Tissue specimen extraction devices, systems and methods

Abstract

To provide devices, systems and methods for removal of biological tissue during surgical procedures.SOLUTION: A tissue specimen removal device comprises: a specimen bag; a flexible ring configured to form a top opening of the specimen bag; and a cannula assembly comprising an inner tube handle portion and an outer tube portion. The device may further comprise a connector carrier which retains at least one connector housing having one or more connector portions and residing inside the connector carrier, and where the connector carrier can be moved from a position inside the cannula assembly to outside the cannula assembly.SELECTED DRAWING: Figure 1-D

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This patent application claims priority to U.S. Provisional Patent Application No. 62 / 656,251, entitled "Tissue Sample Extraction Device, System, and Method," filed April 11, 2018, and U.S. Provisional Patent Application No. 62 / 738,652, entitled "Tissue Sample Extraction Device, System, and Method," filed September 28, 2018, which are assigned to the assignee and expressly incorporated herein by reference.

[0002] This application is related to U.S. Patent No. 9,649,147, filed May 16, 2017, entitled "Electrosurgical Device and Method," and U.S. Patent No. 9,522,034, filed December 20, 2016, entitled "System and Method for Reducing and Extracting Large Volumes of Tissue," the entire disclosures of which are incorporated herein by reference for all purposes as if fully set forth herein.

[0003] Various novel features are described herein, which may be used in conjunction with or in conjunction with the inventions and disclosures set forth in the above-referenced patent applications. Accordingly, the relevant text, drawings and other disclosures from these prior patents are incorporated into this disclosure for context, background, and, where appropriate, for incorporation into aspects of the invention described herein.

[0004] The present disclosure relates generally to devices, systems and methods for the removal of biological tissue during surgery, and particularly, but not exclusively, to a specimen bag deployment assembly having integrated connecting components for tissue sectioning and exposure. [Background technology]

[0005] One of the key surgical steps in a tissue specimen extraction system is capturing and packing the tissue specimen into a containment component (see, for example, U.S. Patent Nos. 5,629,992 and 5,729,992). These patents have disclosed a number of systems and methods for capturing the tissue, collapsing an opening in a flexible component to contain the tissue while simultaneously exposing the containment component (i.e., bringing the tissue outside the body), and holding the containment component during the surgical step to ensure that the containment component remains in the desired position for the next surgical step.

[0006] Additionally, many containment components or specimen retrieval bag pouches are available that can perform the function of capturing and containing a tissue specimen. One such containment component can be a specimen bag made of a flexible material such as, but not limited to, polyurethane, nylon ripstop, or other polymer or combination of polymers designed to provide the required containment and mechanical strength required for sectioning the tissue specimen through an incision and subsequent removal of the tissue sections. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 9,522,034 [Patent Document 2] U.S. Patent No. 9,649,147 Summary of the Invention [Problem to be solved by the invention]

[0008] The safe, rapid, accurate, and clean removal of large tissue specimens requires great skill and meticulous care. Improvements in each of these aspects are constantly being sought. In particular, there is a need for efficient and effective tools for sectioning tissue specimens within specimen bags to facilitate removal of the tissue through the smallest possible incision. Therefore, there is a need for devices, systems and methods that improve the tissue sectioning and extraction process. [Means for solving the problem]

[0009] One aspect of the present disclosure provides a tissue specimen extraction device including a specimen bag, a flexible ring configured to form a top opening of the specimen bag, a cannula assembly including an inner tube handle portion and an outer tube portion, and may further include a connector carrier having one or more connector portions and holding at least one connector housing within the connector carrier, the connector carrier being movable from a position within the cannula assembly to an exterior of the cannula assembly.

[0010] Another aspect of the present disclosure provides a method for tissue sectioning and specimen extraction. The method may include inserting a cannula assembly of a tissue specimen extraction device into an incision site of a surgical patient. The tissue specimen extraction device may include a specimen bag, a flexible ring configured to form a top opening of the specimen bag, and a connector carrier. The connector carrier may be configured to hold at least one connector housing including one or more connector portions and reside within the connector carrier. The connector carrier may further be configured to hold at least one connector housing including one or more connector portions. The connector carrier may further be configured to reside within the connector carrier. The cannula assembly may include an inner tube handle portion and an outer tube portion. The method may further include advancing the inner tube handle of the cannula assembly to open the specimen bag and move the connector carrier from a position within the cannula assembly to an exterior of the cannula assembly.

[0011] Yet another aspect of the present disclosure provides a system for extracting tissue specimens, which may include a specimen bag and a flexible ring configured to form a top opening of the specimen bag. The system may further include a cannula assembly, itself including an inner tube handle portion and an outer tube portion, configured to advance and retract the flexible ring. The system may further include a connector carrier configured to hold at least one connector housing including one or more connector pins. The connector carrier may also be configured to reside within the connector carrier. The connector carrier is movable from a position within the cannula assembly to an exterior of the cannula assembly. The one or more connector pins are configured to be attached to one or more tissue sectioning components integrated within the specimen bag. The system may further include a tensioning mechanism assembly. The tensioning mechanism assembly may be attached to the one or more connector pins and configured to apply tension to the one or more tissue sectioning components. [Brief explanation of the drawings]

[0012] [Figure 1-A] FIG. 1-A illustrates one embodiment of a specimen extraction bag system with the specimen bag in an open position, according to various aspects of the present invention. [Figure 1-B] FIG. 1-B illustrates one embodiment of the cannula assembly of the specimen extraction bag system of the present disclosure in a first, retracted position, with the specimen bag held within the cannula assembly. [Figure 1-C] FIG. 1-C illustrates one embodiment of the specimen extraction bag system of FIG. 1-B with the cannula assembly in a second, advanced position, and the specimen bag deployed to an open position. [Figure 1-D] FIG. 1-D illustrates one embodiment of a specimen extraction bag system with the cannula assembly of FIGS. 1-B and 1-C in a third, extended position, with the connector carrier of the present disclosure exposed within the cannula assembly. [Figure 1-E] FIG. 1-E illustrates one embodiment of a connector carrier according to aspects of the present disclosure. [Figure 1-F] FIG. 1-F illustrates a connector housing and a connector according to an embodiment of the present disclosure. [Figure 1-G] FIG. 1-G illustrates a connector housing and connectors according to an embodiment of the present disclosure, and further illustrates the directions in which one or more connectors can be removed. [Figure 1-H] FIG. 1-H illustrates one embodiment of the connector carrier shown in FIG. 1-E, further illustrating a first flat position into which the connector housings can be oriented and the directions in which they can be rotated. [Figure 1-I] FIG. 1-I illustrates the connector housing rotated to a second, upright position and further shows the release and retention mechanism that causes the connector housing to be retained by the connector carrier. [Figure 1-J] FIG. 1-J illustrates the connector housing of FIG. 1-I and further illustrates the directions in which the connector housing and / or individual connectors may be removed. [Figure 1-K] FIG. 1-K illustrates the pull tab and cartridge assembly in a first, flat position and further illustrates the directions in which the pull tab and cartridge assembly can be pulled and rotated. [Figure 1-L] FIG. 1-L illustrates the pull tab and cartridge assembly in a second, upright position and further illustrates the direction in which the pull tab and cartridge assembly can be pulled to remove it from the connector housing. [Figure 1-M] FIG. 1-M shows an enlarged perspective view of the connector carrier, fitting and cannula assembly of the present disclosure. [Figure 1-N] FIG. 1-N is a cross-sectional view of the components shown in FIG. 1-M. [Figure 1-O] FIG. 1-O shows the specimen bag and connector carrier assembly in a configuration separated from the cannula assembly. [Figure 1-P] FIG. 1-P is a flow chart illustrating a tissue sectioning method according to the present disclosure. [Figure 1-Q] FIG. 1-Q illustrates a tissue sectioning device according to some embodiments. [Figure 2] FIG. 2 is a schematic diagram of some of the electrical and mechanical components of an exemplary electrosurgical device. [Figure 3] FIG. 3 shows a perspective view of the introducer. [Figure 4] FIG. 4 shows the introducer. [Figure 5] FIG. 5 shows the introducer. [Figure 6] FIG. 6 shows the detection device. [Figure 7] FIG. 7 is a flow diagram of the controller and method. [Figure 8] FIG. 8 is a flow diagram of a method for controlling a tissue sectioning procedure. [Figure 9A] FIG. 9 is a flow diagram of a method for controlling tissue sectioning. [Figure 9B] FIG. 9 is a flow diagram of a method for controlling tissue sectioning. [Figure 10A] FIG. 10 is a flow diagram of a multiplexed tissue sectioning control method. [Figure 10B] FIG. 10 is a flow diagram of a multiplexed tissue sectioning control method. [Figure 10C] FIG. 10 is a flow diagram of a multiplexed tissue sectioning control method. [Figure 11] FIG. 11 shows an electrosurgical device and system for detecting electrode travel distance. [Figure 12] FIG. 12 is a side cross-sectional view of the tissue sectioning device. [Figure 13] FIG. 13 is a perspective view of a disposable lumen assembly. [Figure 14] FIG. 14 shows a device having a disposable portion and a reusable portion. [Figure 15] FIG. 15 is a perspective view of the extraction device. [Figure 16] FIG. 16 is a perspective view of the device in FIG. 15 with some components removed. [Figure 17] FIG. 17 is a plan view of some components of the device in FIG. [Figure 18] FIG. 18 is a perspective view of some components of the device in FIG. [Figure 19] FIG. 19 is a perspective view of some components of the device in FIG. [Figure 20] FIG. 20 is a perspective view of the extraction device with an introducer tube. [Figure 21] FIG. 21 is another view of the device in FIG. [Figure 22] FIG. 22 is another view of the device in FIG. [Figure 23] FIG. 23 shows a tensioning device. [Figure 24] FIG. 24 is a perspective view of the introduction tube before preparation for insertion. [Figure 25] FIG. 25 is a perspective view of the introducer tube of FIG. 24 prepared for insertion. [Figure 26] FIG. 26 is a side cross-sectional view of the inflator. [Figure 27] FIG. 27 shows multiple views of the tissue extraction bag components. [Figure 28] FIG. 28 shows a bag with an apron. [Figure 29] FIG. 29 shows a bag with a drawstring. [Figure 30] Figure 30 shows the bag. [Figure 31] FIG. 31 shows multiple views of the inflation mechanism for the tissue extraction bag. [Figure 32] FIG. 32 shows two side views of components for an ultrasonic or vibratory sectioning device. [Figure 33] FIG. 33 shows a side cross-sectional view of some components of an electrosurgical device. [Figure 34] FIG. 34 shows a partial perspective view and a partial perspective side view of a harvesting bag. [Figure 35] FIG. 35 shows a plan view of the return electrode. [Figure 36] Figure 36 shows the electrode color coding scheme. [Figure 37] FIG. 37 depicts the electrode encoding means. [Figure 38] FIG. 38 shows the resistor element. [Figure 39] FIG. 39 shows an insulation displacement connector with a resistor. [Figure 40] FIG. 40 shows an insulation displacement connector with a resistor ring. [Figure 41] FIG. 41 shows a flow diagram of the active electrode connector recognition method. [Figure 42] FIG. 42 shows a top and side view of the tissue extraction bag. [Figure 43] FIG. 43 illustrates the use of an inflatable tissue harvesting bag. [Figure 44] FIG. 44 shows several views of the marking device. [Figure 45] FIG. 45 shows multiple views of a tissue extraction bag with marking features. [Figure 46] FIG. 46 shows two perspective views of the ink marking component. [Figure 47] FIG. 47 shows multiple views of a tissue extraction bag. [Figure 48] Figure 48 shows a flow chart of the surgical method. [Figure 49] FIG. 49 shows multiple views of an electrosurgical device having an emergency release mechanism. [Figure 50] Figure 50 shows the release mechanism. [Figure 51] Figure 51 shows the release mechanism. [Figure 52] FIG. 52 shows a perspective view of some components of an electrosurgical device. [Figure 53] FIG. 53 shows a side view of an embodiment of a cutting wire. [Figure 54] FIG. 54 shows a partial cross-sectional view of a dual retrieval bag with wire mesh and inflation mechanism. [Figure 55] Figure 55 shows various views of the crushable retrieval basket. [Figure 56] FIG. 56 shows a rotary power electrode cutting device. [Figure 57] FIG. 57 shows a rotary wire electrode with a sharp cutting edge. [Figure 58] FIG. 58 shows a single electrode wire embodiment. [Figure 59]FIG. 59 shows a bipolar device with active and return wires clamping a tissue specimen. [Figure 60] FIG. 60 shows the cutting and grasping loops in the retrieval bag. [Figure 61] FIG. 61 shows a stationary cutting mechanism and a moving tissue arrangement. [Figure 62] Figure 62 shows the push / pull grid disconnect mechanism. [Figure 63] Figure 63 shows a multi-stage rigid cutting mechanism. [Figure 64] Figure 64 shows a stationary cutting electrode system. [Figure 65] Figure 65 shows a skewer mechanism for tissue sectioning. [Figure 66] Figure 66 shows the spiral electrode cutting mechanism. [Figure 67] FIG. 67 shows an electrode structure with threads woven using a metal filer. [Figure 68] FIG. 68 shows an electrode structure with bipolar / bifilar wire pairs. [Figure 69] Figure 69 shows a square wire electrode. [Figure 70] FIG. 70 shows the harvest bag. [Figure 71] Figure 71 shows the wire and bag structure. [Figure 72] FIG. 72 shows the bag and return electrode configuration. [Figure 73] FIG. 73 shows a dual bag configuration with an inner bag configured to clamp tissue. [Figure 74] FIG. 74 shows a dual bag configuration with an outer bag configured to clamp tissue. [Figure 75] FIG. 75 shows energy delivery using a coded signal controller (multiplexing). [Figure 76] FIG. 76 shows a collection bag specimen capture and cutting device. [Figure 77] FIG. 77 shows another view of the device in FIG. [Figure 78]FIG. 78 shows a guide for the wire loop. [Figure 79] FIG. 79 shows a cam barrel for organizing or sequencing the electrodes. [Figure 80] FIG. 80 shows an electrode loop with opposing springs for tension control. [Figure 81] Figure 81 shows the shaft structure. [Figure 82] FIG. 82 shows an alternative shaft construction. [Figure 83] Figure 83 shows a torsion spring for tensioning the wire / electrode. [Figure 84] Figure 84 shows wire activation using cams and lobes. [Figure 85] Figure 85 shows the wire length locking mechanism. [Figure 86] FIG. 86 shows the introducer tube device and harvest bag. [Figure 87] FIG. 87 illustrates various features of the wraparound harvest bag. [Figure 88] FIG. 88 shows another extraction device. [Figure 89] Figure 89 shows the wire details. [Figure 90] Figure 90 shows other wire details. [Figure 91] FIG. 91 is a cross-sectional view of some components of a bag assembly with leak detection. [Figure 92] FIG. 92 is a partial cross-sectional side view of some components of a bag assembly with leak detection. [Figure 93] FIG. 93 is a side cross-sectional view of some components of a bag assembly with leak detection. [Figure 94] FIG. 94 is a side cross-sectional view of some components of a bag assembly with leak detection. [Figure 95] FIG. 95 is a side cross-sectional view of some components of a bag assembly with leak detection. [Figure 96] FIG. 96 shows partial cross-sectional top and side views of some components of a bag assembly with leak detection. [Figure 97] FIG. 97 shows side cross-sectional views of several components of a bag assembly with leak detection. [Figure 98] FIG. 98 shows a perspective view of some of the components for wire management. [Figure 99] FIG. 99 shows some components for wire management. [Figure 100] FIG. 100 shows a side cross-sectional view of some components of the wire management system. DETAILED DESCRIPTION OF THE INVENTION

[0013] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

[0014] Improvements in surgical techniques have increasingly focused on reducing the invasiveness of procedures. Specifically, surgeons strive to perform “minimally invasive” procedures (meaning incisions limited to a certain size) whenever possible. However, many surgical procedures that can be performed almost entirely through very small incisions ultimately require a final step that is very difficult to perform through a small incision. This final step is the extraction of the resected tissue. The extraction of large tissue sections, such as an entire uterus, a large portion of a kidney, or a cancerous tumor, creates many logistical challenges. Prior disclosures referenced throughout this disclosure describe various devices, systems, and methods for sectioning these large tissue pieces within a specimen while it is still within the patient's body. Current approaches enable the sectioning of tissue into pieces small enough to be pulled one by one through small incisions.

[0015] Several factors make this process time-consuming, difficult, and tedious, and / or poses risks to the patient. For example, if a portion of the tissue is calcified, currently available cutting devices may take a long time to cut through that portion. In such cases, the step of bringing the tissue near the top of the specimen bag and cutting it as it is extracted may take an hour or more and may require many manpower and tools in the area. If the tissue and specimen bag must be excessively manipulated and handled, the opening of the bag may slip back into the incision site. If the tissue specimen is a cancerous tumor, this can pose a significant risk to the patient, as such specimens often contain liquids that can spill and spread cancer cells within the patient's body. The present disclosure provides devices, systems, and methods that improve the ease, safety, and efficiency of sectioning tissue specimens inside a specimen bag.

[0016] One type of existing specimen bag or storage component system is a flexible material that is rolled or folded by the surgeon, surgeon's assistant, and / or scrub nurse in a manner that allows it to be inserted through a trocar or incision site and then opened once inside the patient. In this type of system, the surgeon first excises the tissue to be removed and then manipulates the bag opening with laparoscopic tools to place the tissue specimen inside the bag. After capturing the tissue, the bag opening is elevated with a laparoscopic capturing instrument and guided out of the incision site and secured externally by the surgeon either manually or with the addition of a Kelly clamp or clamps.

[0017] Some of these types of specimen bags include a polymer ring formed or attached to the top of the bag to keep the bag opening biased in a fully open position. This polymer ring can help keep the exposed bag open and in place, preventing it from falling back into the patient's peritoneum or other surgical site.

[0018] Another common type of specimen bag or storage component system uses a bag that is typically placed inside a cannula or lumen for insertion into the peritoneum through a trocar or incision site, with the specimen bag advanced over the cannula to access the opening.

[0019] Many specimen bag systems use mechanical means to bias the bag opening into an extended position to assist the surgeon in placing the tissue sample inside the bag. Such systems may include a spring-biased molded metal ring attached to the top of the specimen bag so that the spring bias opens the top of the specimen bag when it is outside the cannula. Most systems using this type of metal ring also include string or suture material as a drawstring to close the bag opening for exposure. In these devices, the string remains outside the patient's body and can be pulled to seal the bag. The string closes the opening while the metal ring is retracted back into the cannula, leaving the bag free from the cannula and metal ring, and similarly leaving the bag within the incision site after the cannula and metal ring are withdrawn. The surgeon can then use the string to pull the bag opening through the incision site. In other systems, string or suture material is used as a drawstring that tears the bag from the metal ring while closing the bag opening, leaving the bag free from the metal ring and cannula. The string is then used to retrieve the bag opening through the incision site.

[0020] As previously mentioned, currently available specimen retrieval bags are designed to contain tissue while the surgeon loads and subsequently exposes the specimen bag. The tissue specimen extraction systems described in the above-referenced and incorporated patents utilize tissue sectioning devices that include wires, return electrodes, and other components. The tissue specimen extraction system of the present disclosure integrates various tissue sectioning device components (e.g., sectioning wires and return electrodes) and may further include one or more "connectors." The term "tissue sectioning device component" or simply "sectioning component" refers to any type of cutting device configured to physically cut tissue. Often, these sectioning components include individual wires or wire loops that cut tissue by being pulled through the tissue by mechanical force, with the assistance of RF energy, or a combination of the two. However, any sectioning component described herein may include those referenced in each of the above-incorporated patents, any referenced throughout this disclosure, or any other type of tissue cutting device known or to be developed in the future. In many embodiments, these sectioning components may be integrated into the specimen bags of the present disclosure prior to deployment within a patient. Examples of such specimen bags with integrated sectioning components (e.g., sectioning wire loops) are described below in this disclosure.

[0021] The term "connector" refers to either a connector housing containing one or more connector pins, or the individual connector pins themselves. "Connector pins" are sometimes referred to as "connector portions." These connectors are attached at one end to the sectioning component inside the specimen bag. The connectors are configured to allow separate portions of the sectioning device to be connected at a later time. To facilitate distinction and reference between the tissue sectioning device component and the separate connectable portion, the separate connectable portion may be referred to herein as a "connectable (tissue sectioning) instrument" or "part of a connectable instrument." For example, the connectable instrument may be a tensioning mechanism assembly configured to tension the sectioning component (cutting device) against the tissue specimen in preparation for drawing it through the tissue. In embodiments, the connectable instrument can apply the desired force and RF energy to the sectioning component and provide return current to the RF generator. Thus, the specimen bag of the present disclosure, which integrates a connector, sectioning wire, and return electrode, has additional components that are not required in passive specimen retrieval bag applications, since the tissue sectioning step is performed by the surgeon using a separate tool that is not integrated with or connected to the bag.

[0022] In the devices of the present disclosure, including a specimen extraction bag that is connectable to a connectable tissue sectioning device, components associated with connectors are not required for tissue packing or during exposure. The devices and systems of the present disclosure include these connectors because it is highly advantageous to integrate one or more mechanisms (i.e., connectors) for connecting the tissue sectioning device into the tissue specimen collection bag itself. Specifically, when collected tissue needs to be sectioned while held inside the specimen bag, it can be advantageous for the surgeon to be able to quickly and easily connect a sectioning component (e.g., a sectioning wire or other cutting device) to a connectable tissue sectioning device (e.g., an RF-powered tensioning device). Rapid activation and use of the sectioning component can save valuable time at crucial moments after tissue mobilization. In embodiments, the sectioning component includes multiple wire loops integrated with the bag. It is highly desirable to manage and keep the ends of these sectioning wires out of the way, yet still be readily accessible when needed. This reduces the time spent retrieving additional instruments and reduces the risks associated with repeatedly detaching and attaching the device. The integrated connector system of the present disclosure therefore provides multiple conveniences and advantages. However, the connector and return electrode portion must be protected during tissue packing and exposure.

[0023] The present disclosure provides devices, systems, and methods for tissue specimen extraction utilizing a specimen bag and integrated connector carrier. Referring initially to FIG. 1-A, a specimen bag and connector carrier assembly 10100 is shown. Because the specimen bag and connector carrier assembly 10100 is integrated in the illustrated embodiment, it may be referred to simply as the "specimen bag assembly." The specimen bag assembly includes a specimen bag 10101 with a flexible ring 10102 that can be attached to the bag opening. The flexible ring 10102 in the illustrated embodiment may be fabricated from a metal that is thin enough to be flexible and have a spring-like quality. In the illustrated embodiment, the flexible ring 10102 includes two separate spring arms 10107A and 10107B that are coupled at their distal end to a flexible member 10103 and held securely at their proximal end 10104. It is contemplated that the flexible ring may include more or fewer separate components. For example, it may be a single flexible ring, or it may be more separable pieces. Although not shown, the specimen bag 10101 may include multiple sectioning components within or adjacent to its walls.

[0024] A connector carrier 10105 is shown in a location intermediate the specimen bag 10101 and the cannula assembly (not shown in FIG. 1-A). The connector carrier 10105 serves several functions shown and described in subsequent figures, including holding a connector configured to attach to the sectioning device, providing a guide for running along the flexible ring 10102 to open and close the bag opening, providing a channel for the return electrode 10108 to extend outward away from the bag to secure the return electrode cable 10108 to the proximal end of the assembly, releasing forces that may be applied by pulling on the return electrode cable 10108, and providing a lock that may be integrated with the cannula or outer tube to provide a mechanical anchor at the distal-most position of the outer tube. The return electrode 10108 may be configured to plug into a component of the sectioning device in embodiments in which the sectioning device is powered by an RF power source. In such embodiments, the return electrode 10108, which may be attached to a conductive material inside the specimen bag 10101, may complete the circuit created by the sectioning components (e.g., wire loops) inside the specimen bag 10101 and the sectioning device. Embodiments of RF-powered sectioning devices are shown and described throughout this disclosure.

[0025] FIG. 1-B shows a cannula assembly 10201 into which a connector carrier 10105 (from FIG. 1-A; not shown in FIG. 1-B) can be packed during manufacturing. The connector carrier 10105 can be positioned in close proximity to a mechanical anchor 10802. The cannula assembly 10201 can include a proximal inner tube and handle assembly 10206 (also referred to herein as the “inner tube,” “handle,” or “inner tube handle”) and a distal outer cannula portion 10203 (also referred to as the “outer wall”). The inner tube handle can also include a proximal end grip 10204. During manufacturing, the specimen bag 10101 (from FIG. 1-A; not shown in FIG. 1-B) can be rolled and positioned inside the distal outer cannula portion 10203. After the cannula assembly 10201 is inserted through the incision site, the specimen bag 10101 can be advanced into the surgical subject's body by advancing the inner tube handle 10206, which pushes the inner tube 10206 into the outer tube 10203. The inner tube 10201 and outer tube 10203 can be attached such that the medical gripping portion 10202 can be positioned anywhere between a fully extended position and a fully enclosed position. That is, the tubes can be positioned end-to-end, or inner tube within outer tube, or any position in between.

[0026] As the bag 10101 advances, the flexible ring 10102 begins to release the bag as it extends beyond the distal edge 10205 of the outer tube 10203. As shown and described in subsequent figures, as the connector carrier 10105 reaches the distal edge 10205, a mechanical anchor 10802 integrated within a top portion of the connector carrier 10105 can interface with an opening 10207 (also referred to herein as a “locking opening”) in the outer tube 10203 to secure it in position within the cannula assembly 10201. The mechanical anchor 10802 may be implemented as a spring-loaded detent mechanism that remains in a depressed position within the cannula assembly 10201 until it reaches and protrudes through the opening 10207 to secure the connector carrier 10105 in position within the outer tube 10203.

[0027] Once the mechanical anchors 10802 of the connector carrier 10105 are securely fastened within the outer tube securement openings 10207, the user can control the opening and closing of the bag by advancing or retracting the inner tube handle 10206. A linkage 10405 (shown more clearly in FIG. 1-H ) is attached to the flexible ring 10102 and is moved by the inner tube and handle 10206. Movement of the linkage 10405 causes the flexible ring 10102, which holds the bag, to slide around the side of the connector carrier 10105. Thus, the flexible ring 10102 is unconstrained and can reach a fully open bag position or can be retracted in such a way that the bag opening is closed or bunched against the distal edge 10205 of the outer tube 10203 and connector carrier 10105. Although the bag can open and close based on movement of the flexible ring 10102, the connector carrier 10105 can remain inside the outer tube 10203, protected from exposure to bodily fluids, tissue and other biological materials within the surgical site.

[0028] As shown in FIG. 1-C, the connector carrier mechanical anchor 10802 is secured relative to the outer tube 10203, while the portion of the bag assembly distal to the outer tube 10203 remains open. FIG. 1-C shows the inner tube 10206 being fully retracted such that it is mostly located inside the outer tube 10203. The specimen bag 10101 and flexible ring 10102 (not shown here) are consequently pushed completely out of the outer tube 10203. The flexible ring 10102 is not shown here to illustrate that the top of the specimen bag 10101 includes a plurality of flexible loops 10310 that attach the flexible ring 10102 to the specimen bag 10101. The flexible loops 10310 can be bunched together (i.e., when initially wound within the cannula assembly 10201 or when the flexible ring 10102 is pulled back into the cannula assembly 10201), or they can be spread apart when the flexible ring 10102 is advanced, keeping the top of the bag open.

[0029] 1-C, however, the connector carrier 10105 remains inside the outer tube 10203, secured by the mechanical anchors 10802 and the securement openings 10207. In this manner, the tissue sectioning component and the connectable device connector are secured within the interior volume of the connector carrier 10105 and protected from the running of the flexible ring. The flexible ring 10102 runs along the side of the connector carrier 10105 during advancement and retraction of the handle 10204, as shown and described in subsequent figures. Additionally, the return electrode cable 10108 (shown in FIGS. 1-M and 1-N) is located within an internal notch in the handle 10206, such that the return electrode cable is protected during advancement and retraction of the bag.

[0030] In this embodiment, tissue is packed once the bag is opened, i.e., once the handle 10206 is advanced forward, securing the connector carrier 10105 to the mechanical anchor 10802, and the bag opening is opened by the unconstrained flexible ring 10102. After the tissue has been packed into the bag by the surgeon, the handle 10206 can be fully retracted to pull the flexible ring 10102 back into the outer tube 10203 using the linkage 10406 ​​and inner tube handle 10206. The flexible ring 10102 retracts along with the connector carrier housing 10105 and back into the outer tube 10203.

[0031] In this position, the material comprising the specimen bag 10101, which has expanded into an open bag and now contains the tissue specimen, is now too large to be pulled back into the outer tube 10203. Therefore, the flexible loop 10310 bunches against the distal edge 10205, closing the bag opening against the distal edge 10205 of the outer tube 10203. This allows the surgeon to pull the outer tube 10203 out of the incision site with the bag closed. The closed, bunched bag opening can now slide easily through the incision site. After the bag and its opening are fully exposed, the inner tube handle 10206 can be advanced again until the flexible ring 10102 reopens the bag. Because the open flexible ring 10102 forms a somewhat rigid circle, it allows the cannula and specimen bag to rest on the external surface of the patient's abdomen just outside the incision site, without rolling over the incision, sliding away from the incision, or falling back into the incision. In other words, once the bag opening is fully exposed, the open flexible ring 10102 holds the bag in place, eliminating the need for the surgeon or surgeon's assistant to hold the bag or use additional Kelly clamps to secure it in place. The packed portion of the specimen bag remains inside the patient, thus allowing the surgeon to perform additional sectioning of the tissue inside the bag while inside the patient, so that the tissue can be sectioned into pieces small enough to pass through the incision site. One benefit of quickly and safely placing the specimen bag opening and cannula assembly is that it allows the surgeon to save time and retrieve fewer instruments during critical moments in the surgical procedure.

[0032] After the bag exposure is complete, the outer tube 10203 and handle 10206 (i.e., the entire cannula assembly 10201) can be removed from the specimen bag assembly 10101. This disengagement can be accomplished by advancing the handle 10206 past the point where the connector carrier mechanical anchor 10802 locks into the locking opening 10207 of the outer tube 10203. This tube advancement can be implemented by releasing the mechanical anchor 10802 from the opening 10207. This can be done in many ways, including but not limited to the embodiments described below. For example, in embodiments where the mechanical anchor is a spring-loaded detent, the spring can be manually depressed while the handle 10206 is advanced. The handle 10206 includes a mechanical stop 10305 near the proximal grip portion 10204 that is inserted into the handle 10206 during manufacture and shipping to limit the advancement of the handle 10206 to a location that secures the mechanical anchor 10802 within the outer tube 10203. The mechanical stop 10305 can be removed by the user to advance the handle and release the outer tube from the mechanical anchor.

[0033] Another embodiment may include a mechanism designed into the outer tube 10203 that would have a control mechanism coupled to a lever that allows the handle 10206 to be advanced to a position that pushes down on the mechanical anchor, thereby releasing the mechanical anchor from the outer tube fixation opening 10207 and allowing the outer tube 10203 to be removed.

[0034] In another embodiment, a control mechanism can be provided that moves the mechanical anchor 10802 in a radial direction that allows the handle 10206 to rotate, releasing the mechanical anchor 10802 feature and disengaging it from the outer tube 10203. This allows the handle 10206 to advance and disengage the outer tube 10203. One skilled in the art can envision other mechanisms that can be designed to allow a user to apply a control or action to the handle or another component that increases or overcomes the force required to maintain any type of latching feature in relation to any locking feature on the outer tube 10203.

[0035] FIG. 1-D shows the specimen bag and cannula assembly 10201 immediately after the connector carrier 10105 has advanced beyond the location of the locking feature in the outer tube 10203. In this position, the fitting 10405 and connector 10401 between the inner tube handle 10206 and the flexible ring guide 10406 ​​are exposed. An embodiment of each of these components is more clearly shown in FIG. 1-H. The fitting mechanism 10405 shown is a simple connection that allows the cannula assembly 10202 to be raised relative to the fitting 10405 to initiate disengagement.

[0036] 1-N, one embodiment of a fitting 10405 capable of implementing the described release is shown. Once the interface between the inner tube 10206 and the fitting 10405 extends past the distal end of the outer tube 10203, the joint can be separated. To separate these (now exposed) parts, the user can first lift on the inner tube 10206 (which may still be attached to the outer tube 10203) and then pull downward on the fitting 10405. This allows the bag assembly (including the bag 10101, flexible ring 10102, connector carrier 10105, fitting 10405, and return electrode cable 10108) to be completely separated from the cannula assembly 10201. That is, the cannula assembly 10201 can be detached, leaving the lower portion of the specimen-loaded bag inside the patient, and the opening of the bag and connector carrier assembly 10105 outside the patient's incision.

[0037] A person skilled in the art can easily imagine other ways to create a connection of the inner tube handle 10206 to the flexible ring guide 10406 ​​while within the outer tube 10203 that allows the connection to be released when extended out of the outer tube 10203.

[0038] When the cannula assembly 10201 is detached from the specimen bag assembly, the return electrode cable 10108 can be pulled out through the internal notch in the inner tube handle 10206, leaving it (bag and cable) on the patient's external abdominal surface. In this way, after removal of the cannula assembly 10201, the surgeon has free access to the connector and connection of the return electrode cable 10108 for subsequent sectioning steps without the cannula assembly 10201 interfering with the surgeon's focus on the subsequent sectioning process.

[0039] FIG. 1-E shows a connector carrier 10105 configured to temporarily hold a connector housing 10520. The connector housing 10520, shown in an enlarged view in FIG. 1-F, is configured to couple to one or more types of tissue sectioning devices. The connector housing 10520 is housed within the connector carrier 10105 in a manner that allows the specimen bag assembly 10100 to be integrated with various types of tissue sectioning components within the bag. In the illustrated embodiment, the connector housing 10520 manages multiple wire loops 10601, which are one particular type of cutting device for tissue sectioning. The wire loops may be implemented as shown and described in U.S. Patent Nos. 9,649,147 and 9,522,034. Any other type of cutting device may be used without departing from the scope of this disclosure.

[0040] The connector housing 10502 may be configured such that the connector pins 10603 can only withdraw in one direction (i.e., upward and away from the bag, thus pulling the wire or other cutting device toward the tissue to be cut). These connector pins allow multiple wire loops 10601 (or any other type of cutting device) to be connected to additional tissue sectioning devices. An exemplary type of tissue sectioning device may include a tensioning mechanism assembly such as that shown and described with reference to Figures 13 and 14.

[0041] The illustrated connector can be easily coupled to the tensioning mechanism assembly via a downward pressing motion on the connector. The tensioning mechanism assembly can then be pulled upward, away from the connector carrier 10105, to disengage the connector housing 10520. The surgeon can then move the tensioning mechanism assembly above the specimen to a position directly above the central opening of the specimen bag 10101 and press a button on the tensioning mechanism assembly to tension the sectioning component (e.g., wire loop). In other words, the wire can be pulled taut against the tissue specimen. Because the connector pins 10603 can move independently of one another, the wire can be pulled taut against oddly shaped tissue specimens. That is, some connector pins and wires can be pulled further into the tensioning mechanism assembly than others based on the shape of the tissue specimen to which the particular wire is contacting.

[0042] The purpose of the connector housing 10502 is to hold multiple (four in this embodiment) individual connection points (of wire loops in this embodiment) so that the user can plug all the individual connections in one plugging step. In other embodiments, there may be more connector pins (e.g., six, eight, or ten) per connector housing to facilitate connection to devices with more connection points. Likewise, there may be more than the two connector housings 10502 shown. The connector pins may also be configured with different shapes to mate with different types of devices.

[0043] Each individual connector pin 10603 is configured to be individually and independently pulled away from the connector housing 10502. Thus, each of the connector pins 10603 can be separately manipulated as needed to operate the coupled cutting device. If desired, the connector pins 10603 can be manually pulled or moved to facilitate cutting tissue with a wire loop or manual sawing. In other words, the connector pins 10603 can be configured to be attached to different types of tissue sectioning devices or not attached to any tissue sectioning device at all.

[0044] The specimen bag and cannula assembly as shown in the illustrated embodiment has a return electrode cable 10108 that allows for the use of instruments assisted by the application of RF energy to the sectioning wire, as described in subsequent figures. The return electrode cable 10108 can be plugged into an RF sectioning instrument. However, the sectioning mechanism of the tissue specimen using these wires can be achieved by mechanical, electrical, or any combination thereof.

[0045] In the illustrated embodiment, the connector housing 10520 couples multiple wire loops to the tensioning mechanism assembly in an efficient or otherwise reduced number of steps compared to previously available mechanisms for coupling to the tensioning mechanism assembly. However, the connector housing 10520 and connector pins 10603 can be used to couple to any type of multi-pin insertion device. Alternatively, the connector pins 10603 can be used to couple mechanical, electrical, or other equipment to a cutting device. The particular connector housing 10520 design shown has the advantage of providing an audible click, giving the user confidence that the proper connection has been made. This, in turn, allows for the management of multiple wire loops or other complex sectioning components integrated inside a specimen bag and their connection to the sectioning device in a single step.

[0046] To facilitate easier retention, management, and removal of the connector housing 10520, features can be added to the connector carrier 10105 and the connector housing 10520 such that the housing is held in place until such time as the housing is rotated (or moved) to provide an easier position for coupling and removal of the tensioning mechanism assembly from the connector carrier 10105.

[0047] FIGS. 1-H and 1-I show the connector housing 10520 in one of two positions that the connector housing 10520 can be rotated between. In FIG. 1-H, the connector housing 10520 is in a flat position that aids in storage and protection of the connector housing 10520, and in FIG. 1-I, the connector housing 10520 is in an upright position. When the connector housings 10520 are rotated (moved) to their upright position, they can be easily coupled to a tensioning mechanism assembly and easily removed from the connector carrier 10520 that temporarily held them. Once attached to the sectioning instrument, the connector housing 10520 can be pulled away from the connector carrier 10105. In the embodiment shown, when the connector housing 10520 is pulled away, it can expose the sectioning wire loop, which can then be placed in a specimen bag for tissue sectioning purposes.

[0048] 1-F and 1-G, a plurality of connector pins 10603 cover a plurality of wire loops 10601 and are individually removable from the connector housing 10520. In the embodiment shown, these connector pins 10603 themselves provide a physical connection from the wires or other slicing components inside the specimen bag 10101 to a tensioning mechanism assembly such as that shown and described with reference to FIGS.

[0049] In many embodiments, it may be necessary to be able to release the entire connector housing 10520 from the connector carrier 10105. For example, coupling and subsequent use of the sectioning device may require positioning the sectioning device over the center of the specimen bag opening. FIG. 1-I shows a retention and release mechanism 10901 that achieves this release. The retention and release mechanism 10901 that is part of the connector carrier 10105 may be implemented by a latch, a mechanical bias or tension between two parts configured to snap or lock into place, or any other latching mechanism known in the art. In the embodiment shown, the tension between the material of the connector housing and the shape of the retention and release mechanism 10901 may be achieved by the physical force of a manual pull to remove the connector housing 10520 from the retention and release mechanism 10901.

[0050] If necessary, the connector housing 10105 can be returned from its upright position (for attachment to the tensioning mechanism) to its collapsed position (for retention within the connector carrier 10105). In other embodiments, additional features, referred to herein as a "pull tab and cartridge mechanism," can be implemented to facilitate rotation of the connector housing 10520. The pull tab and cartridge mechanism 11001 is shown in FIG. 1-K and includes a pull tab 11002 and a cartridge 11003. The cartridge 11003 can be positioned over a portion of the connector housing 10520 and / or connector 10603. The cartridge 11003 can be positioned in the configuration shown in FIG. 1-K during manufacturing. The pull tab 11002 can be pulled in the direction indicated by the arrow to rotate the connector housing 10520 to the upright position shown in FIG. 1-L.

[0051] Once the cartridge 11003 and connector housing 10520 are upright, the user can continue to pull the pull tab 11002 in the direction of the depicted arrow and / or upward, which disengages the cartridge 11002 from the connector housing 10520. It is contemplated that the force required to remove the cartridge 11003 from the connector housing 10520 will be less than that required to completely remove the connector housing 10520 from the connector carrier 10105 in order to prevent accidental removal of the connector housing 10520. In embodiments, the pull tab 11002 may be attached to a protective barrier that temporarily lines the interior of the specimen bag 10101 during tissue loading. The protective barrier may be a flexible, coated, and / or slippery material that forms an open cylinder. The purpose of this protective barrier is to protect wires or other sectioning components inside the specimen bag 10101 from shifting when the tissue specimen is loaded. However, before sectioning begins, the protective barrier can be removed so as not to interfere with the sectioning process. The pull tab 11002 provides a quick and convenient way to rotate the connector housing and simultaneously remove the protective barrier in one step.

[0052] 1-K and 1-L illustrate steps for preparing the connector housing for coupling and / or tensioning. With the connector housing in the upright position, the surgeon can "stab" the sectioning instrument into the (4-pin) connector housing 10502 to achieve a one-step insertion process. The connector housing 10502, which was held within the connector carrier 10105, can be lifted away from the connector carrier 10105, allowing the surgeon to position the sectioning instrument directly over the tissue specimen and centered over the bag opening. If the sectioning instrument is the tensioning device described above, a single press of the tensioning device (now plugged in) will tension each of the wire loops 10603 via the associated pins 10603, allowing the surgeon to separate the tissue specimen using each of the wire loops via an RF power source.

[0053] FIG. 1-M shows a side perspective view of the connector carrier 10105, fitting 10405, and inner tube handle 10206, while FIG. 1-N shows a cross section thereof. The return electrode cable 10108 is shown held within a notch 10905 that runs from the cannula assembly 10201 to the connector carrier 10105 and into the specimen bag 10101. The return electrode cable 10108 can terminate inside the specimen bag at a conductive pad to conduct any RF energy delivered by the tissue sectioning instrument. The other end of the return electrode cable 10108 can be plugged into a component of the sectioning instrument to complete the circuit.

[0054] FIG. 1-O shows the specimen bag assembly 10100 and cannula assembly 10201 in their fully detached configuration.

[0055] FIG. 1-P is a flow chart illustrating a method 120000 of the present disclosure. The method may include, in step 120001, inserting a cannula assembly of a tissue specimen extraction apparatus into an incision site of a surgical patient. The tissue specimen extraction apparatus may include a specimen bag, a flexible ring configured to form a top opening of the specimen bag, and a connector carrier. The connector carrier may be configured to hold at least one connector housing including one or more connector portions and reside within the connector carrier. The connector carrier may further be configured to hold at least one connector housing including one or more connector portions. The connector carrier may further be configured to reside within the connector carrier. The cannula assembly may include an inner tube handle portion and an outer tube portion. The method 12001 may further include advancing the inner tube handle of the cannula assembly to open the specimen bag and move the connector carrier from a position within the cannula assembly to an exterior of the cannula assembly.

[0056] In embodiments, the connector carrier may further include a mechanical anchor, and method 120000 may further include, in step 120003, releasing the mechanical anchor to move the connector carrier from a position within the cannula assembly to an exterior of the cannula assembly. In embodiments, method 120000 may further include, in step 120004, pulling the top opening of the specimen bag out of the patient's incision site. In embodiments, method 120000 may further include, in step 120004, disengaging the cannula assembly from the specimen bag, flexible ring, and connector carrier. In embodiments, method 120000 may further include, in step 120005, coupling at least one component of the tissue sectioning instrument to one or more connector portions. In embodiments, method 120000 may further include, in step 120006, rotating at least one connector housing to an upright position. In embodiments, method 120000 may further include, in step 120007, sectioning the tissue specimen using at least one component of a tissue sectioning instrument.

[0057] (Bag return monitor) A common method for reducing alternate site burns in monopolar electrosurgery is to use a contact quality monitor to detect the quality of the return pad connection to the patient. This contact quality monitor uses an AC waveform as an interrogation signal applied between two separate return electrodes inside the return pad. The resulting electrical parameters between the two separate return electrodes allow the contact quality monitor system to determine the impedance of the tissue or patient connection between the two electrodes. This impedance is used to infer the quality of the contact, both absolute and relative.

[0058] Previous disclosures have described how the same impedance detection method can be used for the return electrode inside the specimen bag, albeit in bipolar applications, utilizing RF sectioning of the wire. The same principles applied to the return pad contact quality monitoring system also apply to specimen bags, where poor tissue contact can be identified prior to application of RF energy, allowing manipulation of the bag to improve electrical contact between the return electrode and the tissue.

[0059] The present disclosure provides a method for a contact quality system that includes two separate return electrodes within a specimen bag and has a known resistance across the two electrodes. This method can result in a baseline resistance that is effectively considered to be in parallel with the tissue. In this way, although sensitivity to tissue impedance may be reduced, it is possible to use the known impedance to verify that the return electrode conductive layer is intact and that the total return electrode impedance is within an acceptable range. This method can be used in applications where the return electrode is implemented using a coating on a flexible substrate, where mechanical forces applied to the substrate would compromise the impedance of the return electrode coating. Those skilled in the art will readily appreciate that select known resistance values ​​can be selected to optimize sensitivity to parameters advantageous to the application. That is, other systems for measuring contact quality and site thermal injury are designed for use in applications where a return pad is placed on the patient's skin. However, the application of RF energy in this disclosure is directed to the tissue to be sectioned. The tissue that needs to be sectioned has different resistance values ​​that must be measured and considered. A higher resistance value can be selected to allow the tissue impedance to dominate the measured impedance, and a lower resistance can be selected to allow the return electrode trace's electrical impedance to dominate this measurement. This value can range from 0 ohms, a single electrode that is considered to only provide the return electrode trace's electrical impedance, to an open circuit that is considered to include the tissue impedance as well as the electrical impedance of the return electrode connection. Other systems used with a return pad on the patient's skin may not tolerate values ​​below 5 ohms, for example.

[0060] In addition to the impedance of a coated return electrode on a flexible substrate, the location of the resistance transition from the coated substrate to the cable poses challenges under mechanical loading conditions due to differences in elasticity and resulting shear forces. One aspect of the present disclosure provides a method for creating this transition by using compression of the silver coating against the return cable. In this embodiment, a flat surface can be attached to the return electrode cable via soldering or crimping, such that the flat surface is located in close proximity to the silver coating. Compression can be applied to the silver coating against the flat surface to provide electrical coupling. In this way, slight variations in the flexible substrate do not affect the overall resistance of the transition from the substrate to the flat surface, as the compression holds the substrate in place. The size and shape of the flat surface can be selected to provide an interfacial impedance to ensure adequate electrical transition between the coated substrate and the cable. Methods for measuring the electrical impedance of the return electrode trace can detect this transition as well as changes in the impedance of the trace on the substrate.

[0061] (Variable Force Sectioning Instrument) In the previous disclosure, it was identified that RF tissue specimen extraction devices have advantages in using a constant force tensioning mechanism, such as that shown and described with reference to Figures 12-14, to apply a mechanical load to the sectioning wire during sectioning. This method ensures that the minimum force required to perform cryo-cutting is always applied during sectioning. A disadvantage of constant force application is that as tissue density and specimen size vary, a constant force value must be selected to accommodate the range of tissue variations.

[0062] When RF cutting with a wire loop wrapped around a tissue specimen under an applied axial mechanical load (e.g., the exemplary wire loop devices shown in Figures 50, 78, and 80), the combination of mechanical and electrical energy creates a cut that initiates at the side of the tissue specimen, pulling the wire into the tissue toward the center of the specimen. This is due to the distribution of mechanical force and electromagnetic field along the wire. As sectioning progresses, the cutting effect propagates into the tissue and down the surface of the tissue toward a distal point. This ultimately propagates to the most distal point where the wire is pulled completely into the tissue. As this change in wire geometry occurs, the force applied by the wire changes. The force can be modeled as infinitesimal segments, where each segment has a normal force into the tissue and an axial force relative to the wire. The location of the segment around the tissue determines the amplitude of the normal and axial force vectors. The normal force is the component that drives the wire into the tissue and performs the cut. The axial force only advances the wire and does not significantly contribute to the cutting effect. As previously mentioned, cut initiation begins at the midpoint of the tissue specimen. At this location, the normal force is at its minimum, approximately 90 degrees from the axis of the applied load. As a result, the cut begins very slowly with a small normal component. As the wire cut progresses, the advancement and shape change of the cut toward the distal portion of the specimen increases the normal force component at the distal end of the wire. As a result, higher cutting forces are applied as the sectioning progresses.

[0063] One aspect of this increasing force is that tissue compression due to the applied mechanical load increases during cutting. This compression can be observed by changes in tissue impedance. At the beginning of cutting, the compressive force begins at a nominal value determined by the tissue impedance and the vapor pocket created around the initiating wire. As the force increases, the wire increases the tissue compression, and the resulting tissue impedance decreases. This is primarily a result of the compressed tissue and the greater challenge for the RF energy to maintain the arc needed to sustain the cut. For most tissue specimens, this phenomenon does not have a negative impact, but for very large tissue specimens and when very large mechanical loads are applied, the RF energy needed to sustain the cut to the end can be challenging. It can be beneficial to take this effect into account when selecting the range of applied load and tissue compression and the size of the system.

[0064] As an alternative to a constant force, one aspect of the present disclosure is a variable force mechanism for applying a load to the segmentation wire. The load can be varied from a high value to a lower value to maintain a range of applied forces during cutting. This approach is believed to keep the impedance more constant and increase the ability of the RF energy to sustain cutting.

[0065] The variable force can be applied with a linear reduction, with a starting applied force and a predetermined final force selected to model typical tissue compression and size, or it can be an exponential decay to more closely model the increase in force as the wire shape changes.

[0066] Adjustable applied force can be delivered using a DC motor. The motor can be coupled to the wire using a spool, such as a winch, a worm gear, or a rack and pinion that travels a length that matches or exceeds the total wire cutting length required for the largest specimen. The DC motor can be used with a current driver that can modulate the applied force based on measured tissue impedance. In this way, a maximum force is applied to the wire that also maintains the generator's ability to deliver power to the tissue. The DC motor can also be selected with inherent load characteristics that match the desired applied force range so that the force delivered by the motor can be controlled with a constant current.

[0067] (Reusable sectioning equipment) Previous disclosures have demonstrated that RF tissue sectioning can be readily adapted to create a reusable portion that works in conjunction with the disposable portion of the sectioning instrument, which has the benefit of reducing the overall procedure cost while also reducing the amount of material disposed of after each use.

[0068] One embodiment of the described reusable sectioning instrument uses a tensioning mechanism that utilizes a motor to apply force. Using a motor, such as a small DC motor, has advantages in reusable applications in that it can automatically advance or retract the position of the sectioning instrument tensioning mechanism. This allows for easy reloading of the sectioning instrument in preparation for the next use, which is much more difficult with coil spring embodiments. Furthermore, the motor may incorporate an encoder to provide real-time position information for the wire during cutting and reloading in preparation for the next use. This allows for automatic tensioning for cutting and repositioning of the tensioning mechanism to its pre-loading position after sectioning is complete. Using this embodiment, the reusable portion of the device may include the electronics needed for communication between the sectioning instrument and the controller, tensioning mechanism, and user controls. The disposable portion may be limited to the interface between the sectioning instrument and the sectioning wire.

[0069] The features and embodiments described above can be used on their own or in conjunction with, and as improvements to, the systems described below.

[0070] In one exemplary application, an advanced electrosurgical system 100 may be provided, as illustrated in FIG. 1-Q. System 100 may be configured to perform some or all of the functions, such as tissue sectioning and / or extraction, described in Applicant's International Application PCT / US15 / 41407, filed July 21, 2015, with a priority date of July 22, 2014, entitled "System and Method for Reducing and Extracting Large Volumes of Tissue," which is incorporated herein by reference in its entirety for all purposes as if fully set forth herein. System 100 may include an electrosurgical device 102 and a generator 104 coupled together by a number of leads 106. Generator 104 may include a controller 108.

[0071] Unless otherwise stated herein, the term "sectioning device" shall be understood to include devices for sectioning tissue and may include mechanical sectioning action, and / or electrosurgical sectioning action and / or, for example, bipolar or monopolar sectioning action.

[0072] 2, the generator 104 may include a data store 110 for storing one or more sets of tissue sectioning parameters. The tissue sectioning parameters may include parameters associated with normal or expected responses during an electrosurgical procedure and may relate to tissue sectioning voltage, current, power factor angle, impedance, power, energy, electrode or wire travel speed, electrode or wire travel distance, and / or mechanical sectioning force applied to tissue by the electrode or wire. The data store 110 may be a component of the controller 108 or a component separate from the controller.

[0073] The tissue sectioning parameters are derived by analytical and / or empirical methods and are target boundaries that ensure optimal operation of the system 100 or its components, preferably while maintaining safe tissue temperatures.

[0074] In some embodiments, the tissue sectioning voltage parameter Vmin is defined as the minimum voltage required to initiate sectioning by providing an arc through the active electrode exposed area between the electrode / wire and the tissue. In some embodiments, the tissue sectioning voltage parameter Vmin is defined as the minimum voltage required to sustain sectioning. The tissue sectioning voltage parameter Vmin can be calculated by considering the dielectric value of the electrode or wire coating, the coating thickness, and the coating uniformity. The tissue sectioning voltage parameter Vmin can also, or alternatively, be determined empirically by measuring the voltage between the return and the electrode / wire at the initiation and / or during sectioning of a control tissue.

[0075] In some embodiments, the tissue sectioning current parameter Imin is defined as the minimum current required to achieve the current density necessary to create a tissue sectioning cut. In some embodiments, the tissue sectioning current parameter Imin is defined as the minimum current required to sustain the cutting effect. The tissue sectioning current parameter Imin can be calculated by multiplying the surface area of ​​the active electrode by the known current density that achieves the desired cutting effect in the control tissue. The tissue sectioning current parameter Imin can also, or alternatively, be determined empirically by increasing the RF current applied to the control tissue until cutting occurs and measuring the current delivered to the control tissue. In some embodiments, the control tissue can be the tissue of a patient during an electrosurgical procedure.

[0076] In some embodiments, a power factor angle PFAcut variable is measured during an electrosurgical procedure on a patient. The power factor angle PFAcut variable can be determined by measuring the phase angle between the voltage and current waveforms delivered to the electrosurgical device and is a representation of the complex load impedance presented by the system, including the tissue, to the generator during an electrosurgical procedure. The power factor angle PFAcut variable can be measured and tracked to determine whether a short or open circuit condition exists between the active electrode or active sectioning wire and the return electrode.

[0077] Direct impedance measurement from the controller 108 to determine a short circuit is difficult because the series cable inductance becomes dominant. Applicant has determined that the power factor angle PFAcut during a short circuit is likely to be mostly inductive and will have a phase angle near 90 degrees. Therefore, the short circuit power factor angle parameter PFAshort can be empirically determined by measuring the lowest or least inductive power factor angle PFAcut variable while a short circuit is intentionally applied between the active and return electrodes during RF activation. The lowest power factor angle PFAcut variable can then be defined as the short circuit power factor angle parameter PFAshort.

[0078] Similarly, direct impedance measurement of an open circuit is difficult due to parallel system capacitance. The power factor angle PFAcut variable during an open circuit is considered to be mostly capacitive and will have a phase angle near -90 degrees. Therefore, the open circuit power factor angle parameter PFAopen can be empirically determined by measuring the highest or least capacitive power factor angle PFAcut variable during a known open circuit condition between the active and return electrodes during PF activation. The highest power factor angle PFAcut variable can then be defined or assumed as the open circuit power factor angle parameter PFAopen.

[0079] In some embodiments, the power factor PF can be used instead of the power factor angle PFA described above to determine open circuits and / or short circuits. The power factor is the ratio of the actual or active power Preal being delivered to the product of the RMS voltage Vrms and the RMS current Irms. The product of the RMS voltage Vrms and the RMS current Irms may be referred to herein as apparent power. This ratio is 1.0 when the active and apparent power are the same, as would be the case if a purely resistive load were applied. As more inductive or capacitive loads are applied, the phase shift of these loads reduces the value of the ratio, approaching zero, because the active power decreases but the apparent power remains the same. In this way, the power factor PF can be used instead of the power factor angle PFA, thereby providing or enabling detection of minimum power factor thresholds for disconnection, PFcut, short circuit power factor threshold PFshort, and open circuit power factor threshold PFopen.

[0080] In some embodiments, the average active power Preal can be sensed or derived using voltage and current sensors, as described above. However, to obtain the instantaneous active power Preal, the output of the sensor can be connected to an analog multiplier. The output of the multiplier can then be coupled to an analog circuit having a specific capacitance to provide a window for averaging the active power Preal. The average RMS voltage Vrms and RMS current Irms can also be measured using analog RMS voltage and RMS current sensing circuits that provide RMS analog outputs. The RMS outputs of these sensors can also be connected to a multiplier to obtain the instantaneous apparent power, and the output of the multiplier can be connected to an analog circuit having a specific capacitance to provide a window for averaging the apparent power, as described above for active power measurements. This circuit can be read using an A / D converter, allowing the power factor PF to be easily calculated by dividing the average active power analog output by the average apparent power output.

[0081] In some embodiments, the outputs of the real power multiplier and the apparent power multiplier can be directly coupled to an analog divider to obtain the instantaneous power factor PF, which can be read with an A / D converter to measure the power factor directly, or can be connected to an analog circuit with an intrinsic capacitance to provide a window for averaging the power factor.

[0082] In some embodiments, a purely analog method of power factor calculation may include the use of a comparator as a threshold detector to provide analog short and / or open circuit detection that does not require a microprocessor, FPGA, or other software or RTL programmable instruction set to execute.

[0083] The impedance Zcut variable can be deduced from the voltage V and current I variables (see, e.g., FIG. 2) in the leads 114, 116 and used to compare against a minimum tissue impedance parameter Zmin and a maximum tissue impedance parameter Zmax. The tissue impedance parameters Zmin, Zmax are affected by the active electrode surface area, the coating characteristics of the active electrode wire, the tissue type, and the amount of tissue hydration, and can be determined empirically by measuring a range of impedance values ​​during the cutting process in a patient's tissue or in control tissue under controlled conditions.

[0084] Relatedly, the power variable Pcut can be deduced from the voltage V and current I (see FIG. 2) at the leads 114, 116 and compared against a minimum power parameter Pmin and a maximum power parameter Pmax. The minimum power parameter Pmin may be determined or defined by the minimum power Pmin required to meet the power density necessary to initiate or sustain a cutting effect, as previously described herein. The maximum power parameter Pmax may be determined or defined as a value that will deliver a slicing or cutting effect without excessive charring, tissue desiccation, and / or the generation of steam or smoke. In some embodiments, the minimum and maximum power parameters Pmin, Pmax can be calculated by multiplying the active electrode surface area by the desired power density. The active electrode surface area may be defined or determined as illustrated and described in applicant's co-pending International Application PCT / US15 / 41407. The minimum power parameter value Pmin may also be determined empirically by adjusting the RF power and measuring the power delivered to the tissue until the desired cutting effect is observed.

[0085] In some embodiments, a method for improving the efficiency of power delivered from the generator to tissue may be provided. In some embodiments, the controller may employ power factor correction. Power factor correction may be achieved by using a variable capacitance that the controller (see, e.g., FIG. 2) can adjust to offset system cable inductance. The controller 108 may continuously monitor the power factor phase angle, PFAcut, and use this value to adjust the variable capacitance applied in parallel between the return electrode 126 and the active electrodes or wires 122, 124 coupled to the controller 108. In this way, the PFAcut angle is altered, allowing the controller to control the phase to achieve a near-zero phase angle, resulting in maximum power efficiency for cutting. This technique may be used to maximize the power delivered to the tissue, thereby providing faster cutting or allowing for more efficient cutting of larger tissue specimens.

[0086] The energy variable Etissue delivered to the tissue is defined by the accumulated energy applied to the tissue during RF activation. The energy variable Etissue can be deduced by accumulating the active power components from, for example, the voltage V and current I values ​​(see FIG. 2) at the leads 114, 116 on a cycle-by-cycle basis. Using the energy variable Etissue delivered to the tissue, a control tissue sample of known volume and / or size can be used to determine the relationship between the energy delivered to the tissue and the resulting temperature rise of the tissue specimen. Using this relationship, the energy variable Etissue can be compared to the maximum energy parameter Emax to ensure that the tissue temperature does not exceed an intended value and a temperature deemed safe. The travel speed variable Rtravel is defined as the distance traveled by the tensioning mechanism or cutting electrode or wire over a fixed time period and can be compared against the minimum travel speed parameter Rmin and the maximum travel speed parameter Rmax to determine whether the cutting electrode or wire (see, for example, FIG. 1-Q) is traveling at a safe cutting speed and a speed consistent with a properly functioning system 100. The electrode travel speed variable Rtravel is a critical variable for ensuring the desired cryo-cutting. For a fixed power delivery, as the electrode travel speed Rtravel through the tissue decreases, the total energy delivered to the tissue increases, and the resulting localized tissue temperature near the electrode will increase at a faster rate. If the resulting temperature increase is too great or too rapid, injury to the patient can occur.

[0087] The minimum travel speed parameter Rmin can be empirically determined by adjusting the power P, derived from the voltage V and current I applied to the active electrode or wire, and measuring the travel speed that achieves the maximum allowable temperature rise on the surface of a control tissue specimen. In some embodiments, the mechanical force F can be adjusted to a known mechanical force F greater than or equal to zero pound-force. In addition to varying the power and force, a vibration or other dynamic load can be applied to the wire to accelerate its progress upon detecting a low travel speed.

[0088] The maximum travel speed parameter Rmax can be empirically determined by measuring the rate of rise without any mechanical force F on the tensioning mechanism or electrode or wire. This value represents a condition where the wire is not applying force against the tissue specimen, such as a broken wire.

[0089] Many methods can be used to measure or determine travel speed. In some embodiments, as illustrated in FIG. 6, an optical motion sensor 676 is provided in close proximity to the spring or force application mechanism 674. The optical motion sensor may be focused on the location of the spring such that as the spring moves, the focal area of ​​the optical sensor can detect this motion as a linear translation. In some embodiments, motion may be detected as motion within a plane.

[0090] In some embodiments, multiple motion sensors can be provided and configured to compare images at time T0 to images at time T0+1 to determine the direction and / or distance of movement of the tensioning mechanism, cutting electrode and / or wire.

[0091] In some embodiments, the sensor includes one or more integrated circuits, a sensor optical lens, and a light source. In some embodiments, the sensor has separate components dedicated to the application. The focal area on the spring can be near the spool of the spring cylinder on the flat side of the spring coil so that the movement of the spring appears as horizontal, transverse, or X-direction movement. In some embodiments, the focal area of ​​the optical sensor is along the extension of the spring away from the spring spool or cylinder. In some embodiments, the focal area is at the top of the spool cylinder, so that the sensor is configured to detect rotational movement, which is detected as movement in both X and Y directions or transverse and longitudinal directions as the spring moves.

[0092] In some embodiments, one or more optical sensors are provided and configured to detect contrast variations rather than creating an image. The contrast variations can be surface irregularities within the spring or force-applying mechanism, or can be patterns created on the spring surface. In some embodiments, contrasting patterns can be provided at preselected or known regular intervals on a moving component, such as a tensioning mechanism, cutting electrode, or wire, and one or more optical sensors are configured to count the number of patterns that move past a focal area to determine travel speed and distance. In some embodiments, the patterns are configured to provide a reference interval for measuring speed. The patterns can be separate patterns integrated or modulated into or near the primary pattern as secondary patterns, thereby providing additional information such as absolute distance traveled, start or end of travel markers, and / or key points in the travel distance.

[0093] In some embodiments, the device may be configured to adjust power in response to information detected and / or transmitted by a sensor or sensors. For example, the device may be configured to increase the sectioning power being applied to the cutting electrode in response to determining that the tensioning mechanism, electrode, or wire is translating or moving at a rate lower than a preferred rate. As another example, the device may be configured to decrease the sectioning power being applied to the cutting electrode in response to determining that the tensioning mechanism, electrode, or wire is translating or moving at a rate higher than a preferred rate.

[0094] In some embodiments, a wheel of known diameter may be provided in contact with a spring or force application mechanism, with measured wheel rotation providing an indication of spring travel. Wheel rotation can be measured by including spokes of known width or angle within the wheel and optically counting the number of spokes observed by light sources and detectors positioned on opposite sides of the wheel.

[0095] In some embodiments, the wheel is mechanically coupled to a potentiometer or variable resistor. As the wheel rotates, the resistance of the potentiometer changes. The change in resistance can be used to calculate the corresponding change in travel of the spring.

[0096] In some embodiments, a resistive film is provided on the exposed top surface of the wheel. As the wheel rotates, a variable resistance along the surface can be provided, varying from low to high impedance values. A pair of contacts can be placed at the center and edge of the surface of the resistive film so that rotation varies the resistance, and rotation can be calculated by tracking these resistance changes.

[0097] In some embodiments, the device may be configured to detect capacitance changes to determine running speed or distance traveled. In some embodiments, an electrical plate is provided that does not cover the entire wheel surface, such as a semicircular plate with a second conductive semicircular plate. A time-varying voltage can be applied between these two plates to measure the change in capacitance as the wheel rotates. In this approach, the change in spring travel can be calculated in a manner similar to previous examples using resistive films.

[0098] In some embodiments, an encoder is mechanically coupled to the spring or force applying mechanism to indicate travel speed or distance traveled. The encoder may provide waveforms that can be used to determine travel speed using the phase of two waveforms.

[0099] In some embodiments, the output of one or more sensors or sensing circuits provides information used to calculate or infer travel speed. The electrosurgical instrument 102, which may also be referred to herein as a sectioning instrument, can use this information directly to determine whether the travel speed is acceptable. The sectioning instrument can include a processor, analog circuitry, and / or digital circuitry for calculating, processing, and / or tracking the sensor output. In some embodiments, the instrument can initiate an action responsive to information from one or more sensors only if, for example, the travel distance is outside an acceptable or expected range.

[0100] It may be beneficial to scale this information into units meaningful to the user, such as cm / sec. In some embodiments, the device has a processor configured to scale digital, analog, or other signals into an information-providing output in a manner known to those skilled in the art. One advantage of using this method is that it quantifies the motion of the spring in a traceable form that can be compared to external measurement equipment. An additional advantage is that correction algorithms can be applied if nonlinearities are observed in the travel speed of the spring or force-applying mechanism throughout its full travel range.

[0101] In some embodiments, the sectioning tool has a processing unit in communication with the sensor. In some embodiments, the sectioning device can have a microprocessor, a state machine, and / or a field programmable gate array (FPGA) to perform processing and / or allow a user to configure the sectioning device.

[0102] In some embodiments, a signal is transmitted from the sectioning instrument to a separate device, such as a controller or another on-site or off-site processing unit, to perform this processing. The travel distance variable Dtravel can be measured directly from the tensioning device within the electrosurgical device 102 and used for comparison to the pre-tensioning travel distance parameter Dpreten and the complete-cutting travel distance parameter Dcomplete. The pre-tensioning travel distance and the complete-cutting travel distance parameters Dpreten and Dcomplete are calculated by the design of the tensioning mechanism and active electrode assembly, such that the pre-tensioning travel distance parameter Dpreten indicates the minimum distance achieved during pre-tensioning in the largest intended specimen, and the complete-cutting travel distance parameter Dcomplete indicates the maximum distance achieved once the active electrode wire has completed cutting. For details of the tensioning device, see applicant's International Application PCT / US15 / 41407. The variable Dtravel can also be used to measure the travel of each separate tensioning mechanism after pre-tensioning is applied. These values ​​can be used to approximate the volume and / or shape of the tissue specimen by comparing Dtravel to Dpreten at the completion of pretensioning. Using this approximation, the maximum energy delivered to the tissue, Emax, can be adjusted to accommodate the tissue specimen being sectioned.

[0103] Those skilled in the art will recognize that the methods and / or components used to measure traveling speed described previously herein can also be used to determine, calculate, or infer distance traveled. In some embodiments, distance traveled is calculated or determined as a relative distance. In some embodiments, the measured distance is calculated or determined as an absolute distance, for example, when an initial position is known or when an absolute position indicator, as described previously, is included.

[0104] In some embodiments, the device may be configured to transmit signals or information related to sectioning to a user. For example, the sectioning device may be configured to indicate the percentage of completion of the sectioning procedure, the rate of completion, the speed traveled, the absolute distance traveled, and / or the relative distance traveled.

[0105] In some embodiments, the sectioning device can be configured to transmit an audible or visual warning signal to the user if the sectioning speed, running speed, and / or other parameters are not within an expected range, such as the expected range that would be associated with the sectioning power being applied to the electrodes. That is, the expected running speed range can be associated with a particular power level and / or sectioning force. If the actual running speed is outside the expected range, this can be an indication of a problem with the procedure, and the user may need to stop and / or adjust the procedure.

[0106] 20-22, pretensioning of the active electrode wire will now be described. In some embodiments, an introducer tube mechanism 1500 may be provided to allow a user to pretension the wire against a tissue sample, i.e., bias the wire toward the tissue sample. Upon actuation of this mechanism 1500, the introducer tube 1501 will extend in length toward the tissue sample (instead of pulling the tissue sample back toward the introducer tube). This mechanism 1500 may include a telescoping spring-loaded tube that freely retracts and retracts out toward the specimen upon release of the mechanism. This telescoping introducer tube may include, but is not limited to, a jackscrew mechanism that unscrews to extend the introducer tube, an inflatable bladder that extends a multi-piece introducer tube, and / or manually extends a telescoping introducer tube with self-locking teeth to prevent the extended introducer tube from collapsing back on itself.

[0107] The extendable distal end portion of the sectioning instrument can be inserted into a patient's cavity in direct contact with the tissue to be sectioned. This distal tip of the instrument tube, referred to as the introducer tube 1501, can present an opportunity for a high friction drag point between the active sectioning wire and the tissue / introducer tube interface. Some embodiments therefore include a toothed feature 1505 (see, e.g., Figure 1) on the distal end of the introducer tube that allows the introducer tube to make firm contact with the tissue specimen, yet still allows space for the sectioning wire to be freely pulled through the tissue and into the sectioning instrument without becoming pinched between the tissue specimen and the distal tip of the introducer tube.

[0108] Some embodiments include a standoff platform 1506 to reduce friction. In some embodiments, the standoff 1506 can be a spherical standoff. However, one skilled in the art will appreciate that the platform 1506 can be any shape so long as it provides intimate contact with the tissue and provides an unobstructed space for the active sectioning wire to travel through. In some embodiments, the platform provides intimate instrument / sectioned tissue contact while still providing more space for the sectioning wire to travel more freely between the distal tip of the introducer tube 1501 (on the sectioning instrument) and the tissue.

[0109] In some embodiments, the distal tip of the introducer contains a lubricious, high-temperature insert such as PTFE that reduces friction on the wire traveling through the tube and into the instrument, as illustrated in FIG.

[0110] Returning now to FIG. 4 , introducer 400 can have two or more features for maintaining pneumoperitoneum. The introducer can have an inflation ring 401 around the distal portion of the device that is placed near the interior surface of the peritoneum. In some embodiments, a second mechanical sealer 402 is included that can be adjusted downward toward the incision to compress tissue between inflatable ring 401, which is inside the peritoneum, and mechanical sealer 402, which is outside the peritoneum. In some embodiments, inflation can be achieved by using a separate syringe that is attached to the introducer, if desired. In some embodiments, a syringe-like feature is incorporated into the handle of introducer 403, such that as the proximal handle is moved, the feature creates pressure that is directed against the inflatable ring.

[0111] 5, some embodiments include a flexible membrane 501 near the distal end of an introducer 500. The proximal section 502 of the introducer can be slid toward the distal end 504 of the introducer by applying force to a handle 505, causing interference between a ramp 506 on the distal end and semi-rigid fingers 507 coupled to the proximal section. The interference causes the semi-rigid fingers to expand outward, expanding the flexible membrane 501 outward, away from the introducer, creating a protrusion that can be used to seal the interior of the peritoneum. As previously described, a mechanical sealer 508 can be applied to provide compression at the incision site.

[0112] In some embodiments, a flexible membrane is positioned near the distal end of the introducer. Semi-rigid "fingers" can be disposed around the circumference of the introducer shaft beneath the membrane and attached to the proximal section of the introducer. Beneath the "fingers" is a ramp attached to the most distal portion of the introducer, positioned such that in its normal position the ramp begins at the distal edge of the finger. As the proximal portion of the shaft is advanced toward the distal end of the introducer, the fingers stretch away from the introducer, similarly stretching the flexible membrane. This creates a protrusion that can be used to seal the interior of the peritoneum. A mechanical sealer can be applied, as previously described, to provide compression at the incision site.

[0113] In some embodiments, the introducer has a film attached near the distal end of the device. The film is disposed within the cross-sectional axis of the introducer so that it can provide a seal against the incision site once the introducer is withdrawn to the proper location. In this embodiment, the introducer can be held in place by the user to maintain pneumoperitoneum, or the use of a seal on the exterior surface, as previously described, can help hold the introducer in place.

[0114] Those skilled in the art will appreciate that any combination of flexible membranes, inflation rings, or mechanical sealers can be used on the interior and / or exterior surfaces of the incision site to provide a seal that maintains the pneumoperitoneum. Additionally, the distal-most portion of the handle can include a number of user interface features for effecting the sealing feature, including an inflation or motion-applied slide, a section of tubing that can move up and down the introducer shaft, or a protrusion that acts as a lever to create the motion needed to initiate the seal.

[0115] In some embodiments (see, e.g., FIG. 4), a drawstring connection to the distal portion of introducer 403 can be included along with a sealing feature to provide multi-functionality to the introducer, thereby increasing the efficiency of the procedure by minimizing the stress required to insert the bag, seal the peritoneum during tissue packing, and allowing for easy withdrawal of the introducer while simultaneously pulling the bag opening through the incision site.

[0116] In some embodiments, the generator 104 may be coupled to a first set 120 (shown in FIG. 2 ) of first, second, and third leads 114, 116, 118 to detect and / or transmit analog and / or digital signals associated with tissue sectioning. For example, the analog and / or digital signals may include signals for controlling tissue sectioning variables, including, without limitation, voltage, current, impedance, power, travel speed, travel distance, and / or mechanical sectioning force to be adjusted or applied during the tissue sectioning procedure. The first lead set 120 may be coupled to a first cutting wire 122 coupled to the electrosurgical device 102. A second lead set 130, which may also include first, second, and third leads, may be coupled to a second cutting wire 124. The lead sets 120, 130 may include more or fewer leads per set, and more or fewer sets.

[0117] In some embodiments, the controller 108 can be configured to cause the cutting wires 122, 124 to apply radio frequency (RF) power to a tissue specimen (not shown) for sectioning and excision. Although only two wires 122, 124 are illustrated in Figure 2, the controller 108 can be configured to control multiple tissue sectioning variables associated with multiple wire sets.

[0118] 7, the controller 108, 708 may be configured to control multiple tissue sectioning wires in a time-shared manner. For example, the controller 108, 708 may include a non-transitory tangible processor-readable medium 710 that includes instructions for accomplishing the methodologies described herein. For example, the non-transitory instructions may be accessible by a processing component 712 to perform one or more methods.

[0119] One method may include a step 714 of comparing at least one detected tissue sectioning variable to a tissue sectioning parameter and / or a step 716 of comparing at least one detected tissue sectioning variable to a second tissue sectioning variable, and a step 718 of adjusting a tissue sectioning control signal in response to either comparison step 714, 716.

[0120] The controller 108, 708 may further be configured to control tissue sectioning variables in a manner that causes multiple or all of the cutting wires 122, 124 to complete tissue sectioning cuts substantially simultaneously. Completing tissue sectioning cuts substantially simultaneously can help manage temperature buildup at each wire location.

[0121] The controller 108, 708 can be configured to switch RF power between each of the cutting wires intended to receive RF power to complete the cut substantially simultaneously. This can be achieved by switching RF energy in a sequential algorithm over a fixed time period, switching RF energy so that the mechanism with the slowest travel speed receives the most energy, and controlling the cutting wires 122, 124 based on electrical parameters or having the same travel length during the cut such that cutting wires 122, 124 exhibiting different or lower impedance values ​​or shorter travel lengths during the same period receive more RF power on average than the remaining wire set to maintain the cut. Those skilled in the art will recognize that when the electrode is not traveling, vapor puddles collapse, resulting in a lower impedance; in contrast, when cutting is active, vapor puddles can increase impedance.

[0122] Particularly when using a multiplexed approach, the inactive time must be limited to maintain a higher impedance and vapor around the wire to sustain the cut.

[0123] The inactivity time must also be limited if the first tensioning mechanism or cutting wire 122, 124 is not advancing or is not advancing as fast as the second tensioning mechanism or cutting wire 122, 124, for example, due to a highly calcified tissue specimen or other cause of failure (e.g., encountering a staple within the tissue sample). In this case, the cutting wire 122, 124 or wire set that is not properly advanced may be excluded from receiving RF power. In some embodiments, the remaining cutting wires 122, 124 or wire sets are allowed to complete the cut.

[0124] 8, further details of the tissue sectioning method 800 will be described. As illustrated, the method 800 includes a step 802 of receiving a plurality of tissue sectioning variables. The tissue sectioning variables may be associated with the tissue sectioning procedure being performed, for example, the sectioning of a large tissue specimen prior to extraction through a small incision. The tissue sectioning variables may include variables applied to the tissue specimen by the tissue sectioning wire, such as energy, power, voltage, current, mechanical force, etc., and / or feedback variables, such as impedance, resistance, travel speed, and distance traveled.

[0125] Receiving 802 may include receiving a plurality of tissue sectioning variables over time.

[0126] Method 800 also includes a step 804 of comparing one or more of the tissue sectioning variables to respective tissue sectioning parameters or a step 806 of comparing one or more of the tissue sectioning variables to a second tissue sectioning variable, and a step 808 of adjusting the energy and / or sectioning force on the tissue specimen in response to the comparing step 804 or the comparing step 806.

[0127] Method 800 may be accomplished using the apparatus illustrated in any of Figures 1-Q through 3 or otherwise described herein.

[0128] The method 800 may include comparing the detected power factor angle PFAcut variable to a short circuit power factor angle parameter PFAshort and / or an open circuit power factor angle parameter PFAopen, which are described in previous sections of this disclosure.

[0129] 1-Q, the system 100 and / or method 800 can optionally include a circuit check 810 with a short and / or open circuit check. That is, in some embodiments, the system 100, controller 108, 708 and / or generator 104 can be configured to send a short, small electrical pulse at a power well below full power or operating power levels to check 810 for electrical shorts or open circuits without damaging the segmented wire / bag assembly. The power during the circuit check 810 is at a level of 10 watts or less to avoid electrosurgical effects.

[0130] For example, system 100 may include current and voltage sensors to provide separate real and imaginary components of the complex load impedance applied to tissue by system 100. Those skilled in the art will appreciate that the imaginary, or reactive, component of the cable impedance can make accurate measurement of a generator short circuit very challenging. However, by providing system 100 or method 800 in which the real and imaginary components of the complex impedance are known, the real component can be used to provide a better measure of shorts, opens, and intermediate impedance values. In some embodiments, system 100 or method 800 may include mechanisms for short and open circuit checking and / or short and / or open circuit checking.

[0131] The phase and magnitude of the composite load impedance can also be used as a relative comparison, as in the case of a short circuit, where the cable impedance contributes significantly to the load resulting in a positive phase angle, and in an open circuit, the cable and system capacitance contributes significantly to the load resulting in a negative phase angle. Methods for calculating phase include using an analog phase detector, comparing zero crossing points and peak amplitudes, or using digital sampling and software methods, such as the Goertzel algorithm.

[0132] In some embodiments, the system 100 can be configured to adjust the power or RF energy delivered to the tissue to provide controlled results during cutting. For example, the first and / or second sets of leads 120, 130 can be used to monitor and adjust the power variables applied to the wires 122, 124 as desired, or any suitable number of leads for monitoring and adjusting the power to the wires 122, 124, and any number of cutting wires 122, 124 can be provided as well.

[0133] Those skilled in the art will appreciate that the leads 120, 130 can be configured to carry digital and / or analog or control signals coupled to the power variables. The RF power can be amplitude modulated to control the cutting travel speed. Travel speed feedback can be used to adjust the power to maintain a substantially constant desired travel speed, to maintain the travel speed above a minimum value Rmin to ensure a low temperature cut, and / or to maintain the power below a maximum value to reduce the power delivered when the cut is complete.

[0134] In some embodiments, a force gauge can be coupled to the tensioning mechanism and the power can be adjusted to assist the spring in maintaining a substantially constant force and / or a force above or below a desired threshold for proper tissue sectioning. These methods can be used for other means of applying tissue sectioning forces, such as linear actuators or hand tension.

[0135] In some embodiments, the controller 108, 708 may be a box that fits onto the generator 104 and has a separate power cord, or in some embodiments, the controller 108, 708 may be integral with and a component of the generator 104 as illustrated in FIGS. 1-Q or 2, or may be integral with or a component of the electrosurgical instrument 102. The controller 108, 708 may have only a power source, such as an RF power connection attached to the generator 104, or may have additional connections for communication with the generator 104, the data store 110, the electrosurgical instrument 102, and / or the user interface 112, as illustrated in FIG. 2. This additional communication allows information to be transferred to and from the generator 104. This information may include power and mode settings, return electrode impedance information, error information, deviations from tissue sectioning parameters, such as those described previously herein, storage and statistics of procedure parameters and variables, and historical statistics in a procedure parameter database.

[0136] The controller 108, 708 may be embodied as a battery-powered device, making it more portable and easy to use by eliminating the need for duplicate AC power connections to perform electrosurgical procedures.

[0137] The controller 108, 708 and / or the generator 104 utilizing the controller 108, 708 may have the capability to measure the current I, voltage V and / or other variables associated with the power delivered by the generator 104 before connecting the output of the generator 104 to the electrosurgical device 102. This allows the controller 108, 708 to ensure that the user has selected the proper generator settings before applying electrosurgical PF energy to the wires / electrodes 122, 124 and to ensure that the safety of any coatings on the wires / electrodes 122, 124 is maintained for start-up.

[0138] In some embodiments, one or more internal resistors may be included selected to ensure the proper voltage, current, and power ranges Vmin, Vmax, Imin, Imax, Pmin, Pmax are delivered by the generator 104 to ensure the safety of any coating on the wires / electrodes 122, 124 is maintained. In some embodiments, the controller 108, 708 or system 100 is configured to alert the user, recommend corrective action, and / or initiate communication with the generator 108, 708 to change power settings in response to a determination that the safety of the coating has been compromised.

[0139] In some embodiments, the controller 108, 708 can have means for applying power, such as RF energy, to individual tensioning mechanisms and wire sets within the electrosurgical device 102 so that the controller 108, 708 can selectively and / or sequentially energize the wires 122, 124.

[0140] 2, a user may select the appropriate sequence through a user interface 112 with the generator 104 or controller 108, although one skilled in the art will recognize that the user interface 112 may be located on one component of the electrosurgical device 102 and / or on any other component of the system 100. That is, the user interface 112 may include one or more means for inputting, receiving, and / or viewing and / or manipulating how the device 102 treats tissue.

[0141] In some embodiments, the controller 108 may be configured to determine the crest factor of the generator output to verify that the user has selected the proper output mode setting. In some embodiments, measuring the RMS or average voltage (current, power) and peak voltage (current, power) is utilized to deduce the crest factor.

[0142] 9 is a flow diagram of a method 900 for controlling tissue sectioning. Method 900 may be accomplished using the controller 108, 708 or system 100 described previously herein. In some embodiments, method 900 includes one or more of: (a) determining 902 whether pretension has been applied to the tissue; (b) determining 904 whether the power applied to the tissue is acceptable; (c) determining 906 whether the impedance between the wires 122, 124 and the tissue is acceptable; (d) determining 908 whether the voltage applied to the tissue is acceptable; (e) determining 3010 whether the current applied to the tissue is acceptable; (f) determining 912 whether the power factor angle is acceptable; (g) determining 914 whether a minimum travel speed has been reached; (h) determining 916 whether the travel speed is acceptable; and / or (i) determining 918 whether cutting is complete.

[0143] In response to one or more of the determining steps 902, 904, 906, 908, 910, 912, 914, 916, 918, the method 900 may include one or more of: (a) advising an operator to pretension the device 102 at step 920; (b) adjusting or suspending the power and advising the operator to change the power at step 922; (c) aborting the power activation and alerting the operator at step 924; (d) determining whether a short circuit exists at step 926; (e) determining whether an open circuit exists at step 928; or (f) adjusting the power or advising the operator to change the power at step 930.

[0144] The method 900 may include, in response to determining 926 that a short circuit exists, interrupting power activation and alerting an operator 924 or adjusting the power or advising the operator to change the power 930.

[0145] The method 900 may include, in response to determining 928 that an open circuit exists, suspending power activation and alerting an operator 924 or adjusting the power or advising the operator to change the power 930.

[0146] Method 900 may include requesting power be delivered 932, applying power 934, and removing power 936. Applying power 934 may be responsive to determining that pretension has been applied 902. Removing power 936 may be responsive to determining that cutting is complete 918.

[0147] FIG. 10 is a flow diagram of a multiplexed tissue sectioning control method 1000. Method 1000 may be accomplished using controller 108, 708 or system 100 described earlier herein and may include some or all of method 900 described earlier herein applied to each electrode X of a plurality of electrodes 1-N. Method 1000 may further include step 1038 of determining whether a maximum off-time has been reached for any of electrodes 1-N, and, in response to determining step 1038, step 1040 of updating X to the electrode that has reached the maximum off-time, or step 1042 of updating X = X + 1 until all electrodes 1-N have been activated and then updating X to the remaining active electrode with the lowest Rtravel, and / or step 1042 of determining whether power activation has been suspended for all electrodes 1-N. In other words, system 100, 200 may be configured such that if one of the electrodes has reached its maximum off-time, the system will use that electrode next. If none of the electrodes has reached their maximum off-time, the system will apply power to the electrode that is moving slowest.

[0148] 11 , in some embodiments, various methods and systems are disclosed herein for detecting the distance traveled and the travel speed of one or more wire electrodes 122, 124, such as electrodes 1-N associated with methods 3000, 4000. In some embodiments, for example, multiple visual or electrical markers 1102 may be provided on one or more constant force springs 1104. The markers 1102 may include lines (colored or electrically isolated) placed at uniform distances along each spring 1104, and associated optical or electrical sensors 1106 may be provided to detect or count each encounter of the spring marks 1102 and thereby infer the distance traveled, DTravelX, and / or the travel speed, RTravelX. These marks may also include larger widths included periodically at uniform distances different from those previously described to act as major scale marks. The major scale marks may be used as a total distance measure and / or for counting correction, such as when the travel speed RTravelX approaches the upper limit of the device 102 or system 100's capability to measure the travel speed RTravelX. In some embodiments, the spring marks 1102 are color coded or otherwise decorated relative to the distance along the spring 1104, allowing a color optical sensor or other identification means to determine the position of the cutting wire assembly or wires 122, 124.

[0149] Similarly, in some embodiments, as illustrated in Figure 12, a first RFID tag 1220 can be assembled to a first connector block 1224 in a manner that allows a single sensor (not shown) within the sectioning tool 102, or a controller 108, 708, or generator 104, to determine the position of a first cutting assembly 151 having multiple wires or electrodes 153, 155 (see, e.g., Figure 1-Q) during tool operation. A second RFID tag 1222 can be assembled in a similar manner to a second connector block 1226 to determine the position of a second cutting assembly 160 having multiple wires or electrodes 157, 159 (see, e.g., Figure 1-Q).

[0150] In some embodiments, a force gauge or Wheatstone bridge-like device can be included to measure the deflection of the touch probe and test the deflection in the spring coils. Those skilled in the art will understand that a greater deflection means more spring material is deflected, which in turn means further travel of the electrode or wire or set of electrodes or wires 153, 160.

[0151] In some embodiments, a bearing mount can be provided for each constant force spring 1904. Rotation measurements of each bearing mount can be used to determine the travel distance (and travel speed) of each spring and electrode or wire.

[0152] In some embodiments, a micro "radar" optical measurement of each connector block can be provided along its axis of travel to visually measure how far each connector block is from the measuring sensor and thereby determine the distance (and speed) traveled by each spring and electrode or wire.

[0153] In some embodiments, a resistive strip or set of strips can be applied in close proximity to the tensioning mechanism and along the travel of the mechanism. Contacts can be attached to the tensioning mechanism or tensioning block near the distal end to provide an electrical connection to the resistive strip or film. As the tensioning mechanism moves, the contacts act similar to a "wiper" or variable resistor. By using an electrical circuit to apply a voltage across the end of the resistive film and the contacts, the resistance change can be measured, which is related to the distance traveled. The rate of resistance change can also be measured and related to the speed of travel.

[0154] In some embodiments, contacts and resistive strips are provided as described above, but with a second conductive strip that is parallel to but not electrically coupled to the resistive strip. The contacts provide electrical coupling to both the resistive and conductive strips. In some embodiments, an electrical circuit can apply a voltage across the fixed ends of the resistive and conductive strips. Those skilled in the art will appreciate that this approach can be modified to utilize contacts that are not directly connected to the strips but would operate in close proximity for the duration of travel. This approach allows the electrodes to apply a variable capacitance or mutual inductance that could be used to measure distance traveled or rate of change.

[0155] The mechanical sectioning force variable Fseg can be measured by a force gauge on the tensioning mechanism. The force gauge can be any gauge suitable for the intended purpose, including any analog, digital, or mechanical signaling mechanism. The mechanical sectioning force variable Fseg can be compared to a minimum mechanical sectioning force parameter to ensure that the correct mechanical load is being applied to the tissue specimen. The minimum mechanical sectioning force parameter Fmin can be defined by the design specifications of the tensioning mechanism force characteristics. In some embodiments, the minimum mechanical sectioning force parameter Fmin can be empirically defined by measuring the force associated with a desired electrode travel speed at a known power level in control tissue.

[0156] 12-14, a reusable tissue sectioning device 1300 may be provided. The reusable tissue sectioning device 1300 may be configured to perform some or all of the functions previously described herein in connection with the device 102 or system 100 described herein above and the device described in Applicant's International Application No. PCT / US15 / 41407. The reusable tissue sectioning device 1300 may be used as a connectable sectioning instrument used to connect to the connectors referred to in FIGS. 1-A-1-O.

[0157] The device 1300 can include a proximal portion 1302 that is releasably coupled or coupleable to a distal portion 1304. A coupling region 1319 between the proximal portion 1302 and the distal portion 1304 can be a block for a wire tensioning mechanism, thus allowing attachment of a disposable lumen 1303. The disposable lumen 1303 can provide a guide 1306 for one or more tensioning mechanisms with a post 1316 that couples to a tensioning block 1318 on the proximal portion 1302, and can have a coupling point at its distal end 1308 that allows it to couple to an active electrode wire coupling (not illustrated). The disposable lumen 1303 may also include a means 1310 for advancing the tensioning spring (or tensioning force mechanism) to a pretensioned position, a pretensioning mechanism 1312 that allows the user to pretension the tensioning mechanism, and an introducer 1314 (see, e.g., FIG. 1-Q) for placement of the bag within the incision site.

[0158] 13 and 14, the use of the disposable lumen 1303 will now be described in further detail. In some embodiments, a control mechanism 1310 can be included to enable advancement of the spring and tensioning block 1318 of the proximal portion 1302 to a distal position. The control mechanism 1310 can be a control tab. The spring and tensioning block 1318 can be held in a distal position by a locking mechanism (not illustrated) within the proximal portion 1302.

[0159] A user can couple the distal portion 1304 to the proximal portion 1302 by sliding the portions 1304, 1302 together such that the post 1316 (see FIG. 13 ) in the distal portion 1304 snaps / slides / locks into the receiving opening 1318a of the terminal block 1318 at the end of the tensioning mechanism in the proximal portion 1302. This attachment can also be accomplished by sliding the control mechanism 1310 or control tab back proximally or away from the distal portion 1304 to allow alignment of the locking mechanism in the proximal portion 1302 with the pretensioning mechanism control mechanism 1312. The proximal and distal portions 1302, 1304 can be configured such that, after attachment, pressing the pretensioning mechanism control mechanism 1312 releases the locking mechanism and pretensions the four tensioning mechanisms. One skilled in the art will recognize that many different release methods may be provided.

[0160] With continued reference to Figures 13 and 14, in some embodiments, the tensioning mechanism 1306 can be coupled to an active electrode connector (not illustrated) prior to pretensioning and can be housed within the guide 1306 during the pretensioning and cutting steps.

[0161] The applied force generated by the tensioning mechanism within the proximal portion 1302 can be mechanically and electrically coupled from the tensioning block 1318 through the posts 1316, through the alignment block 1320, through the distal end 1308, and through the active electrode connector. In some embodiments, all patient contact areas can be part of the disposable lumen 1303, thus simplifying cleaning and reprocessing of the reusable portions, including the proximal portion 1302.

[0162] In some embodiments, as illustrated in FIG. 14 , one or more reusable portions 1404 of the sectioning device are surrounded by or carried within a sterile bag 1402 using a sterile transfer process. The sterile bag 1402 can surround the reusable portion 1404, and a disposable portion 1406 can be attached to the reusable portion by a user. Access through the bag can be through an access opening 1408 in the bag 1402. In some embodiments, the access opening 1408 is left open behind a moving, translating, or collapsible sleeve and / or is punctured by a feature on the disposable portion when the user couples the disposable and reusable portions. In some embodiments, a sterile adapter is integrated into the sterile bag 1402 to facilitate coupling of the sterile disposable portion and the non-sterile reusable portion of the device while maintaining sterility in the sterile field. Those skilled in the art will readily recognize the numerous means of providing the reusable portion 1402 and disposable portion 1404 and enabling coupling of these portions. Any and all means now known and hereafter developed are contemplated herein.

[0163] Some embodiments that provide a means for separating the reusable components from the patient-contacting components may include a disposable insert within the reusable tissue sectioning device 1300. The disposable insert can capture the wire after cutting. In some embodiments, the device can be easily disassembled, reassembled, and resterilized so that the internal area that houses the wire can be cleaned after cutting.

[0164] 15-22, in some embodiments, the tissue sectioning device 200 may provide multi-wire tissue sectioning in a manner that provides the user with the ability to tension only those sets of wires that should be activated with power, such as radio frequency (RF) energy. This capability may be useful in isolating the application of all power or RF energy to only those wires currently involved in tissue sectioning. Specifically, a tissue sectioner may find it useful to have the ability to tension only the wires in one planar direction, e.g., all the "X" direction wires, in order to activate those wires or sets of wires in conjunction with the introduction of power or RF energy. These "X" direction wires may be configured so that they do not overlap one another in physical space to reduce the likelihood of electrical coupling between active and inactive wires. Those skilled in the art will readily envision numerous ways to create a mechanism 1502 that could selectively apply tensioning forces to only those wires to be activated, or to all wires in one planar direction.

[0165] In some embodiments, a constant force spring 1503 is wrapped around a gear-like spool 1504 that may be locked in place by a flange or tab 1506 or the like prior to tensioning or power activation.

[0166] 23 , the constant force spring 2302 is provided with notches 2304 or additional engagement features. One or more detent gates 2306 are configured to be temporarily inserted into the engagement features or notches 2304, thus maintaining the constant force spring 2302 in a temporarily extended state. The detent gates 2306 can be selectively lifted, rotated, or slid to unlock one or both of the constant force springs 2302 and allow the springs 2302 to tension the wires 122, 124 or wire sets 153, 160. In some embodiments, a slotted collar 2308 can be provided to allow a user to lift or disengage the gate 2306 by, for example, rotating the slotted collar 2308. The slot 2310 can be oriented so that rotational motion converts to linear or vertical motion at preselected rotational locations.

[0167] In some embodiments, a plurality of detent gates 2306, e.g., four, are provided to engage each spring 2302 of the four spring assemblies. In some embodiments, the gates 2306 are configured to lift or ascend at a predetermined angle of rotation of the collar 2308. In some embodiments, the first gate 2306a is configured to lift or disengage from the first spring 2302a before the second gate 2306b lifts or disengages from the second spring 2302b. The collar 2308 may be configured to control the disengagement in this manner.

[0168] In some embodiments, the slot 2310 in the collar 2308 can be replaced by a powered spring and / or a bi-valve pneumatic device.

[0169] 24 and 25, in some embodiments, the tissue sectioning device is provided with a harvesting bag 161, 2400. The bag 2400 may include a flexible container 2402, substantially as described elsewhere herein, and an introducer 2404 to aid in inserting the bag 161 through the incision. In some embodiments, the introducer 2404 may include a mandrel having a distal shape that protects the wires / electrodes from tangling. The introducer 2404 may be a separate component that is removed after the bag 161 is fully placed within the patient's cavity, or in some embodiments, it may be an attachment to the distal end of the tissue sectioning device, which may be removed after the bag 161 is placed, or it may be a designed feature at the distal end of the tissue sectioning device. The introducer 2404 may be placed within the bag 161, 2400, and the flexible container 2402 may be collapsed around the introducer 2404 to hold it in place during insertion. A recessed area 2406 at the proximal end of the introducer 2404 can be provided so that the active electrode connector 2410 can be recessed during insertion to reduce the chance of it becoming trapped on the patient's incision site.

[0170] 24-25, in some embodiments, the introducer 2404 can have means for mechanically coupling the drawstring 2405 to a semi-rigid ring around the bag opening. In some embodiments, the introducer 2404 can be withdrawn from the bag by a user or a grasping instrument to access the drawstring 2405 through the incision site, thus aiding the user in accessing the drawstring 2405 when exposure of the bag opening is desired. The means for coupling the drawstring 2405 can be any means known to those skilled in the art, now developed, or to be developed in the future, and can include tying, gluing, welding, fastening (e.g., threaded fasteners), or any other means.

[0171] Those skilled in the art will also understand that the pull cord 2405 and / or other components described herein may be made of or include surgical steel, flexible metallic materials, metallic coatings, flexible metallic coatings, sterile polymeric materials, springs, coils, memory-retaining materials, and / or other materials selected for their intended use in a surgical environment and to minimize the transfer of contaminants to the patient. In some embodiments, the pull cord 2405 may be configured to bias the introducer 2404 and bag 161, 2400 into a primed or compressed configuration.

[0172] In some embodiments, a return cable integrated with the tubing to form a secure tether can be provided to allow the user to expose the bag 161, as illustrated in FIG. 26 . In some embodiments, the resection bag 161 includes multiple inflation areas 2604 therein that can be inflated with low-pressure air. These inflation areas 2604 are used to provide rigidity to the bag opening and / or sidewalls of the bag 161 to aid in loading the tissue specimen into the bag 161. The inflation areas 2604, along with the return electrode cable 2602, can include or be coupled to a common inflation tube 2606 that protrudes outside the patient's body when the resection bag 161 is inserted for loading of the tissue specimen.

[0173] In some embodiments, the return electrode cable 2602 and inflation tube 2606 are mechanically attached and supported together where they exit the harvesting bag 161, so that they can be used as a means to pull the bag 161 toward the incision site after it has been loaded with a tissue specimen. After deflating the bag 161, the bag opening can be pulled through the incision site by pulling on the return cable / inflation tube assembly 2602, 2606 until the bag opening, or a portion of the bag opening, is exposed and the user can withdraw the remaining bag opening from the patient's body. This integration of the return electrode cable 2602 and tubing 2606 can be a molded assembly, a film applied around both components, laminated together as a single assembly, tied together along the length of a common attachment, or secured using adhesive or other means.

[0174] 27, a tissue extraction bag 2700 for system 100 may be provided. Bag 2700 may utilize a thin film layer 2702 containing perforations 2701 to secure the electrodes / wires against the interior surface of bag 2700. These perforations 2701 may be designed to control the release of the electrodes / wires during the pretensioning step, or to partially release the electrodes / wires at selected locations and release them at remaining locations during the travel of the electrodes / wires during cutting. In some embodiments, perforations 2701 may be sized / spaced to provide approximately 4-5 perforations per centimeter (i.e., about 12 perforations per inch). In some embodiments, 3-4 perforations per centimeter (i.e., about 8 perforations per inch) may be selected. Control of electrode / wire release during pretensioning can be achieved by selection of the perforation configuration per length in combination with the thickness T and elasticity of the film 2702 containing the perforations 2701, along with the thickness and stiffness of the material in which the perforated layer is provided.

[0175] Additionally, the width W of the dimension where the film 2702 is not attached to the bag 2700 defines a wire channel 2707. This wire channel 2707 is a critical dimension related to the ability of a wire (such as the wire 151 as illustrated, or any wire 122, 124 or electrode described herein) to find the perforations 2701 when a tensioning force is applied to create the separation needed to release the electrodes / wires 151, 122, 124. This width W, in combination with the elasticity and / or thickness T of the material 2702, can be adjusted to provide optimal wire release performance, in addition to the perforation-per-length value and pattern discussed above.

[0176] In some embodiments, the width W of the wire channel 2707 for the tissue extraction bag 2700 is less than 0.5 centimeters (i.e., less than about 0.200 inches). In some embodiments, the width is less than about 1.63 centimeters (i.e., less than about 0.064 inches). Another means to help increase the probability that the wire 151 will separate the perforations is to have multiple lines of perforations 2701 parallel to each other in the film 2702 so that as the wire 151 is routed through the channel 2707, it is more likely to find a line of perforations 2701.

[0177] By selecting an appropriate combination of these values, progressive release of the electrode / wire as it advances during cutting and guidance of the electrode / wire along the perforation channel 2707 can be achieved, resulting in a more predictable sectioning cut. This can be achieved by the same perforations per length value across some or all sections with perforations 2701, or can be enhanced by using different perforations per length values ​​in different sections, which can be linear, logarithmic or other patterns of increasing or decreasing perforations per length, or a pattern of perforations 2701 followed by open areas 2709 to enhance separation as the electrode / wire travels.

[0178] Those skilled in the art will recognize that the large number of wires used inside the bag creates crossover points where wire sets intended to apply power, such as RF energy, to tissue meet in close proximity to wire sets not intended to carry power or RF energy. A certain amount of power tends to couple capacitively, inductively, or conductively to inactive wire sets. Because the total surface area of ​​the active electrode increases, this can result in the cutting of unintended wire sets, which can reduce current density and therefore prevent the desired cutting performance from being achieved. Therefore, this coupling must be managed to avoid cutting unintended wire sets.

[0179] 99, in some embodiments, one or more electrode wires 9908 may be molded or housed within a portion of the bag wall 9906 or film 9910. FIG. 99 illustrates a plan view of how several electrode wires 9908 could be positioned.

[0180] In some embodiments, coupling can be managed electrically by providing higher isolation between intended and unintended wire sets. This can be achieved by aligning the perforated portions of the channels at the crossover points, which provides the greatest benefit for conductive coupling and a higher dielectric for capacitive coupling.

[0181] In addition to increasing isolation, the overall amplitude of the electric field can be reduced. This is accomplished by controlling the amount of exposure of the active wire to the tissue. As contact between the wire and tissue increases, the effective impedance decreases, resulting in a lower amplitude of the electric field along the wire. Furthermore, as the voltage on a wire set reaches a level at which arcing begins, the arc path will be preferentially within the tissue and will not pass through unintended wire sets.

[0182] Bonding can be mechanically managed by providing a higher mechanical load to the wire set intended for cutting compared to the unintended wire set. This can be achieved using separate pretensioning forces or different forces applied over the duration of the cutting process. If bonding is observed between the intended and unintended wire sets, the force difference between the two wire sets will increase the separation between them as the intended wire set advances through the tissue. This increased separation ultimately reduces the amplitude of bonding between the two wire sets to an insignificant level.

[0183] 27, the perforations 2701 in the bag material can be used as a temporary method to secure or contain the wire until force or increased temperature assisted force allows for the wire to be released. Those skilled in the art will appreciate that if the material containing the perforations or attaching the wire is a film with a very low melting point, the wire channel can be configured to release primarily through the temperature created by power or RF energy activation. In this way, mechanical force is a secondary means of releasing the wire from the bag, and the active electrode wire that is activated for cutting will be more easily released from the channel at the outset.

[0184] A feature can be combined with the wire to enhance the ability of the wire set to break away from the bag perforation. For example, wire 151 can have a wedge feature attached to the wire or Teflon tubing to cut or improve tearing of the perforation as the wire moves through the tissue.

[0185] Some embodiments may be configured to reduce the likelihood of the cut tissue section becoming too large to extract through the incision site. In some embodiments, multiple active electrode wire set layers are attached to the bag layer using perforations.

[0186] For example, if the electrosurgical device 102 is designed with four tensioning mechanisms that apply power to four separate active electrode wire sets, the bag may include an outer layer, a second layer with a return electrode coupled to the outer layer, and a series of inner layers stacked inside the bag. Each of these inner layers may be an insulating layer with perforations running along its length, with the four active electrode wire sets attached using the perforations. These layers may conform to the shape of the outer layer so that they can be easily inserted into the outer layer. The layers may also have an opening in the bottom area of ​​each layer so that the return electrode is exposed to the tissue when the inner layer is in place. The user can attach the active electrode wire set connector to the electrosurgical device 102 from the innermost layer.

[0187] Tissue sectioning can be performed as described in applicant's co-pending International Application PCT / US15 / 41407. Once sectioning is complete and the wires have been removed from the layer, the layer can be removed manually by the surgeon, for example, by pulling the exposed portion of the inner layer to separate the perforations in the layer and allow the film to be removed. This removal exposes the next set of active electrode wire set connectors. A second electrosurgical device 102, which can be repacked into a fully extended position, can be connected to the tissue extraction bag in the same manner as described above. One skilled in the art will appreciate that this increases the number of sectioning cuts and reduces the likelihood of large tissue sections remaining after all sectioning steps are completed. The layers of the bag can be constructed such that each inner layer is slightly rotated from all other layers to further reduce the likelihood of large tissue sections remaining after all sectioning steps are completed.

[0188] Continuing with reference to FIG. 27 , film 2702 is separated into multiple distinct regions, and in some embodiments, two regions. The bottom surface of bag 2700a can include bottom region 2706, which can be a hemispherical region as illustrated, although one skilled in the art will appreciate that a box-like shape or any other shape can be selected depending on the particular purpose of bag 2700. The sides of bag 2700 can have side regions 2704. Due to pretension and the force applied by the electrodes / wires against the tissue specimen during cutting, the force in bottom region 2706 is less than the force in side region 2704, thereby biasing release of the wire from the side before release from the bottom. To counter this tendency, one skilled in the art will appreciate that it may be desirable to provide film 2702 with a first thickness T1 in the side portions that is different from, e.g., thicker than, the second thickness T2 in the bottom portion. It may be desirable to provide a side section of film 2702 with a first pattern of perforations 2701 and a bottom section of film 2702 with a second pattern of perforations 2701 that is different from the first pattern of perforations 2701 .

[0189] For example, FIG. 27 illustrates an embodiment in which bottom region 2706 has a 0.001 inch (25.40 μm) thick film and 12 teeth per inch (approximately 4.72 teeth per centimeter) perforations to provide a lower break force to separate perforations 2701. Side region 2704 can have an approximately 0.0022 inch (approximately 55.88 μm) thick film 2702 and 8 teeth per inch (approximately 3.15 teeth per centimeter) perforations 2701 to ensure that a slightly higher force is required to separate perforations 2701 in side region 2704 than in bottom region 2700a. This embodiment takes advantage of the fact that higher forces are generated on side region 2704 compared to bottom region 2700a during tissue specimen manipulation and packing, allowing a lower perforation force to be used in bottom region 2700a without fear of failure during the packing process. This configuration also takes advantage of the higher side area forces to prevent the electrode / wire from releasing completely and / or prematurely with or during the pretensioning step, allowing the electrode / wire to release during cutting, with the perforations 2701 acting as guides to align the perforations 2701 with the run of the wire through the tissue.

[0190] Another example of a perforation pattern is illustrated in FIG. 27. In some embodiments, a method of manufacturing a retrieval bag for an electrosurgical device may be provided. The method may include providing a flexible bag 2700 having an interior region at least partially coated with a film 2702, and perforating the film in a pattern configured to control the release pattern of at least one electrosurgical electrode or wire. Methods may include providing a film 2702 having a first thickness T1 at side portions and a second thickness T2 at a bottom portion, the second thickness T2 being different from the first thickness T1.

[0191] In some embodiments, providing open windows 2709, i.e., omitting the perforated layer at desired intervals or locations, aids in the release of the wire from the bag, as illustrated in Figure 27. These windows 2709 do not constrain the wire 151, allowing direct contact between the active electrode wire 151 and the tissue. The perforations or areas of perforated wall provide temporary attachment of the wire 151 to maintain alignment.

[0192] The ratio of window 2709 to perforation wall can be adjusted or selected in a similar manner to the perforation per length value to control the force required to release the wire 151 through the perforation. Additionally, the perforation wall can provide an isolation layer and / or the isolation layer can comprise the perforation wall, since the perforation wall covers the active electrode wire 151 prior to release.

[0193] In embodiments having a window 2709 located at a desired location around the tissue specimen, initiation of the cut and early cut execution can be enhanced. For example, due to the mechanical loading and electric field distribution of the wire 151, the active electrode wire may preferentially initiate initiation of the cut at a first portion of the bag's side wall. Placing the window 2709 at or near the first portion will enhance this initiation. In contrast, placing a wall at or near the second portion will shift initiation of the cut toward the second portion. On the other hand, placing a perforated wall at or near the first portion may limit initiation of the cut in the first portion unless the voltage created on the active electrode wire 151 creates an arc through the perforated wall. Thus, the window and / or perforated wall can be configured such that a selected portion of the bag provides the first portion of the tissue being cut.

[0194] That is, the cut can be controlled to travel from a first region of tissue towards a second region of tissue.

[0195] 28, perforation 801 or perforation wall 2883, in some embodiments, does not extend to the bag opening area, thus allowing the proximal end of the electrode or wire to be easily terminated into connector 2884 during manufacturing and / or allowing the user to easily guide the wire set connector or terminate the wire to a corresponding receptacle in a sectioning tool or other device to which the wire connector is intended to be attached. Having a portion of the electrode or wire not securely secured by the perforation wall near the bag opening allows the wire to freely extend away from the interior surface of the bag.

[0196] Referring briefly to FIG. 100, the bag 10000 may include an outer bag 10002 and an apron 10004 to manage placement of the wires / electrodes 10006.

[0197] Turning now to FIG. 28 , an “apron” or additional film layer 2885 is provided within the bag to protect the wires from damage during stuffing. This apron can be attached at the proximal end to or near the bag opening. The apron can have a continuous cylindrical shape or be a series of segments extending around the interior of the bag. The apron can be positioned so that the wires and / or connectors are between the apron and another feature within the bag. The apron can extend distally along the interior surface of the bag to a point near or beyond the perforations so that any wires not contained by the perforations remain below the apron. The presence of the apron prevents tissue from coming into direct contact with the wires or wire connectors, making stuffing easier. The apron can also protect the wires during stuffing, bag manipulation, and exposure.

[0198] The apron 2885 may have one or more pouches 2881 for temporarily holding the proximal portion of the wire set or connector.

[0199] Those skilled in the art will appreciate that an apron may be beneficial if any features located on the bag surface may interfere with specimen loading and / or may provide protection during loading, manipulation, exposure, or other procedure steps. In some embodiments, the apron 2885 may isolate or protect the electrodes or wires 151 described above, mechanical members such as wires, cables, or mesh, protrusions on the bag surface, monitoring electrodes, temperature sensors, pressure sensors, features embedded within the bag, and / or other items located within the bag or installed within or used near the interior surface of the bag.

[0200] The apron 2885 may also be used as a containment flap 2986 (see FIG. 29) to help retain the contents of the bag after packing. The containment flap 2986 may be sized to remain between the packed tissue specimen and the interior surface of the bag such that the apron does not restrict the tissue from being packed into the bag. The containment flap may also be sized so that the tissue falls or rests below the distal-most edge of the apron as it is packed into the bag, or so that the distal-most edge of the containment flap can be raised above the tissue after packing is complete. As a result, the apron 2885 may be configured to limit premature or unintentional extraction or displacement of tissue.

[0201] In some embodiments, the device 102, 200 can have a bag with a removable apron 2885. The removable apron 2885 can be selectively positioned within the bag and one or more cutting electrode wires 151. The removable apron 2885 can be movable relative to the bag to expose the wires 151.

[0202] In some embodiments, a drawstring 2987 may be provided and located or positioned on the bottom or distal edge of the containment flap 2986 to allow a user to close the containment flap or capture the tissue specimen and contain fluids. This feature may be beneficial when it is desired that the contents of the bag be contained during manipulation and exposure of the bag, for example, when the tissue specimen is believed or suspected to contain cancer cells. The containment flap and drawstring may also protect the bag features during tissue packing.

[0203] In some embodiments (see FIG. 29), two apron layers may be provided: a first apron layer 2885 for protecting the bag features as previously described, and a second containment flap layer 2986 that may be used to contain tissue specimens substantially as previously described herein.

[0204] After loading the tissue specimen, the containment flap 2986 can be used to assist in exposing the bag opening. Using a drawstring 2987 coupled to the distal edge of the containment flap along its periphery, pulling the drawstring through the incision site lifts the distal edge of the containment flap around the tissue specimen and draws the opening toward the incision. The drawstring can close or substantially close the containment flap and guide it through the incision. The bag opening can follow the incision opening as it is pulled through the opening. Once the bag reaches its intended exposure location, it can be secured with a semi-rigid member 2889 around the opening, inflated for fixation, or held in place using other mechanical means, including being held in place by a surgeon's assistant. The drawstring can be loosened, and the containment flap can be spread and / or cut to gain access to bag features on the interior surface, such as electrodes and / or wires or wire connectors.

[0205] In some embodiments, a separate means of exposing the bag can be used, allowing the apron 2885 to remain in place until after exposure. The bag can be exposed by attaching leads or sutures 2888 (see FIG. 28 ) to a semi-rigid member 2889 that helps guide the bag opening toward and through the incision site. After exposure, the apron is accessible and can be lifted out of the incision site around the tissue specimen, where it can be cut or have perforation features 2890 that allow the user to pull it apart, thereby accessing bag features on the interior surface, such as electrodes and / or wires or wire connectors 2884. This embodiment has the added benefit of reducing the likelihood of contact between the peritoneum or the incision site and portions of the apron layer that came into contact with the tissue specimen during packing and manipulation. The apron can collapse somewhat within the interior bag volume. This “curtaining” effect prevents the apron from remaining too close to the interior surface of the bag. A feature can be added at a corresponding location on the interior surface of the apron and bag to help keep the distal most portion of the apron in place.

[0206] In some embodiments, as illustrated in Figure 30, a feature or tab 3092 on the apron 3085 can be included in the bottom or distal portion of the apron. A corresponding feature, slot 3093, can be included in a film layer added to the interior surface of the bag. The tab can be inserted into the slot during manufacture to help hold the apron close to the bag surface until a user applies force to pull the tab out of the slot and release the distal end of the apron.

[0207] One method of holding the distal portion of the apron against the interior surface of the bag is to weld or heat seal a small area around the perimeter of the bag. This weld holds the bag in place but is designed to easily break and release when the user applies force to remove the apron. Additionally, a larger portion of the distal apron can be welded to the interior side of the bag with perforations added to the apron to allow the user to pull the apron apart.

[0208] In some embodiments (see, e.g., FIG. 28), the interior surface of the bag can have a location feature configured to create a location for the wire crimp connector to reside in until connection by the user. The location feature can be a pouch, fold, or pocket 2891 created in the interior side of the bag. The pocket can be shaped to accommodate one or more connectors and / or removably hold the connectors in place until they are to be used. In some embodiments, an opening in the bottom of the bag can be provided and sized so that the connector can be placed into the opening but cannot unintentionally fall back through the opening.

[0209] In some embodiments, the bag has a pocket with an opening at the top and slots along the sides so that wires can be placed in the slots and connectors can be placed in the pockets.

[0210] In some embodiments, the pocket location is selected to align with a connector on the sectioning instrument to allow for connection. In some embodiments, the bag, bags, pocket, or pockets are positioned slightly below the proximal bag opening in a manner that remains under the apron to protect the connector during bag insertion, tissue specimen loading, and / or exposure.

[0211] One advantage of the apron is that it keeps the wires and connectors out of the way during packing. It is contemplated that multiple different aprons could be used to cover different wire sets, with one apron being removed first to expose one or more connectors for connection to an instrument, followed by a second apron being removed to expose one or more other connectors. In another embodiment, one apron could have openings for wire connectors to allow connection to an instrument while keeping the wires out of the way and avoiding accidental wire entanglement. In this embodiment, it is contemplated that one or more first aprons with connector openings could cover the wires while still allowing access to the connectors, while one or more second aprons could be used for the primary purpose of protecting the connectors prior to connection to an instrument.

[0212] The bag can include additional guides to house the common wire set to maintain alignment over the perforations near the bag opening. The guides can include heat shrink, tubing, and / or other means to hold the wires crimped together or attached proximally within a common wire connector. One or more guides can be used at locations along the wires that will allow the wires to perform as intended when held together, such as over perforations in locations near the wire connector.

[0213] 98 , in some embodiments, a guide lumen 9802 can be provided to control the relative positioning of a plurality of wires 9804, 9805 or a wire set 9810 having electrodes. The proximal end of the guide lumen 9802 can be coupled to or integral with a connector 9808 for attaching the wire set 9810 to the remainder of the device 102 (see, e.g., FIG. 1-Q). The guide lumen 9802 can be flexible or relatively rigid in some embodiments. In some embodiments, an isolating coating 9806 or material can provide an isolation zone for the electrode wires. The isolating coating 9806 or material can be configured to bias the wire electrodes 9804, 9805 away from each other so that the wires 9804, 9805 are better spaced apart once positioned around a tissue specimen.

[0214] The guide may extend from a location proximal to the bag opening toward the point where the wires need to separate in order to be routed into their corresponding wire channels. This distal end of the guide should be selected so as not to create excessive tension on the wires such that they naturally remain very close to the bag's inner surface as they exit the wire channels, and similarly should not interfere with tissue packing or the process of pre-tensioning the tissue during advancement of the introducer tube.

[0215] Some embodiments for guiding the wire near the bag opening can include an elongated wire channel, which can be used independently or in conjunction with heat shrink or other means of capturing the wire as previously described. The elongated wire channel can be composed of two polyurethane films that create a narrow channel for the wire to be placed inside during manufacturing. The film can be an extension of the wire channel attached to the inside surface of the bag, and may or may not be attached to the interior surface of the bag above the perforation.

[0216] In some embodiments, a common film can be provided that is attached to the sidewall of the bag up to the height of the maximum tissue specimen and free from the inner surface of the bag above this point. The connector can be pulled out of the bag to facilitate connection to a sectioning tool while still maintaining wire containment between the wire connector and the wire channel on the bag.

[0217] In some embodiments, the two film layers are attached together by RF sealing, welding, and / or any other means to form the lumen where desired containment is desired. In some embodiments, perforations are provided to allow the user to release the wire from the guide. The film may also be designed with a thin inner film layer to allow the user to "tear" the wire through the film before applying pretension, allowing unrestricted travel of the pretension introducer tube into the incision site in preparation for the cutting procedure.

[0218] In some embodiments, an elongated wire channel is positioned under the apron with its proximal end near the connector temporarily attached to the inside surface of the bag. This attachment may be by a heat-sealed connection designed with perforations for the user to tear when attaching the wire, by a thin film that allows the user to "tear" the elongated wire channel from the inside surface of the bag, or by using a slot in the side of the bag into which the elongated wire channel will be installed during manufacturing and / or other methods of attaching the channel to the inside surface of the bag. In some embodiments, attachment can be made with a wire connector by using an area of ​​the bag or pouch near the opening into which the connector will be installed during manufacturing that the user can remove during wire attachment.

[0219] The shape of the elongated wire channel can be designed or configured to reduce the likelihood of twisting the wire when released from the interior of the bag. In some embodiments, a relatively wide elongated channel can be provided. In some embodiments, multiple wire channels are provided and aligned side-by-side on the same elongated wire channel. The width of the elongated wire channel is adapted to withstand twisting of the wire as the user makes the connection. In some embodiments, a Mylar strip or other material is attached to the wire channel film to enhance this anti-twist feature. In some embodiments, the Mylar strip or other material is placed between the outer layer and a third layer of film to ensure the elongated wire channel remains naturally aligned in the proper position.

[0220] Some embodiments provide separate channels within the sectioning instrument. For example, a tray may provide separate channels that also align the tensioning mechanism during cutting. Keeping the different wire sets separate within the instrument eliminates potential entanglement or interference with each of the different wire sets as they are tensioned and as the cut progresses.

[0221] The guide structure described above becomes extremely important when the wire length is designed to allow for long separation of the wire connector from the specimen bag after exposure, or when the connection is secured to a tensioning mechanism such as described in applicant's co-pending U.S. patent application Ser. No. 14 / 805,358, the entire contents of which are incorporated herein by reference.

[0222] In some embodiments, the return electrode cable extends from the distal portion or bottom of the specimen bag along the sidewall of the bag out the bag opening. To ensure that the cut is not compromised, a means to ensure that the return electrode cable does not interfere with the wire set is important. This return electrode cable can be separated from the wire set by routing the cable in a location between the wire set under a return electrode cable "wire channel" constructed of polyurethane film, similar to a wire channel that houses the wire set channel by securing the cable to the inner sidewall, or it can be routed between layers of polyurethane film, or it can be created by depositing a conductive material on the bag surface with an additional insulating layer to ensure electrical isolation.

[0223] The sectioning device can include markings on its exterior surface that visually align the device's orientation with specific features on the exposed portion of the specimen bag. This allows the user to maintain proper alignment during connection of the specimen bag's wire connector to the sectioning device. The alignment feature can be a label, an inserted feature, an overmolded feature, a molded feature in the housing, a silkscreened shape, a shape with a similar color, a registration number or other symbol, or other means of identification for the user. Some embodiments can include a contrasting line applied axially to the outer housing of the distal tube so that when the line is aligned with the return electrode cable, the device is in proper alignment with the specimen bag for wire connection.

[0224] With the introducer tube extended into the sample bag and against the tissue sample, any slack within the wires is removed, and tension is applied to all wire sets. This tension aligns the wires from the distal end of the introducer tube to the wire attachment point inside the sectioning device. This alignment ensures that each wire set can advance through the device without interfering with the other wire sets. Without this alignment, there is an increased chance that a non-activated wire set will catch or become entangled with a cutting wire set.

[0225] 31 , a retrieval bag 3130 for the system 100 may be provided, which may include an inflatable feature. Inflation of the bag 3130 may be achieved using a honeycomb pattern of inflated or inflatable cells 3132. The multiple inflatable cells 3132 may provide a thermal barrier between the patient and the electrodes / wires inside the bag 3130. If the inner layer is punctured or thermally fails, the cells 3132 will collapse, leaving the remaining cells 3132 intact and continuing to provide thermal protection. In some embodiments, the cells 3132 may include multiple inflation channels 3132, some or all of which are associated with separate pressure retention means, such as separate syringes or stopcocks. In some embodiments, the bag 3130 may include small, isolated areas of quiescent air trapped under pressure.

[0226] The inflated cells 3132 provide an additional insulating barrier between the tissue sample or electrodes and adjacent structures outside the exterior surface of the extraction bag. In contrast, if the entire bag were inflated as a single cell, failure of one of the layers would result in a loss of inflation and insulation. By providing multiple independent inflation regions 3132 within the bag 3130, if one of the layers within an individual region fails, the insulation of that layer may be lost or degraded, but the remaining inflated cells 3132 continue to provide insulation, minimizing any thermal damage caused to the patient.

[0227] 31 , a harvesting bag 3130 may be provided with multiple inflation areas 3134 (labeled 1, 2, 3, 4), each with a separate pressure source or separate pressure maintaining means. Those skilled in the art will appreciate that any number of inflation areas 3134 may be provided, and that an equal or fewer number of means for inflation may be provided. For example, a first inflation area 3133 may be fluidly coupled to a second inflation area 3135, allowing a single pressure source 1 to pressurize both areas 3133, 3135.

[0228] In some embodiments, an expansion feature or function is integrated within the wire channel. For example, the channel can include a third layer. The first layer is a perforated layer, the second layer is a boundary layer, and the third layer is a bottom layer. The boundary and bottom layers are sealed so that when low-pressure air or fluid is applied, the channel expands to provide structure directly beneath the wire channel. This has the benefit of providing insulation directly beneath the wire, which helps provide structure to aid in the release of the wire from the channel.

[0229] Turning now to FIG. 32, some embodiments for tissue sectioning include using ultrasonic energy to provide a vibratory motion to the electrodes or wires, either in combination with or independent of voltage and current applied to the tissue through the electrodes or wires. As previously explained, the mechanical load F (see also FIG. 2) on the wires 122, 124 is crucial and can be a constant force or dynamically applied. Dynamic loading includes the use of vibrations, where a transducer can be used to generate high-frequency vibrations on the wire or wire end. The use of ultrasound to create vibrations can be used alone or in conjunction with RF energy. In some embodiments, the ultrasonic transducer is on the sectioning instrument. When the wire connector on the bag is coupled to the sectioning instrument, ultrasonic or high-frequency vibrations are transmitted to the wires within the bag while the wires are pulled through the specimen using a spring or alternative means to apply force.

[0230] In some embodiments, a piezoelectric crystal or piezoelectric crystal stack 3202 is coupled to the end of a tensioning mechanism 3204, which may include a spring 3206 or other means of applying a mechanical load. As illustrated, the active electrode wire 3208 may be mechanically linked onto an arm 3212 that vibrates orthogonally to the tensioning mechanism 3204. The vibrating arm 3212 may be acoustically coupled to the piezoelectric crystal 3202. The crystal 3202 may use an ultrasonic horn 3214 or coupling to amplify the displacement and may be oriented in a way that torsional motion within the ultrasonic range causes vibrations axially or longitudinally along the electrode or wire.

[0231] A control system can be applied to the piezoelectric crystal electrodes to drive vibrations at an optimal frequency. The control system can utilize a phase-locked loop to control the optimized frequency to provide the highest ultrasonic power transmission through the wire and into the tissue. The phase-locked loop can also have an amplitude-modulated gain stage designed to maintain vibrations from the lowest to highest forces applied by the tensioning device. Other control systems that do not maintain a constant displacement, such as a fixed oscillation or Wien bridge oscillator, can be used as a complement to RF energy cutting.

[0232] In some embodiments, the introducer (see FIG. 5) can act as a protective sleeve for the incision site. In some embodiments, referring again to FIG. 32, one side of the electrode / wire 3217 terminates at a fixed location 3216 on the tensioning mechanism 3204, and the other side of the wire 3217 is coupled to a vibrating portion of the piezoelectric crystal 3202. The wire 3217 is thus configured to expand and contract, allowing tissue sectioning to occur with the stirring and frictional heating response of the wire 3217 against the tissue interface. The wire 3217 can be configured to capture the entire specimen and cut large sections, or in some cases, to cut smaller portions of the tissue specimen that would be extracted as smaller sections, in a manner similar to a mechanical sectioner.

[0233] 33, a tissue sectioning device 102, 200 (see, for example, FIGS. 1-Q or 2) may be provided having one or more wire electrodes 3302 and a tissue extraction bag 3304. The wire electrode 3302 may be coupled to the tissue extraction bag 3304 by embedding the wire electrode 3302 in a film 3306 on the interior of the tissue extraction bag 3304. The tissue cutting effect can be initiated by applying power to the wire electrode 3302 and causing the film 3306 to break down, which releases the wire electrode 3302 from the bag and initiates a spark between the tissue and the wire electrode 3302 to achieve the tissue cutting effect.

[0234] Those skilled in the art will understand that generally, activation of the wire to initiate the cutting effect results from separation between the wire electrode 3302 and the tissue when power such as RF energy is applied, and that a coating on the wire electrode or film material or any other component within the bag 3304 may be suitable to achieve this effect.

[0235] In some embodiments, a separate means for pretensioning the tissue sample and an insulating layer between the wire electrode 3302 and the tissue are provided for this purpose. This layer could be a layer of pressurized air, a layer of non-conductive fluid, an insulating film or layer applied between the wire and tissue that can serve the alternative function of applying tension to the tissue sample, or it could be achieved using a design of the bag, wire attachment, and pretensioning mechanism that results in a gap within the tissue-wire / bag interface during operation. The desired wire set to be activated can have power, such as RF energy, applied, and after sufficient power with voltage is applied, the wire set can be pulled to the tissue surface or can be mechanically, electrically, or thermally broken through the separating layer to initiate the cutting effect. Generally speaking, any easily electrically removable (or degradable) adhesive or holding volume can be provided to hold the wire electrode in place, as illustrated in FIG. 33. Upon electrical input, the bare wire electrode 3302 will cut through the holding medium (adhesive / holding volume) or film 3306. This degradable medium or film 3306 may also provide pseudo-voids to facilitate initiation of the tissue cutting effect.

[0236] 34 , a return electrode 3420 is attached to the bag and includes extensions 3421 that extend longitudinally down the sidewall of the bag. These extensions 3421 are positioned between active electrode channels 3422 and are electrically connected using a ring 3423 at the distal portion of the sidewall of the bag. In the illustrated configuration, the wire 151 crosses the return electrode 3420 only at the ring 3423. Therefore, one skilled in the art will recognize that the return electrode 3420 should be isolated from the wire 151 at the ring 3423, such as by a film 802, as previously described herein. The isolation required to insulate the return electrode 3420 from the active electrode / wire 151 is reduced in the illustrated embodiment by the use of the extensions 3421. That is, in some embodiments, the device 102 or system 200 can include multiple conductive elongated portions or extensions 3421 coupled to a base or ring portion 3421. Additionally, this configuration provided the lowest observed impedance occurring at the beginning of the cut (e.g., near the bottom of the bag or ring 3421). As the wire 151 travels into the tissue, the impedance increases slightly, providing more energy to sustain the cut as the wire travels away from the return electrode 3420.

[0237] One additional benefit of the return electrode 3420 is that the bag assembly can be more easily compressed to a smaller diameter to aid in insertion through an incision site.

[0238] 35, the return electrode 3540 may include an area for folding or collapsing the return electrode 3540 to aid insertion through an incision site. For example, the return electrode 3540 may be a dual return electrode 3540 having a first return portion 3544 and a second return portion 3546 attached to the inner surface of the distal portion of the bag. The portions 3544, 3546 may have recessed areas 3542 that allow the extension portions 3548 to collapse, for example, similar to an umbrella. At least a portion of the extension portions 3548 may have a pie shape or taper between a wide distal portion and a narrow proximal portion relative to the center of the return electrode 3540. In some embodiments, the first portion 3544 of the dual return electrode 3540 has approximately five extension portions 3548, and the second portion 3546 of the dual return electrode 3540 has approximately five extension portions 3548. In some embodiments, the first and second portions 3544, 3546 are mirror images of each other.

[0239] The dual return electrode 3540 can be configured to collapse upon entry and allow for easier insertion, while providing a large surface area 3549 when tissue is packed and tension is applied to the bag. One skilled in the art will appreciate that the number of recessed areas 3542 and the ratio of return electrode surface area 3549 to recessed area 3542 can be adjusted to ensure that the surface area 3549 remains large enough to maintain lower return electrode heating during power activation and ease of collapsibility during insertion of the bag into the incision site.

[0240] Methods for manufacturing return electrodes such as those described herein can include adhering the return electrode and cable to a bag or forming the electrode on the surface of the bag using vapor deposition, spray coating, or conductive printing processes. Deposition or conductive printing methods can provide improved flexibility of the finished bag, allowing for easier insertion. The adhering return electrode and return electrode cable can be made from a flexible circuit adhered with an adhesive or integrated into the bag layer by heat sealing at the interface of the cable and / or return electrode.

[0241] In some embodiments (not illustrated), tissue sections can be marked for identification through the use of power modulation of each wire or set of wires, such as by providing different power settings or waveforms to leave a distinctive dry layer or pattern as part of the sectioning cut. The different power settings or waveforms can be modulated higher frequency waveforms combined with the basic waveform that delivers RF power to the tissue. Thus, the primary function of controlling the RF power delivered to effect the cut can be relatively unaffected by the modulated waveform by using analog or digital low-pass or band-pass filters in the control system feedback loop. That is, the method 10000 can include adjusting the power settings to cause each of wires 1-N to leave an identification pattern in the cut associated with it. In some embodiments, the identification pattern can be different for each wire, or some wires can have the same identification pattern as others (e.g., some can simply identify direction, or which wire is first or last, etc.).

[0242] 36, the electrodes / wires can have color-coded powder applied to their surfaces such that each electrode / wire has a different color and the distal end of the tissue specimen becomes marked when the wires are pretensioned against the tissue specimen. For example, a first wire 1 can have a powder coating with color A, and a second wire 2 can have a powder coating with color B. The resulting markings on the tissue specimen can be used to recreate the orientation of the sectioned tissue specimen pieces.

[0243] Referring now to FIG. 37 , in some embodiments, electrodes or wires can be equipped with insulating or highly conductive sections that provide a “signature” or orientation mark at each tissue tip as the wire travels through the tissue specimen. For example, as illustrated in FIG. 37 , a coating 3702 can be applied to a first active electrode 3712 to define an active electrode surface area. Within the active electrode surface area, there can be two bands 3704 of insulating material that are less conductive to power or RF energy than the surrounding area. As a result, the current concentration at the tissue / insulation 3704 interface is lower. This results in a visual difference in the drying of the tissue specimen after cutting. The surface of the tissue will have lines created by these insulating bands 3704, which can be used to identify which tissue sections have been cut by the first active electrode 3712. These bands 3704 can be repeated throughout the first active electrode 3712 to leave this pattern across the cutting plane.

[0244] 37, the second active electrode 3714 can have multiple bands of insulating material 3704 in a number different from the number of the first electrode 3712. The third active electrode 3716 can have multiple bands of insulating material 3704 in a number different from the number of the first active electrode 3712 and the second active electrode 3714. More or fewer electrodes may be provided with bands 3704 in any suitable pattern to distinguish section planes cut from each active electrode 3712, 3714, 3716 from other planes.

[0245] In some embodiments, the first ring of material 1006 can have a different longitudinal dimension than the second ring of material 3708. In some embodiments, the first and second rings of material 1006, 3708 can have a different conductivity than the remainder of the coating 3702 of the electrode 3716. In some embodiments, the rings of material 1006, 3708 have a higher conductivity than the remainder of the coating 3702. In some embodiments, the rings of material 1006, 3708 have a relatively low conductivity. In some embodiments, the first ring 1006 has a total surface area that is different from the total surface area of ​​the second ring 3708.

[0246] In some embodiments, the length of the insulating material 3704, the number of bands per given length, and / or the spacing of the bands 3704 can be modulated to adequately distinguish between cuts made by each active electrode. In some embodiments, instead of an insulating material, the bands can comprise a highly conductive material that conducts a higher percentage of electrical current than the typical coating 3702 on the active electrode surface. That is, generally speaking, the identification bands 3704 can be more or less conductive than the coating 3702.

[0247] In tissue sectioning procedures, the surgeon can pre-mark the tissue specimen during packing or after the bag has been exposed.

[0248] In some embodiments, when the bag is exposed, an ink stamp may be provided on the surface of the proximal tissue specimen, which may be an ink stamp marked during packing or may be a dye injected into the area of ​​interest within the specimen prior to sectioning.

[0249] 1-Q, in some embodiments, a harvesting bag 161 may be provided that contains multiple sets of active electrode wires 153, 155, 157, 159. The bag 161 and active electrode wires 153, 155, 157, 159 may be designed with a specific wire 153, 155, 157, 159 activation sequence to avoid interference between a first set of wires and a second set of wires. To prevent a user from activating power or RF energy in the wrong sequence, the connectors may be color-coded or shaped to correspond with the connections of the tensioning mechanism. Relatedly, the tensioning mechanism may have a predetermined operation sequence selected by a user or a controller.

[0250] The receptacles of the tensioning mechanism designed to couple to the active electrode wire connectors can have a color and shape associated with them. Corresponding active electrode wire connectors can have the same color or shape, allowing the user to couple similar colors or shapes together to ensure proper coupling order is maintained. In some embodiments, a method for ensuring proper coupling order is maintained includes giving each tensioning rod receptacle a unique shape so that it will only accept corresponding active electrode wire connectors with unique mating shapes. Alternatively, each wire can have a coating impedance that increases from one wire to the next. Energy can then be applied to all wires, but the coating variations will force the wires to ignite or cut sequentially rather than simultaneously.

[0251] In some embodiments, the spring 676 is used as a direct conductor for applying power or RF energy to the wire, and an insulating coating can be applied to the surface of the spring to control when power can be applied. The location of this insulating material can be applied such that when the spring is in a fully extended or pretensioned position, the insulating coating is positioned at the contact point between the power or RF energy and the spring's electrical interface. When the device is pretensioned and the spring advances to apply tension on the tissue sample, the insulating coating advances up the spring coils, and the conductive portion of the spring is now in contact with the RF energy and spring's electrical interface. An additional insulating coating can be applied where the spring completes its cut so that the power or RF energy is terminated.

[0252] Some organs for specimen dissection include, but are not limited to, the uterus, ovaries, kidneys, colon, spleen, liver, gallbladder, and lungs. For some organs, a non-circular distal instrument tip is beneficial for minimally invasive specimen access and removal, such as in video-assisted thoracoscopic surgery (VATS) for the lungs. In this case, due to the spacing between ribs, the incision may be wider than it is tall. In this case, a non-circular sectioning instrument may be advantageous to accommodate or optimize the use of available space. For example, typically three or more tensioning mechanisms may be arranged in a line within an elongated, oval-shaped instrument tip. The bag shape may also be modified to better align the electrode wire assembly with the shape and size of the tissue specimen. This may in turn require a different number of active electrode assemblies or different active electrode wire lengths.

[0253] In some procedures, the specimen is likely to contain staple lines or clips remaining from the resection. This is particularly common in pulmonary and colonic procedures. It may be desirable to utilize a stronger wire that is more likely to penetrate the staple line during cutting without fracturing the active electrode. This can be achieved through the use of a stronger material, such as titanium. Similarly, it can be achieved through the use of a larger diameter wire or strand than would typically be used.

[0254] As technology advances and drives more minimally invasive procedures, the incision sizes commonly used in surgery continue to shrink. As these sizes become smaller, the need to extract tissue specimens routinely removed using currently available methods becomes more challenging. In addition to the organs mentioned above that are candidates for specimen sectioning for removal, smaller portions and chunks of these organs that are not deemed necessary for tissue sectioning prior to removal will also be candidates for removal in the future. An example would be the appendix or gallbladder, which can easily be removed through a 5 mm trocar today, but as the use of 3 mm or smaller instruments becomes more common, instrumented sectioning becomes an obvious solution for removal.

[0255] In some embodiments, a pressure-displacement connector including a resistor, optical feedback, or RFID with corresponding circuitry within the tissue sectioning device 100 or controller 108, 708 may be provided that can implement an identification method. In some embodiments, the identification method includes (a) identifying a specific exposure length to the controller to inform the controller of the proper power setting (the controller can adjust if a different length exposure is used), and / or (b) identifying the type of bag being used to the controller. The identification method may include distinguishing or identifying the use of a small uterine bag, a large uterine bag, a lung bag, a colon bag, a kidney bag, etc. The bag identification method may be achieved using a resistor value, optical signature, or RFID as an index to a pre-programmed lookup table within the controller 108 or data store 110 of the device 102. The index may point to stored parameters that update the parameters for the specific type of bag or specific active electrode wire set coupled to the connector housing the resistor. In some embodiments, information programmed in optical encoding or RFID content is used to update the parameters with information passed to the controller 108. This information, in some embodiments, may include a sequence number so that the controller is configured to apply RF energy in the correct sequence for any connections made by the user, or may include impedance or other performance information that can be used as adjustments to the parameters for that particular active electrode wire set.

[0256] 38 and 39, some embodiments may include resistors 3800, 3901 integrated into a pressure-displacement connector 3905 to provide a resistance value that can be used to provide information about the active electrode wire set. FIG. 38 illustrates one example of a resistor 3801 with a resistive element 3802 and contacts or end cap 3803. The resistive element 3802 provides the desired resistance and can be a carbon film or wirewound material. The contacts or end cap 3803 is constructed of a highly conductive material, such as tin-plated copper or aluminum, and is attached to the resistive element 3802 in a manner that allows the desired resistance provided by the resistive element 3802 to be electrically measured between the two contacts 3803.

[0257] 39 illustrates one embodiment of integrally coupling a resistor 3901 within a crimp connector 3905 and crimp ferrule 3906. The crimp ferrule 3906 includes the termination of common active electrode wires 3907 that are intended to be mechanically and electrically coupled. These wires 3907 pass through lumens within the crimp ferrule 3906 and are crimped to mechanically secure the wires while also providing an electrical coupling between the active electrode wires 3907 and the crimp ferrule 3905. Those skilled in the art will recognize that these wires can be welded, secured, or captured inside the crimp ferrule by means other than crimping, so long as that method provides an electrical coupling from the wires 3907 to the crimp ferrule 3906.

[0258] In some embodiments, the insulation displacement ferrule 3906 has a stepped feature at its proximal end such that the insulation displacement ferrule 3906 is secured within or relative to the insulation displacement connector 3905, thereby providing a mechanical and electrical coupling between the insulation displacement ferrule 3906 and the insulation displacement connector 3905. The resistor 3901 may be placed inside the insulation displacement connector 3905 such that the distal end cap 3909 is in electrical contact with the distal insulation displacement ferrule 3906. This provides an electrical coupling from the outer surface of the insulation displacement connector 3905 to one end of the resistor 3901.

[0259] Notably, the proximal end cap 3910 is electrically isolated from the insulation displacement connector 3905. This is achieved by creating an isolation barrier 3908 which may be provided, for example, by an insulating film between the body of the resistor 3901 and the interior surface of the insulation displacement connector 3901. This may be a physical separation with an insulating film or coating applied to the top portion of the interior surface of the insulation displacement connector, an insulating film or coating applied to the sides of the end cap 503, an end cap having a smaller diameter than the resistive element, or by placing the resistor inside an insulating component that exposes only the center of the top end cap prior to insertion into the insulation displacement connector.

[0260] In some embodiments, the resistance of the resistor 3901 can be measured electrically between the proximal end cap 3910 and the outer surface of the insulation displacement connector 3905 .

[0261] 39, the component within the tensioning tool that interfaces with the insulation displacement connector includes a central axial component (not shown) that is electrically isolated from the outer portion. The axial component may have a spring or other means to ensure contact when the insulation displacement connector 505 is installed within the tensioning tool. The resistance of resistor 501 is then measured by applying a known voltage or current between the central axial component and the outer portion that contacts the remaining surfaces of the insulation displacement connector 505 and measuring the resulting other, i.e., current or voltage.

[0262] 40, in some embodiments, a resistive element 4020 may comprise a coating or ring of material at the proximal end of the insulation displacement connector 4021. This resistive element 4020 may be applied by spraying, vapor deposition, machined and bonded in place, or applied by other means. An electrical coupling may be provided from the wire 4007 to the insulation displacement ferrule 4006 as described above with reference to FIG.

[0263] Here, the component inside the tensioning tool (not shown) that interfaces with the insulation displacement connector 4021 must have a separate contact point on the internal mating surface at the proximal end and be electrically isolated from the lower portion. The resistance of resistor 4020 is then measured by applying a known voltage or current between the proximal contact point and the outer portion that contacts the remaining surface of the insulation displacement connector, and measuring the other resulting current or voltage.

[0264] The step of measuring the resistance can be accomplished using analog circuitry, such as an operational amplifier or other means for applying a reference voltage and an analog-to-digital converter for measuring the resulting electrical parameter. This circuitry can be located within the tensioning tool or within the controller.

[0265] Each side of the resistor 501, 4020 can be provided with a separate electrical trace, which can be achieved by applying a thin conductive trace onto the surface of the spring, separated from the spring by an isolator film. The conductive trace can be routed to either an axial contact (see FIG. 39) or a proximal contact (see FIG. 40) by a termination block that connects the tensioning rod to the spring at the distal end of the device. At the proximal end of the spring, a separate spring contact located on the spring coil aligns with the conductive trace and the rest of the spring surface.

[0266] In some embodiments, the electrical traces are provided by using separate contact areas on the outer surface of the termination block that are routed to either the axial contacts illustrated in FIG. 39 or the proximal contacts illustrated in FIG. 40. When the insulation displacement connectors 4006 are attached, the instrument is in a fully extended position. In this position, spring contacts located within the instrument housing can be aligned with the contact areas on the termination block to take a resistance measurement prior to applying pretension to the instrument. In some embodiments, the measured resistance value for each insulation displacement connector is stored in a data store that may be located on the tensioning instrument or in the controller itself.

[0267] 1-Q, in some embodiments, a system 100 may be provided that includes a bag 161. The bag 161 may include multiple active electrode sets 153, 155, 157, 159, each having a resistor (not shown). The first electrode set 153 may include a resistor having a first resistance, such as 100 ohms. The second electrode set 155 may include a resistor having a second resistance, such as 200 ohms, the third electrode set 157 may include a resistor having a third resistance, such as 300 ohms, and the fourth electrode set 159 may include a resistor having a fourth resistance, such as 400 ohms. The controller 108, 708 may detect each resistor value and apply RF activation to the electrode sets 153, 155, 157, 159 according to a specific order. In some embodiments, power is applied first to the first electrode set 153, second to the second electrode set 155, and so on, regardless of the tensioning mechanism in which the electrode sets are coupled.

[0268] A second type of bag, similarly with four active electrode wire sets, might house resistors of 1100 ohms, 1200 ohms, 1300 ohms, and 1400 ohms, respectively. Using this approach, one skilled in the art would recognize that a large number of bag types with various combinations could be supported using a controller containing look-up table information.

[0269] In some embodiments, the system is configured to perform a tissue-to-return interface impedance check. Those skilled in the art will appreciate that having good contact between the device's return electrode and the tissue specimen is paramount to maintaining cryosection. One method for ensuring this contact is described in the open-circuit check described earlier in this specification. Another method utilizes two segments of the return electrode in a manner similar to methods known in the art. Using known methods, a small interrogation signal is applied by the electrosurgical generator between the two segments of the return electrode. This signal is used by many currently available generators to calculate the impedance between the two return electrode segments. As tissue simultaneously contacts the two segments, the tissue impedance between the segments will offer a low resistance. This is continuously monitored by the generator; if the tissue loses contact with the return electrode, a change in impedance can be observed and an alarm condition can be triggered, allowing the user to respond to the situation.

[0270] In some embodiments, a travel / position indicator is provided. Graduated markings on the surface of the spring, in conjunction with an optical encoder or transmitter / receiver pair, allow for relative measurement of spring travel. By integrating the travel length over a period of time, the electrode / wire travel speed can be detected. The travel length can be determined by counting the markings from the pretension location. A travel stall condition can be identified and indicated by a travel speed lower than acceptable.

[0271] 41 , as illustrated, an active electrode connector recognition method 4100 is disclosed. The method 4100 may include one or more of: (a) coupling an active electrode to a tensioning mechanism 4102; (b) reading a resistance value 4104; (c) determining whether the resistance value has a corresponding lookup table index 4106; (d) determining whether the active electrode index value is consistent with other prior couplings 4108; (e) determining whether all expected active electrodes have been coupled based on the index values ​​4110; (f) updating parameters 4112; and (g) alerting an operator 4114.

[0272] Applicant has determined that as tissue is sectioned with multiple power or PF energy activations of system 100, the tissue structure may weaken and the tissue may "flow" or change shape, resulting in irregular or non-repeatable section sizes. Methods for reducing this tissue flow may be provided, including holding the tissue during sectioning to inhibit flow.

[0273] For example, with reference to Figures 42 and 43, expansion may be provided in specific areas to hold tissue in place.

[0274] FIG. 42 illustrates plan and side views of an extraction bag 4200 having four separate active electrode wire sets 4202. The bag 4200 also includes inflatable channels 4204 that run parallel to the wire sets and are positioned on the surface of the bag between the wires. These inflatable channels 4204 are deflated when the tissue specimen is loaded and inflated after the bag 4200 is exposed and connected to the electrosurgical device 102. The inflation stretches the inflation channels 4204 on the bag 4200 into contact with the surface of the tissue specimen and provides support around the bag 4200. At this time, the tensioning mechanism is pretensioned to begin the sectioning process. The location of the inflation channels 4204 can be selected to allow the active wire electrodes to contact the tissue and perform the cut without interfering with the channels 4204. The location of the inflation channels 4204 can also support the tissue throughout the cut and reduce tissue “flow.” After cutting is complete, inflation channel 4204 may be deflated to allow for specimen removal. This inflation and deflation may be accomplished using a syringe. In some embodiments, controller 108 or a second device may be configured to automatically adjust the pressure. Feedback about successful pressure application can be provided by observing the acceptable volume range applied for inflation using a syringe and the resistance to pressure increase with a pressure sensor, either manually with automated syringe application or in an automated pressure delivery device.

[0275] 43 illustrates a method 4300 of using a tissue extraction bag for tissue support. The method 4300 may include one or more of: (a) loading a tissue specimen 4302, (b) exposing a bag opening 4304, (c) coupling an active electrode wire connector to a tissue sectioning device 4306, (d) expanding an expansion channel to hold the tissue specimen 4308, (e) inserting an introducer into the patient as pretension is applied to the tensioning mechanism 4310, (f) sectioning tissue for all active electrode wire sets 4312, and (g) contracting the expansion channel 4314.

[0276] Returning now to FIG. 41 , in some embodiments, after successful completion of active electrode recognition, the instrument or controller can update parameters as shown in FIG. 41 . The activation order can be included as part of this parameter update. Thus, the instrument or controller can automatically select the active electrode wire corresponding to the initial pull for applying power or RF energy. Additionally, the instrument or controller can also select a pretensioning mechanism associated with the active electrode wire corresponding to the initial pull. A solenoid or other electromechanical means for locking out the pretensioning mechanism until an enable signal is applied from the instrument or controller can provide the pretensioning mechanism selection capability of the instrument or controller. It may be desirable to simultaneously enable the pretensioning mechanisms of the first and / or second active electrodes to assist in retaining the tissue specimen before and / or during cutting.

[0277] Some methods and / or systems improve the reliability of cutting by pretreating the tissue sample prior to cutting, for example by applying low temperatures to freeze the tissue. This can result in a more rigid specimen and reduce the thermal consequences of cutting. Some methods include injecting a fixative material into the tissue specimen, which increases the specimen's rigidity.

[0278] In some embodiments, the tensioning mechanism may include a constant force spring 702 and / or other mechanisms such as a pulley system, a cable drive or winch system, a non-linear spring, a linear drive with a rotational coupling such as a gear or contact coupling, a linear drive with a magnetic coupling, a linear drive with manual control, and / or an electromechanical drive, such as a servo or stopper motor drive or linear actuator, as previously described.

[0279] In some embodiments, methods for preparing or examining tissue specimens are provided. One method for marking and reassembling tissue specimens for subsequent pathological examination involves a surgeon marking the area or margin of interest before or immediately after placing the specimen in a bag. The surgeon can then section the tissue and remove the section from the bag. Once removed, the specimen can be reassembled or otherwise identified and examined for pathological assessment. Marked specimens can be identified visually or can include fluorescent or similar chemical markers to allow the user to identify sections using fluorescent light.

[0280] 44 , in some embodiments, a dedicated marking tool 4400 may be provided and utilized by a surgeon to mark areas or margins of interest on a specimen prior to sectioning. The marking tool 4400 may include a shaft 4402 configured to fit through a laparoscopic opening or trocar. In some embodiments, the shaft 4402 of the marking tool 4400 has a small diameter of 2 to 20 millimeters, although one skilled in the art will appreciate that other sizes may be suitable. The marking tool 4400 may include marking ink present on the surface of its distal end 4400. In some embodiments, when placing the marking tool 4400 within a patient's cavity, a sheath 4406 may be used to cover the ink-containing distal end 4404, which may then be retracted or withdrawn by the user to expose the inked portion of the tool 4400. The length of the exposed portion 4408 and / or distal end 4404 can be determined by the user based on the length to which the sheath 4406 is retracted. In some embodiments, the ink can only be released by the user in a manner that is on the marking end of the device only after the device has been placed inside the patient.

[0281] In some embodiments, distal end 4404 has a relatively long, inked exposed portion 4408, e.g., up to about 6-8 inches in length, for rapid marking of large surfaces on a specimen. In some embodiments, the entire distal end 4404 can have exposed portion 4408. In some embodiments, exposed portion 4408 is less than the entire distal end 4404.

[0282] Alternatively, in some embodiments, a relatively small exposed portion 4408 may be provided to control ink placement in more precise or selective areas. One skilled in the art will appreciate that the length of the exposed portion 4408 can be adjusted or selected based on many factors, including, but not limited to, specimen size, patient size, surgical cavity size, specimen location, and / or other factors. In some embodiments, the marking tool 4400 has an articulating link 4410 to allow articulation of the distal end 4404 to the proximal end 4412 to facilitate marking of the specimen.

[0283] In some embodiments, the dedicated marking tool 4400 can have a means for expanding the diameter of the distal end 4404 once inserted into a patient's body, reducing the diameter before removal from the patient, and in some embodiments, returning to its original diameter before removal from the body. In some embodiments, an inflatable balloon 4414 can be provided that contains ink on its outer surface. A user can inflate the balloon 4414, mark an area of ​​interest on a specimen, deflate the balloon 4414, and then remove the marking tool 4400 from the body. The balloon 4414 can be contained within the shaft 4402 of the marking tool 4400 and extended from the distal end of the shaft 4402 prior to inflation of the balloon 4414. The ink can be present on the expansion member prior to insertion into the patient's body, or can be present in a small pouch inside the device, allowing the user to expand the marker and then rupture the pouch or otherwise release the ink to apply it with the expanded member.

[0284] Continuing with reference to FIG. 44 , the distal end can be configured to expand within a patient using a leaf spring-like expansion mechanism 4418 or fan 4416 that holds the ink pad. In some embodiments, a self-expanding material such as a sponge, or a material that expands upon exposure to water or liquid, any memory-retaining material, or similar means can be provided to allow expansion after insertion into a patient. That is, the expandable marking ends 4414, 4416, 4418 can be provided to be minimized before removal from the patient, such as by retracting the expandable marking ends 4414, 4416, 4418 back into the instrument shaft 4402 or by extending the sheath 4406 back over the marking ends. Those skilled in the art will readily envision any number of actuation mechanisms to achieve this functionality.

[0285] Turning now to FIG. 45, the bag 4500 with marking features will be discussed in more detail. Because the cryo-cutting approach creates a very clean cut with minimal damage to the tissue, a sectioning approach can be used for tissue that requires subsequent pathological assessment, such as in cancer surgery. As previously explained, ink or markers can be used to help identify the specimen piece while it is in the bag or once removed from the bag. Additional approaches may be used to facilitate pathological examination.

[0286] For example, as illustrated in FIG. 45, a tissue extraction bag 4500 can be provided with a different color marker or ink 4502 for each predicted tissue section by storing ink on the return portion 4504 of the bag 4500. The ink 4502 can be heat-sensitive ink (or a small pouch that opens with sufficient heat and releases the ink) or the like that is released when the electrodes or wires are activated to ensure that the ink 4502 is properly placed on the resulting section. In some embodiments, one or more of the electrodes or wires 4508 can have a coloring material 4510 integrated therein that remains on the tissue during cutting, such as by using a low-temperature material that elutes from the electrode or wire 4508 onto the tissue.

[0287] In some embodiments, the bag 4500 may be manufactured with ink 4502 contained in one or more relatively small ink bags 4506 that are attached to the bag 4500 during manufacture. Alternatively, the ink bags 4506 may be assembled empty into the bag 4500, with ink being injected into the bag 4506 by the surgeon prior to or during use through a channel opening on the distal end of the bag. This has the advantage of allowing the surgeon to select their own ink or marker of choice. In some embodiments, one or more ink bags 4506 may be attached to the return pad 4504 of the bag 4500. In some embodiments, one or more ink bags 4506 may be attached to the flexible container 4512 of the bag 4500. In some embodiments, multiple ink bags 4506 may be attached to both the return pad 4504 and the flexible container 4512.

[0288] 46, in some embodiments, the sectioning instrument can be provided with a distal end 4600. The distal end 4600 can include ink 4602 attached to or coated on one or more expansion valves 4604 or other sectioning instrument features that expand the wires / electrodes 4608. In some embodiments, the distal end 4600 of the sectioning instrument can have ink 4602 positioned on one or more distal surfaces 4606 of a tube and / or one or more valves 4604 intended for contact with tissue. Once the sectioning instrument 102 (see, e.g., FIG. 1-Q) is pretensioned, the specimen is brought into contact with the inked features 4604, 4606.

[0289] In some embodiments, the physician can apply a marker after sectioning and prior to removal of the section from the bag. Marking of the sample can be done on the end of the sample section closest to the exposed bag opening using a surgical marker, ink 2314 (see, e.g., FIG. 45), or a physically attached tag, clip, or RFID tag. This allows the pathologist to reorient the sample sections once they are transported from the operating room. These markers may also be integrated into the bag.

[0290] 45, one or more RFID tags 2316 may be attached or removably attached to the bottom surface of the bag 2300 on one or more of the return portions 2304 (defined by the pattern created by the electrodes / wires prior to cutting). One or more barbs 2318 or any other means may be provided to attach the RFID tag 2316 to the tissue section.

[0291] In some embodiments, prior to or immediately after loading the specimen into the bag, the surgeon can mark the surface or portion of the specimen that requires pathological evaluation for margins. This can be done with a marker or ink. The specimen can then be sectioned and removed from the patient. A pathologist can then find a section containing this surface and assess the margin or any cancer cells that may be found on this surface.

[0292] Some embodiments include using imaging recognition, including but not limited to a digital camera and / or ultrasound, to image the specimen prior to sectioning, removal, or during removal of the section from the bag. Digital image processing can then be used to reorient the section to recreate the specimen using software designed to recognize features on the section and reorient them to the correct location relative to one another. Low-cost digital cameras with digital imaging software can also provide an inexpensive, automated means for reorienting the section to its original orientation. This can be done with or without pre-marking the specimen before imaging.

[0293] Some embodiments include reconstructing the excised tissue specimen after removal and using common imaging modalities, such as fluoroscopy, on the sectioned tissue specimen to determine the location of the area of ​​interest within the tissue specimen, which may also be used to perform additional diagnostics on the specimen to determine the extent of pathological evaluation required or to guide any remaining surgical intervention required.

[0294] In some embodiments, markers can be used to identify known tumors or structures of interest either prior to or during surgery. The bag can also have markers or fiducials that can be packed and imaged or scanned as part of the bag to indicate the orientation of the specimen (and tumor) relative to the bag. By tracking specimen sections as they are sectioned and removed, the known original location of the tumor, and therefore the section containing the tumor, can be determined. This provides the pathologist with additional information during their evaluation.

[0295] In some embodiments, the wire can be used as a fiducial prior to cutting. To further enhance the location of the wire, a small portion of the wire can be coated with an ultrasound-sensitive or radiopaque coating. Using commonly available image capture approaches, the location of the wire, its predicted path, and the location of the tumor can all be determined and analyzed. This information can then guide the pathologist as to which sections are particularly useful for pathological assessment. The surgeon or operating room staff can use this image information to place additional markers on the tissue section before leaving the operating room to identify the section in question. Images from the specimen taken using the wire or bag fiducial to estimate the section can also be accessed during pathological examination to show the assembled section structure (i.e., vasculature, tumor, etc.) that can be compared to the section itself.

[0296] In some embodiments, methods for handling cancerous tissue are provided. During removal of sectioned tissue known or suspected to be cancerous from a sectioning bag, great care may be desired to ensure that fluid or tissue does not leak out and thereby cause specimen site seeding. Various methods can be used to limit tissue leakage, such as an absorbent pad 4708. The pad 4708 can have holes therein located above, below, or around the exposed bag opening 4710 to absorb any fluid that may leak out (see, e.g., FIG. 47).

[0297] 47 , separate bags 4700 can be provided for capturing tissue sections 4704 as they are exposed from the patient. The separate bags 4700 can be twisted around each individual section 4704 as the section 4704 is extracted from the patient and / or the primary bag 4702. In some embodiments, the separate bags 4700 can be twisted around the primary bag 4702 as the primary bag 4702 is removed along with one or more tissue sections 4704.

[0298] 47, an expandable or elongated bag 4700 can be provided to capture the tissue sections 4704 as they are extracted from the patient. For example, the elongated bag 4700 can have a depth D that is greater than a maximum width W that is suitable for extracting a particular tissue. For example, where a standard bag for a uterus may have a first width W and a first depth D, the elongated bag 4700 can have the same first width W as the standard bag and a second depth D that is greater than the first depth D, and in some embodiments, the second depth D can be several times the first depth D to ensure that sufficient material is provided to capture the tissue sections 4704.

[0299] As illustrated, the elongated bag 4700 can have a flexible container that is twistable at one or more twist regions 4706, thereby individually capturing individual tissue sections 4704. For example, a section 4704 can be captured, the bag 4700 can be twisted to accommodate the section 4704, and the process can be repeated with another tissue section 4704 placed within the bag 4700 (note that this twisting process also applies to secondary bags 4700). One skilled in the art will understand that even when an elongated or secondary bag 4700 is provided that allows a user to twist the tissue sections 4704 to separate them, the user need not necessarily perform this step, and optionally all tissue sections 4704 are captured within a single cavity. One skilled in the art will also understand that a user can optionally seal, tie, clamp, or otherwise fasten the twist regions 4706 to permanently separate the individual tissue sections 4704 from one another. In some embodiments, the film 802 described earlier herein can provide a semi-permanent sealing feature between the cavities formed around the segments 4704 .

[0300] As new dyes are created for use in identifying cancerous cells, these dyes can be placed in the bag so that once the specimen is sectioned, the surgeon can view the bag and determine whether any signs of cancer are present in the sample. For example, in a method similar to fluorescence-guided surgery using contrast agents and a cancer cell "auto-navigator" created by researchers at Purdue University, it is believed that new contrast agents could be injected prior to surgery and be visible in the specimen at the time of removal. Relatedly, similar contrast agents could be placed in the bag (walls of the bag, small pouches on the bag return) or injected into the bag by the surgeon using a syringe or similar device before or after removing the section from the bag, substantially as described earlier in this specification with respect to Figures 41-46.

[0301] 48, further described herein is a novel tissue sectioning method 4800. The method 4800 includes steps of identifying 4802 the tissue type of the specimen to be sectioned, selecting 4804 a collection bag for the particular tissue, inserting 4806 the collection bag into the patient's cavity, loading the specimen into the bag, exposing 4808 the bag (and optionally connecting the bag to a sectioning instrument), and sectioning 4810 the tissue (and optionally removing the instrument). The method 4800 may include step 4812 of removing the sectioned tissue from the patient and / or bag.

[0302] As previously explained, a coating on the wire or electrode can be provided to allow for relatively rapid initiation of tissue sectioning cutting and for tissue sectioning at relatively low power and low temperatures.

[0303] As illustrated in FIG. 48 , in some embodiments, selecting a bag 4804 may include selecting a bag with a wire coating to match the wire coating impedance to the impedance of the tissue being cut. For example, lung is a high impedance tissue compared to many other tissues found in the human body. Therefore, selecting a lung-specific bag 4804 may include selecting a bag with a wire with a relatively high impedance coating to optimize energy into the tissue, resulting in faster and cooler cutting compared to wires used to cut tissue with relatively low impedance, such as uterus or ovarian cysts. A user could select a bag with a specific wire or a specific return electrode impedance based on the tissue targeted for sectioning and extraction. Those skilled in the art will appreciate that various alerts can be provided to the user to indicate which bag has been selected and / or to confirm whether the selected bag does in fact have wires / electrodes with a coating whose impedance matches the impedance of the tissue being cut.

[0304] 49, systems and methods are disclosed herein for providing emergency release, interruption, or release of wire connectors in an electrosurgical instrument. In some embodiments, the emergency release device 4900 has a plunge cutter 4902 within a slot 4904 in the instrument housing 4906, such as between the distal end of the trough (spring assembly) and the introducer tube. That is, the emergency release device 4900 can function in a manner similar to a guillotine cutter to sever one or all of the electrodes / wires 4908 for emergency release, and can be included in the system 100 illustrated in FIG. 1-Q.

[0305] In some embodiments, emergency release of the wire connector from the instrument is provided. The emergency release device may include a clamp or "brake" coupled with a spring that allows a force exceeding the force or strength of the wire to pull the device apart and break the wire.

[0306] The emergency release may include pressing the insertion tube against tissue, causing it to extend beyond the reach of the wire, creating higher forces on the wire, which ultimately breaks the wire or link. The emergency release may include the use of a nitinol spring or clip within the wire crimp barrel to release the crimping of the wire from the connector barrel. The emergency release device may include a member or release feature configured to apply a force from the rear to re-extend the spring to its pre-tensioned position, allowing the user to remove the connector, retract the distal insertion tube, and insert a component that couples to the springs and pulls them forward to enable the user to uncouple. The emergency release device may include an opening that, when crushed, tightens around the wire to sever the link. The emergency release device may include a connector system in which a magnetic coupling holds the link and removal of the magnetic field causes the connectors to separate. The emergency release device may include a release feature coupled within the device, such as a lockout collar that can be rotated to move the spring in a different direction and then stretch the spring back to its original position.

[0307] In some embodiments, the emergency release device includes a tensioning rod designed with a release force just above the maximum range of intended use, where the connection will either separate or collapse if the applied force exceeds the trip point or the maximum range of intended use. In some embodiments, the slicing device is configured to allow a user to apply a higher force away from the patient, and the tensioning rod is configured to release in response, for example, when this higher force reaches the trip threshold or the maximum range of intended use.

[0308] In some embodiments, a locking feature is provided on the tension rod that releases the jaws holding the connector if force is lost with user-initiated control or after tensioning has begun. The locking feature can be used in conjunction with a force relief and brake by pushing the device inside the patient's body to release the connector.

[0309] In some embodiments, a cutting feature is provided on the tensioning rod that is configured to cut the wire when activated by a user, such as a knife blade or pinch point that moves into contact with the wire.

[0310] In some embodiments, an ejection feature on the tension rod is provided that, when activated by the user, ejects the connector and the distal end of the tray, electrical excitation, e.g., at a different resonant frequency or energy level, lifts and melts the gate that disconnects the wires, driving a phase change and softening or releasing the retainer pin, the connector rod pin with the pin pushed out from behind to release.

[0311] In some embodiments, a release device similar to a "kite harness release" is provided, as illustrated in FIG. 50, in which the tension rod has a pin attached to a loop captured by a collar 5002, with the loop 5006 connected to the end of the tension rod. Once the collar 5002 is moved so that it no longer captures the pin, the pin flips, allowing the end of the tension rod to release. The collar 5002 can be moved with an interference designed into the tube and replaced with a tight contact fit of the tube that holds the pin from flipping and allows release. In this way, release can be enabled by using a concentric tube with a slot in such a way that when aligned with a solid portion of the tube, release cannot occur because there is not enough open space to allow the pin to flip, but when the tube is aligned with the slot, the pin flips and the connector releases the wire 5008 from the spring 5004.

[0312] Looking now at some embodiments of Figure 51, there is provided a release device similar to the "sailing cable release device" similar to the "kite harness" described with respect to Figure 50. By analogy, in sailing these "under tension release mechanisms" are found in pelican hooks and rope clutches.

[0313] In some embodiments, an emergency release device is provided that includes a "jack" engagement, where the tension rod has a raised portion that aligns with the open portion of the flat spring on the wire connector. The wire connector is pushed onto the tension rod until the open portion of the wire connector captures the raised tension rod. The flat spring on the wire connector extends distally beyond the tension rod and has a raised shape that interferes with a feature within the lumen of the instrument when a counter force is applied. This counter force can be a stepped feature molded, machined, or added to the interior surface of the lumen, or can be provided by a strip on the inner tube that can obstruct the spring only when rotated to the "release" position, thus allowing release only when the user actively activates the feature.

[0314] In some embodiments, emergency release of the tensioning mechanism or other component is provided using a detent connection. For example, a movable protrusion biased toward an extended position in the first component may be provided and configured to selectively engage a recess or passage in the second component. The detent connection may be configured to selectively release in response to a trip force or override input.

[0315] The spring isolation feature will now be described in more detail with reference to Figure 52. As illustrated in Figure 52, selective insulating regions 5202 can be provided to prevent electrical flow (only the "drag strip" contacts the insulation) and control when the electrode / wire can be energized.

[0316] Additionally, parallel sections of conductive, but electrically uncoupled, springs can be incorporated onto the spring surface. In some embodiments, this effect is created by applying a thin conductive layer with an insulated backing. The addition of these electrical "traces" can provide separate contact members that align with these traces and allow different electrical signals to be coupled along the length of the spring without interference. In some embodiments, the resistance value from the electrode wire resistor is supplied to circuitry within the stationary portion of the electrosurgical instrument 102, for example, to identify the electrode type as described previously herein.

[0317] In some embodiments, a return electrode wire can be incorporated into the cutting mesh, as illustrated in Figure 53. The wire 5302 is activated as it is retracted, slicing the specimen.

[0318] As illustrated in FIG. 54, some embodiments include a dual bag, where an outer bag 5402 and an inner bag contain a cutting mesh 5406 of multiplexed power or RF energy. A mesh of bipolar RF cutting wires may line the retrieval bag to cut the tissue. Upon capture, the wires may be activated (e.g., in the sequence previously described herein) to retract the mesh into the shaft, cutting the sample into smaller pieces. For example, a balloon 5404 within or coupled to the outer or inner bags 5402, 5406 may be used to seal the bags against the shaft, thereby assisting in pushing the sample or pieces of the sample into the shaft. The resulting sectioned pieces may be elongated pieces.

[0319] As illustrated in Figure 55, some embodiments include a collapsible basket 5502, such as a cutting mesh or basket 5502, of electrodes 5504 oriented perpendicular to the open specimen bag. The bag can then be closed around the shaft and reoriented parallel to the shaft axis and wire mesh. The wire is then activated as it is retracted into the shaft, cutting the specimen into smaller pieces. The resulting sectioned tissue pieces can have a pie shape.

[0320] As illustrated in Figure 56, some embodiments include a stationary specimen held by a bag and a rotating bipolar power source, such as a radio frequency energy cutting mechanism. The cutting mechanism 5602 can be configured to advance or move distally or proximally as it rotates. The resulting sectioned tissue 5604 can be extracted from the specimen during the procedure. A return electrode 5606 can be part of the bag.

[0321] 57, in some embodiments, the rotary cutting mechanism 5702 can include a rotating wire that can have sharp corners to maximize electrical density and / or bend to expand the cutting structure.

[0322] As illustrated in Figure 58, in some embodiments, a single bipolar electrode can be provided to section the tissue. The wire 5802 can be advanced and retracted while rotating in different orientations. The resulting tissue section has a substantially cylindrical shape.

[0323] 59, in some embodiments, the active electrode 5902 and return electrode can be wrapped around the specimen or arranged in such a way that the wire can be clamped around the specimen captured in the retrieval bag. The wire is then simultaneously retracted and activated to slice the sample. The resulting tissue slice can be shaped substantially like a slice of rotini pasta.

[0324] As illustrated in FIG. 60, in some embodiments, a cutting / grasping loop within the retrieval bag 1616 may be provided. The cutting loop is an electrode that is extended down the retrieval bag shaft. A wire 6002 runs from the exterior of the specimen, "scraping" the specimen and cutting it into smaller, more manageable pieces. A linking operation may be provided. The electrode wire loop 6002 is crushed or collapsible on each sliced ​​piece 6004, allowing the piece to be pulled from the patient's cavity. The tissue slices 6004 may resemble orange slices.

[0325] As illustrated in FIG. 61 , some embodiments provide a stationary cutting mechanism 6102 with moving tissue 6104. For example, the specimen 6104 can be pulled into the bipolar RF electrode wire 6102. The specimen can be captured in a collection bag portion of the device. The bag can then be pulled into the device shaft, partway through an activated wire electrode. Another bag 6106 or electrode mesh can be outside the specimen to contain the specimen as it is being cut. The mesh can also serve as a return electrode. The bag / cutter can be rotated by hand to obtain multiple cuts in the tissue.

[0326] As illustrated in Figure 62, a push-pull electrode grid with an expandable funnel can be provided in some embodiments. The specimen can be drawn through the electrodes and into the device shaft. The distal end of the shaft can expand into a funnel 6202 to collect the specimen within the shaft as the collection bag is retracted. The shaft / cutter can be rotated by hand to obtain multiple cuts.

[0327] As illustrated in Figure 63, some embodiments provide for drawing the specimen into a multi-stage rigid electrode or RF cutting mechanism. A series of bipolar electrode wires are locked at different angles to cut through the tissue as it is drawn into the device shaft. No manual rotation is required. The electrode wires may be inside a funnel, for example, first stage 6302 and second stage 6304.

[0328] As illustrated in FIG. 64, some embodiments provide a stationary cutting wire with a grasper / manipulator as the return electrode. In some embodiments, one or more stationary electrode wires 6402 with a grasper that can also be the return electrode are used to draw the specimen into the electrode wire. The sectioned tissue can be extracted through the shaft or incision. The funnel 6202 illustrated in FIG. 62 can also be included here.

[0329] As illustrated in Fig. 65, some embodiments may provide a rotational edge peeling / cutting action. For example, rather than simply pushing or pulling the specimen through the wire, some embodiments provide a "skewer" 6502 to rotate the specimen through one or more bipolar electrode cutting wires or wire loops. In this way, a spiral cut is created as the specimen is drawn into the shaft, which elongates the sectioned tissue.

[0330] In some embodiments, a spiral cutting electrode can be provided, as illustrated in Figure 66. In some embodiments, a rotating skewer or rotating bag imparts rotation to the enclosed specimen. One or more bipolar electrode cutting wires can then be used to peel or slice the tissue as it is pulled through or against the wire. The skewer and / or bag can include a return electrode.

[0331] 67, the electrode structure 6700 may include a yarn 6704 woven with a metal filer 6702. The return electrode 6700 may be incorporated into the fabric that makes up the specimen bag. For example, a wire 6702 woven directly into the yarn 6704 used to manufacture the bag may provide one embodiment of the return electrode 6700.

[0332] As illustrated in FIG. 68 , a bipolar / bifilar wire pair 6800 can provide the electrode structure 6800. In some embodiments, a series of bifilar wire pairs can be provided to enable bipolar RF energy to create cutting. Each wire pair 6800 can include an active electrode 6802 and a return electrode 6804. The wires 6802, 6804 can be exposed through the insulation 6806 on opposite sides of the structure through one or more windows or recesses 6808 in the insulation 6806.

[0333] While most wire electrodes illustrated herein are shown as substantially circular, as illustrated in FIG. 69 , one skilled in the art will recognize that wire electrodes 6900 having other wire electrode shapes are contemplated, such as rectangular wire electrodes 6900. A rectangular wire electrode 6900 may maximize current density at the corners, thereby reducing the power required to initiate a cut using bipolar RF energy. The wire 6902 may have a coating 6904. The corners 6906 of the wire electrode 6900 provide areas for concentrating current density, thereby making cutting or initiating a cut more efficient.

[0334] 70, some embodiments of the bag structure 7000 can include a bag 7002 that incorporates both a return electrode 7004 and an active electrode 7006 for applying power, such as bipolar RF energy. A transducer can be used to fabricate the structure 7010 before welding the flat pattern into the bag shape.

[0335] As illustrated in Figure 71, some embodiments provide a bipolar electrode 7102 and a return electrode woven into the bag. In some embodiments, a thin wire 7104 can provide the return electrode. The thin wire 7104 can be woven into a polymer fabric 7106 that forms the retrieval bag.

[0336] 72, some embodiments provide a bag structure 7200 having an active electrode and a return electrode. In some embodiments, the active electrode wire can be incorporated into the specimen bag by providing a multi-layer structure. An outer layer 7202 can include nylon or an elastomer, the next layer 7204 can include a foil return, the next layer 7206 can include an insulating layer, the next layer 7208 can include the active electrode wire, and the next or innermost layer 7210 can include a perforated bag material.

[0337] As illustrated in Figure 73, some embodiments include a dual bag structure 7300 for pretensioning a specimen. The dual bag structure 7300 may include an inner bag 7302 that can be crushed against the device to clamp the specimen, while an outer bag 7304 can house or surround a wire / electrode (not shown) used to cut the specimen. A return electrode (not shown) may also be housed within the outer bag 7304.

[0338] As illustrated in Figure 74, some embodiments provide a dual bag configuration with a return electrode (not illustrated) in the outermost bag 7402. A dual layer bag configuration 7400 can be used where the outer bag 7402 clamps the specimen and houses the return electrode. The inner bag 7404 can house an active electrode (not illustrated) for cutting.

[0339] Some embodiments provide a cryptographic signal controller (multiplexing), as illustrated in Figure 75. To accommodate the potential use of various generators for power (e.g., RF energy) to perform cutting, a controller 108, 708, 7502 can be provided in series with the device cable. The controller 108, 708, 7502 can be used in conjunction with projects requiring signal multiplexing.

[0340] 76, the retrieval bag 7602 can include an overtube 7604 for cutting and exposing tissue. In some embodiments, a support arm 7606 and a drawstring 7608 positioned between the overtube 7604 and the main device shaft (not shown) can assist in reorienting the retrieval bag 7602. In some embodiments, providing more than one drawstring 7608 can improve control of bag closure and increase the tendency of the bag 7602 to close onto the device shaft (not shown).

[0341] As illustrated in FIG. 77 , in some embodiments, a method of using the specimen retrieval bag 7602 is provided. One method includes capturing a specimen within the bag 7602 and then dissecting the tissue into smaller pieces for extraction. The bag 7602 may initially open perpendicular to the shaft (not illustrated), as illustrated in FIG. 76 , and then can be rotated onto the shaft or through the incision to apply a cut to the specimen therein using one or more electrodes 7610, as illustrated in FIG. 73 . An external drawstring 7612 can assist in positioning the bag 7602.

[0342] Some embodiments provide guides for the wire loops, as illustrated in Figure 78. For example, the shaft tip 7802 or distal portion of the shaft may include a guide 7804 for each wire electrode 7806. The guides 7804 may bias the wires 7806 away from each other to prevent them from touching, thereby maintaining the cutting path of the wires 7806.

[0343] As illustrated in FIG. 79, some embodiments can include a cam barrel 7902 for activating bipolar power and tensioning each wire loop. The cam barrel 7902 can organize the sequencing of each cutting wire. The barrel can have slots 7904 to allow only one loop or loop pair to be activated at a given time. Each loop / loop pair can be tensioned by hand. Rotating the cam barrel can also control which wires are available for power or PF energy activation.

[0344] As illustrated in Fig. 80, a wire loop can be provided with opposing springs 8002 to control wire tension over time. In some embodiments, a pair of springs or other components can be used to automate the force of the wire during cutting, creating a variable spring force on the wire 8004 throughout the pull through the tissue. Applicant has determined that by slowing the pull rate near the end of the cut, electrode sparking or flashing is reduced.

[0345] As illustrated in FIG. 81, a handle or shaft structure can be provided for the individual wire loops. In some embodiments, a rotating ring 8102 within the shaft structure 8100 can be used to release the wire column, which is positively tensioned by a tension spring. The user can rotate the ring to release one rod and activate power or RF energy. In some embodiments, each cut requires a travel of approximately 20-25 centimeters (i.e., approximately 8-10 inches).

[0346] The embodiments disclosed herein may be used in polypectomies, dissectors, or other applications where wire cutting accompanied by coagulation or hemostasis is desired.

[0347] Alternatively, manual wire retraction can be provided, as illustrated in FIG.

[0348] As illustrated in Fig. 83, a torsion spring 8302 can be provided to achieve wire tension during cutting. The torsion spring 8302 can be a constant force spring and can provide retraction of the cutting wire / electrode 8304. The torsion spring can be helically wound around the wire or other structure that tensions the wire within the device shaft. The torsion spring 8302 can operate sequentially.

[0349] As illustrated in Fig. 84, some embodiments provide electrode wire activation using a cam and lobe mechanism 8400. A rotating cam can lift each radially spaced wire / electrode out to a different electrical contact to select the wire / electrode for power or RF energy. Rotating the cam can release one wire / electrode and activate another.

[0350] As illustrated in FIG. 85, some embodiments provide a wire / electrode length locking mechanism 8500 or method. In some embodiments, a cam lock slide is provided and can be advanced over the wire / electrode until a certain force is achieved. At that time, the cam can lock the wire / electrode in place as the wire / electrode relaxes slightly. The cam lock provides a way to pre-tension the wire / electrode against the specimen before initiating power and / or cutting tension.

[0351] During applications of low temperature, high speed wire cutting, where some level of hemostasis is desired, the delivery of energy can be modified to provide both hemostasis and high speed cutting.

[0352] One means of increasing hemostasis is to modify the method of initial energy application during wire cutting. Voltage-limited power with low voltage and higher current capability can be initially delivered to the tensioned wire cutter to delay cut initiation and allow tissue coagulation prior to cutting. Energy delivery could be modified to initiate wire cutting through an increase in voltage at a predetermined time point or until a predetermined parameter threshold is met. Another means of achieving this would be to initially apply a non-sinusoidal waveform to enhance the coagulation effect and transition to a sinusoidal waveform to enhance cutting. This could be a single event or could be continuously adjusted as the cut progresses. This could also be adjusted by modulating between a purely sinusoidal waveform and a higher crest factor based on feedback from electrical or travel speed data to improve control and cutting performance. This modulation could be pulse width modulation, altering the distortion characteristics of the waveform, removing or changing the amplitude of cycles or partial cycles of the output, changing the attenuation characteristics by adding or subtracting loads to the RF output stage, or other means.

[0353] Parameters that may be beneficial to monitor include electrical parameters such as impedance or phase change, or mechanical parameters such as tissue contraction or flexibility. During the initial hemostasis step, a higher force than would be required for cutting alone can be applied to the wire during coagulation, with pressures as high as 0.68-1.37 MPa (100-200 psi). The force can then be reduced or maintained to complete the cut. Coagulation or hemostasis times can vary but are expected to be between 0.25 and 10 seconds. The wire may or may not have a high-impedance coating or, alternatively, a non-stick coating, depending on the application.

[0354] Turning now to FIG. 86 , an apparatus 8610 suitable for maintaining pneumoperitoneum during packing of the bag 8611 is illustrated. The introducer 8610 can have a sealer 8612 on the shaft 8614 that provides a seal when pressed against the incision site. This sealer 8612 can be inside or outside the patient's body. The sealer 8612 can include an inflatable or non-inflatable feature. A user may be able to move or slide the sealer 8612 along the length of the shaft 8614 to position the sealer 8612 at or near the incision and / or move the sealer 8612 away from the incision at a suitable time. In some embodiments, the sealer 8612 includes a cup-shaped feature that surrounds or encircles the introducer shaft and is flexible in the introducer shaft to allow movement of the introducer with minimal movement of the cup-shaped feature. In some embodiments, the opening that interfaces with the device 200 is flexible in a manner that allows the sealer 8612 to be removed after use and placed on another device (e.g., a grasper) intended to assist in packing and exposing the bag 8611.

[0355] In some embodiments, it may be desirable to reliably close the extraction bag, such as in laparoscopy for vaginal extraction. For example, in some embodiments, a bag sealer tool may be provided to seal the bag opening by melting the bag together. Here, a material with a relatively low melting temperature may be provided at the open end of the bag for a more reliable and easier seal. In some embodiments, a large clip or tie may be provided to enable reliable closure. Here, a user may apply a malleable material (e.g., wax and / or adhesive) area or strip on or around the clip or tie, which is permanently attached to the bag opening to provide a fluid-tight barrier between the contents and the exterior of the bag. The malleable material may be provided on the interior or exterior wall of the bag. Providing a malleable material on the exterior of the bag can reduce potential or accidental pre-engagement, which is possible after the user inverts the end of the bag, for example. In a variation, a removable strip may be provided on the malleable material to prevent pre-engagement.

[0356] Turning now to Figure 87, means for assisting in the removal of a section using a bag will now be described in detail. After the tissue has been sectioned 8722, it may be desirable to remove the bag simultaneously with the specimen section 8722, particularly in situations where cancer is suspected or known. In this situation, a bag 8724 may be provided that is configured to apply a compressive force on the tissue to be removed.

[0357] For example, as illustrated in FIG. 87(b), the bag 8724 can include a seg-clamp 8726 that compresses and / or reorients the segment 8722 simultaneously with applying a force to remove the bag 8724. Specifically, the seg-clamp 8726 can be configured such that as a user pulls the seg-clamp 8726 proximally, the segment 8722 is compressed simultaneously or substantially simultaneously as the bag 8724 is withdrawn from the patient's body (see, e.g., FIG. 87(c)). In some embodiments, the seg-clamp 8726 is integrated onto the interior of the bag 8724 to facilitate reorientation of the tissue segment 8722 through direct contact. The seg-clamp 8726 can be a string or strap-like feature. In some embodiments, the seg-clamp 8726 can have a memory-retaining material and / or be elastic to aid in expanding the bag 8724 to accommodate tissue. In some embodiments, the surface of the segment clamp 8726 is roughened or has protrusions that increase the coefficient of friction between the segment clamp 8726 and the segment 8722 or that effectively "grip" the segment 8722 as the user or instrument pulls proximally.

[0358] In some embodiments, as illustrated in FIG. 87(c), the segment clamper 8722 is configured to apply the clamping force at an angle relative to the direction of the cutting or pulling force F. By applying the clamping / pulling force at an angle α between 15° and 90° relative to the cutting, wire retraction, or pulling force, the segment 8722 can be simultaneously compressed and repositioned to enable extraction through the incision. If more compression is desired, an angle closer to 90° may be desired. In some embodiments, the angle α is between 45° and 89°. In other embodiments, the angle α is between 60° and 85°. In other embodiments, the angle α is between 70° and 80°. If more movement or reorientation of the segment is desired, the angle can be closer to 15°. In some embodiments, the angle α is between 15° and 45°, in some embodiments, the angle α is between 15° and 35°, and in other embodiments, the angle α is between 15° and 20°.

[0359] As illustrated in FIG. 88 , in some instances, a robot or other electromechanical means may be used for the surgical procedure. In such instances, it may be desirable to utilize the same means to extract the section from the bag. FIG. 88 illustrates an exemplary approach that allows for robotic-assisted extraction. As illustrated, a system 8830 having a tissue extraction bag 8831, a robotic grasper 8832, a guide means 8834, and a bag-machine interface 8836 is provided in some embodiments.

[0360] The robotic grasper 8832 may include a camera or arm 8835 that allows the surgeon to view the robotic grasper 8832 as it advances in and out of the patient's body or incision. The guide means 8834 provides the ability to guide the robotic grasper 8832 in and out of a trocar or incision, including guiding it between the trocar or incision site. In some embodiments, the robotic grasper 8832 is configured to travel between the incision site and another location (e.g., a specimen or lesion container or a tray for receiving tissue).

[0361] A bag machine interface 8836 may be provided on or proximal to the bag opening and is configured to interface with a robotic arm 8838 that provides tension on the bag 8831 during extraction of the tissue section 8822 so that the section can be easily identified and grasped.

[0362] Some embodiments disclosed herein can be used to remove lung tissue. For example, the surgical method provided herein includes the following steps (not necessarily in this order): (1) marking or identifying an area or margin of interest for pathology, (2) inserting a specimen bag into the thoracic cavity to capture the specimen, (3) packing the specimen into the bag, (4) exposing the bag opening, (5) connecting a wire connector to an instrument, (6) inserting the distal end of the instrument into the thoracic cavity, (7) pretensioning the wire before cutting, (8) sectioning the tissue using either mechanical or mechanical / electrical cutting, (9) removing the instrument, (10) applying an external compressive force on the tissue section at an angle of 15-90° to the direction of the cutting or wire retraction tension force to reduce the diameter of the bag and / or reorient the tissue section, and (11) removing the bag with the contained specimen.

[0363] The tissue removal methods disclosed herein include the following steps (not necessarily in this order): (1) marking or identifying an area or margin of interest for pathology, (2) inserting a specimen bag into the thoracic cavity to capture the specimen, (3) packing the specimen into the bag, (4) exposing the bag opening, (5) connecting a wire connector to the instrument, (6) inserting the distal end of the instrument into the thoracic cavity, (7) pretensioning the wire before cutting, (8) sectioning the tissue using either mechanical or mechanical / electrical cutting, (9) removing the instrument, (10) removing the specimen section, and (11) removing the bag.

[0364] Temporarily holding the wire to the bag can be accomplished in several ways. The bag can include multiple layers, or a single layer with additional features attached to temporarily hold the wire in place. The bag can include multiple film pieces welded or glued together, or can be formed by reshaping a film or blown in a mold similar to a balloon. Regardless of the approach, the means for holding the wire in place is releasable and must be released to complete tissue sectioning.

[0365] Another important feature of using a wire to section a specimen, with or without radio frequency energy, is ensuring that the wire is held against the sidewall of the bag as illustrated. By keeping the wire attached to the sidewall of the bag, the specimen can be packed without inadvertently shifting or catching the wire, resulting in complete packing of the specimen. To this end, the wire can be held in place using loops, perforations, or similar bag features that release upon tension applied to the wire. Additionally, the retention feature may release in response to the application of energy to the wire, which melts or softens the retention feature. An additional approach is to have a mechanical pull tab or feature that the user can pull to release the wire from the retention feature. The mechanical pull tab or feature could be a separate string attached to the retention feature that, when exposed, is accessible to the user near the opening of the bag. An inflatable feature within the bag itself could also be used to rupture the retention feature.

[0366] One potential risk of temporarily attaching a wire to the bag is that the bag will rupture during wire removal. The use of multiple bag layers helps ensure that the bag will remain intact upon release of the retaining feature. The retaining feature is attached to the innermost layer of the bag, with one or more additional layers on the exterior of the bag to ensure that the bag remains intact and fluid-tight.

[0367] Additional features can be added to provide feedback to the user regarding the safety of the bag. The bag can be inflated or have an inflatable channel. Upon inflation, the measured inflation pressure maintained by the bag or inflatable channel will indicate any possible holes in the bag. The use of a pressure valve with a sensor can be used to detect any pressure drop. The pressure valve and / or means for inflating the bag or inflatable channel can be integrated into the bag or, alternatively, integrated into the sectioning instrument itself. Other potential approaches include the use of a camera to allow the user to view the exterior of the bag during the procedure, the use of a color-changing indicator on the inside of the outer two layers of a three-layer bag that changes color upon contact with bodily fluids, or the use of a transparent outer bag layer or film that allows the user to visually determine whether any fluid has penetrated between the two layers. Another method would be to have a conductive coating on the inside of the outer bag layer and a central layer separated from the outer layer by inflation. The capacitance between the two conductive layers can be monitored such that a pressure drop changes the capacitance reading, similar to pressing a capacitive touchscreen. Capacitance can be measured at regular intervals, on command, or continuously, or a threshold can be predetermined such that if pressure is lost, the system can identify the condition and issue an alert. The two conductive layers can also be used similarly to a resistive touchscreen, in that a change in resistance between the two layers can be used to indicate a loss of pressure condition. Finally, the outer two layers of the bag can contain sterile fluid, allowing the user to be confident in the safety of the bag if the fluid level does not drop during the course of the procedure.

[0368] If the user visually determines there is a gap in the bag, an adhesive patch can be applied to reduce the risk of fluid or tissue loss from the contents of the bag. The user can also decide to irrigate (rinse and suction) the patient's body cavity.

[0369] While this specification is primarily directed to electrosurgical systems, it should be understood that tissue sectioning and extraction may, in some embodiments, be accomplished using a sectioning device that does not have an electrosurgical component. Specifically, a surgical device may be provided having one or more wires that mechanically section tissue, such as by force, motion, and / or vibration. Many of the examples disclosed herein apply to such mechanical surgical devices as well. For example, a surgical device may utilize the wire tensioning methods disclosed herein without an electrical aspect, with or without a controller configured to control the pulling force or cutting speed. Similarly, a robotic system may provide cutting functions that are not inherently electrosurgical. As with electrosurgical sectioning procedures, the extraction bag may provide a means for keeping the cutting wires in place (and from tangling with each other) while the tissue sections are placed within the extraction bag; similarly, the wires may be configured to detach from the extraction bag at a desired, set force or time. The use of mechanical-only cutting may be advantageous in applications where the tissue is not calcified, has relatively little variability in mechanical properties, or is generally more friable and therefore does not require extremely high forces to reliably cut through the tissue. To address this case, a tissue excision device or wire cutting device may be configured without the elements required for electrosurgical cutting. For example, the return electrode or connection to the controller or electrosurgical generator may be omitted. Those skilled in the art will appreciate that an excision device without an electrosurgical cutting element requires fewer instrument connections to be completed by the user. This, in turn, may reduce the production cost of the product. In some embodiments, an excision device without an electrosurgical cutting feature may allow for tissue cutting at lower temperatures and may be a safer alternative for frail patients. Those skilled in the art will appreciate that the mechanical pull forces in an excision device without electrosurgical cutting will be significantly greater than those with an electrosurgical cutting feature.

[0370] As previously mentioned in U.S. Patent Application No. 14 / 805,358, bipolar applications of RF energy may have some merit. FIG. 89 illustrates one embodiment of a bipolar wire assembly 8950. The wire is created with two conductive outer regions 8951 and 8952 separated by an insulating member 8953. The two conductive regions 8951 and 8952 are not electrically coupled, and the separation of the insulating member 8953 is such that a voltage applied to perform tissue sectioning does not arc across the insulating member. RF voltage may be applied between the conductive regions 8951, 8952, with one acting as the active electrode and the other active as the return electrode. In some optimal embodiments, the conductive regions 8951, 8952 and the insulating member 8953 are secured or formed in a manner such that they are mechanically coupled and twisted 554 throughout the length of the wire assembly. This twisting ensures contact of both conductive regions 8951, 8952 with the tissue at a single point across the tissue specimen. Initiation of cutting occurs at a single point across the length of the wire assembly, and as the wire advances into the tissue during cutting, contact occurs along the entire length of the wire. By configuring the device as described herein, the probability that both conductive regions will remain in contact with the tissue through completion of the cut can be increased.

[0371] 90 illustrates a bipolar wire assembly 9060 having two parallel wires 9061, 9062 separated by an insulating member 9063 that are mechanically secured or formed together to create a mechanical coupling. This configuration may be left parallel or twisted as described with respect to FIG.

[0372] As previously described herein, rupture of the bag 161 is a potential problem that must be monitored for, prevented, and / or mitigated, whether using a tissue sectioning device or an extraction device that simply does not section tissue.

[0373] 91 , a harvesting bag system 9100 can be provided that includes an outer bag layer 9102, an inner bag layer 9104, and a space 9106 therebetween. The layers 9102, 9104 can be bonded or fused together using any means known in the art, such as at a joint 9108. Either vacuum or pressure between the bag layers 9102, 9104 can be used as part of a breach detection or mitigation strategy.

[0374] In some embodiments, the pressure in the space 9106 between layers 9102, 9104 can be used to inflate the outer bag layer 9102. If a breach occurs in the outer bag layer 9102, the loss of pressure can be detected visually by probing for a drop in the size or pressure of the inflated bag.

[0375] In some embodiments, a vacuum can be applied to the space 9106 between the bag layers 9102, 9104. The vacuum can serve two purposes. First, the vacuum provides a visual indication of failure when the outer bag layer 9104 no longer appears to be pulling toward the inner layer 9104. Second, if a failure occurs in the outer bag layer 9104, the vacuum will draw air into the space between the bag layers 9102, 9104, thus minimizing the possibility of other materials or fluids leaking through the hole (especially if the hole is small). That is, the vacuum in the space 9106 between the layers 9102, 9104 may tend to urge an inward flow of fluid, while pressure in the space 9106 would tend to expel fluid out of, and potentially into, the patient's body in the event of a failure.

[0376] 92, the extraction device 102 may include a CO and / or NO sensor positioned, for example, in the introducer tube, to detect the presence of the gas being used for insufflation. That is, for example, if the bag 161 is introduced into the patient's cavity under vacuum or with atmospheric air inside, the gas used for insufflation, e.g., carbon dioxide or nitrous oxide, will tend to enter the interior space 9204 of the bag 161, and a sensor 9202 may be provided and configured to detect a change in the gas characteristics and / or to detect the presence of the insufflation gas within the gas in the interior space 9204. Those skilled in the art will recognize that the sensor 9202 need not necessarily be internal to the extraction device 102, but may simply be exposed to the interior space 9204 for sampling using any suitable means known in the art or yet to be developed.

[0377] 93, in some embodiments having multiple bag layers, a tube (not illustrated), lumen, or channel 9308 may be provided to expose the sensor 9202 to an intermediate space 9306 between the outer and inner bag layers 9302, 9304. The sensor 9202 may be positioned remotely from the bag assembly 9300 and coupled to the channel 9308 in a manner that allows the sensor 9202 to sample the contents of the air within this intermediate space 9306.

[0378] In some embodiments, a slight vacuum can be applied to the spaces 9106, 9306 between the layers 9102, 9104, 9302, 9306 or to the bag interior 9204 to increase the gas contents being detected at the sensor 9202, thereby providing a more accurate indication of a leak. This slight vacuum can be created using a pump (not illustrated), a vacuum air cylinder, or other means for applying negative pressure, including but not limited to, an air flow control valve coupled to the sensor 9202 to draw the contents of the spaces 9106, 9306, 9204 toward the sensor 9202 and ensure that negative pressure can be maintained throughout the procedure.

[0379] 94, in some embodiments, one or more channels 9410, 9412 can be provided and coupled to the intermediate space 9406 between the outer and inner bag layers 9402, 9404. The first channel 9410 can be coupled to a vacuum pump 9408 and can be used to provide negative pressure for sampling the contents of the intermediate space 9406, as described above. A second channel 9412 can be provided to resupply air drawn from or to the space 9406. In this manner, a circulation of air is created that can be continuously monitored, such as at a sensor 9202, using one of the channels 9410, 9412 or another channel 9416 described above.

[0380] This monitoring can establish a baseline and / or provide a more accurate indication of starting levels of CO and / or NO. The sensor 9202, in some embodiments, can monitor for differential or changing levels of CO and / or NO as previously mentioned herein. In some embodiments, the bag system 9500, as illustrated in FIG. 95, can include HEPA, carbon, and / or other filters to condition or maintain the air quality of the space 9204 being monitored. For example, if the channels 9410, 9412 are coupled to the interior of the bag 161, any steam, smoke, or other effects created from the cutting process can be significantly reduced within the bag area 9204.

[0381] The sensor 9202 may be used independently and / or may include a visual or audible indication when CO and / or N O are detected. The sensor 9202 may also be electrically coupled to a processing unit, such as the controller 108, 808, that can create an audible or visual indication to a user when CO and / or N O are detected. The sensor 9202 may also be electrically coupled to the instrument 102 or may be coupled to a separate device dedicated to detecting the presence of a leak in the bag 161, 9100, 9300.

[0382] Alerts provided to the user upon indication of CO and / or N O can enable the surgical team to perform surgical intervention at the earliest opportunity to best manage the patient's outcome.

[0383] 95, one or more sensors 9518, 9520 in-line with the pumps 9408, 9414 may be configured to monitor the quality of the fluid being introduced into or exiting the bag 161, or the space between the two bags 9302, 9304. That is, the systems 9300, 9400, 9500 may be configured to detect changes in gas within the interior space 9204 or the spaces 9106, 9306, 9406, 9506. A leak detection method may include comparing one or more fluid quality values ​​detected at a first time point with one or more fluid quality values ​​detected at a second time point.

[0384] System 100 may use this information to alert the user to the leak as it occurs, allowing the surgical team to perform surgical intervention.

[0385] Continuing with reference to Figures 91, 93, 94, and 95, in some embodiments, high pressure air or fluid can be applied to the spaces 9106, 9306, 9406, and acoustic or ultrasonic waves in the range of 20-50 kHz can be applied to the pressurized structure. Acoustic transducers (not shown) can be provided to monitor the acoustic emissions of the structure and detect changes in emissions that may be indicative of leaks or changes in the structure. Acoustic emission detection utilizes one or more of the following techniques: ringdown counting, energy analysis, amplitude analysis, frequency analysis, pattern recognition and / or spectral analysis to detect changes in acoustic emissions, or any other means known to those skilled in the art.

[0386] In some embodiments, a post-operative leak detection method is provided. For example, fluid pressure can be applied from a pump, cylinder, or other means to the space 9106, 9204, 9306, 9406 between the outer and inner bag layers, or to the interior of the bag 161, with the bag 161, 9100, 9300, 9400 sealed around the pneumatic device. A pressure detector can be used to measure the resulting air pressure and / or damping characteristics. A visual indication can also be provided to determine whether a leak has occurred.

[0387] The detection system can include a pressure detector, a pressure control valve to limit the applied pressure, and a venting mechanism. For embodiments using an intermediate space, the lumen providing access to the space can have fittings that allow the user to easily attach the leak detection system. For embodiments using a bag opening, an interface fits into the bag opening, allowing the user to tighten the opening onto the interface to create a seal. The bag can also have features that aid in creating a seal against the interface to improve the ability to perform tests.

[0388] Post-operative leak detection methods may allow the surgical team to perform surgical intervention, if necessary, before completing the surgery.

[0389] In some embodiments, the leak detection method may involve flushing the bag between layers with fluid (e.g., sterile saline) after use. The fluid contents can then be evaluated for biological materials such as blood.

[0390] In some embodiments, post-operative leak detection methods may include inflating the bag and placing it under a fluid such as water to look for air bubbles.

[0391] In some embodiments, after the sectioning procedure is complete, the specimen bag can be evaluated for leaks. For example, the interior of a used specimen bag can be filled using the operating room air supply by gripping and sealing the bag opening around the air supply while inflating. Once the specimen bag is inflated, the opening can self-twist to seal the pressurized air. This inflated specimen bag can be (partially) submerged in a water bath (i.e., in a small cavity in the tray in which the specimen bag was shipped) to visually observe any air bubbles escaping from any breaches within the specimen bag. Surfactants may be added to the surface of the bag or to the water to modify the surface tension of the water and enhance the visible foaming of the water.

[0392] Some embodiments of leak detection may include filling the intermediate space between the bag layers or the interior of the specimen bag with a liquid, such as water or saline, and applying pressurized air to a predetermined pressure to accelerate any leak through any breach in the bag or bag layer.

[0393] In some embodiments, the bag surface may be visually inspected and / or dried with a towel or air to visually observe the movement of liquid across the boundary of the bag layer.

[0394] In some embodiments, a colorant or dye can be provided in the fluid introduced into the space to enhance the ability to visually identify migration across the bag or bag layer boundary.

[0395] In some embodiments, the outer bag layer 9102 may be made of a first translucent color and the inner bag layer 9104 may be made of a second color, and the space 9106 therebetween may be pressurized. A method for determining a leak may include visually determining a perceived color change at one or more points of contact between the bag layers 9102, 9104. Visually determining may include using an endoscopic camera or viewing the outer layer 9104 during or after the surgical procedure.

[0396] For example, if a blue tint is added to the inner bag layer and a yellow tint is added to the outer layer, the contact area will result in a green tint shape due to increased optical coupling of the two colored layers.

[0397] In some embodiments, as the surgical procedure progresses, a change, particularly an increase, in the size of the combined color area may indicate a change in the area of ​​contact between the two layers. If a volume of air is trapped between the two layers in this intermediate space, or if slight pressure is applied prior to use, this increase in size of the combined color area may identify a leak in one of the bag layers.

[0398] Those skilled in the art will recognize that the above procedure may be suitable even when the space between the layers 9106 is under vacuum. For example, if the layers 9102, 9104 are pulled away from each other, a leak will be similarly indicated.

[0399] In some embodiments, the leak detection method may include providing a moisture detection layer and / or monitoring for changes in impedance due to fluid or electrical patterns indicative of a conductive fluid.

[0400] As illustrated in FIG. 96 , which illustrates a side cross-sectional view and partial top view, for example, a method of detecting leaks in an inner layer may include providing a conductive mechanism 9606 in an intermediate space between an inner bag layer 9604 and an outer bag layer 9602. The mechanism 9606 may be a conductive film or mesh and / or a coating or layer deposited or printed on the outer surface of the inner bag layer 9604 and / or the inner surface of the outer bag layer 9602.

[0401] In some embodiments, a first electrode 9608 and a second electrode 9610 can be positioned between the layers 9602, 9604 with or without the conductive mechanism 9606 or mesh remnants.

[0402] The conductive mechanism 9606 may be in a pattern with fixed spacing between two separate electrodes 9608, 9610. The two electrodes 9608, 9610 may be a single electrode pair covering some or most of the interior surface of the bag layer, or may be pairs located at multiple locations electrically connected in parallel. The electrodes may be electrically coupled to a signal, preferably an AC waveform, similar to the dual-electrode monitoring interrogation waveform applied by the electrosurgical generator to monitor return electrode contact quality. The signal may be generated from an electrical circuit located within the sectioning instrument 102, the monitoring unit, or the controller 108, or at a separate, remote location. The characteristics of the voltage measured across and the current measured between the electrodes can provide the impedance across the electrodes. If the intermediate space is dry, the impedance will approach an open circuit and be characteristic of the conductance of the bag layer material at the spacing of the two electrodes. If the inner layer is leaking, fluid or other material may enter the intermediate space. This fluid or foreign material will provide a change in impedance due to the conductivity of blood, tissue, or other bodily fluids. By measuring the decrease in impedance between the two electrodes, leakage of fluid or other tissue across the electrode spacing can be detected.

[0403] Some embodiments of leak detection include measuring the complex impedance in such a way that the power factor angle can be used to distinguish short circuits created by folds or other means in the bag from the introduction of fluids or other bodily fluids or materials. This can also be enhanced by applying positive pressure to the intermediate space to reduce the likelihood of folds in the bag, as well as designing the shape of the electrodes to align with areas of the bag that are expected to have folds, so that a folded bag will cause electrodes to contact the same electrode and not opposite electrodes.

[0404] Because it is likely that a significant amount of bodily fluid will fall to the bottom of the bag, an electrode or series of electrodes on the bottom of the bag can be used to detect when fluid comes into contact with the electrode or circuit. The electrode can sense resistance or capacitance. For example, the electrode can have a fluid-absorbing gel on the bottom of the bag that changes capacitance when liquid is added.

[0405] Some embodiments for detecting leaks in a bag may involve applying a constant amount of helium (He) or inert gas into the contained intermediate space between the inner and outer layers of the bag. Using gas spectroscopic detection technology, a helium or inert gas detector installed inside the bag is incorporated into the instrument, such that the sensor is positioned inside the introducer tube or external to the tube, with the lumen connected to the introducer tube so that the sensor can sample the contents of the air flowing from the inside of the bag, as in a smoke evacuation system, for example. Any trace of helium or inert gas indicates the migration of gas from the intermediate space into the interior of the bag, which in itself indicates the occurrence of a leak.

[0406] In some embodiments, a detector is placed through an additional laparoscopic port so that any detection of helium or inert gas inside the abdominal cavity will indicate a leak between the bag midspace and the outer bag layer. The method may include the step of temporarily suspending insufflation while measuring for a leak.

[0407] Some leak detection methods may involve optically scanning for leaks during or after a surgical procedure.

[0408] Some embodiments of the leak detection method include using a camera to view the surface of the bag during the procedure. The camera could be inserted through a separate port and could be an endoscopic camera used during laparoscopy, or it could be a separate camera designed to detect leaks. The camera's images could be sent to a processing unit, such as the controller described earlier in this specification, or a different unit capable of digitizing the images in real time. The processing unit could also include a data store for storing digitized images that can be used to compare real-time imaging data. This comparison can be used to determine changes in the bag's geometry as the procedure progresses, such as the thickness of the intermediate space, which could provide an indication of a bag leak. The visual image can also detect fluid accumulation on the surface or bottom of the bag, or droplets forming or falling from the bag, and can be used in conjunction with some of the other embodiments presented in this disclosure. For example, if a material is placed inside the intermediate space that has a specific color, the processor can use a filtering algorithm to identify changes in the amplitude of this color on the bag's outer surface.

[0409] Some embodiments include comparing the bag after the procedure is complete with measurements taken before placing the bag in the patient or with manufacturer specifications.

[0410] 97, some embodiments of leak detection include providing or using an audible or visual indicator 9708 that expands or "sounds" when vacuum pressure is lost in the space 9706 between the two bag layers 9702, 9704 (analogous to a jar lid that makes a noise when opened). For example, if a breach in either the inner or outer bag 9702, 9704 occurs, the vacuum loss indicator 9708 feature will sound, stretch, or change from a first tensioned state to a second state, indicating to the surgeon that a breach in either layer of the bag has caused a loss of vacuum in the interstitial space between the two layers of the specimen bag.

[0411] Some leak detection embodiments can include providing or using a color-changing moisture indicator between bag layers. For example, a specimen bag layer can be constructed of two welded layers of polyurethane to create a sealed interior space between the two layers. A compromise or leak in either of these two layers can be indicated by a color-changing chemical that would be applied to the interior space during bag construction. When the chemical indicator comes into contact with aqueous body fluids, a chemical reaction with the fluid would create a color change in the agent, which would be observable from an endoscopic camera inside the body cavity or by a surgeon after removal of the bag. The agent can be sprayed onto either or both of the polyurethane interior walls during bag assembly. The agent may also be inserted into the construction as a loose powder or as a liquid film. A strip of colored paper or fabric could hold the color-changing agent.

[0412] In some embodiments, a liquid agent may be inserted through the port after placement of the bag in the body. Because fluid may have migrated into the interior space from either side, a color change between the two layers would only indicate that at least one of the two layers has been compromised. Follow-up testing may be useful to determine which layer has been perforated.

[0413] In some embodiments useful for leak detection, a spray-on coating on the interior surface of the outer bag may be provided and configured to chemically bond to the liquid. After the procedure, visual inspection of the exterior surface of the inner bag and / or the interior surface of the outer bag, for example with a black light, may reveal whether a leak has occurred.

[0414] A coating on the exterior of the inner specimen bag layer to identify fluid leakage from a breached inner bag layer. This coating is configured to bind with the infiltrating fluid when combined with bodily fluids, thus creating a marker that can be visualized with the naked eye and / or with a secondary device such as a black light. Inspection for breaches in the inner bag layer can be incorporated into every specimen extraction procedure by scanning each post-operative bag for the presence of this breach marker.

[0415] Some embodiments of the leak detection method and apparatus may include the use of a water-based color "no mess" marker pad that changes color in the presence of liquid. That is, to visually indicate a breach in the inner bag layer, a coating similar to dry watercolor pigment can be applied to the gap between the inner and outer bags during specimen bag manufacture. If a breach occurs in this gap and bodily fluids infiltrate the gap, the dry pigment will become saturated, providing visual identification of the breached inner bag layer.

[0416] Some embodiments of the leak detection method and apparatus may include a fingerprint "dust" for leak detection. Similar to the watercolor pigment method and apparatus described above, a powder can be inserted into the interstitial space between two layers of the specimen bag. Infiltration of bodily fluids into this space transforms the powder into a paste-like substance. This paste substance is believed to allow for visual identification of a damaged inner bag layer.

[0417] In some embodiments, a color-changing material can be used as one of the bag layers, or in addition to and between the bag layers. If any of the bag layers is breached, the color-changing material could change color as a visual indication of the breach. For example, the material between the layers could change color when CO or N O, typical inflation gases, enter the space between the bag layers.

[0418] Some embodiments include using a color change material only on the bottom of the bag that absorbs any fluid within the layer, and may be configured to change color as a result of proteins, fluids, or other chemical characteristics of biological fluids.

[0419] Some embodiments of the leak detection method or device include the use of a visual indicator, which may or may not involve a camera between the layers. To provide a visual indication of whether a breach has occurred in the inner bag, the outer bag layer may be made of a white or similarly contrasting material, allowing the surgeon to search for blood on the inside of the outer white layer, such as with a camera, during or after instrument use. A discoloration of the inner surface of the outer bag may indicate that a breach of the inner bag layer has occurred.

[0420] Some embodiments of the leak detection apparatus 9700 and method may include the use of one or more vacuum loss indicators, such as indicator tubes or geometries as illustrated in FIG. 97. For example, one or more pockets, tubes, or expansion members 9708 may be positioned at locations around the periphery of the outer layer 9702 of the bag assembly. The one or more expansion members 9708 are unnoticeable in their normal, relaxed state, and under normal conditions, with a fully retracted and pressurized bag assembly, the geometries would remain in their relaxed state. However, if a leak occurs within the inner bag layer 9702, the expansion members 9708 on the outer layer 9702 would expand to provide a readily identifiable indication of the inner bag layer leak.

[0421] To mitigate any adverse effects that may be caused by leakage, leak management embodiments are also described herein. For example, in some embodiments, a chemotherapy agent specific to the procedure being performed can be placed within the interior space of bag 161. The agent can be pre-placed within the bag, for example, during manufacturing or pre-packaging of the bag, or the agent can be positioned within the bag.

[0422] In some embodiments, the chemotherapeutic agent in the space between the bag layers can be configured to kill cells it contacts. The agent can be a specific agent selected or configured to target the intended procedure.

[0423] In some embodiments, the agent is contained within the hydrogel or gel such that any cells that come into contact with the agent are likely to adhere or attach to the surface of the hydrogel or gel.

[0424] Chemotherapeutic agents may be selected based on the procedure and / or patient history. For example, if a hysterectomy is in progress, a chemotherapy agent suitable for the patient that may be suitable for leiomyosarcoma may be used to best address any cancer cells that may migrate into the interior space of the bag or the spaces between the bag layers.

[0425] For colectomy, the agent required for adenocarcinoma can be selected and placed in the bag.

[0426] In some embodiments, the surgeon and / or oncologist selects a chemotherapeutic agent and adds it to the space between the outer and inner layers immediately prior to use.

[0427] In some embodiments, the surgeon and / or oncologist can select from a range of pre-administered chemotherapy agents that are placed between or within the bag layers during manufacture. The agents may be applied in liquid form in safe quantities or may be applied as a film to either the outer layer of the inner bag or the inner layer of the outer bag.

[0428] In some leakage mitigation embodiments, the layer antiseptic or disinfectant solution can be provided in a manner substantially similar to that described for the chemotherapeutic agent previously described herein.

[0429] Some leak mitigation embodiments include placing or using an absorbent material layer between the inner and outer bag layers such that if a leak occurs in the inner layer, the absorbent material will contain an amount of fluid or other material that would damage the inner layer. This also provides some protection to both layers of the bag from damage by instruments or other mechanical edges. The absorbent material can be fabric, foam, gel, or other material with high moisture absorption properties.

[0430] Some leak mitigation embodiments include providing or using an absorbent material that changes hardness or phase when in contact with fluid. The material can be placed between the bag layers. This can be a dry substance that, in some embodiments, changes to a gel. In some embodiments, the substance can change to become harder or more flexible, can be a powder or film that changes to a gel, or can even change color as a result of a chemically activated change. The material changes phase and can be detected in any way, such as visually, through physical palpation of the bag, etc.

[0431] Some leak mitigation embodiments may include the use or placement of a viscous gel material layer between the inner and outer bag layers, such that if a leak occurs, the gel is configured to minimize the effects of the leak. The gel, in some embodiments, may seal the leak. In some embodiments, the thickness of the bag may be increased in a manner that makes it less likely that a leak will penetrate both the inner and outer bag layers and the gel layer. In some embodiments, the gel may be composed of or include a biocompatible material. In some embodiments, the gel may include a hydrogel, such as that placed on the return electrode. In some embodiments, the gel includes a hydrophilic polymeric material, a biodegradable hydrophilic material, and / or an organic hydrophilic material. The gel may be added to the interlayer space during manufacturing, or the gel may be added through the lumen.

[0432] The gel may be selected and configured to insulate the outer layer from the inner layer, reducing the likelihood of failure of both layers.

[0433] Some embodiments of leak mitigation include the use of a multi-cell intermediate layer. The multi-cell layer between the outer bag layer and the inner bag layer can contain multiple interior spaces that help reduce the volume of fluid that could potentially leak if the inner layer is compromised. For example, multiple walls joining the inner and outer layers can create multiple smaller, fixed volumes of air, fluid, gel, or other leak mitigation or management measures described herein within the space between the inner and outer layers of the bag.

[0434] In some embodiments, a smaller fixed volume of air, fluid, gel, or other leak mitigation or management means described herein may be provided by a third bag layer positioned between the inner and outer layers. The third layer may include an inner wall, an outer wall, and a number of connecting walls joining the inner and outer walls to create a fixed volume therebetween.

[0435] In some embodiments, the multi-cell layer can include multiple sealed pockets of fluid or leak mitigation means. The multi-cell layer can be positioned between the inner and outer layers. The multi-cell layer can limit the passage of contaminated material, reducing the likelihood that contaminated material, such as portions of a sectioned cancerous tissue sample, will damage the bag assembly. In some embodiments, the multi-cell layer can be positioned on the exterior of both bag layers.

[0436] Some leak mitigation embodiments may include the use of a material that solidifies upon contact with bodily fluids. For example, an epoxy or any thermosetting material may be provided within the space between the outer and inner bag layers. The thermosetting material may be configured to solidify or harden if a breach in the inner bag layer allows the material to reach the interspace. In some embodiments, solidification may seal the breach. In some embodiments, the thermosetting material may be selected or configured to harden within a period of time. In some embodiments, this period of time may be 5 minutes or less. In some embodiments, the period of time may be 2 minutes or less. In some embodiments, the period of time may be 1 minute or less. In some embodiments, the period of time may be 30 seconds or less. In some embodiments, the period of time may be 15 seconds or less.

[0437] Those skilled in the art will recognize that the faster the setting time of the thermosetting material, the weaker the resulting bond. However, this feature can be advantageous by allowing the surgeon to break up the hardened material and extract it through the incision site after the sectioning procedure is complete. Breaking up the hardened material can, in some embodiments, be accomplished without destroying the outer bag layer.

[0438] In some embodiments, a material reactive with carbon dioxide and / or nitrous oxide may be used or placed in the space between the outer and inner layers, which may be selected or configured to form bubbles or a gel or solidify to mitigate the effects of any breach of the inner bag layer.

[0439] Each of the various elements disclosed herein can be achieved in a variety of ways. The present disclosure should be understood to encompass each such variation, whether it be a variation of one embodiment of any apparatus, method, or process embodiment, or simply a variation of one element of any of these. In particular, it should be understood that the language for each element can be expressed in equivalent apparatus or method terms, even if only the function or result is the same. Such equivalent, broader, or even more general terms should be considered to be encompassed in the description of each element or action. Such terms can be substituted, where desired, to make explicit the implicitly broad coverage to which the invention is entitled.

[0440] By way of example only, it should be understood that any action can be expressed as a means for taking that action or as an element that causes that action. Similarly, each disclosed physical element should be understood to encompass a disclosure of the action that the physical element facilitates. With regard to this last aspect, a disclosure of a "cutting mechanism" should be understood to encompass a disclosure of the "cutting" act (whether explicitly discussed or not), and conversely, if there is a disclosure of only the "cutting" act, such disclosure should be understood to encompass a disclosure of the "cutting mechanism." Such variations and alternative terms should be understood as being expressly included in the description.

[0441] The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the invention as defined by the claims. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein. The following are examples of reference modes: [Reference Example 1] A specimen bag, a flexible ring configured to form a top opening of the specimen bag; a cannula assembly having an inner tube handle portion and an outer tube portion; a connector carrier including one or more connector portions and holding at least one connector housing therein, the connector carrier being movable from a position within the cannula assembly to an exterior of the cannula assembly; A tissue specimen extraction device comprising: [Reference Example 2] The tissue specimen extraction device of Reference Embodiment 1, wherein the one or more connector portions are configured to be connected to one or more components of a tissue sectioning device disposed inside the specimen bag. [Reference Example 3] A tissue specimen extraction device as described in reference embodiment 2, wherein the at least one connector housing and the one or more connector portions are configured to connect to at least one additional component of a tissue sectioning instrument. [Reference Example 4] The tissue specimen extraction device of Reference Embodiment 1, wherein the specimen bag is configured to be wound and stored within the cannula assembly in a first retracted position. [Reference Example 5] The tissue specimen extraction device of Reference Embodiment 1, wherein the cannula assembly is configured to advance the specimen bag to an open position by pushing the inner tube handle portion. [Reference Example 6] The tissue specimen extraction device of Reference Example 1, wherein the flexible ring is configured to be placed in a collapsed position when the specimen bag inside the cannula assembly is in a first retracted position. [Reference Example 7] A tissue specimen extraction device as described in reference embodiment 6, wherein the flexible ring and the specimen bag are configured to be pushed to a second forward position outside the cannula assembly, and the flexible ring holds the top portion of the specimen bag in an open position. [Reference Example 8] A tissue specimen extraction device as described in Reference Embodiment 1, wherein in a first retracted position, the specimen bag, the flexible ring, and the connector carrier are retained inside the cannula assembly, the specimen bag is closer to the distal end of the cannula assembly than the connector carrier, and at least a portion of the flexible ring is configured to slide from the proximal end of the cannula assembly to the distal end around the connector carrier. [Reference Example 9] The tissue specimen extraction device of Reference Example 8, wherein the flexible ring is configured to slide out from the distal end of the cannula assembly, push the specimen bag out from the distal end, and hold the top opening of the specimen bag in an open position in a second extended position. [Reference Example 10] A tissue specimen extraction device as described in reference embodiment 8, wherein the flexible ring is configured to be retracted around the connector carrier into the interior of the cannula assembly while closing the top opening of the specimen bag and leaving the specimen bag substantially outside the cannula assembly. [Reference Example 11] The tissue specimen extraction device of Reference Example 1, wherein the at least one connector housing within the connector carrier is configured to exist in a first flat position. [Reference Example 12] The tissue specimen extraction device of reference embodiment 11, wherein the at least one connector housing is configured to rotate to a second upright position. [Reference Example 13] The tissue specimen extraction device of Reference Example 1, wherein the at least one connector housing is removable. [Reference Example 14] The tissue specimen extraction device of Reference Example 1, wherein the one or more connector portions inside the connector housing are removable. [Reference Example 15] A tissue specimen extraction device as described in reference embodiment 14, wherein the at least one connector housing is removably coupled to one or more mechanisms for pulling the connector housing from a first flat position to a second upright position. [Reference Example 16] The tissue specimen extraction device of Reference Embodiment 15, wherein the one or more mechanisms for pulling the connector housing include a pull tab and a cartridge. [Reference Example 17] A tissue specimen extraction device as described in reference embodiment 1, wherein the connector carrier is positioned in a protective position inside the cannula assembly and is configured to be firmly secured by a mechanical anchor when the specimen bag is open. [Reference Example 18] A tissue specimen extraction device as described in reference embodiment 17, wherein the connector carrier is configured to be positioned in an open position outside the cannula assembly after being advanced through the mechanical anchor. [Reference Example 19] 3. The tissue specimen extraction device of claim 2, wherein the one or more components of the tissue sectioning device include one or more cutting wires. [Reference Example 20] The tissue specimen extraction device of Reference Embodiment 3, wherein the at least one component of the tissue sectioning instrument includes a tensioning mechanism assembly. [Reference Example 21] 4. The tissue specimen extraction device of Reference Embodiment 3, wherein the at least one component of the tissue sectioning instrument is configured to apply RF energy for tissue sectioning. [Reference Example 22] 1. A system for extracting tissue samples, comprising: A specimen bag, a flexible ring configured to form a top opening of the specimen bag; a cannula assembly having an inner tube handle portion and an outer tube portion, the cannula assembly configured to advance and retract the flexible ring; a connector carrier having one or more connector pins and carrying at least one connector housing therein, the connector carrier being movable from a position within the cannula assembly to an exterior of the cannula assembly, the one or more connector pins being attached to one or more tissue sectioning components coupled to the interior of the specimen; a tensioning mechanism assembly attached to the one or more connector pins and configured to apply tension to the one or more tissue sectioning components; A system including: [Reference Example 23] In a method for extracting a tissue sample, Inserting a cannula assembly of a tissue specimen extraction device into an incision site of a surgical patient, the tissue specimen extraction device comprising: A specimen bag, a flexible ring configured to form a top opening of the specimen bag; A connector carrier comprising: a connector carrier including one or more connector portions and configured to hold at least one connector housing residing within the connector carrier; and a connector carrier including one or more connector portions and configured to hold at least one connector housing residing within the connector carrier; the cannula assembly having an inner tube handle portion and an outer tube portion; advancing the inner tube handle of the cannula assembly to open the specimen bag and move the connector carrier from a position inside the cannula assembly to an exterior of the cannula assembly; retracting the inner tube handle portion to close the top opening of the specimen bag; A method for extracting a tissue sample, comprising: [Reference Example 24] the connector carrier further comprises a mechanical anchor; The method of reference embodiment 23, further comprising the step of releasing the mechanical anchor to move the connector carrier from a position inside the cannula assembly to an exterior of the cannula assembly. [Reference Example 25] 24. The method of claim 23, further comprising the step of pulling the top opening of the specimen bag out of the patient's incision site. [Reference Example 26] The tissue specimen extraction method of reference embodiment 23 further comprises the step of detaching the cannula assembly from the specimen bag, the flexible ring, and the connector carrier. [Reference Example 27] The method of extracting a tissue specimen described in Reference Embodiment 23, further comprising the step of connecting at least one component part of a tissue sectioning device to the one or more connector parts. [Reference Example 28] The tissue specimen extraction method of reference embodiment 23 further comprises the step of rotating the at least one connector housing to an upright position. [Reference Example 29] the one or more connector portions having at least two connector portions; The tissue specimen extraction method of reference embodiment 23 further comprises the step of moving the at least two connector portions independently of each other. [Reference Example 30] A method for extracting a tissue sample according to Reference Example 27, comprising the step of sectioning the tissue sample using at least one component of the tissue sectioning device.

Claims

1. A tissue specimen extraction device, comprising: A specimen bag, a flexible ring configured to form a top opening of the specimen bag; a cannula assembly having an inner tube handle portion and an outer tube portion; a connector carrier configured to hold at least one connector housing, the at least one connector housing including one or more connector portions; the outer tube portion has an opening configured to hold the connector carrier; a connector carrier having a mechanical anchor configured to selectively engage and disengage from the opening, whereby the connector carrier is removable from the cannula assembly; and A tissue specimen extraction device comprising:

2. A plurality of sectioning components disposed within the specimen bag; A return electrode, a return electrode, wherein the one or more connector portions are configured to electrically couple the plurality of sectioning components to the return electrode when the mechanical anchor engages the opening in the outer tube portion; and 10. The tissue specimen extraction device of claim 1, further comprising:

3. A tissue specimen extraction device as described in claim 2, wherein the specimen bag is configured to be rolled up and stored inside the cannula assembly in a first retracted position.

4. A tissue specimen extraction device as described in claim 1, wherein the cannula assembly includes a handle configured to advance the specimen bag to an open position by pressing the handle.

5. A tissue specimen extraction device as described in claim 1, wherein the flexible ring is configured to be placed in a folded position when the specimen bag inside the cannula assembly is in a first retracted position.

6. A tissue specimen extraction device as described in claim 5, wherein the flexible ring and the specimen bag are configured to be pushed to a second forward position outside the cannula assembly, and the flexible ring holds a top portion of the specimen bag in an open position.

7. In a first retracted position, the specimen bag, the flexible ring, and the connector carrier are held within the cannula assembly, and the specimen bag is closer to the distal end of the cannula assembly than the connector carrier; The tissue specimen extraction device of claim 1 , wherein at least a portion of the flexible ring is configured to slide from a proximal end of the cannula assembly to a distal end around the connector carrier.

8. A tissue specimen extraction device as described in claim 7, wherein the flexible ring is configured to slide out from the distal end of the cannula assembly, pushing the specimen bag out from the distal end of the cannula assembly and holding the top opening of the specimen bag in an open position in a second extended position.

9. A tissue specimen extraction device as described in claim 1, wherein the at least one connector housing inside the connector carrier is configured to exist in a first flat position.

10. The tissue specimen extraction device of claim 9, wherein the at least one connector housing is configured to rotate to a second upright position.

11. A tissue specimen extraction device as described in claim 1, wherein at least one connector housing is removable.

12. A tissue specimen extraction device as described in claim 1, wherein the one or more connector portions inside the at least one connector housing are removable.

13. A tissue specimen extraction device as described in claim 12, wherein the at least one connector housing is removably coupled to one or more mechanisms for pulling the at least one connector housing from a first flat position to a second upright position.

14. A tissue specimen extraction device as described in claim 13, wherein the one or more mechanisms for pulling the at least one connector housing include a pull tab and a cartridge.

15. The connector carrier is configured to be positioned in a protective position within the cannula assembly; 2. The tissue specimen extraction device of claim 1, wherein the mechanical anchor is configured to secure the connector carrier when the specimen bag is open.

16. A tissue specimen extraction device as described in claim 15, wherein the connector carrier is configured to be positioned in an open position outside the cannula assembly after being advanced through the mechanical anchor.

17. The tissue specimen extraction device of claim 2, wherein the plurality of sectioning components includes a plurality of cutting wires.

18. The tissue specimen extraction device of claim 17, including a tensioning mechanism assembly configured to selectively pull each of the plurality of cutting wires.

19. The tissue specimen extraction device of claim 17, wherein the plurality of cutting wires are configured to selectively apply RF energy for tissue sectioning.

20. A system for extracting tissue samples, comprising:

1. A tissue specimen extraction device comprising: The tissue specimen extraction device comprises: (a) a specimen bag; (b) a flexible ring configured to form a top opening of the specimen bag; (c) a cannula assembly having an inner tube handle portion and an outer tube portion; (d) a connector carrier configured to hold at least one connector housing, the at least one connector housing having one or more connector portions, the outer tube portion having an opening configured to hold the connector carrier, the connector carrier having a mechanical anchor configured to selectively engage and disengage from the opening, whereby the connector carrier is removable from the cannula assembly; one or more tissue sectioning components; a tensioning mechanism assembly removably coupled to the one or more connector portions, the tensioning mechanism assembly configured to apply tension to the one or more tissue sectioning components; and an RF generator configured to selectively apply RF energy to the one or more tissue sectioning components; 1. A system for extracting a tissue sample, comprising:

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