Designs and methods for tissue stabilization and access

Abstract

A lung stabilization device for stabilizing a portion of the lung during minimally invasive lung procedures such as tissue resection. The lung stabilization device includes a port defining a first channel extending through the port and configured to provide surgical access to a target tissue site, the port defining a second channel extending through the port and configured to apply suction to a portion of tissue near the target tissue site such the portion of tissue is pulled into contact with a distal end of the port to fix a position of the portion of tissue relative to the first channel, the second channel including one or more support members disposed therein, the one or more support members configured to provide lateral support to the second channel to counteract lateral forces imparted on an outer wall of the second channel.

Description

Attorney Docket No.: PRNA-014 / 01WO 350944-2136DESIGNS AND METHODS FOR TISSUE STABILIZATION AND ACCESSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Patent Provisional Application No. 63 / 719,529, filed November 12, 2024, entitled “Designs and Methods for Tissue Stabilization and Access,” the disclosure of which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] Embodiments described herein relate to the field of surgical devices, specifically focusing on advancements in tissue abnormality diagnosis and treatment.BACKGROUND

[0003] Minimally invasive lung procedures have been increasingly implemented as clinicians have access to improved surgical devices, knowledge, and training, thereby reducing the barriers and challenges associated with minimally invasive techniques and making the percutaneous route more accessible for surgical lung resection (i.e., wedge resections, lobectomies, pneumonectomies, etc.). However, with current techniques, during these types of procedures a patient is intubated under general anesthesia to control lung inflation and movement.SUMMARY

[0004] In some embodiments, an apparatus comprises a port defining a first channel extending through the port and configured to provide surgical access to a target tissue site, the port defining a second channel extending through the port and configured to apply suction to a portion of tissue near the target tissue site such the portion of tissue is pulled into contact with a distal end of the port to fix a position of the portion of tissue relative to the first channel, the second channel including one or more support members disposed therein, the one or more support members configured to provide lateral support to the second channel to counteract lateral forces imparted on an outer wall of the second channel.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0005] In some embodiments, an apparatus comprises a port defining a first channel extending through the port and configured to provide surgical access a target tissue site, the port defining a second channel extending through the port and configured to apply suction to a portion of tissue near the target tissue site such the portion of tissue is pulled into contact with a distal end of the port to fix a position of the portion of tissue relative to the first channel; and a coupling mechanism disposed at a proximal end of the first channel, the coupling mechanism configured to be coupled to a tissue excision device to fix a first portion of the tissue excision device relative to the port and the portion of tissue in contact with the port as a second portion of the tissue excision device is advanced through the first channel to the target tissue site.

[0006] In some embodiments, an apparatus comprises a port configured to provide access to a thoracic cavity, the port including: a first channel extending through the port and configured receive one or more surgical devices therethrough to provide surgical access to a target tissue site in a lung of a patient; a second channel extending through the port; a side opening defined in a distal portion of the port and in fluid communication with the second channel; a suction source configured to be coupled to the second channel and to apply a suction force through the second channel; and a flow controller configured to be coupled to the port, the flow controller configured transition between a first configuration in which the side opening is closed and a second configuration in which the side opening is open such that the suction force through the second channel evacuates fluid from the thoracic cavity via the side opening and the second channel

[0007] In some embodiments, a method comprises forming an incision in a chest wall of a patient; dilating the incision with a dilator; inserting a port through the incision into a thoracic cavity of the patient; applying, via the port, suction to a surface of a lung of the patient to fix a portion of the lung relative to the port; coupling a tissue excision device to the port; and removing, using the tissue excision device, target tissue from the lung through the port. In some embodiments, the port defines a first channel and a second channel, wherein the suction is applied to the surface of the lung via the second channel, and a portion of the tissue excision device is configured to be disposed through the first channel to access the lung.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Described herein are embodiments for a lung stabilization device, configured to fit within the intercostal space between the ribs, offering optimal functionality and patient comfort. These embodiments are detailed in Figures 1 A - 10B. The following drawings showAttorney Docket No.: PRNA-014 / 01WO 350944-2136generally, by way of example, but not by way of limitation, various examples discussed in the present disclosure. In the drawings:

[0009] FIG. 1A is a schematic diagram of a lung stabilization device, according to embodiments.

[0010] FIG. IB is a flow chart diagram of an example method of stabilizing a lung surface using a lung stabilization device, according to embodiments.

[0011] FIGS. 2A and 2B illustrate front views of lung stabilization devices, having channels that form distinct shapes, namely ellipsoid (FIG. 2A) and circular (FIG. 2B), according to embodiments.

[0012] FIGS. 3A and 3B are bottom-surface views, illustrating distal end of each of the lung stabilization devices in FIGS. 2A and 2B, respectively, according to embodiments.

[0013] FIGS. 4A and 4B depict top-surface views of a proximal end of each of the lung stabilization devices in FIGS. 2A and 2B, respectively, according to embodiments.

[0014] FIGS. 5A and 5B show internal support structures within vacuum chambers of the lung stabilization devices of FIGS. 2A and 2B, respectively, the support structures configured to limit lung surface stretch, thereby minimizing stress on the pleura, according to embodiments.

[0015] FIGS. 6A and 6B are isometric views of the lung stabilization devices of FIGS. 2A and 2B, respectively.

[0016] FIG. 7 shows a cannula defining a channel configured to receive a surgical device therethrough and including vacuum ports integrated on opposing sides of the channel, with the lumens of the vacuum ports having a circular or rounded shape, according to embodiments.

[0017] FIG 8 details a cannula defining a channel configured to receive a surgical device therethrough and including vacuum ports disposed on opposing sides of the channel, with gaps in a wall of the cannula, according to embodiments.

[0018] FIG 9 shows a lung stabilization device including a proximal end configured to secure surgical instruments relative to the lung stabilization device and / or relative to a tissue excision or resection device, according to embodiments.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0019] FIGS. 10A and 10B illustrate lung stabilization devices including a side opening port for evacuating air from the thoracic cavity and an outer collar or sleeve to control the opening of the side opening port, according to embodiments.DETAILED DESCRIPTION

[0020] It may be desirable to remove a core of tissue from a target tissue site including, but not limited to, the lungs, the liver, pancreas, the gastrointestinal (GI) tract, and other target tissue sites. A core of tissue may have a prescribed (e.g., pre-defined) shape (e.g., columnar) and dimension based on a coring apparatus. Such coring apparatus may be used to core the same or substantially the same shaped tissue core in a repeatable manner. Such coring may be distinguished from other tissue removal, for example using scissors or scalpel, where the cut tissue will not have a pre-defined shape or dimensions.

[0021] A method for coring tissue may comprise disposing a tissue excision or resection device at a target tissue site, causing the tissue excision or resection device to resect a core of tissue from the target tissue site, and removing the core of tissue from the body, wherein the removing the core of tissue from the body creates a core cavity at the target tissue site. The resecting of the core of tissue from the target tissue site may comprise steps including one or more of mechanical compression; the delivery of energy to tissue (e.g., to the mechanically compressed tissue) such as radiofrequency (RF) energy, microwave energy, and / or ultrasonic energy; or transection of tissue with an energized wire. Other resection devices and procedures may be used.

[0022] In some embodiments, once the tissue core has been removed, a tissue stabilization device (e.g., a tissue stabilization port) may be disposed in a secured configuration near or at least partially inside the core cavity to maintain access to the target tissue site. A secondary procedure may be performed for therapeutic management of the tissue (whether benign or malignant). There are a number of possible procedures (e.g., local delivery of chemotherapy agents or immunotherapy drugs; ablation by heating or freezing using RF, microwave, or cryotherapy; fiducial placement, etc.) depending on the state and malignancy of the lesion, the size and state of tissue core removed, and the type of cancer.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0023] Various methods and systems are disclosed herein that synergistically combine a tissue stabilization mechanism with a surgical access system to enhance efficacy and safety in thoracoscopic procedures.

[0024] In some embodiments, the system includes a tissue stabilization device (e.g., a port) including a channel (i.e., a surgical access channel) configured to provide continuous and open access to the lung while fixing the area of tissue resection relative to the open surgical access channel. The surgical access channel can allow for the introduction of surgical instruments and / or therapeutic agents to an area of tissue that has been fixed or stabilized (e.g., prevented from shifting or moving relative to the surgical instruments and / or therapeutic agents). The apparatuses and systems described herein can be configured to accommodate various chest wall thicknesses (including skin, fat, and intercostal muscle) and fit between the intercostal space of the ribs. Chest wall thickness herein refers to a thickness of the skin, fat, and intercostal muscle of the chest wall. For example, the lung stabilization device can include a flange configured to adjust a length of the port that can extend through the chest wall. The flange may be configured to be fastened to the chest to stabilize the tissue stabilization device relative to the chest.

[0025] In the embodiments described herein, the tissue stabilization device can include an opening in a distal end thereof that is in fluid communication with a channel (e.g., a vacuum chamber or channel). The distal end may include one or more features to facilitate direct contact with the surface of the lung. For example, the distal end may include smooth, well-defined contours to enable direct contact with the surface of the lung. The shape formed by the distal end may correspond to an anatomy of the tissue to be stabilized. For example, a distal surface of the distal end may have contours or surfaces that conform to a surface of the lung. The distal surface may have smooth transitions such that the distal surface of the tissue stabilization device is atraumatic and / or prevents damage to the tissue. For example, the distal end may form rounded edges and / or angled surfaces (e.g., inclined toward a center point of the opening in the distal end) configured to support the surface of the tissue (e.g., lung) when a suction or vacuum force is applied to the surface of the lung. The surfaces can prevent tissue from contacted abrupt edges under suction. Proximal to the vacuum chamber or channel (e.g., on a proximal end of the tissue stabilization device), the tissue stabilization device can include a port or inlet (e.g., a vacuum port or inlet) configured to be coupled to a vacuum or suction source (e.g., a surgical vacuum systems). The tissue stabilization device can include an interface (e.g., a couplingAttorney Docket No.: PRNA-014 / 01WO 350944-2136mechanism) at a proximal end thereof configured to couple to or interface with surgical devices such that the surgical devices can be fixed relative to the tissue stabilization device.

[0026] In some embodiments, a method of stabilizing tissue includes placing the tissue stabilization device into a thoracic cavity; creating an incision in a first portion of tissue including the skin, fat, and intercostal muscle; dilating the first portion of tissue and advancing the tissue stabilization device through the first portion of tissue until the distal end of the tissue stabilization device is in the thoracic cavity; connecting a vacuum source to the vacuum port of of the tissue stabilization device; activating the vacuum source; and allowing for the surface of the lung to come into contact with one or more features or contours on a distal end of the tissue stabilization device. The distal features or contours of the device can have sufficient features to allow for firm adhesion to the surface of the lung, immobilizing the tissue resection area of the lung at a specific location during both mechanical ventilation and spontaneous breathing.

[0027] In some embodiments, a tissue stabilization device can function as a surgical access device that establishes a secure and stable passageway for introducing surgical tools and / or therapeutic agents directly to a tissue resection site. The tissue stabilization device can allow a physician to perform precise and complex surgical interventions with augmented or improved control, through reduced tissue movement (e.g., lung tissue movement), translation, and shifting, thereby reducing tissue trauma.

[0028] In some embodiments, the tissue stabilization device can be configured to evacuate a thoracic space of the patient. In some embodiments, a method of evacuating the thoracic space and restoring to a negative pressure state comprises activating a vacuum source connected to the tissue stabilization device, pulling a negative pressure through the vacuum chamber of the device, and allowing for all air to be evacuated (e.g., similar to the function of chest tubes currently used in post-thoracic surgical procedures). Therefore, the port can be configured to evaluate fluid from the thoracic cavity (e.g., after the procedure) such that the lungs can reinflate post-operation.

[0029] Embodiments described herein provide a comprehensive range of tissue stabilization devices, systems and methods, each designed to optimize surgical efficacy, minimize patient discomfort, and enhance overall safety in thoracic surgical procedures.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0030] Lung abnormalities, including pulmonary nodules (round or oval-shaped growths in the lung measuring less than 3 centimeters), are becoming increasingly discoverable. The rising prevalence of these abnormalities are driven by multiple factors including:1. The growing adoption of lung cancer screening in high-risk individuals. The National Lung Cancer Screening Trial (NLST) demonstrated that screening high-risk individuals for lung cancer using low-dose computed tomography (LDCT) can reduce mortality from lung cancer by 20% compared to screening with standard chest X-rays. Although the percent of eligible patients being screened is <6% in the United States, it is expected that screening rates will rise as clinics and hospitals adopt formal screening programs.2. Advancements in imaging technologies and interpretation. CT imaging continues to advance, allowing for higher fidelity evaluation of abnormalities, particularly in smaller lesions. Artificial Intelligence overreading these images affords improved discovery of lesions that may otherwise be missed or overlooked.3. Prolonged cancer survivability leading to extended surveillance periods. Patients with known cancer are frequently surveilled for potential of reoccurrence, metastasis, or development of a subsequent primary cancer. This additional monitoring coupled with the aforementioned factors leads to more abnormalities requiring intervention.

[0031] The groundswell of lung abnormalities, namely pulmonary nodules, may outpace the current diagnosing and treatment capabilities of the clinical community. The embodiments described herein can ameliorate the impact of increasing prevalence of lung abnormalities by providing an expansion of accessible services, further refining of current procedural options, and a broadening of practitioner scope.

[0032] Embodiments described herein relate to the field of surgical devices, specifically focusing on advancements in lung abnormality diagnosis and treatment. Of note, this technology could be used in other solid organs with discovered abnormalities requiring resection and potential further therapy.

[0033] Specifically, devices and methods described herein can be used to stabilize and hold the surface of the lung fixed (e.g., such that there is no relative movement to the lung stabilization device or port) during minimally invasive lung procedures. The embodiments described herein are aimed at eliminating the need for patient intubation for control of patientAttorney Docket No.: PRNA-014 / 01WO 350944-2136respiration and lung movement and / or lung volume during such surgical procedures. Additionally, the devices and methods disclosed provide a means for shifting associated lung procedures from the operating room to an outpatient setting. Furthermore, the lung stabilization port can also provide the benefit of resisting torquing associated with coring procedures by fixing the a lung stabilization device (e.g., port) to the lung surface.

[0034] In some embodiments, the lung stabilization device can be secured to a non-movable constraint and be disposed on or near a surface of tissue to be operated on. Suction (negative, relative atmospheric pressure) can be applied, thereby fixing, from movement, the tissue of interest to the lung stabilization device. Fixing the tissue to the lung stabilization device can allow the clinician to perform the surgical procedure with minimal movement of subject.

[0035] For procedures which require the lung to remain stationary, this systems and devices described herein are aimed at providing lung surface stabilization relative to the chest wall, and in some embodiments, between the ribs. It should be noted that this invention could also be used in open cases, e.g., thoracotomy.

[0036] Embodiments described herein combine lung stabilization technology with a trocar / port system for enhancing efficacy and safety during minimally invasive and open thoracic surgery. The port system described herein may include an open vacuum chamber with one or more features at the distal end (e.g., smooth features), designed to come into direct contact with the visceral pleural surface of the lung. On the proximal end, this port system may include a vacuum port (e.g., standard luer fitting) to facilitate device connection with operating room vacuum supply. Upon activation and / or connection of a vacuum source, a suction force is created. The suction force creates a negative pressure within the open vacuum chamber of the port system, causing the distal end of the device to adhere firmly to the visceral pleura (top surface of the lung), effectively fixing the surgical area of the lung at a specific location during both mechanical ventilation and spontaneous breathing.

[0037] In some embodiments, the lung stabilization device can simultaneously function as a trocar or surgical port, providing a secure and stable channel through which surgical tools and / or therapeutics can be introduced directly into the thoracic cavity. Integrating functionality of a surgical port and a stabilization device allows surgeons to perform precise and complex procedures using the trocar function with enhanced control, while minimizing potential traumaAttorney Docket No.: PRNA-014 / 01WO 350944-2136to the lung tissue caused by movement, translation or shifting through use of the vacuum function.

[0038] During typical minimally invasive and open thoracic surgery, lung respiration is often controlled with positive pressure ventilation. This control allows surgeons to manipulate the lung to create more space for the surgical window (i.e., move the lung out of the way) by reducing the peak inspiratory and peak exhalatory expiratory pressures (PIP / PEEP). Under this control, the lung translates during each breath (i.e., horizontal and vertical translation due to expansion of the alveoli during each breath) and can reduce the stability of the procedure, increase operating time due to navigating around a translating surgical site, reduced surgical precision, high complexity, and in some cases, lead to incidental trauma / intraoperative complications that decrease patient safety. The systems, devices, and methods described herein stabilize the lung at a fixed location under positive pressure ventilation and spontaneous breathing to maintain continuous access to the surgical site, reduce lung translation, and reduce operative complications.

[0039] In some embodiments, the tissue stabilization device can include a port system with an open vacuum chamber configured to evacuate the thoracic space and return it to a negative pressure environment (in a similar manner as with chest tubes used after thoracic surgery).

[0040] In some embodiments, the systems and devices herein can combine the functions of (1) a lung stabilizer with suction and (2) surgical port into a single device. This addresses a critical need in the field of thoracic surgery, facilitating more accurate and safer procedures, with the potential to significantly improve patient outcomes.

[0041] Akin to how surgical trocars revolutionized access to body cavities, systems and devices described herein allows transcutaneous access to internal organs for further surgery to be performed. However, in current trocar technology, a cavity is created within patients using gas or air (e.g., insufflation). Unlike current trocar technology, the systems and devices described herein instead allow passage and / or access directly to a target tissue site without the need for insufflation. With this approach (e.g., creating access without insufflation), new opportunities are created, but there are also new challenges can be encountered. Systems, devices, and methods described herein address some of these opportunities and challenges, including the following:Attorney Docket No.: PRNA-014 / 01WO 350944-21361. Single-Port Access through Solid Organs: The systems and devices described herein can access lung abnormalities through a single port. This approach allows direct access to the tumor site in a solid organ, minimizing invasiveness and enhancing precision. Through the presently disclosed single port, not only is resection of part or the whole nodule possible, but also direct application of adjuvant therapies to the tumor or tumor bed is also possible. This capability is a significant stride in cancer treatment, offering a comprehensive approach that includes both resection and localized treatment.2. Eliminating Ventilation Requirement: Current surgical lung resection techniques, like video assisted thoracoscopic surgery (VATS) or open thoracotomy, require the patient to be intubated and ventilated under general anesthesia. This allows for precise respiratory control of the patient and the ability to deflate the lung requiring surgery. The tissue stabilization devices described herein can allow surgical procedures without ventilation (e.g., without precise respiratory control or deflation of the lung). Embodiments described herein address the challenges of lung movement in lung surgeries through a system and method for stabilizing a portion of the lung in a fixed position, relative to the chest wall, thereby facilitating continuous and unobstructed access to the portion of the lung. Although this stabilization technology (e.g., the tissue stabilization devices described herein) is effective during positive pressure ventilation, it can also be used in a patient with spontaneous breathing. For example, the stabilization device or port can stabilize a first portion of the lung while a second portion of the lung that is not stabilized move around the stabilized portion as the patient breaths. The tissue stabilization device described herein allows surgical procedures to be completed without ventilation, meaning that the procedure can be completed under conscious sedation with local anesthesia.3. Treatment Expansion to Non-Surgical Patients: Many patients have comorbidities that place them at a higher risk for undergoing general anesthesia. This higher risk profile impacts the options available to them, reducing access to more effective diagnostic techniques and surgical treatments. The embodiments described herein obviate the need for ventilation and provide a minimally invasive approach; therefore, embodiments described herein can be used to conduct precision lung surgery and adjuvant therapy in patients previously thought to be inoperable.Attorney Docket No.: PRNA-014 / 01WO 350944-21364. Broadening Practitioner Scope: Due to the reduction in complexity of anesthesia requirements and level of invasiveness with the embodiments described herein, a wider range of medical professionals, such as interventional radiologists, can perform precision tissue resection and treatment. This expansion improves patient access to advanced diagnostic and treatment options, significantly impacting the field of oncological care.

[0042] In summary, the embodiments described herein addresses the current clinical challenges with innovative solutions that enhance patient safety, expand treatment eligibility, and improve surgical outcomes. Details of a tissue resection device are described in U.S. Patent Application No. 63 / 687,436, titled, “SYSTEMS, DEVICES, AND METHODS FOR CONTROLLING ACTUATION OF TISSUE RESECTION DEVICES,” filed August 27, 2024 and PCT Application No. PCT / US2025 / 043743, titled, “SYSTEMS, DEVICES, AND METHODS FOR CONTROLLING ACTUATION OF TISSUE RESECTION DEVICES,” filed August 27, 2025, the disclosure of which is hereby incorporated by reference in its entirety.

[0043] FIG. 1 A is a schematic block diagram of a tissue stabilization device 110 (e.g., a port) configured to stabilize tissue (e.g., a lung) and / or provide surgical access to the tissue, according to embodiments. As shown, the tissue stabilization device 110 may define a first channel 112 (e.g., an open cannula, access point, port, etc.) extending through the tissue stabilization device 110 and configured to provide surgical access to a target tissue site. In some embodiments, the first channel 112 (also referred to herein as “main channel” or “surgical device channel”) can be configured to receive one or more surgical device(s) 100 (e.g., including a tissue excision or tissue resection device) therethrough. The first channel 112 may have any suitable cross-sectional shape such as, for example, a circular cross-sectional shape or an elliptical cross-sectional shape. The tissue stabilization device 110 may further define one or more additional channels or vacuum chambers 114 (e.g., vacuum channels, tubes, etc.). In some embodiments, the vacuum chamber(s) 114 can be configured to apply suction (e.g., apply a suction force, apply a vacuum, form a negative pressure therethrough) to a portion of tissue near the target tissue site such that the portion of tissue is brought into contact with the distal end of the tissue stabilization device 110 to fix a position of the portion of tissue relative to the first channel 112. In some embodiments, the vacuum chamber(s) 114 may be disposed around the first channel 112. In some embodiments, the portion of tissue can form a seal withAttorney Docket No.: PRNA-014 / 01WO 350944-2136the distal end of the tissue stabilization device 110 (e.g., the first channel 112). The first channel 112 and the vacuum chamber(s) 114 may extend longitudinally through the tissue stabilization device 110. In some embodiments, the vacuum chamber(s) 114 may be disposed around or concentric with the first channel 112. In some embodiments, a cross-sectional shape and / or a position of the vacuum chamber(s) 114 may correspond to the cross-sectional shape of the first channel 112, as described in further detail below.

[0044] In some embodiments, the tissue stabilization device 110 may define a first channel 112 and a second channel or vacuum chamber 114. In some embodiments, the second channel 114 can terminate with a distal opening at a distal end of the device 110. In some embodiments, the second channel 114 can be disposed concentric with or around the first channel 112 such that the second channel 114 fixes the portion of tissue defined within the first channel 112 relative to the first channel 112. In some embodiments, the tissue stabilization device 110 can further include a third channel or vacuum chamber terminating with a distal opening at a distal end of the device 110. In some embodiments, the second channel and / or the third channel can be configured to apply suction to a portion of tissue (e.g., a surface of the lung) near the target tissue site such that the portion of tissue is brought into contact with the distal end of the tissue stabilization device 110 to fix the position of the portion of tissue relative to the first channel 112. In some embodiments, the second channel and the third channel and each may be disposed on either side of (e.g., opposite sides of) the first channel 112 such that the second channel and third channel hold a position of the tissue relative to the first channel 112.

[0045] The distal end of the tissue stabilization device 110 may be configured to contact (e.g., abut, press against, etc.) a surface of the tissue 101 of a patient. In some embodiments, the tissue stabilization device 110 may be configured to be disposed between ribs of a patient to provide access to the thoracic cavity of the patient such that the distal end of the tissue stabilization device 110 contacts the surface of the tissue 101 (e.g., lung tissue). In some embodiments, the shape (e.g., a cross-sectional shape) of the stabilization device 110, first channel 112, and vacuum chamber(s) 114 may correspond to a shape of the space between the ribs of the patient 101. The vacuum chamber(s) 114 (e.g., the second channel and / or the third channel) may include one or more support members 115 (or reinforcements, struts, ribbed features, etc.) configured to provide lateral support to the vacuum chamber(s) 114 to counter act lateral forces imparted on an outer wall of the vacuum chamber(s) 114. The support members 115 can prevent the vacuum chamber(s) 114 from collapsing, deforming, or closingAttorney Docket No.: PRNA-014 / 01WO 350944-2136in response to inward forces from the ribs onto the tissue stabilization device 110 (e.g., lateral forces from the ribs to the tissue stabilization device 110). In some embodiments, the support members 115 may be disposed in the vacuum chamber(s) 114 along a portion (e.g., at a distal end portion) of the tissue stabilization device 110. In some embodiments, a position of the support members 115 along the length of the vacuum chamber(s) 114 may correspond to a location of where the patient’s ribs may press on the tissue stabilization device.

[0046] In some embodiments, the support member(s) 115 can extend in a lateral direction of the tissue stabilization device 110 (e.g., from a wall of the second channel 112 closer to a center of the device 110 radially outward), and may extend in a longitudinal direction through at least a portion of the vacuum chamber(s) 114. The support members 115 can be strategically offset (e.g., spaced) from the distal end where suction or negative pressure is applied. Therefore, the support members 115 can enable the tissue to be suctioned to or pulled into contact with the distal end of the tissue stabilization device 110, while also providing a stop to prevent surface stretching that can cause damage. In some embodiments, the support member(s) 115 can extend through the vacuum chamber 114 to provide support along a length of the tissue stabilization device 110. In some embodiments, the tissue stabilization device 110 can have any suitable number of support members 115 such as, for example, between 1 support member and 10 support members, inclusive of all values and subranges therebetween. In some embodiments, the tissue stabilization device 110 can include 4 support members. In some embodiments, the support members 115 can be distributed or spaced around the tissue stabilization device 110 to provide uniform or substantially uniform support. In some embodiments, the support members 115 can be evenly spaced around the circumference of the first channel 112. In some embodiments, the tissue stabilization device 110 may define an inlet (e.g., vacuum inlet) 113 near a proximal end of the tissue stabilization device 110. In sone embodiments, the inlet 113 can be disposed on or defined in a sidewall of the proximal portion of the device 110. In some embodiments, the vacuum chamber(s) 114 may be configured to be coupled to a vacuum supply (or suction source) via the vacuum inlet 113. Therefore, when the vacuum supply is activated, a negative pressure or suction force can be applied to the thoracic cavity and / or the surface of the lung via the vacuum chamber(s) 114.

[0047] The proximal end of the tissue stabilization device 110 may include a coupling mechanism (e.g., connector, fastener, support structure, etc.) at a proximal end thereof. In some embodiments the coupling mechanism can be configured to couple to a cavity sleeve catchAttorney Docket No.: PRNA-014 / 01WO 350944-2136(e.g., a latch, a connector, a support structure, etc.) configured to receive a sleeve 116. In some embodiments, the cavity sleeve catch can be configured to couple to the proximal end of the tissue stabilization device 110 to fasten the sleeve 116 to the tissue stabilization device 110. In some embodiments, the sleeve 116 may extend through at least a portion of the first channel 112, and the surgical devices may be configured to be disposed through an inner volume of the sleeve 116. In some embodiments, the coupling mechanism at the proximal end of the tissue stabilization device 110 may further be configured to couple to a portion of the surgical device(s) to secure the surgical device(s) 110 relative to the first channel 112 and / or the surface of the tissue 101. In some embodiments, the surgical device(s) 110 may be coupled to the tissue stabilization device 110 such that an elongate portion of the surgical device(s) 110 is configured to be maintained at or near a center point of the channel. In some embodiments, the surgical device(s) 110 may be coupled to the tissue stabilization device 110 at a predetermined distance or range of distances from the surface of the tissue 101. In some embodiments, the coupling mechanism of the tissue stabilization device 110 may be configured to be coupled to a first portion of a tissue excision device (or tissue coring device) to maintain a position of the first portion of the tissue excision device relative to the stabilization device 110 while a second portion of the tissue excision device can be advanced through the first channel 112 to the tissue. In some embodiments, the coupling mechanism may be coupled to a handle of the tissue excision device while a distal portion of the tissue excision device is advanced distally through the tissue to excise a target tissue site from the tissue. In some embodiments, the coupling mechanism may be coupled to the cavity sleeve catch such that the sleeve 116 is received through the channel 112 of the tissue stabilization device 110. Once the sleeve 116 is received through the port, the coupling mechanism can be configured to couple to a surgical device (e.g., the tissue excision device) such that the second portion of the tissue excision device can advance through the sleeve 116.

[0048] In some embodiments, the tissue stabilization device 110 may include a flange (e.g., tissue securement mechanism, rim, collar, etc.) moveable along an outer surface of the tissue stabilization device 110. In some embodiments, the flange may be configured to be disposed on a surface of a chest of the patient to fix a distance between the distal end of the tissue stabilization device 110 and the surface of the tissue 101. For example, the flange can be positioned on a proximal portion along the tissue stabilization device 110 such that a longer portion of the tissue stabilization device 110 extends through the chest wall (e.g., to accommodate thicker chest walls). In some embodiments, the flange can be positioned in aAttorney Docket No.: PRNA-014 / 01WO 350944-2136distal portion along the tissue stabilization device 110 such that a shorter portion of the tissue stabilization device 110 extends through the chest wall (e.g., to accommodate thinner chest walls).

[0049] In some embodiments, the tissue stabilization device 110 can be coupled to or include a collection container and a control mechanism for regulating suction intensity (or a suction force) through the vacuum chamber(s) 114. In some embodiments, activating the suction device via the control mechanism can apply a predetermined suction force through the vacuum chamber(s) 114. In some embodiments, the suction force can be configured to extract fluids from the tissue cavity without damaging surrounding tissues. In some embodiments, the extracted fluids can be collected in the fluid collection container. In some embodiments a suction force can be adjusted based on a viscosity of the fluid (e.g., air or bodily fluid) to be extracted.

[0050] In some embodiments, the tissue stabilization device can be removably secured to the target tissue site. Although the tissue stabilization device is described as applying suction to the tissue to secure the tissue stabilization device relative to the tissue, other suitable methods can be used to secure the tissue stabilization device such as via thermal energy, clips, sutures, suction, anchors, surface finish configured for griping, adhesive, or any other suitable method.

[0051] In some embodiments, the tissue stabilization device 110 can include one or more sensors configured to generate a perioperative measure. Wherein the sensor includes a pressure sensor configured to measure a pressure within the thoracic cavity. In some embodiments, the sensor can be configured to continuously monitor the engagement status of the distal end of the tissue stabilization device 110 with the target tissue and / or detect the degree of suction or mechanical attachment between the tissue and the tissue stabilization device, thereby ensuring that the tissue remains securely attached during the procedure. In some embodiments, a suction force applied to the thoracic cavity can create a negative pressure environment that can cause natural expansion of the lung and stabilization of respiratory functions. In some embodiments, the stabilization device can include a flow controller (e.g., a valve, sleeve, flap, etc.). The flow controller can open and close (e.g., automatically) based on a pressure reading of the pressure sensor in order to maintain the negative pressure in the thoracic cavity within a predetermined range. In some embodiments, the flow control valve can be programmed to open and close at a particular threshold that corresponds to a patient.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0052] In some embodiments, one or more measurements collected by the sensor can be communicated to a processor and / or can be displayed during the surgical procedure. In some embodiments, an indicator (or the display) can be configured to provide information to a user regarding at least one function of the access port, maintenance of tissue engagement to access port, pressure reading of tissue engagement element to target tissue, tissue oxygenation value of target tissue, thermal reading of target tissue that is engaged with the tissue engagement element, or any combination thereof.

[0053] In some embodiments, the one or more sensor can include one or more tissue oxygenation sensors such as, for example, a pulse oximeter or a photoplethysmography (PPG) sensor, the one or more tissue oxygenation sensors configured to be positioned at the interface between the tissue engagement element and the target tissue, the one or more tissue oxygenation sensors configured to measure the oxygen saturation level of the tissue, thereby providing feedback on the tissue’s perfusion and oxygenation status and providing information corresponding to whether the tissue remains viable during the procedure. In some embodiments, the one or more sensor can include a thermal sensor placed within or near the tissue engagement element to monitor the temperature of the tissue in contact with the access port, the thermal sensor may be configured to detect changes in temperature indicative of tissue stress including at least one of overheating due to device energy or inflammation. In some embodiments, the thermal sensor can be coupled to a processor configured to alert the user if the temperature rises above a predetermined safety threshold.

[0054] FIG. IB is a flow chart diagram of an example method 200 for stabilizing a lung using a tissue stabilization device (e.g., similar to tissue stabilization device 110 described with respect to FIG. 1 A), according to embodiments. The method 200 may be applicable to any or all of the tissue stabilization devices described herein. In some embodiments, the method can include forming an incision in a chest wall between ribs of a patient. In some embodiments, the method 200 can include disposing an anchor through the incision such that a distal portion of the anchor anchors to a target tissue site. The method 220 can include dilating the incision. In some embodiments, the method 200 can include disposing a stabilization device through the incision such that a distal end of the stabilization device is disposed in a thoracic cavity near a surface of a lung. In some embodiments, the tissue stabilization device can be disposed through the incision after the incision has been dilated (e.g., with a dilator). In some embodiments, the dilator can be removed before the port is inserted through the incision. In some embodiments,Attorney Docket No.: PRNA-014 / 01WO 350944-2136the stabilization device can be disposed over the anchor through the incision. In some embodiments, the method 200 can include disposing a distal end of the tissue stabilization device near the surface of the lung of a patient, the tissue stabilization device defining a channel (e.g., a first channel) and a vacuum chamber (e.g., a second channel), at 202. In some embodiments, the tissue stabilization device may include a plurality of vacuum chambers. In some embodiments, the vacuum chambers can be disposed on opposite sides of the main channel (e.g., a first vacuum chamber on a first side of the channel and a second vacuum chamber disposed on a second side of the channel). In some embodiments, the vacuum chamber may be disposed around and / or concentric with the channel. At 204, the method includes applying a suction force through the vacuum chamber(s) to seal a portion of the surface of the lung to the distal end of the tissue stabilization device. In some embodiments, applying the suction force may stabilize the lung relative to the tissue stabilization device such that surgical devices can precisely access the lung tissue without intubation of the patient. In other words, the suction force may prevent shifting or movement of the lung relative to the tissue stabilization device and surgical devices coupled thereto. In some embodiments, applying suction to the lung can include applying suction via the vacuum channel such that a portion of the lung tissue is pulled into contact with the distal end of the stabilization device to fix a position of the lung tissue relative to the stabilization device. In some embodiments, the method can include fixing the portion of lung tissue to the tissue stabilization device while the patient is still breathing (without ventilation). In some embodiments, a portion of the lung that is not fixed to the tissue stabilization device may be allowed to move as the patient breaths.

[0055] In some embodiments, the vacuum chamber may terminate in a distal end opening and the suction may be applied through the distal end opening. In some embodiments, the method 200 may further include applying suction via one or more side openings in the port and in fluid communication with the vacuum chamber(s) to evacuate fluid from the thoracic cavity. The evacuation of fluid (e.g., air or bodily fluid) can maintain a negative pressure in the thoracic cavity within a predetermined range. In some embodiments, the method can include controlling a magnitude of the suction force (e.g., through the vacuum chamber(s)) based on the magnitude of pressure in the thoracic cavity (e.g., measured via one or more sensors). At 206, the method can include coupling a portion (e.g., distal end) of a surgical device (e.g., a tissue resection device) to a proximal end of the tissue stabilization device such that a portion of the surgical device configured to contact the lung tissue is aligned relative to the channel of the tissue stabilization device. In some embodiments, the surgical device may be coupled to the proximalAttorney Docket No.: PRNA-014 / 01WO 350944-2136end of the tissue stabilization device such that an elongate member (e.g., helical coil, anchor, etc.) of the surgical device may be stabilized at a center point of the channel. In some embodiments, the tissue stabilization device has a coupling mechanism that couples the surgical device to the tissue stabilization device such that the surgical device is stabilized at the center point or along longitudinal axis of the channel such that the surgical device can be advanced through the channel along the longitudinal axis. This prevents the surgical device from contacting the lung tissue at an angled trajectory, which could lead to tissue damage and / or operating on an incorrect portion of the lung. At 208, the method may include, after the surface of the lung is sealed to the distal end of the tissue stabilization device, disposing the surgical device through the channel to the surface of the lung (e.g., to resect a portion of tissue from the lung). In some embodiments, method 200 may be performed without insufflation of the thoracic cavity.

[0056] FIGS. 2A and 2B illustrate perspective, side views of tissue (e.g., lung) stabilization devices (e.g., a port), including a tissue stabilization device having an ellipsoid shape 310 (e.g., cross-sectional shape) and a tissue stabilization device having a circular shape 410 (e.g., cross-sectional shape), respectively. The shape of the tissue stabilization device 310, 410 can be configured to fit comfortably in the intercostal space. In some embodiments, a proximal end of the tissue stabilization devices 310, 410 can incorporate connection features such as, for example, a standard barbed fitting or standard slip fit for vacuum connectivity. The distal end 304, 404 of each device can be structured to rest in direct contact with the visceral pleural surface of the lung. Therefore, the distal end 304, 404 can have a surface or contour configured to accommodate or conform to the surface of the lung. The cross-sectional shapes of the tissue stabilization devices 310, 410 are intended to facilitate reduced incision lengths / widths through the skin and intercostal muscle, thereby potentially minimizing compressive force exerted on the rib cage and subsequently decreasing chronic pain associated with placement of the tissue stabilization device 310, 410. For example, the tissue stabilization device 310 with an elliptical cross-section may better fit in a space between adjacent ribs, thereby reducing a compressive force on the rib cage. FIG. 2A shows the lung stabilization port including a cap with an open vacuum chamber (or channel) and a barbed fitting for negative pressure (e.g., to couple to a suction or vacuum source), an intermediary piece transitioning from ellipsoid to a standard circular ring, and an ellipsis-shaped cannula. This cannula design aims to minimize a first width of the tissue stabilization device 310 that extends along a dimension perpendicular to the ribs, thereby reducing the incision size between the ribs and lessening compressive pressure. TheAttorney Docket No.: PRNA-014 / 01WO 350944-2136tissue stabilization device 310 can have a second width along a dimension extending along a length of the ribs. In some embodiments, the first width can be smaller than the second width. In some embodiments, the distal end of the tissue stabilization device can be atraumatic and include a curve with a fixed or variable radius, complemented by an open vacuum chamber for lung surface adhesion. FIG. 2B shows a two-piece tissue stabilization device 410 (e.g., lung stabilization device) with a cap featuring an open vacuum chamber and a slip fitting for negative pressure, alongside a cylindrical cannula (e.g., with a circular cross-section). In some embodiments, the tissue stabilization device 410 incorporates a flat, atraumatic distal surface for pleural contact. The tissue stabilization devices 310, 410 each include a proximal end 302, 402 configured to receive a portion of a surgical device (e.g., a tissue resection device). The surgical device may be configured to attach (e.g., snap fit) to the proximal end 302, 402 of the tissue stabilization device 310, 410 to stabilize or secure the surgical device relative to the tissue stabilization device 310, 410.

[0057] FIGS. 3A and 3B are bottom-surface views, showing the distal ends 304, 404 of the tissue stabilization devices 310, 410 in FIGS. 2A and 2B. In some embodiments, the distal ends 304, 404 can include smoothed tissue-contacting edges with fixed radii, an open vacuum chamber 314, 414 for facilitating tissue adhesion to the distal end 304, 404, and one or more support members (e.g., support structures, ribbed features, struts, or reinforcements) 315, 415 reinforcing the device’s structural integrity (e.g., in a lateral direction) against compressive rib forces. In some embodiments, the support members 315, 415 can extend in a lateral direction from a first wall of the vacuum chamber 314, 414 (e.g., closer to a center of the tissue stabilization device 310, 410) to a second wall of the vacuum chamber 314, 414 (e.g., closer to an outer wall of the tissue stabilization device 310, 410. The support members 315, 415 may extend in a longitudinal direction through at least a portion of the vacuum chamber 314, 414. Notably, these support members 315, 415 can be strategically offset from the distal end 304, 404 where negative pressure is applied. Therefore, the support members 315, 415 can enable the tissue to be suctioned to the distal end of the tissue stabilization device 310, 410, while also providing a stop to prevent surface stretching that can cause damage. In some embodiments, the support members 315, 415 can be distributed or spaced around the tissue stabilization device 310, 410 to provide uniform or substantially uniform support. In some embodiments, the support members 415 can be evenly spaced around the circumference of the main channel 412. In some embodiments, the tissue stabilization devices define a main channel 312, 412 (e.g., an open cannula, access point, or channel for introducing surgical devices (also referredAttorney Docket No.: PRNA-014 / 01WO 350944-2136to herein as, “the surgical device channel”). The tissue stabilization device 310 shown in FIG.3 A includes two open vacuum chambers 314 positioned adjacent to (e.g., two channels on opposing side of) the main channel 312. In some embodiments, the main channel 312 and the vacuum chambers 314 can collectively define an ellipsoid cross-section. In some embodiments, the vacuum chambers 314 may form two separate openings at a distal end of the tissue stabilization device 310 but may be in fluid communication (e.g., have a fluid path therebetween) within an inner volume of the tissue stabilization device 310. In some embodiments, the vacuum chambers 314 can be disposed on opposite sides of the main channel 312 such that the vacuum chambers hold a position of the tissue relative to the main channel 312. In some embodiments, the tissue stabilization device 310 includes a first vacuum chamber on a first side of the main channel 312 and a second vacuum chamber on a second side of the main channel 312. The tissue stabilization device 410 shown in FIG. 3B shows the vacuum chamber 414 encircling (or concentric with) the main channel 412. For example, the device 410 can include one vacuum chamber 414 having a distal opening disposed concentric around a distal opening of the main channel 412. Therefore, the main channel 412 and the vacuum chamber 414 may collectively define a circular cross-section.

[0058] FIGS. 4A and 4B depict top-surface views of the proximal end 302, 402 of the tissue stabilization devices 310, 410 in FIGS. 2A and 2B. As shown, the main channel 312, 412 can extend through an entirety of the tissue stabilization device 310, 410, providing continuous, unobstructed access to the surgical lung area while maintaining lung stability via the vacuum chamber 314 (not shown in FIG. 4B). Each of the tissue stabilization devices 310, 410 include a vacuum inlet 313, 413 configured to supply a suction or vacuum force to the vacuum chambers 314, 414. The vacuum inlet 313, 314 can be in fluid communication with the vacuum chambers 314, 414 and not the main channel 312, 312. Therefore, when a vacuum force is applied at the vacuum inlet 313, 314, a pressure differential forms along the vacuum chambers 3134, 414. In some embodiments, the vacuum inlet 313, 413 can extend through a sidewall such that a vacuum source can be coupled thereto without obstruction of the main channel 312, 412 of the tissue stabilization device 310, 410.

[0059] FIGS. 5A and 5B show internal support members 315, 415 (e.g., ribbed features, struts, or reinforcements, etc.) disposed within the vacuum chambers 314, 414, configured to limit tissue (e.g., lung) surface stretch, thereby minimizing stress on the tissue (e.g., the pleura). As the cross-sectional area of the vacuum chamber 314, 414 expands, additional support membersAttorney Docket No.: PRNA-014 / 01WO 350944-2136315, 415 can be incorporated to maintain a continuous, uninterrupted perimeter that enhances grip on the pleural surface. In other words, the support members 315, 415 may have a distance therebetween that prevents deformation of the perimeter of the vacuum chamber 314, 414 is prevented. To further reduce trauma, the leading edges (e.g., distal ends) of these support members 315, 415 include radiused edges, promoting an atraumatic interface with the tissue surface.

[0060] FIGS. 6A-6B are isometric views of the tissue stabilization devices 310, 410 of FIGS.2A and 2B, respectively. As shown, the tissue stabilization devices 310, 410 include a distal end configured to contact and / or stabilize a portion of lung tissue and a proximal port configured to connect to a vacuum source. Although not shown, the tissue stabilization devices 310, 410 define the channel (e.g., the surgical device channel) such that devices can be disposed from a proximal end through the channel and to the portion of lung tissue (e.g., at or near a target site). The tissue stabilization devices 310, 410 of FIGS. 3 A-6B can be structurally and / or functionally similar to the tissue stabilization devices 110, and therefore, certain details of the tissue stabilization devices 410, 410 are not described again with respect to these figures.

[0061] FIG. 7 shows a tissue stabilization device 510 (e.g., a cannula or port) including vacuum ports or chambers 514 disposed on opposing sides of a surgical device channel 512, with the lumens of the vacuum ports 514 having either circular or rounded cross-sectional shape. In some embodiments, the cannula may include multiple vacuum ports 514, each port disposed on a side of the surgical device channel 512. The tissue stabilization device 510 shown can minimize the width or diameter of the device between the intercostal space (along a dimension extending between the ribs) while providing suction adjacent to the surgical device channel 512. The tissue stabilization device 510 of FIG. 7 can be structurally and / or functionally similar to the tissue stabilization devices 110, 310, 410, and therefore, certain details of the tissue stabilization device are not described again with respect to FIG. 7.

[0062] FIG 8 shows a tissue stabilization device 610 (e.g., a cannula or port) including vacuum chambers 614 (e.g., channels, ports, etc.) disposed on opposing sides of the channel (e.g., the surgical device channel) 612 and including gaps 611 in the wall of a shaft portion of the port. In other words, the port can include two separate pieces collectively defining the channel 612 (e.g., inner surfaces of the separate portions) and each defining a respective vacuum chamber 614. The two shaft pieces are separate so that the diameter of the port in a first direction is smaller due to the removal of the walls, compared to FIG. 6A-7 or FIG. 9. In someAttorney Docket No.: PRNA-014 / 01WO 350944-2136embodiments, the port can be disposed through the chest wall between adjacent ribs, and the first direction may be a direction extending between the ribs. Therefore, the port can fit more comfortably between the ribs. In some embodiments, the shaft pieces can include an interface or coupling mechanism (not shown) such that the two vacuum chambers 614 join to one vacuum port. The tissue stabilization device 610 shown can minimize the diameter of the device between the intercostal space while providing suction adjacent to the surgical device channel 612.

[0063] FIG 9 illustrates a tissue stabilization device or port 710 (also referred to herein as “device 710”) including an interface (e.g., a coupling mechanism) 718 on the proximal end 702 of the tissue stabilization device 710 that enables surgical instruments to be securely connected and positioned relative to the device 710. The coupling mechanism 718 helps establish a fixed and known distance from the device 710 to the lung surface, allowing for precise depth control during procedures. For example, when a surgical device is coupled to the tissue stabilization device 710 by the coupling mechanism 718, the coupling mechanism 718 may set a known distance between the surgical device coupled thereto and the surface of the lung. The tissue stabilization device 710 defines vacuum chambers therethrough configured to apply a vacuum force “VF” to pull lung tissue toward a distal end 704 of the tissue stabilization device. The tissue stabilization device 710 may be coupled to (e.g., placed in fluid communication with) a vacuum source via a vacuum inlet 713 near the proximal end 702 of the tissue stabilization device 710. The tissue stabilization device 710 further includes a flange (e.g., stopper, tissue securement mechanism, etc.) 719 movable relative to the cannula or main channel of the tissue stabilization device 710. The flange 719 can help establish a fixed and known distance from the device 710 to the lung surface, as described with respect to FIG. 1 A. The flange 719 may be configured to be disposed to a surface of the patient’s skin and locked relative to the tissue stabilization device and / or sutured to the patient’s skin. On the lung tissue is sealed to the distal end 704 of the tissue stabilization device and / or the flange 719 is positioned relative to the skin of the patient, surgical device “D” may be disposed from the proximal end 702 of the tissue stabilization device 710 through the main channel (not shown) and toward the lung of the patient. The tissue stabilization device 710 of FIG. 9 can be structurally and / or functionally similar to the tissue stabilization devices 110, 310, 410, and therefore, certain details of the tissue stabilization device are not described again with respect to FIG. 9.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0064] FIGS 10A and 10B illustrate tissue stabilization devices 810, 910 with a side opening or port 833, 933 for evacuating air from the thoracic cavity, according to embodiments. As shown in FIG. 10A, the tissue stabilization device 810 includes vacuum ports 813, 913 (e.g., openings, side openings, ports, inlets, etc.) defined in the wall of the cannula. The vacuum port(s) 813, 913 may be in fluid communication with the vacuum channels 814 (e.g., two vacuum channels 813 on either side of a main channel) such when a vacuum source is coupled to the vacuum port(s) 813, a vacuum force can be applied from the vacuum port(s) 813, through the vacuum channel(s) 813 and to the thoracic cavity or lung tissue. In some embodiments, a flow controller can be configured to be coupled to the port, the flow controller configured transition between a first configuration in which the side port is closed (e.g., obstructed) and a second configuration in which a side port is open (unobstructed) such that the suction force evacuates fluid from the thoracic cavity through the side port and into the vacuum channels 814. In some embodiments, the flow controller can control an amount of suction through the vacuum channels 814 and ports 813. In some embodiments, the flow controller can be a sliding collar or ring 820 may be disposed around the cannula (e.g., a distal end portion of the tissue stabilization device 810) to cover or uncovers the vacuum port(s) 813. The sliding collar can be configured to rest on the lung such that when the lung deflates, the collar slides down and the vacuum port is uncovered, allowing negative pressure to be applied to the thoracic cavity such that air can be removed or vented from the thoracic cavity, through the vacuum ports 813, through the vacuum chambers 814, and external to the patient. As shown in FIG. 10B, in some embodiments, the tissue stabilization device 910 (e.g., the cannula of the stabilization device) may include a rotating outer sleeve 930 configured to encase the cannula (e.g., distal end portion of the tissue stabilization deice 910) with an opening 933 that aligns with the vacuum port(s) 913 when one of the port cannula or the outer sleeve 930 is rotated. In some embodiments, the port can be configured to evacuate fluid from the thoracic cavity during or after surgery to remove excess bodily fluids and / or air. In some embodiments, tissue stabilization device 910 can be configured to evacuate fluid after the surgery such that the lung can properly reinflate and function post-operation. In some embodiments, the vacuum ports and the vacuum channel(s) 814, 914 can be coupled to one or more sensors (e.g., pressure sensors) such that the vacuum force (e.g., negative pressure) applied to the thoracic cavity can be controlled based on the one or more sensor readings. In some embodiments, the tissue stabilization devices 810, 910 can be structurally and / or functionally similar to any of the tissue stabilization devices described herein 110, 310, 410, 510, 610, 710, and therefore, certain details are not described herein with respect to FIGS. 10A-10B.Attorney Docket No.: PRNA-014 / 01WO 350944-2136Cavitary Access

[0065] In some embodiments, a tissue excision or resection device may include tissue (e.g., lung) stabilization device (e.g., a port including a trocar channel), an anchor, and a coring device. To access a target site, an incision can be made in the skin, and one or more dilators can be used to carefully spread the tissue around the incision to place the port (e.g., any of the tissue stabilization devices described herein). In some embodiments, after the port is inserted through the incision, the anchor of the device can be deployed through the port such that a distal portion of the anchor engages a target tissue location of an organ, such as a target lesion in a human lung.

[0066] To spare the healthy tissue between the organ surface and the target tissue from being removed, the tissue may be dilated to carefully spread the incision and allow subsequent insertion of the port and coring device (e.g., through the port) to gain access to the target tissue and to remove the target tissue only. The dilation may be achieved as follows. One or more rods (e.g., rigid rods) with center holes extending longitudinally through the rods may be advanced over the anchor until the distal ends of the rods reach the target tissue. The rods may have a diameter increasing from small to larger diameters. In some embodiments, a plurality or rods can be disposed through the incision (e.g., over the anchor) sequentially, each rod having increasing diameter to gradually dilate the incision, in some embodiments, an expandable rod may be advanced over the anchor until the distal end of the expandable rod reaches the target tissue. At this point, the distal end of the rod may be expanded to a desired diameter. In some embodiments, the dilator can include a catheter having an expandable portion or member disposed thereon configured to transition to an expanded state to dilate the tissue. For example, a balloon catheter in its collapsed state may be advanced over the anchor. Once the distal end of the balloon catheter reaches the target site, the balloon may be expanded to dilate the tissue. The balloon may have a similar shape as an angioplasty balloon, or it may be configured to have square corners at the distal end. In some embodiments, the body of the balloon may have features, such as a corrugated balloon, to minimize tissue slippage along the balloon as the balloon is inflated. A rigid structure (e.g., a structure with similar geometry as the trocar, but scaled up) may be advanced over the anchor to facilitate the smooth introduction of the trocar.

[0067] In some embodiments, a removable multi-piece dilator may be nested inside the lung stabilization device (e.g., the trocar, port, etc.) being placed to facilitate the smooth insertionAttorney Docket No.: PRNA-014 / 01WO 350944-2136of the lung stabilization device and can be removed after the lung stabilization device is placed. Access to a target tissue site may be achieved via the lung stabilization device including a channel (e.g., trocar channel, main channel, surgical device channel, etc.). The channel may be used to allow air to be introduced into the pleural space when the first layer of the pleural space is penetrated. When the pleural space is penetrated, the intrapleural vacuum may be lost, and thus the lung may be dropped away to minimize the potential of damaging to the lung pleura. Once a lesion has been successfully located, an anchoring device may be used to stabilize the target tissue lesion. The tissue coring device may also be introduced directly to the location of the target lesion using the trocar or under direct visualization with or without a guide anchor to perform the tissue resection.

[0068] The lung stabilization device may have a rigid structure and vacuum features that hold access to these sites and provides a working channel (e.g., the surgical device channel) for procedures to take place. Any surgical device or surgical tool requiring access stability fitting the internal diameter of the lung stabilization device may be used. A flange (e.g., a stopper, support structure, projection, rim, collar, etc.) may be used to fit the lung stabilization device and sit atop the skin to provide additional support to the device and / or control a length of lung stabilization device that extends through the chest wall. The flange may have features that lock and unlock to the lung stabilization device for customized length based on the chest wall thickness of the patient. The flange may also have features that allow for suturing into the skin. Suturing the flange to the skin may stabilize the lung stabilization device relative to the chest wall. Once the lung stabilization device has been placed, it offers continual access to the site of interest. The lung stabilization device may be used to provide or support access to various target sites, such as any sub-dermal tissue, pleural surfaces, or subpleural surfaces.Energy Delivery and Tissue Ablation

[0069] Various types of energy (e.g., radiofrequency, electrosurgical, ultrasonic, microwave, cryogenic, thermal, laser, etc.) can be applied to tissue to achieve a desired result, e.g., to cut, ablate, coagulate, and / or seal tissue during the procedure.

[0070] Electrosurgery involves the application of radio frequency (RF) or microwave energy to a surgical site to cut, ablate, coagulate, and / or seal tissue. In monopolar electrosurgery, a source or active electrode, which is typically part of the surgical instrument held by the surgeon,Attorney Docket No.: PRNA-014 / 01WO 350944-2136delivers RF electrical current from a generator to tissue, while a patient return electrode is placed remotely from the active electrode to carry the current back to the generator.

[0071] Ablation is an important therapeutic strategy for treating certain tissues such as benign and malignant tumors, cardiac arrhythmias, cardiac dysrhythmias and tachycardia. In tissue ablation electrosurgery, for example, the RF or microwave energy may be delivered to targeted tissue by an ablation device such as a probe, needle, or electrode assembly. RF ablation of tumors can be performed using one or more electrodes attached to an RF generator, which emits RF energy from the exposed, uninsulated portion of the electrode. This energy translates into ion agitation, which is converted into heat and induces cellular death via coagulation necrosis.

[0072] More specifically, with respect to the use of an ablation probe, the probe is typically advanced through tissue to a desired position, or positioned adjacent to a target tissue site, either prior to or during application of energy to tissue.

[0073] In some embodiments, the lung stabilization device can be configured to facilitate introduction of an ablation delivery device into the tissue cavity via the tissue stabilization port and delivering energy to eradicate cancerous tissue. As an illustrative example, a core of tissue from the target tissue site is removed as described above, in some embodiments, an ablation probe can be inserted to a target tissue site via the lung stabilization device described herein, the ablation probe configured for the delivery of energy via an ablation modality comprising at least one of microwave, RF, cryo-, chemical, laser, ethanol, water vapor, or ultrasound ablation. Once the probe is in place, the ablation procedure can begin, and the probe / heads are rotated to give radially continuous ablation on the wall and bottom tissues of the cavity.Cavitary Tissue Ablation Device

[0074] Accordingly, a tissue ablation system consistent with the present disclosure may be well suited for treating hollow body cavities, such as irregularly-shaped cavities in breast tissue created by a lumpectomy procedure. It should be noted, however, that the systems of the present disclosure are not limited to such post-surgical treatments and, as used herein, the phrase “body cavity” may include non-surgically created cavities, such as natural body cavities and passages. Additionally, or alternatively, tissue ablation systems of the present disclosure may be used for the ablation of marginal tissue in various parts of the body and organs (e.g., skin, lungs, liver, pancreas, etc.) and is not limited to treatment of breast cancer.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0075] In some embodiments, an ablation catheter can be placed into the cavity via the tissue stabilization port. In some embodiments, the ablation catheter can include an expandable portion or member disposed thereon (e.g., a basket, a balloon, or any other suitable expandable portion. The expandable portion (e.g., the balloon) can be expanded. In some embodiments, a balloon can be inflated with fluid or air / gas to ablate the cavity wall tissue. The tissue ablation system can be used during an ablation procedure to destroy the thin rim of marginal tissue around the cavity in an effort to manage residual disease in the local environment that has been treated. In some embodiments, a cavitary tissue ablation system including an ablation device can be delivered into a tissue cavity and emit non-ionizing radiation, such as radiofrequency (RF) energy, to treat the marginal tissue around the tissue cavity. The ablation device can include a probe having a deployable applicator member or head coupled thereto and configured to transition between a collapsed configuration, in which the applicator head can be delivered to and maneuvered within a previously formed tissue cavity (e.g., formed from tumor removal), and an expanded configuration, in which the applicator head is configured to ablate marginal tissue (via RF) immediately surrounding the site of a surgically removed tumor in order to minimize recurrence of the tumor. The tissue ablation device of the present disclosure is configured to allow surgeons, or other medical professionals, to deliver precise, measured doses of RF energy at controlled depths to the marginal tissue surrounding the cavity.Drug Delivery

[0076] At the cored site, administration of chemotherapy drugs may be done via the lung stabilization device through injection of the agent. The method of drug / therapy delivery containing one or more lumens at the distal end may be inserted via the port. The desired therapeutic and / or diagnostic agent may then be delivered through the lumen to the tissue via the distal end of the probe. Additionally, anti-cancer drugs may be vectorized using porous particles, such as mesoporous silica nanoparticles, and delivered to the cored tissue site.

[0077] Chemotherapy drugs and short interfering RNA (siRNA) may be co-delivered to the cored tissue site via the port through injection to promote cancer cell death. Multi drug resistance in cancer cells may be suppressed using siRNA-based formulations to induce specific silencing of a broad range of genetic targets. Delivering siRNAs in combination with chemotherapy drugs may enhance the efficacy of the chemotherapy through conquering the resistance mechanism of the cancer cells. For example, siRNA encapsulated in mesoporous silica nanoparticles may be co-delivered with doxorubicin to the target core site.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0078] Immunotherapy agents may be administered directly to the cored site for localized intratumoral immunotherapy. Immunotherapeutics may include small molecules, nucleic acids, proteins and peptides, or immune cells. Immunotherapeutics may be packaged within delivery vehicles such as nanoparticles or viral vectors, or delivered inside implantable scaffolds such as hydrogels or biodegradable polymers.Implant Delivery

[0079] Chemotherapy drug-eluting particles may be delivered to the cored site, promoting controlled and sustained locoregional release of therapeutic agents in high concentration with prolonged administration.

[0080] Radioactive pellets or "seeds" can be used to treat cancerous tumors, especially in the prostate gland. These seeds usually are about 4 mm long and 0.8 mm in diameter and emit low energy x-rays in the 20-40 keV range. The first such source utilized Iodine- 125 (125 I) with a 60-day half life. Palladium-103 (103 Pd) with a 17-day half life can also be used. Radioactive seeds may be delivered to the cored site, promoting controlled and sustained locoregional release of a low level of radiation in high concentration with prolonged administration. The radioactive seeds may be removed after treatment or left behind permanently.

[0081] Fiducial markers may be delivered to the cored site to improve the accuracy and effectiveness of cancer treatment modalities that rely on precise tumor localization. Delivering the markers to the tumor bed while the lung is stabilized via the port ensures precise placement of the markers at the site of interest, which is critical for subsequent imaging and targeted therapies.Fluid Delivery

[0082] Fluids may be introduced via the lung stabilization device to the cored site. Precise fluid delivery is crucial for effective irrigation, cleaning, or sealing the cavity, which aids in the healing process and reduces potential complications. This is particularly beneficial in managing the tumor bed post-resection, ensuring a more controlled and effective treatment approach.

[0083] The delivery of irrigation solutions or saline to the cored site removes cellular debris, surface bacteria, and wound exudate. Irrigation of the site assists in debridement and promotes wound healing.Attorney Docket No.: PRNA-014 / 01WO 350944-2136Device Delivery

[0084] The lung stabilization device allows for the introduction of various medical devices, such as imaging probes or drug delivery systems, tailored to fit snugly within the cavity sleeve. This compatibility ensures stability and precision in positioning these devices, enhancing the effectiveness of subsequent diagnostic or therapeutic procedures performed within the cored site. The embodiments described herein aim to maximize the utility of the cored space while minimizing tissue disruption and promoting efficient medical intervention.

[0085] An endoscope may be used to visualize the cored site. Additional laparoscopic or surgical instruments include grasping instruments, cutting instruments, and / or a cutting stapler may be introduced via the port for subsequent procedures. Using the endoscope and the other instruments, a “triangulation” technique is utilized where, for example, the endoscope is used to view as the grasping instrument is brought in from one direction, and the stapler is brought in from another, and tissue is cut with the stapler and removed through one of the ports. Instruments used as end effectors in robotic surgery may be introduced, including grasping instruments, cutting instruments, and / or a cutting stapler for subsequent procedures.

[0086] Wound healing devices may be delivered to the cored site. The deployment of a biodegradable matrix embedded with growth factors could promote tissue regeneration. The introduction of a micro-pump system for continuous delivery of therapeutic agents directly to the wound site to optimize the healing environment.

[0087] Closing the cavity may comprise using biological tissue adhesive, tissue grafts, hemostatic sealing patches, staple closure, sutures or the like. The delivery of sealing material such as a hemostatic patch, hemostatic agents such as fibrin, a biological adhesive material such as Dermabond, or any combination thereof can be used to close or seal the tissue cavity.Wound Healing

[0088] The application of suction via the lung stabilization device can be used to promote wound healing of the cored site. By creating a controlled negative pressure environment, the method aids in reducing edema, increasing blood flow, and stimulating the growth of granulation tissue at the wound site. With the application of suction, the open cavity volume of the core is reduced in volume to aid in the healing process by minimizing wound surface area. Further, it is known that the healing process can be accelerated through Vacuum AssistedAttorney Docket No.: PRNA-014 / 01WO 350944-2136Closure (VAC) by gently pulling fluids, such as bacteria, from the wound to cleanse the region, reduce inflammation and stimulate the growth of new tissue by pulling more white blood cells and macrophages that help the wound close.Fluid and Air Removal

[0089] The application of suction via the lung stabilization device can be used to efficiently extract excess fluids, such as blood or exudate, which can accumulate in the tissue cavity postresection. The suction mechanism aids in maintaining a clean and clear surgical area, enhancing visibility and reducing the risk of infection.

[0090] The application of suction via the lung stabilization device can be additionally and / or alternatively be used for the removal of air and / or evacuation of the thoracic cavity at the cored site. This functionality is especially crucial in thoracic surgeries where the precise and controlled removal of air or fluid from the thoracic cavity is necessary to prevent complications such as pneumothorax. The suction capability of the lung stabilization device facilitates a safer, more controlled post-operative environment, significantly improving patient outcomes by ensuring the stability of the thoracic cavity during and after the procedure.

[0091] Applying suction via the lung stabilization device can be used instead of a separate chest tube placement, a common procedure in thoracic surgeries. By integrating the suction functionality directly into the port, the device simplifies the surgical process, reduces the number of interventions and access points required, and minimizes the potential for complications.Intracorporeal and Extracorporeal Stabilization

[0092] The stabilization feature of the lung stabilization device is used to maintain the integrity and position of tissue structures during surgery, thereby enhancing surgical accuracy and outcomes. By providing a stable surgical field, the port reduces tissue movement, allowing surgeons to perform intricate maneuvers with greater control and reduced risk of inadvertent tissue damage.

[0093] The lung stabilization device can be used for intracorporeal stabilization of tissue, which is instrumental in enabling controlled microsurgery. Additionally, the use of suction viaAttorney Docket No.: PRNA-014 / 01WO 350944-2136the lung stabilization device could be used as means to grasp or manipulate tissue once initial access to the pleural surface has been established.

[0094] Additionally or alternatively, the lung stabilization device and its accessories can be used for extracorporeal stabilization of tissue, leveraging its flange and other external components. This functionality is pivotal in enabling robotic surgery via the lung stabilization device, as it provides an external support structure to maintain tissue stability. The design of the flange and associated components is tailored to integrate seamlessly with robotic surgical systems, ensuring precision and control during complex surgical maneuvers.Pressure Sensing

[0095] The lung stabilization device may have a pressure sensor disposed thereon or integrated into its system. This sensor can be configured to alert the user to any loss of pressure within the system. The pressure sensor can provide real-time feedback, enabling the user to quickly identify and rectify any issues related to pressure loss, which could mean the tissue is no longer stabilized against the lung stabilization device during surgical procedures. An indicator can be incorporated to the lung stabilization device to inform if suction has been lost at any point during the procedure.Cavitary Visualization

[0096] Once the tissue core has been removed, there is a cavity left that provides direct access to the excision site. Access to the cavity is facilitated by the port. There are multiple ways that this cavity can be utilized intraoperatively and postoperatively.

[0097] A light source can be incorporated into the thickness of the lung stabilization device in order to allow for better visualization of the excision site and the tissue around it. The lung stabilization device can be transparent with this light source as well to better visualize the tissue surface / work area and the surrounding tissue.

[0098] A probe with a light source, with or without a camera, such as an endoscope, may be introduced through the port and down the cavity to provide illumination and visualization, through a scope or to the naked eye, to the excision site and the tissue around it.

[0099] An endoscope may be used to facilitate visualization of a target tissue site. Specifically for the lung, endoscopy may be used within the chest, thereby precluding the need for a largeAttorney Docket No.: PRNA-014 / 01WO 350944-2136thoracotomy incision. Thoracoscopy is the use of a specialized viewing instrument, usually a rigid endoscope, introduced through a thoracostomy, or a small hole placed in between the ribs. Once the endoscope is placed in the space that surrounds the lung, known as the pleural space, additional thoracostomy holes may be made to introduce additional instruments. Additional instruments include grasping instruments, cutting instruments, and / or a cutting stapler. Using the endoscope and the other instruments, a “triangulation” technique is utilized where, for example, the endoscope is used to view as the grasping instrument is brought in from one direction, and the stapler is brought in from another, and tissue is cut with the stapler and removed through one of the ports.

[0100] The port may be substantially transparent to allow for confirmation of proper tissue fixation and / or successful tissue stabilization.Aspects:

[0101] Aspect 1. A method for performing a procedure on a target tissue site of a patient, the method comprising: selecting a target location on the surface of the target tissue site to establish an access port; introducing an access port to the target location; removably securing the access port to the target tissue site; resecting a core of tissue from target location via the access port so as to create a tissue cavity; and performing a procedure on the target tissue site.

[0102] Aspect 2. The method of aspect 1, wherein the target tissue site is substantially located within a solid organ.

[0103] Aspect 3. The method of aspect 1, further comprising inserting a visualization device into the access port so as to visualize at least a portion of the tissue cavity.

[0104] Aspect 4. The method of aspect 1, further comprising performing a procedure on the target tissue site via the access port and tissue cavity.

[0105] Aspect 5. A system for accessing target tissue, comprising: a cannula configured to provide percutaneous access to a target tissue site, wherein: the cannula includes a protective wall configured for creating separation between the lumen and the surrounding tissue through which the cannula extends, and the protective wall configuration is designed to minimize tissue disruption and ensure a secure passageway to the target site (essentially providing access through a portion of a solid organ); wherein the protective wall of the cannula is composed ofAttorney Docket No.: PRNA-014 / 01WO 350944-2136a biocompatible material intended to reduce irritation and inflammation of the surrounding tissue wherein the protective wall circumferentially provides pressure to the surrounding tissue preventing collapse of working channel wherein the protective wall circumferentially provides pressure to the surrounding tissue reducing bleeding through tamponade of surrounding tissue an elongated tube wherein the tube is adapted for facilitating the passage of at least one selected from a group consisting of surgical instruments, therapeutic compounds, and visualization equipment; and a cavity sleeve, wherein the cavity sleeve is housed within the cannula and may be decoupled from the cannula and left behind temporarily to facilitate passage of at least one of the aforementioned selected group, wherein the cavity sleeve may be decoupled from the cannula and left behind temporarily to facilitate direct visualization of the created cavity, an attachment mechanism for coupling an elongated tube with the cannula, wherein the tube is configured to access a cavity formed by resection of the target tissue, thereby enabling direct delivery of therapeutic or diagnostic agents or equipment to the resected area.

[0106] Aspect 6. A tissue-engaging system to be used in performing a medical procedure on a body organ accessed through one or more incisions into a body cavity, the system comprising: an access port, comprising an elongated tube configured to facilitate passage therethrough of at least one of instrumentation, therapeutic compounds, visualization equipment, or any combination thereof; a tissue engagement element positioned adjacent a distal end of the access port, the tissue engagement element configured to operatively engage and removably secure the access port to a target tissue site; and; a tissue securement mechanism such that the migration of the target tissue site relative to the distal end of the access port is inhibited.

[0107] Aspect 7. The system of aspect 6, wherein the tissue secure mechanism is configured to cause reversible tissue securement through the transfer of thermal energy.

[0108] Aspect 8. The system of aspect 6, wherein the tissue secure mechanism is configured to cause reversible tissue securement using clips.

[0109] Aspect 9. The system of aspect 6, wherein the tissue secure mechanism is configured to cause reversible tissue securement using suture.

[0110] Aspect 10. The system of aspect 6, wherein the tissue secure mechanism is configured to cause reversible tissue securement using suction.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0111] Aspect 11. The system of aspect 6, wherein the tissue secure mechanism is configured to cause reversible tissue securement using anchors.

[0112] Aspect 12. The system of aspect 6, wherein the tissue secure mechanism is configured to cause reversible tissue securement using a surface finish configured for gripping.

[0113] Aspect 13. The system of aspect 6, wherein the tissue secure mechanism is configured to cause reversible tissue securement using adhesive

[0114] Aspect 14. The system of aspect 6, wherein the access port further comprises at least one sensor configured for generating a signal corresponding to a perioperative measure.

[0115] Aspect 15. The system of aspect 14, further comprising at least one transducer that outputs at least one signal corresponding to the pressure within the system.

[0116] Aspect 16. The system of aspect 6, further comprising a display.

[0117] Aspect 17. The system of aspect 6, further comprising an indicator configured to provide information to a user regarding at least one function of the access port, comprising: maintenance of tissue engagement to access port, pressure reading of tissue engagement element to target tissue, tissue oxygenation value of target tissue, thermal reading of target tissue that is engaged with the tissue engagement element, or any combination thereof.

[0118] Aspect 18: The system of aspect 17, wherein the system uses a sensor integrated into the tissue engagement element or lung stabilization device to continuously monitor the engagement status of the access port with the target tissue, the sensor configured to detect the degree of suction or mechanical attachment between the tissue and the access port, thereby ensuring that the tissue remains securely attached during the procedure.

[0119] Aspect 19: The system of aspect 18, wherein feedback from the sensor allows for realtime adjustments if engagement weakens.

[0120] Aspect 20: The system of aspect 17, wherein the system includes a pressure sensor embedded within the tissue engagement element configured to measure the pressure applied to the target tissue, the pressure sensor providing data on the suction force or mechanical pressure being exerted, thereby ensuring that the pressure is within a safe and effective range to avoid tissue damage while maintaining secure engagement.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0121] Aspect 21: The system of aspect 17, wherein the system includes one or more tissue oxygenation sensors including at least one of such as a pulse oximeter or a photoplethysmography (PPG) sensor, the one or more tissue oxygenation sensors configured to be positioned at the interface between the tissue engagement element and the target tissue, the one or more tissue oxygenation sensors configured to measure the oxygen saturation level of the tissue, thereby providing feedback on the tissue’s perfusion and oxygenation status and providing information corresponding to whether the tissue remains viable during the procedure

[0122] Aspect 22: The system of aspect 17, wherein the system includes a thermal sensor placed within or near the tissue engagement element to monitor the temperature of the tissue in contact with the access port, the thermal sensor may be configured to detect changes in temperature indicative of tissue stress including at least one of overheating due to device energy or inflammation.

[0123] Aspect 23: The system of aspect 22, wherein the system is configured to alert the user if temperatures rise beyond a predetermined safe threshold.

[0124] Aspect 24. A method for providing an access port to a target tissue site, comprising the steps of: providing an access port, the access port comprising: an elongated tube configured to facilitate passage therethrough of instrumentation, therapeutics, biological tissue, or any combination thereof; and a tissue engagement element positioned adjacent a distal end of the access port, the tissue engagement element configured to operatively engage and removably secure the access port to the target tissue site; introducing the access port to the target tissue site; and removably securing the access port to the target tissue site.

[0125] Aspect 25. The method of aspect 24, wherein the tissue engagement element is additionally configured to operatively manipulate and reposition at least a portion of the target tissue site.

[0126] Aspect 26. The method of aspect 24, wherein removably securing the access port to the target tissue site comprises at the use of at least one of an adhesive, a surface finish configured for gripping, anchors, clips, suction, or any combination thereof.

[0127] Aspect 27. A method for delivering energy to a target tissue site, the method comprising; providing an access port, the access port including: an elongated tube configured to facilitate passage therethrough of instrumentation, therapeutics, biological tissue, or anyAttorney Docket No.: PRNA-014 / 01WO 350944-2136combination thereof; and a tissue engagement element positioned adjacent a distal end of the access port, the tissue engagement element configured to operatively engage and removably secure to a target tissue site; introducing the access port to a target location; removably securing the access port to the target tissue site; resecting a core of tissue from the target tissue site via the access port; positioning an ablation device substantially adjacent the target tissue site; and activating the ablation device so as to deliver energy to at least a portion of the target tissue site.

[0128] Aspect 28. A system for delivering cancer therapy, the system comprising: an access port configured to operatively engage and removably secure to a target tissue site, wherein the access port comprises: an elongated tube configured to facilitate passage therethrough of instrumentation, therapeutics, biological tissue, or any combination thereof; and; a tissue engagement element positioned adjacent a distal end of the access port; a tissue resection device configured for coring tissue, the tissue resection device comprising: a first clamping element comprising a helical coil; a second clamping element, the second clamping element being positioned to oppose at least a portion of the first clamping element; a first electrode and a second electrode configured for the delivery of radiofrequency energy to an area adjacent one or more of the first clamping element and the second clamping element to seal tissue; and a cutting element configured for the transection of at least a portion of the sealed tissue, an ablation device configured for delivering energy to a target tissue site, the ablation device comprising: an elongated body and at least one electrode configured to deliver energy to a target tissue site; and a generator configured to deliver energy to at least one of the tissue resection device or the ablation device.

[0129] Aspect 29: A method for applying negative pressure to a surgical site, comprising: providing an access port, the access port comprising: an elongated tube, wherein the elongated tube is configured to: facilitate passage therethrough of instrumentation, therapeutics, biological tissue, or any combination thereof; and apply a source of negative pressure to a surgical site; a tissue engagement element positioned adjacent a distal end of the access port, the tissue engagement element configured to operatively engage and removably secure the access port to a target tissue site; introducing the access port to a target tissue site; removably securing the access port to the target tissue site; and applying a negative pressure to the surgical site via the access port to remove accumulated fluid and gas, reduces the overall cavity surface area, to promote healing, or any combination thereof.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0130] Aspect 30: The method of aspect 29, wherein: a controlled suction force is applied to the tissue cavity to draw the edges of the tissue cavity towards each other to close the cavity; and the suction force is maintained for a predetermined time period to promote wound healing

[0131] Aspect 31: The method of aspect 30, wherein the controlled suction force is adjustable based on cavity size and type.

[0132] Aspect 32: The method of aspect 30, further comprising the step of applying a therapeutic agent to the wound site before activating the suction mechanism.

[0133] Aspect 33: The method of aspect 29, further comprising: providing an access port equipped with a fluid collection container and a control mechanism for regulating suction intensity; inserting the access port to a target tissue site; activating the suction device via the control mechanism to apply a predetermined suction force through the suction tube, wherein the suction force is configured to extract fluids from the tissue cavity without damaging surrounding tissues; and collecting the extracted fluids in the fluid collection container.

[0134] Aspect 34: The method of aspect 33, wherein the suction force is adjustable based on the viscosity of the fluids being extracted.

[0135] Aspect 35: The method for aspect 29, further comprising: applying suction at the distal end of the access port to remove air or fluid at the surface of the lung and within the thoracic cavity; creating a negative pressure environment within the thoracic cavity through controlled suction to facilitate lung stabilization and lung expansion.

[0136] Aspect 36: The method of aspect 35, wherein the suction is applied within the thoracic cavity to create a negative pressure environment conducive to the natural expansion of the lung and the stabilization of respiratory functions.

[0137] Aspect 37: The method of aspect 35, further comprising: embedding a pressure sensor in the access port for monitoring the pressure within the throracic cavity; and a flow control valve that automatically opens and closes based on the pressure readings to maintain a desired negative pressure within the thoracic cavity, ensuring optimal conditions for thoracic surgery.

[0138] Aspect 38: The method of aspect 37, wherein the flow control valve is programmable to adjust the negative pressure threshold values based on patient-specific requirements.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0139] Aspect 39: The method of aspect 37 or 38, further including the use of a digital control unit interfaced with the pressure sensor and flow control valve to provide real-time monitoring and adjustment of the thoracic cavity environment.

[0140] Aspect 40: A system for visualizing internal anatomic structures, the system comprising: an access port with a center hole to visualize, with or without visualization tools, anatomical internal structures, the anatomical internal structures comprising biologic tissues, parenchyma, blood vessels, airways, cancerous tissue, diseased tissue, bones, tissue surfaces, or any combination thereof; and visualization tools, comprising: at least one of an LED, endoscope, arthroscope, fibroscope, or laparoscope.

[0141] Aspect 41: A system to visualize a surgical site, the system comprising: an access port configured to operatively engage and removably secure to a target tissue site, wherein the access port comprises: an elongated tube configured to facilitate passage therethrough of instrumentation, therapeutics, biological tissue, or any combination thereof; and a tissue engagement element positioned adjacent a distal end of the access port, the tissue engagement element configured to operatively engage and removably secure the access port to a target tissue site; and an instrument configured for the visualization of at least a portion of the surgical site.

[0142] Aspect 42: The instrument configured for the visualization of at least a portion of the surgical site of aspect (above), wherein the visualization modality comprises direct visualization, optical imaging, ultrasonic imaging, optical coherence tomography, etc., or any combination thereof.

[0143] Aspect 43: A method to create and maintain a pathway for the introduction of illumination or visualization tools, the method comprising: providing an access port, the access port comprising: an elongated tube, wherein the elongated tube is configured to: facilitate passage therethrough of instrumentation, therapeutics, biological tissue, or any combination thereof; and a tissue engagement element positioned adjacent a distal end of the access port, the tissue engagement element configured to operatively engage and removably secure the access port to a target tissue site; introducing the access port to a target tissue site; removably securing the access port to the target tissue site; and introducing tools for illumination or visualization including at least one of LED, endoscope, arthroscopy, fibroscope, or laparoscope.Attorney Docket No.: PRNA-014 / 01WO 350944-2136

[0144] Terms used in the claims and specification are defined as set forth below unless otherwise specified. It must be noted that, as used in the specification, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. The phrase “and / or,” as used in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and / or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and / or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements).

[0145] As used in the specification and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used shall only be interpreted as indicating exclusive alternatives (i.e., “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.”

[0146] The term “about,” as used herein, means approximately, in the region of, roughly, or around. Unless otherwise stated for a numerical value noted, when the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. Unless otherwise stated for a numerical value noted, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, or 50%. For nonlimiting example, a range of “about 2 to about 20” can mean 1.98 to 22, or 1 to 30, or other ranges therebetween. Unless otherwise stated for a percentage range noted, when the term “about” is used in conjunction with a percentage range, it modifies that range by extending theAttorney Docket No.: PRNA-014 / 01WO 350944-2136boundaries above and below the percentages set forth. Unless otherwise stated for the percentage noted, the term “about” is used herein to modify a percentage above and below the stated percentage by 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, or 50% (as an absolute, which may be limited to 0% as a minimum), or by a percentage of the stated percentage i.e. 1% 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, or 50% of the percentage. For nonlimiting example, a range of “about 2% to about 20%” can mean 1% to 21%, or 0% to 70%, or other ranges therebetween, or 1.98% to 22%, or 1% to 30% (as a percentage of the percentage range). For nonlimiting example, a percentage value of “about 30%” can mean 29% to 31%, or 0% to 80%, or other ranges therebetween, or 27% to 33%, or 15% to 45% (as a percentage of the percentage value), or other ranges therebetween. Unless otherwise stated for a numerical range noted, numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, and 5). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about.”

[0147] The term “subject,” as used herein, is meant to include both human and non-human animals. Exemplary human subjects include human patients (referred to as patients) with a disorder (e.g., lung cancer) or normal subjects. The term "non-human animal" in some aspects includes all vertebrates, such as non-mammals (e.g., chickens, amphibians, reptiles), and mammals, such as non-human primates, domestic and / or agriculturally useful animals, such as sheep, dogs, cats, cattle, pigs, and the like.

[0148] The term “substantially,” as used herein, is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning) and refers without limitation to being largely but not necessarily wholly that which is specified. For example, the term “to substantially separate,” as used herein refers to the removal, whether completely or partially (e.g., removal of 1% or more, 5% or more, 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, 95% or more, 96% or more, 97% or more, 98% or more, 99% or more, or 99.9%), of an unwanted constituent from a mixture containing two or more constituents mixed together.

[0149] Where ranges are given, endpoints are included. Furthermore, unless otherwise indicated or otherwise evident from the context and understanding of one of ordinary skill in the art, values that are expressed as ranges can assume any specific value or sub-range withinAttorney Docket No.: PRNA-014 / 01WO 350944-2136the stated ranges in different embodiments of the inventions described and provided herein, to the tenth of the unit of the lower limit of the range, unless the context clearly dictates otherwise.

Claims

Attorney Docket No.: PRNA-014 / 01WO 350944-2136CLAIMS1. An apparatus, comprising:a port defining a first channel extending therethrough and configured to provide surgical access to a target tissue site, the port further defining a second channel extending therethrough and configured to apply suction to a portion of tissue near the target tissue site such that the portion of tissue is brought into contact with a distal end of the port to fix a position of the portion of tissue relative to the first channel,the second channel including one or more support members disposed therein, the one or more support members configured to provide lateral support to the second channel to counteract lateral forces imparted on an outer wall of the second channel.

2. The apparatus of claim 1, wherein the port is configured to be disposed through a chest wall such that the distal end of the port is disposed near a surface of a lung of a patient.

3. The apparatus of claim 2, wherein the one or more support members are configured to resist deformation of the outer wall of the second channel caused by the lateral forces imparted by ribs of the patient on the port.

4. The apparatus of claim 2, wherein the port further includes a flange disposed around the port, the flange moveable along the port such that a length of a portion of the port configured to be disposed through the chest wall is adjustable based on a thickness of the chest wall of the patient.

5. The apparatus of claim 1, wherein the one or more support members extend longitudinally though a portion of the second channel and terminate at a location offset from the distal end of the port.

6. The apparatus of claim 1, wherein the port includes an inlet defined in a proximal portion thereof and in fluid communication with the second channel, the inlet coupleable to a suction source.

7. The apparatus of claim 1, wherein a distal opening of the second channel is concentric around a distal opening of the first channel.Attorney Docket No.: PRNA-014 / 01WO 350944-21368. The apparatus of claim 7, wherein the first channel and the second channel collectively define a circular cross-section.

9. The apparatus of claim 1, wherein the port further includes a third channel configured to apply suction to the portion of tissue, wherein the second channel and the third channel are disposed on opposite sides of the first channel, the second channel and the third channel configured to be coupled to a suction source via an inlet defined in a proximal portion of the port.

10. The apparatus of claim 9, wherein the first channel, the second channel, and the third channel collectively form an elliptical cross-section.

11. The apparatus of claim 1, wherein the port includes a coupling mechanism at a proximal end thereof, the coupling mechanism configured to be coupled to a tissue excision device to fix a first portion of the tissue excision device relative to the port as a second portion of the tissue excision device is advanced through the first channel to the target tissue site.

12. An apparatus, comprising:a port defining a first channel extending therethrough and configured to provide surgical access a target tissue site, the port further defining a second channel extending therethrough and configured to apply suction to a portion of tissue near the target tissue site such that the portion of tissue is brought into contact with a distal end of the port to fix a position of the portion of tissue relative to the first channel; anda coupling mechanism disposed at a proximal end of the first channel, the coupling mechanism configured to be coupled to a tissue excision device such that a first portion of the tissue excision device is maintained relative to the port as a second portion of the tissue excision device is advanced through the first channel to the target tissue site.

13. The apparatus of claim 12, wherein the port is configured to be disposed through a chest wall such that a distal end of the port is disposed near a surface of a lung of a patient.Attorney Docket No.: PRNA-014 / 01WO 350944-213614. The apparatus of claim 13, wherein the second channel includes one or more support members disposed therein, the one or more support members configured to provide lateral support to the second channel to counteract lateral forces imparted by ribs of the patient on the port.

15. The apparatus of claim 13, wherein the port further includes a flange disposed around the port, the flange moveable along the port such that a length of a portion of the port configured to be disposed through the chest wall is adjustable based on a thickness of the chest wall of the patient.

16. The apparatus of claim 12, wherein the port includes an inlet defined in a proximal portion thereof and in fluid communication with the second channel, the inlet coupleable to a suction source.

17. The apparatus of claim 12, wherein a distal opening of the second channel is concentric around a distal opening of the first channel such that first channel and the second channel collectively define a circular cross-section.

18. The apparatus of claim 12, wherein the port further includes a third channel configured to apply suction to the portion of tissue, the second channel and the third channel configured to be coupled to a suction source via an inlet disposed on a proximal end portion of the port.

19. The apparatus of claim 18, wherein the second channel and the third channel are disposed on opposite sides of the first channel such that the first channel, the second channel, and the third channel collectively form an elliptical cross-section.

20. A system, comprising:a port configured to provide access to a thoracic cavity, the port including:a first channel extending through the port and configured to receive one or more surgical devices therethrough to provide surgical access to a target tissue site in a lung of a patient;a second channel extending through the port;Attorney Docket No.: PRNA-014 / 01WO 350944-2136a side opening defined in a distal portion of the port and in fluid communication with the second channel;a suction source configured to be coupled to the second channel and to apply a suction force through the second channel; anda flow controller configured to be coupled to the port, the flow controller configured to transition between a first configuration in which the side opening is closed, and a second configuration in which the side opening is open such that the suction force through the second channel evacuates fluid from the thoracic cavity via the side opening and the second channel.

21. The system of claim 20, wherein the port includes an inlet defined in a proximal portion thereof and in fluid communication with the second channel, the inlet configured to couple the suction source to the second channel.

22. The system of claim 20, wherein the second channel terminates in a distal opening, the second channel configured to apply suction to a surface of the lung to pull the surface of the lung into contact with a distal end of the port to fix the surface of the lung relative to the first channel.

23. The system of claim 21, wherein the distal opening of the second channel is concentric around a distal opening of the first channel such that first channel and the second channel collectively define a circular cross-section.

24. The system of claim 21, wherein the side opening is a first side opening, the port further includes a third channel configured to be coupled to the suction source such that the suction source applies the suction force through the third channel, and a second side opening in fluid communication with the third channel.

25. The system of claim 24, wherein the second side opening is closed when the flow controller is in the first configuration, the second side opening is open when the flow controller is in the second configuration such that the suction force through the third channel evacuates fluid from the thoracic cavity via the second side opening.Attorney Docket No.: PRNA-014 / 01WO 350944-213626. The system of claim 25, wherein the flow controller is a sleeve disposed around a portion of the port and moveable along a length of the port.

27. The system of claim 24, wherein the second channel and the third channel are disposed on opposite sides of the first channel such that the first channel, the second channel, and the third channel collectively form an elliptical cross-section.

28. The system of claim 20, further comprising:a sensor coupled to the port and configured collect measurements corresponding to at least one of a negative pressure in the thoracic cavity or engagement between the port and the lung; andcontrol the suction force applied by the suction source based on the measurements.

29. The system of claim 20, the second channel includes one or more support members disposed therein, the one or more support members configured to provide lateral support to the second channel to counteract lateral forces imparted by ribs of the patient on the port30. The system of claim 20, wherein the port further includes a flange disposed around the port, the flange moveable along the port such that a length of a portion of the port configured to be disposed through a chest wall is adjustable based on a thickness of the chest wall of the patient.

31. A method, compri sing :forming an incision in a chest wall of a patient;dilating the incision with a dilator;inserting a port through the incision such that a distal portion of the port is disposed in a thoracic cavity of the patient;applying, via the port, suction to a surface of a lung of the patient to fix a portion of the lung relative to the port;coupling a tissue excision device to the port; andremoving, using the tissue excision device, target tissue from the lung through the port.Attorney Docket No.: PRNA-014 / 01WO 350944-213632. The method of claim 31, wherein the port defines a first channel and a second channel, wherein the suction is applied to the surface of the lung via the second channel, and a portion of the tissue excision device is configured to be disposed through the first channel to access the lung.

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