device gear mechanism. Sequences can have different modes of input, such as operator actions, advances, warnings, and the like. The concept of using the inputs of this mode to automate post-tissue coring procedures follows.

A design description of the handle mechanism and step sequence to be controlled by the controller follows. The sequence shows the target tissue to be cored out 3 cm below the tracheal surface as an example.

A handle design 3200 is shown, for example, in FIG. 32 . As shown, handle 3200 can be configured for a tissue coring device having a spiral coil and an anvil electrode, for automated rotation, tissue clamping, control of device position relative to an anchor, and ligation/cutting of target tissue. Can include subordination mechanisms (eg, 4). As described above, when a coring device is positioned over an anchor and contacts a tissue surface with the distal tip of a helical coil, the sequence of steps is a planetary gear system having three states of rotation for coil and machine blade rotation; A clamping camshaft 3202 for sealing, an optical anchor position monitoring mechanism to identify if cored target tissue is within the mechanical blade tube, and an integrated bi-directional pulley system 3204 for ligation/severing of the cored target tissue. is performed with Handle 3200 may further include an automated housing cap 3206, solenoid 3208, manual clutch wing 3210, automated handle housing 3212, coil cam pin 3214 and machine blade cam pin 3216. can The following mechanism is described in more detail below.

33 illustrates an example rotation control assembly 3300 (eg, planetary gear assembly). The rotation control assembly 3300 shown in FIG. 33 is configured to require the system to maintain two degrees of freedom by controlling bi-directional rotation of the tissue coring coil and uni-directional rotation of the mechanical blade tube 3310 with one motor control. It can be. To initiate rotation of the coil to engage the coil into tissue, the motor 3302 is rotated counterclockwise and the coil one way bearing 3316 along the motor shaft 3304 may be engaged. The planetary gear mechanism can then be driven and the ring gear 3306 rotated clockwise to engage the jack shaft 3322. The jack shaft 3322 may then be rotated counterclockwise to engage the coil tube gear 3312 to allow the coil to rotate a predetermined rotational distance. The motor 3302 can be rotated clockwise to initiate rotation of the machine blade tube 3310 to cut the tissue core, and the machine blade one-way bearing 3308 along the motor shaft 3304 can be engaged; The planetary gear mechanism may be deactivated to allow the machine blade tube 3310 to rotate a predetermined rotational distance. Manual clutch 3320 can be shifted to an upper position and cone clutch 3318 can be moved into contact with the planetary gear system to initiate counterclockwise rotation of the coil to separate the coil into tissue. Then, the motor 3302 can be rotated counterclockwise, and the coil one-way bearing 3316 along the motor shaft 3304 can be engaged. The planetary gear mechanism can be activated and the ring gear 3306 can engage the jack shaft 3322 and rotate counterclockwise. The jack shaft 3322 can then be rotated clockwise and engaged with the coil tube gear 3312 to allow the coil to rotate a predetermined rotational distance.

34 illustrates a linear translation control assembly 3400 in the form of a clamping camshaft and pin mechanism. The clamping camshaft and pin mechanism shown in FIG. 34 controls linear translation of the machine blade tube (not shown) and coil tube 3408 for tissue engagement, vessel sealing, and cutting. After the helical coil rotates a predetermined distance to engage the target tissue, the camshaft 3402 with a machined slot housed on the servo motor 3420 can be rotated clockwise. Then, the coil cam pin 3404 follows the cam path 3406 and the coil tube 3408 can be linearly transformed to clamp tissue between the helical coil and the anvil electrode to a predetermined gap that can be suitable for sealing a vessel. . Then, the servo motor 3420 can be rotated clockwise, the machine blade cam pin 3410 can follow the machine blade path 3412, and the machine blade tube (not shown) can be linearized into the cutting position. can be converted to At the end of the cycle, the servo motor 3420 may be rotated counterclockwise to separate the anvil electrode from the spiral electrode and translate the machine blade tube out of the cutting position.

35 illustrates an anchor position monitor 3500. Anchor position monitor 3500 may be an optical anchor position monitoring mechanism and may actively monitor target core tissue position on an anchor to a tissue coring device via an optical sensor 3502 along the anchor. When the target tissue is coring and is within the machine blade tube, preset markings on the anchor alert the system, according to the optical sensor 3502 or optical sensing unit, that the tissue coring device is in the optimal position. The solenoid 3504 can then be triggered and engaged with the spring loaded anchor lock 3506, locking the anchor position to the tissue coring device.

36 illustrates an exemplary ligation and cutting system 3600. Ligation and cutting system 3600 can be a bi-directional pulley system and can control the placement of the ligating and cutting machine lines. When the target tissue is within the blade tube described with respect to FIGS. 34-35, the servo motor 3602 can be rotated clockwise. Then, a one-way bearing 3604 housed within the ligation pulley 3606 can be engaged, a ligation machine line can be placed, and a ligation pawl 3608 is placed between the second set of electrodes to hold the target tissue. It can hold the line in tension to squeeze the distal end. After the RF energy is complete between the second set of electrodes to seal the fluid tube within the ligation loop, the servo motor 3602 can be rotated counterclockwise and the one-way bearings housed within the cutting pulley 3612 ( 3610) can be engaged to position the cutting machine line to cut the target tissue proximal to the ligation line.

38 is a handle design 3800 for a tissue ablation device that includes a spiral coil and one or more anvil electrodes and multiple attachments to a target coring device for automated rotation, tissue clamping, and ligation/cutting of target tissue. can include As described above, where the coring device is positioned over an anchor and contacts the tissue surface with the distal tip of the helical coil, the steps in the sequence described above are two independent gear systems for rotating the coil and mechanical blades, a clamping actuator plate and with two independent spring loaded systems for ligation and cutting. Handle design 3800 consists of machine blade gear set 3802, machine blade stepper motor 3804, coil stepper motor 3806, spring loaded cutting knob 3808, spring loaded ligating knob 3810, clamp plate housing 3812 and clamp linear actuator 3814. The following mechanism is described in more detail below.

39 illustrates a rotation control assembly 3900. The rotational control assembly 3900 can be an independent gear system configured to control the rotation of the machine blade tube and the tissue coring coil in both directions with the control of two motors. To initiate clockwise rotation of the coil (i.e., to engage the coil into tissue), the coil stepper motor (e.g., coil stepper motor 3806 in FIG. 38) can be rotated counterclockwise, and the coil gear system can be activated. Then, the coil can be allowed to rotate a predetermined rotational distance, and the fluid tube caught in the spiral section of the spiral coil can be moved to the flat portion of the spiral coil. To initiate rotation of the machine blade tube to cut the target tissue core, the blade stepper motor (e.g., coil stepper motor 3806 in FIG. can be allowed to rotate. To initiate a counterclockwise rotation of the coil to disengage the coil from the tissue, the coil stepper motor is rotated clockwise and the coil gear system 3902 is activated, allowing the coil tube to rotate a predetermined rotational distance. there is. Rotation control assembly 3900 may further include cutting tool motor bracket 3904 , motor housing/handle 3906 , linear actuator clamp plate 3908 and linear actuator frame 3910 .

40 illustrates an exemplary clamp 4000. The clamping solenoid plate controls the linear translation of the coiled tube for tissue engagement and vessel sealing. After rotating the helical coil clockwise a predetermined distance to engage the target tissue, the linear actuator 4002 housed in the carrier plate 4004 can be activated. The actuator arm can then be linearly translated to clamp tissue between the helical coil and the preargument electrode into a predetermined gap suitable for sealing the vessel. At the end of the RF energy cycle, the linear actuator can be deactivated and the coiled tube can be allowed to unclamp under gravity. The clamp 4000 may further include a coil gear set 4006 , a clamp plate housing 4008 , and a linear actuator frame 4010 .

41 illustrates an exemplary ligation and cutting system 4100. An independent spring loaded mechanism for ligating and cutting can control the placement of the ligating and cutting machine lines. When the target tissue is within the blade tube, the ligating spring 4102 can be engaged (eg, pressed down by an operator) and the pin can be rotated clockwise. The ligating and cutting system may further include a ligating knob 4104 , a spring base 4106 and a locking path 4108 . The spring loaded pins can then be activated, and the ligating machine line can be placed and held between a second set of electrodes in tension to squeeze the distal end of the target tissue. After application of RF energy is complete between the second set of electrodes to seal the fluid tube with the ligation loop, the cutting spring can be engaged (eg by an operator) and the pin can be rotated clockwise; This activates the spring loaded pin and places the cutting machine line to cut the target tissue proximal to the ligation line.

The present disclosure includes at least the following aspects.

Aspect 1. A method for coring tissue from a target tissue location comprising delivering a first energy modality to an end effector of a surgical instrument that interacts with tissue, the end effector being configured to core tissue. and a first clamping element comprising a helical coil and a first electrode, a second clamping element comprising a second electrode and positioned opposite at least a portion of the first clamping element, and a cutting element configured for transverse cutting of tissue. How to.

Aspect 2. The method of aspect 1, comprising: determining a tissue parameter of a tissue interacting with the end effector; and delivering a second energy modality to the end effector based on the determined tissue parameter, wherein the first energy modality is different than the second energy modality.

The method of aspect 2, wherein the tissue parameter comprises tissue impedance.

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

Aspect 5. The method of any one of aspects 2 to 4, further comprising: controlling a first energy modality delivered to the end effector based on the tissue parameter as an input; and selecting a second energy modality to be transmitted by the end effector to interact with the tissue, wherein the first energy modality and the second energy modality correspond to a type of interaction between the end effector and the tissue.

Aspect 6. A method for coring tissue from a target tissue location, comprising: delivering a first drive signal to an end effector of a surgical instrument that interacts with tissue, wherein the end effector is configured for coring tissue and is a helical coil. a first clamping element comprising a first electrode, a second clamping element comprising a second electrode and positioned opposite at least a portion of the first clamping element, and a cutting element configured for transverse cutting of tissue; measuring tissue parameters of tissue interacting with the end effector; adjusting delivery of the first drive signal based on the measured tissue parameter; and ceasing delivery of the first drive signal if the termination parameter is satisfied.

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

Aspect 8. The method of any one of aspects 6 and 7, wherein the first drive signal is an ultrasonic energy signal.

Aspect 9. The method of any one of aspects 6 to 8, wherein the initial tissue impedance, the initial aperture defined by the jaw of the end effector, the current tissue impedance, the rate of change of the tissue impedance, the ultrasound energy supplied to the tissue, the tissue based on at least one of radio frequency (RF) energy supplied to or a time of transection, determining that the tissue is sealed.

Aspect 10. The method of any one of aspects 6 to 9, wherein the first drive signal comprises a first energy signal, and the step of adjusting delivery of the first energy signal based on the measured tissue impedance modifies the output power of the generator. A method comprising: modifying an output waveform of the generator, selecting and passing the second energy signal to a surgical instrument, or modifying a termination parameter.

Aspect 11. The method of any one of aspects 6 to 10, further comprising ceasing delivery of the first drive signal at a tissue parameter that meets or exceeds a threshold value of the tissue parameter.

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

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

Aspect 14. The method of any of Aspects 6-13, wherein measuring the tissue parameter comprises measuring a rate of change of the tissue parameter.

Aspect 15. The method of any one of Aspects 6-14, further comprising determining a condition of the tissue based on the measured tissue parameter.

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

Aspect 17. The method of any one of aspects 6 to 16, wherein delivery of the first drive signal to the end effector is modulated such that the tissue parameter varies according to a predetermined technique.

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

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

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

Aspect 21. A surgical instrument system for coring tissue from a target tissue location, wherein the tissue excision device is configured for coring the tissue, the device comprising a first clamping element comprising a spiral coil and a first electrode, a second electrode and a second clamping element positioned opposite at least a portion of the first clamping element and a cutting element configured for transverse cutting of tissue; a handle assembly including a trigger system, the trigger system configured to facilitate interaction between at least one of the first clamping element, the second clamping element, or the cutting element with tissue; and a generator configured to deliver energy to the tissue ablation device.

Aspect 22. The system of aspect 21, further comprising a controller in communication with the generator, the controller controlling the generator to generate radiofrequency energy sufficient to seal the tissue based on the at least one sensed operating condition of the tissue ablation device. A system configured to serve as first and second electrodes of a tissue ablation device.

Aspect 23. The system of aspect 22, wherein the controller is configured to sense an interaction of the tissue ablation device with the tissue.

Aspect 24. The system of aspect 23, wherein the controller is configured to sense interaction of the tissue ablation device with the tissue based on the measured impedance levels associated with the first and second electrodes.

Aspect 25. The system of aspect 23 or 24, wherein the controller is configured to detect an interaction of the tissue ablation device with the tissue by sensing an amount of force applied to at least one of the first or second clamping elements.

Aspect 26. The system of any one of aspects 22-25, wherein the controller is configured to sense a position of the cutting element relative to at least one of the first or second clamping elements of the tissue ablation device.

Aspect 27. The system of any one of aspects 22 to 26, wherein the controller is configured to control the generator to provide a continuous amount of radiofrequency energy.

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

Aspect 29. The system of any of aspects 22 to 28, wherein the controller is configured to control a position of the first clamping element relative to the second clamping element.

Aspect 30. The system of any of aspects 22-29, wherein the controller is configured to control a position of the cutting element relative to at least one of the first or second clamping elements of the tissue ablation device.

Aspect 31. The system of any one of aspects 22-30, wherein the tissue ablation device and generator are at least mechanically or electrically connected to the handle assembly.

Aspect 32. placing a coring device over the anchor, the coring device including a coil section and a helical coil having a flat portion; engaging the spiral coil into the tissue by rotating the spiral coil of the coring device so that the fluid tube caught between the coil sections is moved to the flat portion of the spiral coil; clamping the tissue between the spiral coil and at least two anvil electrodes of the coring device; applying radio frequency (RF) energy between the spiral coil and the anvil electrode to perform tube sealing between the electrodes; cutting the tissue core through the mechanical blade tube of the coring device; separating the electrodes from each other; and repeating the cycle of rotating the helical coil, clamping the tissue between the electrodes, applying an RF signal to seal the vessel, cutting the tissue core, and separating the electrodes.

Aspect 33. The method of aspect 32, further comprising, when the target tissue is cored and within the blade tube, squeezing the distal end of the target tissue between a second set of electrodes by placing a ligation line; applying RF energy between the second set of electrodes to seal any fluid conduit between the electrodes and within the ligating line loop; positioning a mechanical line to cut the target tissue distal to the ligation line; rotating the helical coil to separate it from surrounding tissue; and removing the coring device with the target tissue sample.

Aspect 34. A surgical instrument system for coring tissue from a target tissue location, the tissue ablation device configured for coring the tissue, the device comprising: a first clamping element comprising a helical coil and a first electrode; a second electrode; and a second clamping element positioned opposite at least a portion of the first clamping element and a cutting element configured for transverse cutting of tissue; and a handle assembly configured to facilitate interaction between at least one of the first clamping element, the second clamping element, or the cutting element and tissue.

Aspect 35. The system of aspect 34, wherein the handle assembly facilitates connection of at least one of the first electrode and the second electrode to the generator.

Aspect 36. The system of any one of aspects 34 and 35, wherein the handle assembly facilitates connection of at least one of the first electrode and the second electrode to a computing device.

Aspect 37. The system of any one of aspects 34-36, wherein the handle assembly facilitates connection of at least one of the first electrode and the second electrode to the robotic system.

Aspect 38. The system of any one of aspects 34-37, wherein the handle assembly is configured to automate advancement of at least one of the first electrode and the second electrode.

Aspect 39. The system of any one of aspects 34-38, wherein the handle assembly is configured to automate the transfer of energy to at least one of the first electrode and the second electrode.

Aspect 40. A surgical instrument system for coring tissue from a target tissue location, the tissue ablation device configured for coring the tissue, the device comprising a first clamping element comprising a spiral coil and a first electrode, a second electrode. and a second clamping element positioned opposite at least a portion of the first clamping element and a cutting element configured for transverse cutting of tissue; and computing logic configured to automatically utilize one or more functions of the tissue ablation device.

Aspect 41. The system of aspect 40, wherein the computing logic is configured to automate advancement of at least one of the first electrode and the second electrode.

Aspect 42. The system of any one of aspects 40 and 41, wherein the computing logic is configured to automate the transfer of energy to at least one of the first electrode and the second electrode.

Aspect 43. The system of any of aspects 40-42, wherein the computing logic is configured to determine an energy distribution provided through the tissue ablation device.

Aspect 44. The system of any of aspects 40-43, wherein the computing 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.

Aspect 45. The system of any of aspects 40-44, wherein the computing logic is disposed in a handle assembly associated with the tissue ablation device.

Aspect 46. The system of any of aspects 40 to 45, wherein the computing logic is disposed in a generator in communication with the tissue ablation device.

Aspect 47. A surgical instrument system for coring tissue from a target tissue location, wherein the tissue ablation device configured to core the tissue, the device comprising: a spiral coil electrode and a cutting configured to cooperate with the spiral coil electrode to transect tissue. contains the element -; and a handle assembly configured to facilitate interaction between the tissue ablation device and tissue.

Aspect 48. The system of aspect 47, wherein the handle assembly facilitates connection of the electrodes to the generator.

Aspect 49. The system of any one of aspects 47 and 48, wherein the handle assembly facilitates connection of the electrode to a computing device.

Aspect 50. The system of any of aspects 47-49, wherein the handle assembly facilitates connection of the electrode to the robotic system.

Aspect 51. The system of any one of aspects 47-50, wherein the handle assembly is configured to automate advancement of the electrode.

Aspect 52. The system of any one of aspects 47-51, wherein the handle assembly is configured to automate the transfer of energy to the electrodes.

Aspect 53. A surgical instrument system for coring tissue from a target tissue location, wherein the tissue ablation device is configured to core the tissue, wherein the device is configured to cooperate with the spiral coil electrode and the spiral coil electrode for transection of tissue. -; and computing logic configured to automatically utilize one or more functions of the tissue ablation device.

Aspect 54. The system of aspect 53, wherein the computing logic is configured to automate advancement of the electrode.

Aspect 55. The system of any one of aspects 53 and 54, wherein the computing logic is configured to automate the transfer of energy to the electrodes.

Aspect 56. The system of any of aspects 53-55, wherein the computing logic is configured to determine an energy distribution provided through the tissue ablation device.

Aspect 57. The system of any of aspects 53-56, wherein the computing logic is configured to receive one or more inputs relating to the tissue ablation device.

Aspect 58. The system of any of aspects 53-57, wherein the computing logic is disposed in a handle assembly associated with the tissue ablation device.

Aspect 59. The system of any of aspects 53-58, wherein the computing logic is disposed in a generator that communicates with the tissue ablation device.

While what is believed to be the most practical and preferred embodiment has been shown and described, it is apparent that departures from the specific designs and methods described and illustrated may be suggested to those skilled in the art and used without departing from the spirit and scope of the present invention. Systems and methods for removal of lesions, eg, from the lung, have been described herein. It will be appreciated by those skilled in the art that the devices and methods described herein may not be limited to the lungs and may be used for tissue ablation and lesion removal in other areas of the body. The invention is not limited to the specific configurations described and illustrated, but should be construed consistent with all modifications that may come within the scope of the appended claims.

Claims (59)

A method for coring tissue from a target tissue location, comprising:
delivering the first energy modality to an end effector of a surgical instrument that interacts with tissue;
including,
wherein the end effector is configured for coring tissue;
The end effector is
a first clamping element comprising a helical coil and a first electrode;
a second clamping element comprising a second electrode and positioned to oppose at least a portion of the first clamping element; and
A method comprising a cutting element configured for transection of tissue. According to claim 1,
determining a tissue parameter of a tissue interacting with the end effector; and
delivering a second energy modality to the end effector based on the determined tissue parameter;
wherein the first energy pattern is different from the second energy pattern. According to claim 2,
Wherein the tissue parameter comprises tissue impedance. According to claim 3,
calculating the tissue impedance based on an electrical parameter associated with the first energy pattern;
How to include more. According to claim 2,
controlling the first energy modality delivered to the end effector based on the tissue parameter as an input; and
selecting the second energy modality for delivery by the end effector to interact with tissue;
Including more,
wherein the characteristics of the first energy modality and the second energy modality correspond to a type of interaction between the end effector and the tissue. A method for coring tissue from a target tissue, comprising:
delivering a first drive signal to an end effector of a surgical instrument that interacts with tissue;
measuring a tissue parameter of a tissue interacting with the end effector;
adjusting delivery of the first drive signal based on the measured tissue parameter; and
stopping transmission of the first driving signal when a termination parameter is satisfied;
including,
wherein the end effector is configured for coring tissue;
The end effector is
a first clamping element comprising a helical coil and a first electrode;
a second clamping element comprising a second electrode and positioned opposite at least a portion of the first clamping element; and
A method comprising a cutting element configured for transection of tissue. According to claim 6,
wherein the first drive signal is a radio frequency (RF) energy signal. According to claim 6,
The method of claim 1, wherein the first drive signal is an ultrasonic energy signal. According to claim 6,
Initial tissue impedance, the initial aperture defined by the jaw of the end effector, the current tissue impedance, the rate of change of tissue impedance, ultrasound energy supplied to the tissue, radio frequency (RF) energy supplied to the tissue, or transection time, either Based on the at least one, determining that the tissue is sealed. According to claim 6,
The first driving signal includes a first energy signal, and adjusting the transfer of the first energy signal based on the measured tissue impedance includes modifying an output power of a generator, modifying an output waveform of the generator, and the like. , selecting and passing a second energy signal to the surgical instrument or modifying the termination parameter. According to claim 6,
stopping delivery of the first drive signal at a tissue parameter that meets or exceeds a threshold value of the tissue parameter;
How to include more. According to claim 6,
The first drive signal comprises a first energy signal, the amplitude of the first energy signal is a first amplitude, the method comprising:
delivering a second drive signal to tissue with a second amplitude different from the first amplitude;
How to include more. According to claim 12,
wherein the first drive signal is a radio frequency (RF) energy signal and the second drive signal is an ultrasonic energy signal. According to claim 6,
The method of claim 1 , wherein measuring the tissue parameter comprises measuring a rate of change of the tissue parameter. based on the measured tissue parameter, determining a condition of the tissue. According to claim 15,
Wherein the condition of the tissue comprises coagulation, sealing or cutting. According to claim 6,
regulating delivery of the first drive signal to an end effector such that the tissue parameter varies according to a predetermined technique. According to claim 17,
wherein the predetermined technique comprises adjusting the tissue parameter according to a threshold value of the tissue parameter or a threshold rate of change of the tissue parameter. According to claim 6,
wherein the tissue parameter is based on dividing a voltage measurement of radio frequency (RF) energy by a current measurement of the RF energy. According to claim 19,
wherein the threshold of the tissue parameter corresponds to an end impedance at which sealing is completed during coagulation of the tissue using RF energy. A surgical instrument system for coring tissue from a target tissue location, comprising:
a tissue ablation device configured for coring tissue;
a handle assembly containing a trigger system; and
a generator configured to deliver energy to the tissue ablation device;
The tissue ablation device is configured for transecting tissue, a first clamping element comprising a spiral coil and a first electrode, a second clamping element comprising a second electrode and positioned opposite at least a portion of the first clamping element. Including a cutting element that becomes,
wherein the trigger system is configured to facilitate interaction between at least one of the first clamping element, the second clamping element, or the cutting element with tissue. According to claim 21,
A controller communicating with the generator
Including more,
wherein the controller is configured to control the generator to provide RF energy sufficient to seal tissue to the first and second electrodes of the tissue ablation device based on at least one sensed operating condition of the tissue ablation device. , surgical instrument systems. The method of claim 22,
wherein the controller is configured to sense interaction of the tissue ablation device with tissue. According to claim 23,
wherein the controller is configured to sense interaction of the tissue ablation device with tissue based on the measured impedance levels associated with the first and second electrodes. According to claim 23,
wherein the controller is configured to sense an amount of force applied to at least one of the first or second clamping elements to detect interaction of the tissue ablation device with tissue. The method of claim 22,
wherein the controller is configured to sense the position of the cutting element relative to at least one of the first or second clamping elements of the tissue ablation device. The method of claim 22,
wherein the controller is configured to control the generator to provide a continuous amount of radiofrequency energy. The method of claim 22,
wherein the controller is configured to control the generator to automatically provide an increase or decrease in the amount of radiofrequency energy. The method of claim 22,
wherein the controller is configured to control the position of the first clamping element relative to the second clamping element. The method of claim 22,
wherein the controller is configured to control the position of the cutting element relative to at least one of the first or second clamping elements of the tissue ablation device. The method of claim 22,
wherein the tissue ablation device and the generator are coupled at least mechanically or electrically to the handle assembly. placing a coring device comprising a coil section and a helical coil having a flat portion over an anchor;
rotating the spiral coil of the coring device to engage the spiral coil into tissue such that a fluid vessel caught between the coil sections is moved to the flat portion of the spiral coil;
clamping the tissue between the spiral coil and at least two anvil electrodes of the coring device;
applying radio frequency (RF) energy between the spiral coil and the anvil electrode to perform tube sealing between the electrodes;
cutting the tissue core through the mechanical blade tube of the coring device;
separating the electrodes from each other; and
repeating the cycle of rotating the helical coil, clamping the tissue between the electrodes, applying an RF signal to seal the tube, cutting the tissue core, and separating the electrodes. 33. The method of claim 32,
positioning a ligation line to squeeze the distal end of the target tissue between a second set of electrodes when the target tissue is cored and within the blade tube;
applying RF energy between the second set of electrodes to seal any fluid conduit between the electrodes and within the ligation line loop;
positioning a mechanical line to cut the target tissue distal to the ligation line;
rotating the helical coil to separate it from surrounding tissue; and
removing the coring device with the target tissue sample
How to include more. A surgical instrument system for coring tissue from a target tissue location, comprising:
A tissue ablation device configured for coring tissue, wherein the tissue ablation device includes a first clamping element comprising a helical coil and a first electrode, a second electrode and positioned opposite at least a portion of the first clamping element. 2 comprising a clamping element and a cutting element configured for transverse cutting of tissue; and
and a handle assembly configured to facilitate interaction between at least one of the first clamping element, the second clamping element, or the cutting element and tissue. 35. The method of claim 34,
wherein the handle assembly facilitates connection to a generator of at least one of the first electrode and the second electrode. 35. The method of claim 34,
wherein the handle assembly facilitates connection of at least one of the first electrode and the second electrode to a computing device. 35. The method of claim 34,
wherein the handle assembly facilitates connection of at least one of the first electrode and the second electrode to a robotic system. 35. The method of claim 34,
wherein the handle assembly is configured to automate advancement of at least one of the first electrode and the second electrode. 35. The method of claim 34,
wherein the handle assembly is configured to automate delivery of energy to at least one of the first electrode and the second electrode. A surgical instrument system for coring tissue from a target tissue location, comprising:
a tissue ablation device configured for coring tissue; and
Computing logic configured to automatically utilize one or more functions of the tissue ablation device.
including,
wherein the tissue ablation device is configured for transecting tissue, a first clamping element comprising a helical coil and a first electrode, a second clamping element comprising a second electrode and positioned opposite at least a portion of the first clamping element. A surgical instrument system comprising a cutting element that is 41. The method of claim 40,
wherein the computing logic is configured to automate advancement of at least one of the first electrode and the second electrode. 41. The method of claim 40,
wherein the computing logic is configured to automate delivery of energy to at least one of the first electrode and the second electrode. 41. The method of claim 40,
wherein the computing logic is configured to determine a distribution of energy provided through the tissue ablation device. 41. The method of claim 40,
wherein the computing 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. 41. The method of claim 40,
wherein the computing logic is disposed in a handle assembly associated with the tissue ablation device. 41. The method of claim 40,
wherein the computing logic is disposed in a generator in communication with the tissue ablation device. A surgical instrument system for coring tissue from a target tissue location, comprising:
a tissue ablation device configured for coring tissue; and
a handle assembly configured to facilitate interaction between the tissue ablation device and tissue;
wherein the tissue ablation device includes a spiral coil electrode and a cutting element configured to cooperate with the spiral coil electrode for transverse cutting of tissue. The method of claim 47,
wherein the handle assembly facilitates connection of the electrode to the generator. The method of claim 47,
wherein the handle assembly facilitates connection of the electrode to a computing device. The method of claim 47,
wherein the handle assembly facilitates connection of the electrodes to the robotic system. The method of claim 47,
wherein the handle assembly is configured to automate advancement of the electrode. The method of claim 47,
wherein the handle assembly is configured to automate delivery of energy to the electrode. A surgical instrument system for coring tissue from a target tissue location, comprising:
a tissue ablation device configured for coring tissue; and
Comprising computing logic configured to automatically utilize one or more functions of the tissue ablation device;
wherein the tissue ablation device includes a spiral coil electrode and a cutting element configured to cooperate with the spiral coil electrode for transverse cutting of tissue. The method of claim 53,
wherein the computing logic is configured to automate advancement of the electrode. The method of claim 53,
wherein the computing logic is configured to automate delivery of energy to the electrodes. The method of claim 53,
wherein the computing logic is configured to determine a distribution of energy provided through the tissue ablation device. The method of claim 53,
wherein the computing logic is configured to receive one or more inputs relating to the tissue ablation device. The method of claim 53,
wherein the computing logic is disposed in a handle assembly associated with the tissue ablation device. The method of claim 53,
wherein the computing logic is disposed in a generator in communication with the tissue ablation device.