Anastamosis devices and methods

Abstract

Described herein are a linear RF closure device configured for even application of compression and uniform thickness of tissue between jaws of the linear RF closure device for forming a seal, a circular RF closure device including a circular embodiment having a collapsible base on a circular sealer configured for a reduced size / cross-section of the circular embodiment of the circular RF closure device after forming a seal, to allow easy removal of the device through an anastomosis with minimal force exerted on newly sealed tissue. Associated RF controls including a system for delivery of RF energy with a handle compatible with the linear and circular / circular embodiment RF closure devices for performing anastomosis in the gut are also described herein.

Description

ANASTAMOSIS DEVICES AND METHODSPRIORITY CLAIM

[0001] This patent application claims priority to U.S. Provisional Application No. 63 / 549,033, titled “COLLAPSIBLE CIRCULAR GASTRIC SEALER,” filed on February 2, 2024, and U.S. Provisional Application No. 63 / 548,992, titled “ANASTOMOSIS DEVICES AND METHODS,” also filed on February 2, 2024, both of which are herein incorporated by reference in their entirety.INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.FIELD

[0003] This application relates to different configurations of linear, curved and circular anastomosis devices and associated methods performed using these devices.BACKGROUND

[0004] Colorectal cancer is the third most common cancer worldwide, with over 1.9 million new cases in 2020. Colorectal cancer is the third most commonly occurring cancer and the 20 second most commonly occurring cancer in women globally. The global incidence of colorectal cancer is expected to increase by 60% to over 2.2 million new cases and 1.1 million annual deaths by the year 2030. The causes of such cancers are certain but are likely related to obesity, processed foods, smoking, and more sedentary lifestyles.

[0005] Treatments for colorectal cancer typically include resection of a diseased part of the patient’s colon. Following such a resection, a surgical anastomosis is performed wherein the free ends of the intestine are reconnected. One of the most serious complications of anastomosis is anastomotic leakage which occurs in up to 20% of patients undergoing such a resection procedure. Leakage from the anastomosis site causes fecal material to enter the abdominal cavity and can lead to serious complications such as peritonitis, septic shock and can be life threatening.

[0006] Such an anastomotic leakage is not always immediately detectable and can result in re-operations and extended times in hospitals.

[0007] While RF sealing and closure systems have been developed for and widely used in the vasculature, surgical staplers and suturing remain the predominate surgical option in performing intestinal anastomosis procedures. While surgical staplers remain in wide use, the performance of staples in terms of sealing quality and risk of leakage between or in a staple line of stapled portion of the intestine. As a result, a need for improved surgical closure systems for use in the gut remains substantially unmet.

[0008] A circular anvil is a common accessory in the performance of anastomosis procedures. While commonly used, there remains a persistent issue relating to the removal of the anvil once the anastomosis is completed since the newly formed lumen often has a smaller inner diameter than the diameter of the anvil. As such, the need for improvements in anvil design remain to address these and other shortcomings of conventional designs.SUMMARY OF THE DISCLOSURE

[0009] Described herein are devices, systems and method for RFA, Hybrid RFA and Augmented RFA techniques for use in completing or supporting sealing procedures within the GI tract.

[0010] For example , there is a linear RF sealing device, having: a handle with an RF connector and a trigger for operating a pair of jaw having a parallel closing joint mechanism configured to form a seal by grasping a uniform thickness of tissue between the pair of jaw and further configured to apply pressure evenly to the grasped tissue; a shaft connected proximally to the handle and distally to the pair of jaws; and the pair of jaws on the distal end of the shaft comprising an electrode array. There are also embodiments having a pivot on the shaft allowing the pair of jaws to move in a lateral or a vertical direction relative to the longitudinal axis of the shaft. In other aspects, there are also embodiments where the pair of jaws is straight, curved downward at the distal end relative to the longitudinal axis of the shaft or curved to the left of the longitudinal axis of the shaft or curved to the right of the longitudinal axis of the shaft.

[0011] In other embodiments, there is provided a circular anvil of a closure system having a head, a central shaft connected distally to the head with a connector on a proximal end adapted and configured for connection to a circular electrode of the closure system along with an anvil base comprising a plurality of segments, wherein each segment is foldable from a deployed condition where all of the segments for an integrated segmented base and a folded condition where each one of the plurality of segments is adjacent to the central shaft within a folded segment storage zone along the central shaft proximal to the head with a segment folding mechanism used to transition the plurality of segments from the deployed conditionto the folded condition; further wherein the folded condition is configured for reducing a size profile of the circular anvil for removal of the circular anvil through an anastomosis; further wherein the reduced size profile of the circular anvil exerts a reduced force on the anastomosis during the removal. In additional embodiments, the segmented base has between 4 to 8 segments. In other aspects, the segments of the segmented base are within the folded segment storage zone a diameter of the head of the circular anvil is the widest portion of the circular anvil.

[0012] In other alternative embodiments, there is a system for performing an RF anastomosis in an intestine having a linear RF sealing device, a circular RF sealing device and an RF controller having computer readable code and a handle to operate the linear RF sealing device and the circular RF sealing device to perform anastomosis procedures on tissue that is responsive to the tissue undergoing a sealing procedure.

[0013] In still other embodiments, there is a method of performing an anastomosis procedure within a portion of the gut having the steps of performing one or more of a resecting step, a cutting step, a sealing step or a hybrid sealing step using a linear or circular RFA device under the control of an RFA controller wherein the performing of the resecting step, the cutting step, the sealing step is performed as part of a surgical procedure performed in a gastrointestinal tract (GI tract). In some aspects, there is also an embodiment where the anastomosis procedure or the surgical procedure performed in the gastrointestinal tract (GI tract) is one of a cancer induced resection and restoration procedure, a gastric reduction or repair procedure, a procedure within the esophagus or the esophageal sphincter, the stomach, the duodenum, the small intestine, the large intestine or adjacent to the anal sphincter including an end to end anastomosis, an end to side anastomosis, a side to side anastomosis and any combination of the above. In still other advantageous aspects, one or more of the steps or procedures further comprises one or more of a hybrid RFA or augmented RFA method or step.

[0014] In one embodiment, there is a method for creating an anastomosis in an intestine having a step of resecting a portion of a diseased section of the intestine with an RF device to form a first resected end and resecting a portion of a diseased section of the intestine with an RF device to form a second resected end. Thereafter, there is a step of joining the first resected end and the second resected end using a circular RF device to form an anastomosis ring and removing the circular RF device through the anastomosis ring. Additionally, in some embodiments, there is a step of also including folding, collapsing or altering a profile of a portion of the circular RF device before the removing step. Additionally or optionally, thereis also before the first resecting step or the second resecting step there is a step of grasping tissue from the intestine between jaws of an RF device having parallel closing characteristics.

[0015] Also described herein is a method for folding and removing a circular anvil of a closure system, including advancing the circular anvil into a spaced apart position from the circular electrode base after completion to an anastomosis sealing procedure to from an anastomosis opening between two ends of a resected portion of an intestine. Thereafter, advancing a head of the circular anvil away from a segmented base of the circular anvil to provide a folded segment storage zone along a central shaft of the circular anvil. Next, operating a segment folding system to collapse the segments of the segmented base into a position adjacent to the folded segment storage zone. Then there is a step of withdrawing the circular anvil having the segments within the folded storage zone through the anastomosis opening.

[0016] In some embodiments the segmented base has between 4 to 8 segments. In still other embodiments, the segments of the segmented base are within the folded segment storage zone a diameter of the head of the circular anvil is the widest portion of the circular anvil.

[0017] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0018] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0019] FIG. l is a perspective view of an RF anastomosis system with a linear RF sealing device, a circular RF sealing device connected to an RF anastomosis controller and power generator.

[0020] FIG. 2A is a side view of the linear RF sealing device of FIG. 1 showing the vertical tip deflection relative to a joint positioned along the longitudinal axis of the device.

[0021] FIG. 2B is a top-down view of the linear RF sealing device of FIG. 1 showing the lateral tip deflection relative to a joint positioned along the longitudinal axis of the device.

[0022] FIG. 2C is an interior view of the linear RF sealing device of FIG. 1.

[0023] FIG. 3 A is an enlarged view of the distal end of the linear RF sealing device ofFIG. 1 detailing the dual hinge parallel jaw details and details of an electrode embodiment and mechanical blade on the lower jaw.

[0024] FIG. 3B is a top view of the straight linear RF sealing device in FIG. 3 A.

[0025] FIG. 3C is a side view of the distal end of the linear RF sealing device of FIG. 3A showing the dual hinge parallel jaw in a closed position. Pins are shown at a proximal end of slot.

[0026] FIG. 3D is a side view of the distal end of the linear RF sealing device of FIG. 3B showing the dual hinge parallel jaw in an open position. Pins are shown positioned towards a distal end of slot.

[0027] FIG. 3E is a side view of the distal end of the linear RF sealing device showing a dual hinge non-parallel jaw in an open position. Pins are shown positioned towards a distal end of slot.

[0028] FIG. 4A is a side view of a pair of jaws of a linear RF sealing device in an open configuration. In the open configuration tissue may be positioned for later sealing operations.

[0029] FIG. 4B is a side view of the pair of jaws in the linear RF sealing device of FIG. 4A showing the advantageous parallel closing mode where contact with the tissue remains along the entire face of the jaws for even application of compression to the tissue along the jaw surface.

[0030] FIG. 4C is a side view of the pair of jaws in the linear RF sealing device of FIG. 4B showing the parallel closing mode in the closed condition that has maintained contact with the tissue along the entire face of the jaws and evenly applied compression to the tissue.

[0031] FIGS. 5 A and 5B are side views of an RF sealing device having a pair of parallel closing jaws that are declined below the longitudinal axis of the device from an angle between 0.5 to 25 degrees. FIG. 5B shows the jaws in the open position like that of FIG. 4A. FIG. 5A shows the jaws in the closed position like that of FIG. 4C.

[0032] FIG. 6 is a top view of a pair of parallel closure RF sealing jaws where the jaws are deflected at a lateral angle relative to the central longitudinal axis of the device by an angle ranging from 5 degrees to 45 degrees.

[0033] FIG. 7A is an enlarged view of the handle of the circular sealing device of FIG. 1.

[0034] FIGS. 7B and 7C are a perspective view of an embodiment of a circular sealing device of FIG. 1 with the anvil removed to show the interior of the electrode assembly. FIG. 7B shows the distal end of the device with the associated electrode and connection port. FIG. 7C shows the anvil head and the connection shaft or stem adapted to couple with the connection port shown in FIG. 7B to achieve the operational configuration shown in FIG. 1.

[0035] FIG. 8 is an alternative configuration of a multi-segment circular sealer as compared to the single electrode of FIG. 7B.

[0036] FIG. 9A is a side view of the RF circular sealing anvil of FIG. 7C.

[0037] FIG. 9B is a side view of an RF circular sealing anvil having a segmented or flexible shaft or stem.

[0038] FIG. 10A illustrates an initial step where resected ends of the bowel have been prepared for anastomosis with the components of the RF circular sealing system separated as in FIGS. 7B and 7C positioned respectively in the ends of the resected intestine.

[0039] FIG. 10B illustrates the cooperative operation of the anvil and base for performing an anastomosis between the two resected bowel portions.

[0040] FIG. 10C represents the performance of one or more of a folding, collapsing, orientation adapting or profile reduction operation to the anvil so as to pass the reconfigured anvil more readily through the newly formed anastomosis.

[0041] FIG. 10D represents the final state of the recently formed anastomosis after removal of the components of the RF circular closure system. The anastomosis ring as shown is not damaged nor strained so as to impede healing or risk of leakage.

[0042] FIG. 11 A is a cross section view of the RF circular closure device as in FIG. 10B that is adapted and configured for the incorporation of an adhesive into the anastomosis seal.

[0043] FIG. 1 IB is a cross section view of the RF circular closure device as in FIG. 10B that is adapted and configured for the incorporation of a wrap or mesh along or within or adjacent to the anastomosis seal.

[0044] FIG. 12 is an example of a linear device weld in an animal study.

[0045] FIGS. 13A-13B is an example of a circular device weld in an animal study forming a side to side anastomosis using RF sealing techniques.

[0046] FIG. 14A is a perspective view of an exemplary handle for use with a collapsible circular sealer.

[0047] FIG. 14B is a perspective view of the distal end of the device of FIG. 14A showing a circular electrode base and connection with the proximal end of a collapsible anvil of a circular sealer prior to attachment to the circular electrode base.

[0048] FIG. 15A is a perspective view of a circular sealer anvil in position at the end of an anastomosis procedure. An operational diameter is also indicated in this view.

[0049] FIG. 15B is a perspective view of the circular sealer anvil of FIG. 15A where the head has been moved away from the segmented base section to allow room for the folding / collapse of the segments.

[0050] FIG. 15C is a perspective view of the circular sealer anvil of FIG. 15B at the completion of the segmented base folding movement. A folded diameter is also indicated in this view.

[0051] FIG. 16A is a perspective view of a circular sealer anvil in a raised position above the segmented base at the end of an anastomosis procedure. In this position, the head has been moved away from the segmented base section to allow room for the folding / collapse of the segments.

[0052] FIG. 16B is a perspective view of the circular sealer anvil of FIG. 16A after an initial step of the collapsible process where the segmented base has separated and begun to pivot out of plane.

[0053] FIG. 16C is a perspective view of the circular sealer anvil of FIG. 16B at the completion of the segmented base folding movement where the outer perimeter of each segment is now moved closer to the stem.

[0054] FIG. 17A is a cross section view of a circular sealer anvil in position at the end of an anastomosis procedure as shown in FIG. 15 A.

[0055] FIG. 17B is a cross section view of the circular sealer anvil of FIG. 17A where the head has been moved away from the segmented base section with the segments in an intermediate stage of the folding / collapse process.

[0056] FIG. 17C is a perspective view of the circular sealer anvil of FIGS. 17A and 17B after completion of the folding movement of the segmented base.

[0057] FIG. 18A illustrates the position of a circular electrode base and a collapsible circular anvil just prior to insertion into the resected ends of an intestine that is the subject of an anastomosis procedure.

[0058] FIG. 18B illustrates the relative positions of the circular electrode base and the collapsible circular anvil of FIG. 18A after insertion into the resected ends of an intestine that is the subject of an anastomosis procedure.

[0059] FIG. 18C illustrates the position of the circular electrode base and the collapsible circular anvil of FIG. 18B while performing an anastomosis procedure on the resected ends of an intestine.

[0060] FIG. 18D illustrates the position of the collapsible circular anvil raised above the circular electrode base after completion of the circular anastomosis procedure.

[0061] FIG. 18E illustrates the position of the collapsible circular anvil raised above the circular electrode base as in FIG. 18D with the anvil head now raised above the segmented base in order to make space for the folding collapse of the base segments.

[0062] FIG. 18F illustrates the position of the collapsible circular anvil at the completion of the folding collapse of the segmented base. The diameter of the circular anvil is now the diameter of the anvil head and more readily able to pass through the recently completed anastomosis.

[0063] FIG. 18G illustrates the intestine after the completed anastomosis with the circular anvil and circular electrode base withdrawn.DETAILED DESCRIPTION

[0064] Embodiments of the present invention provide RF based anastomosis closure systems and techniques adapted and configured for use in the gut. In some embodiments, the closure device is configured to close with even pressure across the entire surface to be sealed. Advantageously, the evenly distributed closure force may also include cooling capabilities as well as duty cycle and power ratios of RF delivery to more precisely adjust the RF closure parameters including specific sealing parameters from monitored or detected tissue characteristics. Additionally or optionally, one or more sensors or electrical parameter measurements may also be obtained during the RF sealing operation. In certain examples, the devices described herein may be intended to be used in laparoscopic (minimally-invasive) or open surgeries.

[0065] While desiring not to be bound by theory, it is believed that tissue of the gut may be characterized using the methods described herein for determining optimal patient specific and seal specific optimization based on desired healing response in the zone of the sealed tissue. Additionally or optionally, the RF anastomosis tools system and techniques described herein may be modified to achieve one or more of the benefits or sealed tissue characteristics described in “Annual Review of Biomedical Engineering “Energy Based Tissue Fusion for Sutureless Closure: Applications, Mechanisms, and Potential Functional Recovery”, E. A. Kramer Annu. Rev. Biomed. Eng. 2018. 20: 1-20.

[0066] As such, embodiments of the RF sealing tools and systems described herein enable the advantageous full surface tissue compression, adaptive RF sealing / heating profiles adaptable and responsive to detected or measured changes in tissue structure and / or desired endpoint of one or more tissue characteristics for improved tissue healing response, sealing performance and long term anastomosis repair stability.

[0067] FIG. l is a perspective view of an RF anastomosis system with a linear RF sealing device 102, a circular RF sealing device 104 connected to an RF anastomosis controller and power generator 101.

[0068] Embodiments of the RF controller may be adapted and configured to provide software controlled welding cycles based on feedback received from the operation of the RF closure tools as well as measured, sensed or detected tissue characterization or electrode performance properties. The welding cycles may be continuous or cyclical. In cyclic mode, it takes a rest period (0. l-5s) after a welding phase of a few seconds (0. l-5s). During the restperiod, the RF controller can measure the electrical parameters of the tissue and, using a control algorithm, modify the parameters and the number of repetitions for the next weld. Additionally, there may be automated welding processes implemented that continue until terminated based on measured data that complies with desired weld characteristics based on tissue type. In additional embodiments, the software controls the operation of the augmentations, so, for example, while welding is taking place on one segment of the electrode, the software can trigger the insertion of nitinol staples on the other electrode segment. (See FIG. 8).

[0069] While desiring not to be bound by theory, it is believed that anastomotic technique selected depends upon site of anastomosis, bowel caliber and quality and underlying disease process. One important factor in the decision to perform a particular anastomosis, however, remains individual surgical experience and personal preference. The various embodiments of the RFA and Hybrid RFA devices, systems and techniques provide additional capabilities and advantages to the surgeon well beyond that of the conventional sealing methods because of the advanced integration of tissue sensing, RF heating control and modulation with dynamic feedback to adapt to specific tissue characteristics and challenges of particular anastomosis type and surgical site to ensure tissue and patient specific performance tuning and results.

[0070] Conventional anastomoses can be described as follows: sutured: (1) interrupted or continuous; (2) single or 2-layer; (3) end-to-end or side-to-side (or any combination); (4) various suture materials; (5) extramucosal or full-thickness sutures; and (6) size of and spacing between each suture; and stapled: (1) side-to-side or end-to-end (or any combination); (2) staple lines oversewn, buried or not; and (3) Various stapling devices. It is to be appreciated that the RFA and Hybrid RFA devices, systems and techniques described herein may be adapted and configured to meet or exceed the surgical performance of these conventional procedures and may be particularly adapted to the surgical and anatomical requirements of each case.

[0071] FIG. 2A is a side view of the linear RF sealing device of FIG. 1 showing the vertical tip deflection relative to a joint positioned along the longitudinal axis of the device.

[0072] FIG. 2B is a top-down view of the linear RF sealing device of FIG. 1 showing the lateral tip deflection relative to a joint positioned along the longitudinal axis of the device.

[0073] Jaw 202 may be bent in two directions 203 (for example 45 degrees from horizontal) around hinge point 204 located at a neck portion of the device to make the device easy to use in the pelvic area.

[0074] FIG. 2C is an interior view of the linear RF sealing device of FIG. 1.

[0075] This cross-sectional view shows the mechanisms responsible for operating the device. The mechanisms may be motorized or mechanical. In certain examples, there can be a plurality of motors 214, including one motor for shaft and one motor for cutting. Motor 214may be a jaw actuating stepper motor. Cutting may also be manual or incorporate available RF mode from an electrode array.

[0076] Handle 211 may incorporate the moving parts that convert power into linear motion. In certain examples, the power source may be a mechanical, electrical drive, or pneumatics. The translation motion may be converted at a distal end for blade actuation 212 or jig closure. Also shown are device control buttons 210. Also shown in jaw position sensing 206 and tissue preload mechanism 208.

[0077] FIG. 3 A is an enlarged view of the distal end of the linear RF sealing device of FIG. 1 detailing the dual hinge parallel jaw details of upper jaw 302U and lower jaw 302L and details of an electrode 316 embodiment and mechanical blade 305 on the lower jaw 302L. Jaw 302U / 302L may open in a 20-40 degree angle, including a 26 degree angle. In certain examples, an outer diameter 318 of the device may be 15mm.

[0078] Slot 303, which may be over or part of lower jaw 302L, may be configured to receive a plurality of pins 303P of upper jaw 302U. A steeper angle of slot 303 may be configured to maximize a distance between the parallel faces of upper jaw 302U and lower jaw 302L.

[0079] FIG. 3B is a top view of the straight 216 linear RF sealing device in FIG. 3 A.

[0080] FIG. 3C is a side view of the distal end of the linear RF sealing device of FIG. 3A showing the dual hinge parallel jaw in a closed position. Pins 303P are shown at a proximal end of slot 303.

[0081] FIG. 3D is a side view of the distal end of the linear RF sealing device of FIG. 3B showing the dual hinge parallel jaw in an open position. Pins 303P are shown positioned towards a distal end of slot 303.

[0082] FIG. 3E is a side view of the distal end of the linear RF sealing device showing a dual hinge non-parallel jaw in an open position. Pins 303PA are shown positioned towards a distal end of slot 303 A.

[0083] By changing the path of the back slot 303 from a straight line, the electrode can be configured to open out in a scissor-like pattern at the end of the range of motion, rather than retaining a parallel configuration.

[0084] There are number of advantages to the use of the two-step jaw closure enabled by the parallel closure designs described herein. First, during the non-parallel step, the doctor can use the instrument as a forceps to grasp the tissue easily and quickly. Second, during the parallel step, the tissue can be gripped with an evenly distributed load so that it does not bunch up and remains uniform in thickness throughout the process.

[0085] In addition, there are a number of advantages provided by RF tissue welding performed using one or more embodiments described herein. While a conventional stapler is associated with possible leakage from the intestinal lumen to the abdominal cavity, it is believed that RFA devices create immediate microbiological barrier in the anastomotic line. Additionally, RF sealers do not have to be replaced or reloaded after each firing, greatly reducing operation time and cost. Finally, compared to staplers, RF welding devices and processes can be more readily adapted for use with robotic surgical platforms.

[0086] FIG. 4A is a side view of a pair of jaws of a linear RF sealing device in an open configuration. In the open configuration tissue may be positioned for later sealing operations. Jaw opening angle 420 may be 0 to 90 degrees, and a base angle 422 which may be 0 to 10 degrees. In certain examples, the base angle 422 may be constant.

[0087] FIG. 4B is a side view of the pair of jaws in the linear RF sealing device of FIG. 4A showing the advantageous parallel closing mode 424 where contact with the tissue remains along the entire face of the jaws for even application of compression to the tissue along the jaw surface. Jaw base angle 422 is also shown again.

[0088] FIG. 4C is a side view of the pair of jaws in the linear RF sealing device of FIG. 4B showing the parallel closing mode in the closed condition that has maintained contact with the tissue along the entire face of the jaws and evenly applied compression to the tissue.

[0089] One advantage of this parallel closure operation over a conventional scissor-type closure is that the parallel jaw embodiments compresses the tissue in parallel at the moment before closing, resulting in better force distribution on the tissue and a more even welding thickness. Advantageoulsly, this mode of compression retains its advantage when gripping and moving the tissue. In one aspect, the various jaw embodiments may also be considered to perform similar to tweezers or graspers.

[0090] According to certain examples, tissue compressed between the parallel jaws may need to reach a certain level of even compression before electrode firing is initiatied. This is in contrast to tradtitional techniques which may result in uneven compression where tissue may be sheared or mechanically compressed beyond a desired magnitude in some areas. One benefit of even tissue compression during electrode firing in addition to even welding thickness is more uniform power deliery to the tissue through the electrode surface as points of variable resistance may be mitigated or eliminated as compared to an uneven tissue compression situation where RF current is likely to be flowing through areas where electrodes are closer to.

[0091] In variour examples, jaw embodiments may be straight or bent, depdending on the location of use.

[0092] FIGS. 5 A and 5B are side views of an RF sealing device having a pair of parallel closing jaws that are declined below the longitudinal axis of the device from an angle 426 between 0 to 25 degrees. FIG. 5B shows the jaws in the open position like that of FIG. 4 A. FIG. 5A shows the jaws in the closed position like that of FIG. 4C.

[0093] FIG. 6 is a top view of a pair of parallel closure RF sealing jaws where the jaws are deflected at a lateral angle relative to the central longitudinal axis of the device by an angle 428 ranging from 5 degrees to 45 degrees.

[0094] In general, the various RF sealing devices of FIGS. 2A-6 provide a number of benefits during an anastomosis surgery. First, the various RFA sealer embodiments maintains the same core functions as conventional linear staplers such as an outer diameter of ~1 l-12mm, a 30-50mm seal length, a mechanical blade in the middle for tissue separation, suitable for open and laparoscopic surgeries. Advantageously, the various embodiments described herein are superior to the conventional stapling systems by providing: a continuous closure line provided by tissue welding (as in no “staple line leaks”); faster operation since there is no need to remove the device from the patient and reload the staple cartridge before repeated use. Staple line leaks and uneven sealing seen with conventional staplers can cause dangerous leakage and migration of bacteria and other infectious materials from the colon into the peritoneal cavity, endangering patients during and after resection procedures.

[0095] In still other alternative embodiments, the inventive RFA devices described herein may be used in a hybrid or mixed closure system where the RFA closure system is complementary to conventional closure procedures. By way of example, there may be a process of closure using traditional staple techniques. In one aspect, there may be employed staples that can be deformed with lower forces, including resorbable polymer staples, magnesium alloys, and other superelastic Nitinol staples or anchors used initially and then are followed by a suitably adapted RFA. It is believed that such features may aid in creation of a stronger and confident tissue weld under certain conditions. It is to be appreciated that when RF is used in combination with complementary technology, the welding and needling cycles should be separated to avoid short circuits. In the case of multi-segment electrodes, these processes can be separated by performing these functions in separate zones. (See FIG. 8)

[0096] FIG. 7A is an enlarged view of the handle of the circular sealing device of FIG. 1. Shown here is manual anvil actuation 713 and manual blade actuation handle 712.

[0097] FIGS. 7B and 7C are a perspective view of an embodiment of a circular sealing device of FIG. 1 with the anvil removed to show the interior of the electrode assembly.

[0098] FIG. 7B shows the distal end of the device with the associated electrode and connection port. Device outer diameter 718 may be 24.5mm and electrode outer / inner diameter 719 may be 21.5mm and 16.7mm, respectively.

[0099] FIG. 7C shows the anvil head 732 and the connection shaft or stem 734 adapted to couple with the connection port shown in FIG. 7B to achieve the operational configuration shown in FIG. 1. While the anvil head 732 is illustrated as having a generally circular shape, it is to be appreciated that different shapes may be used such as oval, oblong, elliptical or rounded with a minor access or other shapes to support folding, collapsing, or manipulating the orientation and width dimension of the anvil for low stress, reduced stress, no-contact or low contact passage through the just created anastomosis opening. It is believed that different anvil head shapes alone or in combination with folding or collapsing head designs may significantly reduce anvil pull-out force and associated stresses on the just reacted anastomosis opening. In certain examples, connection port of FIG. 7B and anvil with head 732 and connection shaft or stem 734 may be configured for attachment in the body during an open or laparoscopic procedure.[000100] FIG. 8 is an alternative configuration of a multi-segment circular sealer as compared to the single electrode of FIG. 7B. The circular sealer may be RFA segmented with multiple mode capabilities. As shown here, RFA circular sealer has segmented electrode surfaces I and II, which may be at a distal end of the shaft. Additionally or optionally, remaining section III and IV may be used for other functions including stapling, anchoring sheath or adhesives, as further described in FIGS. 11 A-l IB.[000101] Thus, multi-segmenting may allow for different preparation, procedure and postanastomosis processes to occur simultaneously in each segment, pair of segments, or segment group depending upon configuration. In certain examples, while one pair of segments is used in welding, another pair of segments may be used in stapling or inserting nitinol spikes. Advantageously, the separate segments may also enable tissue characteristics and variability to be more directly adapted to a particular set of welding parameters adapted to different tissue areas according to the processing controls and algorithms of the RF controller and generator.[000102] In a similar way, head of the anvil may also be adapted and configure for complementary operations. A surgeon may select a straight shaft, flexible shaft, segmented or curved shaft based on which design furthers the particular geometry and tissue characteristics of the anastomosis being conducted.[000103] FIG. 9A is a side view of the RF circular sealing anvil of FIG. 7C.[000104] As shown here, anvil head 932 may have a straight central shaft or stem 934.[000105] FIG. 9B is a side view of an RF circular sealing anvil having a segmented or flexible shaft or stem.[000106] In certain examples, the anvil head 932 may have a flexible or segmented central shaft or stem 934'. Flexible or segmented shaft or stem 934' may be advantageous for maneuvering and handling in tight spaces, such as in laparoscopic environments.[000107] Further described is a RFA gastric circular device with collapsible or folding anvil head. In certain examples, the RFA circular sealer previously described, such as in FIG. 8, may be adapted to collapse, fold, or alter orientation prior to withdrawal.[000108] In conventional sealing operations, removal of the anvil through the staple line may put significant mechanical strain on the stapled tissue, which can lead to leakage of the just created anastomosis opening.[000109] Embodiments of the gastric circular sealer having a reduced profile anvil design may substantially eliminate or significantly reduce this unwanted strain on the anastomosis ring. It is to be appreciated that the benefits of such mechanisms are allowed by the use of RF-based technology as embodied herein.[000110] FIGS. 10A-10D illustrates steps of bowel resection to form an anastomosis with an RF circular closure system. In certain examples, this procedure may be open or laparoscopic.[000111] FIG. 10A illustrates an initial step where resected ends of the bowel, including, for example, a proximal end 1097 and distal end 1098 of the bowel have been prepared for anastomosis with the components of the RF circular sealing system separated as in FIGS. 7B and 7C positioned respectively in the ends of the resected intestine, including anvil head 1032, connections shaft or stem 1034, circular electrode base 1099 and electrical connection 1030.[000112] FIG. 10B illustrates the cooperative operation of the anvil 1032 / 1034 and base 1099 for performing an anastomosis between the two resected bowel portions.[000113] FIG. 10C represents a step which involves the performance of one or more of a folding, collapsing, orientation adapting or profile reduction operation to the anvil 1033' within the two resected bowel portions so as to pass the reconfigured anvil more readily through 1046 the newly formed anastomosis opening.[000114] FIG. 10D represents the final state of the recently formed anastomosis 1002 between the proximal 1097 and distal 1098 resected bowel portions after removal of the components of the RF circular closure system. The anastomosis ring as shown is not damaged nor strained so as to impede healing or risk of leakage.[000115] In certain examples, the RFA gastric circular sealing device may have exemplary supplemental performance. RFA circular sealer may maintain the same core functions as a conventional circular stapler system including a 20-30mm seal diameter and circular mechanical blade to connect lumens.[000116] The RFA gastric circular sealer may also advantageously provide a continuous weld line to eliminate microchannels between staples and avoid staple line leaks when using RFA tissue welding. In contrast to circular staples which require removal and reloading, the RFA system and devices can form multiple anastomosis continuously.[000117] In certain examples, RFA circular sealing system may be supplemented by biological adhesives or other biologies, extraluminal bio textile wraps and nitinol meshes, expandable intraluminal or extraluminal nitinol connectors, stents, and resorbable intraluminal or extraluminal polymer connectors.[000118] As a result. The RFA systems, tools and methods described herein may be used separately for the completion of all or substantially all of the closure steps for an entire anastomosis procedure including, for example, preparation, initial resection and segmented closure and combination closure (see FIG. 8), through to closure and formation of the anastomosis. In yet other examples, there may be hybrid or combination RFA procedures in which one or more conventional closure technologies are augmented by or advantageously combined with one or more RFA tools or RFA enable tissue processing techniques. A partial listing of such exemplary hybrid RFA procedures are listed above and illustrated in FIGS. 11A-11B.[000119] FIG. 11 A is a cross section view of the RF circular closure device as in FIG. 10B that is adapted and configured for the incorporation of an adhesive 1149 into the anastomosis seal of the bowel 1148. Adhesive 1149 may include or consist of bioactive material such as collagen or polymer textiles which may be configured to melt or reflow during the welding procedure, fusing with the welded tissue and resulting in improved strength. Adhesive 1159 may include or consist of a mesh-like structure which remains solid but adheres to the melted components of the welded tissue forming a fiber-reinforced composite structure, with improved strength compared to a bare weld joint. Adhesive 1149 may be an insert which may be placed between two tissue layers as shown. In certain examples, adhesive 1149 may be placed onto electrodes before welding, which may result in an electrode-textile-tissue-tissue- (textile)-electrode configuration.[000120] FIG. 1 IB is a cross section view of the RF circular closure device as in FIG. 10B that is adapted and configured for the incorporation of a wrap or mesh 1150 along or within or adjacent to the anastomosis seal. In certain examples, the wrap or mesh 1150 may be anextraluminal biomedical textile wrap or nitinol mesh, or graft placed outside the intestinal wall. Wrap or mesh 1150 may have a stainless-steel wireframe. Wrap or meshl 150 may be configured to mechanically support and reduce load on the weld during the healing procedure, thus improving the chances of a positive procedural outcome. A wireframe of wrap or mesh 1150 may be covered with a solid covering such as ePTFE or polymer textiles. In case of a leak of GI fluids or materials at the anastomosis during the healing procedure, covered graft or wrap or mesh 150 may serve as a barrier to keep GI fluids within the intestinal tract and out of the rest of abdominal cavity. Furthermore, the various components of the wrap or mesh 150 may be impregnated with anti-inflammatory or anti-bacterial agents. [000121] Additionally or optionally, the augmented embodiments of FIGS. 11 A and 1 IB may also be augmented to provide additional patient benefits not achievable under conventional closure systems. For example, patients having a protein deficiency (i.e., cachexia, tumor-induced deterioration), a thin, albumin-containing tissue network placed between the intestinal walls of the anastomosis and by the RF treatment protein can be “built” into the wall of the anastomosis. Additionally or optionally, an RF protocol may be adapted and configured for activation or enhancement of a biomaterial or pharmacological agent incorporated into the anastomosis for the benefit of the patient. By way of another example, in the case of anastomoses in a septic environment, an antibiotic-containing layer can be placed between the intestinal walls and thus “incorporated” into the wall of the anastomosis. In still another example, in the case of a hemorrhagic patient, a fibrin-containing mesh can be used to support the healing of the anastomosis.[000122] Animal survival studies, such as studies in a 60-70kg pig’s small intestine may be conducted with the previously described linear and circular devices to investigate animal survival and overall device performance, effects of electrode and tissue cooling, and longterm pressure load.[000123] FIG. 12 is an example of a linear device weld in an animal study.[000124] Shown here is a view of a successfully completed and closed intestinal section 1202 using a linear device following the procedure.[000125] FIGS. 13A-13B is an example of a circular device weld in an animal study forming a side to side anastomosis 1302 using RF sealing techniques.[000126] Shown here is a view of the anastomosis 1302 at 14 POD (14 days after surgery). [000127] FIG. 14A is a perspective view of an exemplary handle for use with a collapsible circular sealer. In certain examples, the handle may be for a gastric circular sealer. The handle is connected to an RF Controller 1401 that provides RF energy and other functionality to the closure system depending upon the configuration and power requirements of aparticular embodiment. FIG. 14A also shows exemplary manual actuation mechanisms are shown for the operation of a circular anvil 1413 (See FIGS. 15A, 16A, 18C), the folding or collapse mechanism 1452 (see FIGS. 15B, 15C, 16A-16C, and 17A-17C) as well as activation of a blade or cutting implement actuator 1412 for either the circular base or the anvil depending upon specific configuration.[000128] FIG. 14B is a perspective view of the distal end of the device of FIG. 14A showing a circular electrode base 1499 and electrical connection 1430 with the proximal end of a collapsible anvil having a connection stem for circular head 1434 and collapsible / foldable circular head 1432 of a circular sealer prior to attachment to the circular electrode base. The electrode base includes one or more electrodes as well as cutting or stapling implements depending upon configuration. The device may have an outer diameter 1418 of 24.5mm and the electrode may have an outer diameter / inner diameter 1419 of 21.5mm / 16.7mm, respectively. Circular electrode base may be connected to or part of the handle shown in FIG. 14 A as indicated by the left pointing arrow.[000129] FIG. 15A is a perspective view of a circular sealer anvil in position at the end of an anastomosis procedure. The seal is complete in this view, and an operational diameter 1518 is also indicated in this view.[000130] FIG. 15B is a perspective view of the circular sealer anvil of FIG. 15A where the head 1532 has been moved away from the segmented base section to allow room for the folding / collapse of the segments. Shown here is a segmented ring 1533, stem or central shaft 1534 and connector 1535 (which may remain fixed). Head 1532 may be moved away from segmented ring 1533 and segmented ring may be configured to fold for compactness and clearance of the device through the human anatomy and formed anastomosis. Stem or central shaft 1534 and anvil head 1532 may be configured to move upward before or in tandem with the segmented ring 1533 collapsing or folding upward. Segmented ring 1533 may have sections 1536A and 1536B configured to fold / collapse relative to each other, for example with sections 1536A lifting / folding above sections 1536B which fold or collapse upward as shown.[000131] FIG. 15C is a perspective view of the circular sealer anvil of FIG. 15B at the completion of the segmented base folding movement. A folded diameter 1519 is also indicated in this view. As shown, here segmented ring of FIG. 2B may be folded, putting the device in a compact or stowed configuration configured for withdrawing through an anastomosis. For example, segment 1536A of segmented ring is shown folded upwards and above folded segment 1536B of the segmented ring.[000132] FIG. 16A is a perspective view of a circular sealer anvil in a raised position above the segmented base at the end of an anastomosis procedure, similar to the view show in FIG. 15B. In this position, the head 1632 has been moved away from the segmented base section 1633 to allow room for the folding / collapse of the segments.[000133] FIG. 16B is a perspective view of the circular sealer anvil of FIG. 16A after an initial step of the collapsible process where the segmented base has separated and begun to pivot out of plane 1633'. Movement of the segmented base portions can be defined by either a single or multi-pivot mechanism. The axis of the pivot may be perpendicular or angled compared to the axis of the device shaft 1634. According to certain examples, the separating and pivoting segmented base sections 1633' may be configured to have different movement patterns to minimize a cross section of their closed / folded / collapsed / stowed configuration.[000134] FIG. 16C is a perspective view of the circular sealer anvil of FIG. 16B at the completion of the segmented base folding movement 1633" where the outer perimeter of each segment is now moved closer to the stem 1634.[000135] FIG. 17A is a cross section view of a circular sealer anvil in position at the end of an anastomosis procedure as shown in FIG. 15A (closed position). Shown here is a completed seal, with operational diameter (dOp) 1718 being approximately equal to the diameter of the deployed / assembled segmented base 1733, which is shown sealed on top of electrode base 1799. Also shown are segments 1736A / 1736B of segmented base 1733 as well as upper support arm 1733U and lower support arm 1733L, which may be joined to head 1732. In the closed position, retraction lever 1734 and support arms 1733U and 1733L are shifted upwards.[000136] FIG. 17B is a cross section view of the circular sealer anvil of FIG. 17A where the head 1732 has been moved away from the segmented base 1799 with the segments including segment 1736A in an intermediate stage of the folding / collapse process. Also shown is retraction lever 1734. Segments including segment 1736A may be joined to retraction lever 1734 and support arms 1733U and 1733L (see FIG. 17A).[000137] With head 1732, segmented base 1733 and electrode base 1799 remain stationary, actuating retraction lever 1734 downwards may cause segments, including segment 1736A, to fold / collapse inwards / upwards.[000138] FIG. 17C is a perspective view of the circular sealer anvil of FIGS. 17A and 17B after completion of the folding movement of the segmented base (open position). With folding complete, the device is ready to be withdrawn through the anastomosis. The smaller folded diameter (dF) 1719 may now only be as wide as the width of the head 1732, and the smaller aspect may be presented to the new anastomosis. Thus, the operational diameter(dOp) 1718 may be configured to be greater than the folded diameter (dF) 1719 of FIG. 17 A. In the open position, retraction lever 1734 and support arms 1733U and 1733L (see FIG. 17A) are shifted downwards.[000139] FIGS. 18A-18G illustrated an exemplary anastomosis procedure using an exemplary circular electrode and collapsible anvil embodiment, which may together form a foldable circular RF gastric sealer. Curved outlines represent the tissue walls and their joining to form the anastomosis throughout the procedure.[000140] FIG. 18A illustrates the position of a circular head electrode base 1860 and a collapsible circular anvil 1832 / 1834 just prior to insertion into the resected ends of an intestine that is the subject of an anastomosis procedure. In certain examples, the base may also contain a cutting implement. The down arrow indicates a direction towards the handle as shown in FIG. 14 A.[000141] FIG. 18B illustrates the relative positions of the circular electrode base 1860 and the collapsible circular anvil 1832 / 1834 of FIG. 18A after insertion into the resected ends of an intestine that is the subject of an anastomosis procedure.[000142] FIG. 18C illustrates the position of the circular electrode base and the collapsible circular anvil of FIG. 18B while performing an anastomosis procedure on the resected ends of an intestine. As shown here, the resected ends of the intestine are joined 1898 and positioned between the circular head 1832 of the anvil and the circular head electrode base 1860 as the circular head 1832 is coupled into the circular head electrode base 1860.[000143] FIG. 18D illustrates the position of the collapsible circular anvil 1832 raised above the circular electrode base 1860 after completion of the circular anastomosis procedure.[000144] FIG. 18E illustrates the position of the collapsible circular anvil raised above the circular electrode base as in FIG. 18D with the anvil head 1832 now raised above the segmented base 1833 in order to make space for the folding collapse of the base segments. [000145] FIG. 18F illustrates the position of the collapsible circular anvil at the completion of the folding / collapse of the segmented base 1833". The diameter of the circular anvil is now the diameter of the anvil head 1832 and more readily able to pass through the recently completed anastomosis.[000146] FIG. 18G illustrates the intestine after the completed anastomosis with the circular anvil and circular electrode base withdrawn.[000147] According to certain examples, the device can be smaller or more folded / compact relative to the colon or anatomy of interest than shown here, and may have more componentsthan shown here. A reduced size or profile of the device will aid to reduce the force on the resected region as the device is passed through the anastomosis.[000148] According to certain examples, the foldable circular RF gastric sealer and the folding / collapse of the segmented base may be used in conjunction with the adhesive and wrap or mesh described in FIGS. 11 A-l IB.[000149] In one aspect, the RF sealing devices and system described herein may be advantageously used in a method of implementing RF sealing techniques described herein in the performance of RF anastomosis processes for anterior rectosigmoidal resection after neoadjuvant radiochemotherapy for malignant rectum tumors. In still other methods of sealing, the devices, systems and methods described herein may be used for RRA or Hybrid RFA (RF Anastomosis) sealing in a bowel anastomosis procedure including small bowel, colonic and colorectal anastomotic techniques. In still other embodiments, there are RFA or Hybrid RFA techniques for side-to-side ileocolic anastomosis following a right hemicolectomy for cancer. In yet another embodiment, there are RFA or Hybrid RFA techniques for side-to-side anastomosis after an ileocolic resection for Crohn’s disease. In yet another embodiment, there are RFA or Hybrid RFA techniques applied in the reversal of loop ileostomy to form a side-to-side anastomosis or, optionally, an enterotomy closure, or optionally a spout resection and anastomosis. In yet another embodiment, there are RFA or Hybrid RFA techniques applied along the gastrointestinal tract. In yet another embodiment, there are RFA or Hybrid RFA techniques applied to a right hemicolectomy and ileocolic anastomosis. In still other embodiments, there are RFA or Hybrid RFA techniques applied to an anastomosis formed or resection conducted as part of a bariatric surgery, a duodenal switch, a gastric by-pass surgery, a sleeve gastrectomy, a Roux-en-Y gastric bypass, a biliopancreatic diversion with duodenal switch and a single anastomosis duodeno-ileal bypass with sleeve gastrectomy and gastrojejunal anastomotic technique. In still other embodiments, there are RFA or Hybrid RFA techniques applied to an anastomosis formed or resection conducted as part of a procedure conducted in the esophagus, stomach or duodenum.[000150] Additional details of capabilities, performance and tissue characterization parameters that may be implemented or provided in one or more alternative embodiments may include details, attributes, performance capabilities or operational parameters or characteristics as those described in: (a) U.S. Patent 7,967,839 entitled “Electromagnetic Treatment of Tissues and Cells; (b) U.S. Patent 5,824,015 entitled “Method for Welding Biological Tissue; (c) U.S. Patent 8,808,316 entitled "Devices and Methods for Producing Anastomosis; (d) U.S. Patent 8,303,610 entitled, “Device for the Production of Anastomosis Between Hollow Organs; and (e) Annual Review of Biomedical Engineering “Energy BasedTissue Fusion for Sutureless Closure: Applications, Mechanisms, and Potential Functional Recovery, E.A. Kramer Annu. Rev. Biomed. Eng. 2018. 20: 1-20 (online at https: / / doi.org / 10.1146 / annurev-bioeng-071516-044702), each one of which is incorporated herein by reference in its entirety for all purposes.[000151] While not desiring to be bound by theory, it is believed that the advantageous combination of compression and RF energy will provide a superior intestinal anastomosis. The operation of the parallel jaws and circular sealing devices enable evenly applied compression forces to displace fluid from the tissues that make up the intestinal wall. Still further, the controlled heat produced by the energy in the radiofrequency range changes the 3D structure of the proteins in the anastomosis line so that an immediate, homogeneous tissue connection is created which can function as a microbiological barrier. The resulting continuous seal eliminates the microchannels that are created by sutures and staplers through which intestinal contents and microorganisms can enter the healing anastomosis line, cause infection and the leakage or failure of the anastomosis. These and other advantageous traits of the RFA tools, systems and techniques described herein may be used alone or in combination with other sealing, joining, augmenting or healing methods, devices, regenerative, personalized, biological or pharmacological formulations in order to provide a wide range of RFA Augmented Sealing Techniques or RFA Hybrid Sealing Techniques.[000152] Additional details of aspects of sealing and anastomosis systems may be appreciated by reference to U.S. Patent 8,303,610 entitled “Device for the Production of Anastamosis Between Hollow Organs” and U.S. Patent 8,808,316 entitled “Devices and Methods for Producing Anastamosis,” both of which are incorporated herein by reference in their entirety for all purposes.[000153] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.[000154] The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.[000155] Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like. For example, any of the methods described herein may be performed, at least in part, by an apparatus including one or more processors having a memory storing a non-transitory computer-readable storage medium storing a set of instructions for the processes(s) of the method.[000156] While various embodiments have been described and / or illustrated herein in the context of fully functional computing systems, one or more of these example embodiments may be distributed as a program product in a variety of forms, regardless of the particular type of computer-readable media used to actually carry out the distribution. The embodiments disclosed herein may also be implemented using software modules that perform certain tasks. These software modules may include script, batch, or other executable files that may be stored on a computer-readable storage medium or in a computing system. In some embodiments, these software modules may configure a computing system to perform one or more of the example embodiments disclosed herein.[000157] As described herein, the computing devices and systems described and / or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions, such as those contained within the modules described herein. In their most basic configuration, these computing device(s) may each comprise at least one memory device and at least one physical processor.[000158] The term “memory” or “memory device,” as used herein, generally represents any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or maintain one or more of the modules described herein. Examples of memory devices comprise, without limitation, Random Access Memory (RAM), Read Only Memory (ROM), flash memory, Hard Disk Drives (HDDs), Solid-State Drives (SSDs), optical disk drives, caches, variations or combinations of one or more of the same, or any other suitable storage memory.[000159] In addition, the term “processor” or “physical processor,” as used herein, generally refers to any type or form of hardware-implemented processing unit capable of interpreting and / or executing computer-readable instructions. In one example, a physicalprocessor may access and / or modify one or more modules stored in the above-described memory device. Examples of physical processors comprise, without limitation, microprocessors, microcontrollers, Central Processing Units (CPUs), Field-Programmable Gate Arrays (FPGAs) that implement softcore processors, Application-Specific Integrated Circuits (ASICs), portions of one or more of the same, variations or combinations of one or more of the same, or any other suitable physical processor.[000160] Although illustrated as separate elements, the method steps described and / or illustrated herein may represent portions of a single application. In addition, in some embodiments one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as the method step.[000161] In addition, one or more of the devices described herein may transform data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules recited herein may transform a processor, volatile memory, non-volatile memory, and / or any other portion of a physical computing device from one form of computing device to another form of computing device by executing on the computing device, storing data on the computing device, and / or otherwise interacting with the computing device.[000162] The term “computer-readable medium,” as used herein, generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media comprise, without limitation, transmission-type media, such as carrier waves, and non-transitory-type media, such as magnetic-storage media (e.g., hard disk drives, tape drives, and floppy disks), optical-storage media (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), and BLU-RAY disks), electronic-storage media (e.g., solid-state drives and flash media), and other distribution systems.[000163] A person of ordinary skill in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and sequence of the steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed.[000164] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or comprise additional steps inaddition to those disclosed. Further, a step of any method as disclosed herein can be combined with any one or more steps of any other method as disclosed herein.[000165] The processor as described herein can be configured to perform one or more steps of any method disclosed herein. Alternatively or in combination, the processor can be configured to combine one or more steps of one or more methods as disclosed herein. [000166] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature. [000167] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".[000168] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The devicemay be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.[000169] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.[000170] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.[000171] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps. [000172] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value " 10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriatelyunderstood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.[000173] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.[000174] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMSWhat is claimed is:

1. A linear RF sealing device, comprising: a handle having an RF connector and a trigger for operating a pair of jaws having a parallel closing joint mechanism configured to form a seal by grasping a uniform thickness of tissue between the pair of jaws and further configured to apply pressure evenly to the grasped tissue; a shaft connected proximally to the handle and distally to the pair of jaws; and the pair of jaws on the distal end of the shaft comprising an electrode array.

2. The device of claim 1, further comprising a pivot on the shaft allowing the pair of jaws to move in a lateral or a vertical direction relative to the longitudinal axis of the shaft.

3. The device of claim 1, wherein the pair of jaws is straight, curved downward at the distal end relative to the longitudinal axis of the shaft or curved to the left of the longitudinal axis of the shaft or curved to the right of the longitudinal axis of the shaft.

4. A circular anvil of a closure system, comprising: a head; a central shaft connected distally to the head with a connector on a proximal end adapted and configured for connection to a circular electrode of the closure system; an anvil base comprising a plurality of segments, wherein each segment is foldable from a deployed condition where all of the segments for an integrated segmented base and a folded condition where each one of the plurality of segments is adjacent to the central shaft within a folded segment storage zone along the central shaft proximal to the head; and a segment folding mechanism used to transition the plurality of segments from the deployed condition to the folded condition; further wherein the folded condition is configured for reducing a size profile of the circular anvil for removal of the circular anvil through an anastomosis; further wherein the reduced size profile of the circular anvil exerts a reduced force on the anastomosis during the removal.

5. The circular anvil of claim 4, wherein the segmented base has between 4 to 8 segments, wherein the plurality of segments are configured to pivot out of plane based on one or more of: a single pivot mechanism, a multi-pivot mechanism, parallel to the central shaft,and angled relative to the central shaft; further wherein the plurality of segments are configured to be actuated via a retraction lever.

6. The circular anvil of claim 4, wherein when the segments of the segmented base are within the folded segment storage zone a diameter of the head of the circular anvil is the widest portion of the circular anvil.

7. A system for performing an RF anastomosis in an intestine, comprising: a linear RF sealing device; a circular RF sealing device; and an RF controller having computer readable code and a handle to operate the linear RF sealing device and the circular RF sealing device to perform anastomosis procedures on tissue that is responsive to the tissue undergoing a sealing procedure.

8. A method of performing an anastomosis procedure within a portion of the gut, comprising: performing one or more of a resecting step, a cutting step, a sealing step or a hybrid sealing step using a linear or circular RFA device under the control of an RFA controller wherein the performing of the resecting step, the cutting step, the sealing step is performed as part of a surgical procedure performed in a gastrointestinal tract (GI tract).

9. The method of claim 8, wherein the anastomosis procedure or the surgical procedure performed in the gastrointestinal tract (GI tract) is one of a cancer induced resection and restoration procedure, a gastric reduction or repair procedure, a procedure within the esophagus or the esophageal sphincter, the stomach, the duodenum, the small intestine, the large intestine or adjacent to the anal sphincter including an end to end anastomosis, an end to side anastomosis, a side to side anastomosis and any combination of the above.

10. The method of claim 9, wherein one or more of the steps or procedures further comprises one or more of a hybrid RFA or augmented RFA method or step.

11. A method for creating an anastomosis in an intestine, comprising; resecting a portion of a diseased section of the intestine with an RF device to form a first resected end;resecting a portion of a diseased section of the intestine with an RF device to form a second resected end; joining the first resected end and the second resected end using a circular RF device to form an anastomosis ring; and removing the circular RF device through the anastomosis ring.

12. The method of claim 11, further comprising folding, collapsing or altering a profile of a portion of the circular RF device before the removing step.

13. The method of claim 11, wherein before the first resecting step or the second resecting step there is a step of grasping tissue from the intestine between jaws of an RF device having parallel closing characteristics.

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