Tissue sample 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 by reference herein.

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

[0003] Various novel features are described herein which may be used with or in conjunction with the inventions and disclosures set forth in the above-referenced patent applications, and the relevant text, figures and other disclosures from these prior patents are therefore incorporated into this disclosure for context, background and, where necessary, 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, particularly, but not exclusively, to a specimen bag deployment assembly having integrated interlocking 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. 5,393,633 and 5,433,367). In these patents, numerous systems and methods have been disclosed for capturing the tissue, collapsing an opening in a flexible component to simultaneously contain the tissue and expose the containment component (i.e., bringing the tissue outside of the body), and for packing the tissue 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, there are many containment components or specimen retrieval bag pouches available that can perform the function of capturing and packing the 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 section. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 9,522,034 [Patent Document 2] U.S. Pat. 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 samples requires great skill and 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 samples within a specimen bag to facilitate removal of the tissue through the smallest size incision possible. Thus, a need exists 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, and 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 and 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 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 to 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 an 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 tissue specimen extraction, the system 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 configured to attach to the one or more connector pins and apply tension to the one or more tissue sectioning components. [Brief description 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 in accordance with various aspects of the present invention. [Figure 1-B] FIG. 1-B illustrates one embodiment of a cannula assembly of the specimen extraction bag system of the present disclosure in a first, retracted position with a specimen bag retained 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, with 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 a 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 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 orientation in which one or more connectors may be removed. [Figure 1-H] FIG. 1-H illustrates one embodiment of the connector carrier shown in FIG. 1-E and further illustrates a first flat position in 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 the 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 illustrates 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 diagram 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. [Diagram 2] FIG. 2 is a schematic diagram of some of the electrical and mechanical components of an exemplary electrosurgical device. [Diagram 3] FIG. 3 shows a perspective view of the introducer. [Figure 4] FIG. 4 shows the introducer. [Diagram 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 illustrates 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 of the 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 introduction 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 prior to preparation for insertion. [Diagram 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. [Diagram 30] FIG. 30 shows the bag. [Diagram 31] FIG. 31 shows multiple views of an inflation mechanism for a tissue extraction bag. [Diagram 32] FIG. 32 shows two side views of components for an ultrasonic or vibratory sectioning device. [Diagram 33] FIG. 33 shows a side cross-sectional view of some components of an electrosurgical device. [Diagram 34] FIG. 34 shows a partially transparent perspective view and a partially transparent side view of a harvesting bag. [Diagram 35] FIG. 35 shows a plan view of the return electrode. [Diagram 36] FIG. 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. [Diagram 40] FIG. 40 shows an insulation displacement connector with a resistor ring. [Diagram 41] FIG. 41 shows a flow diagram of the active electrode connector recognition method. [Diagram 42] FIG. 42 shows top and side views of a tissue extraction bag. [Diagram 43] FIG. 43 illustrates the use of an inflatable tissue removal bag. [Diagram 44] FIG. 44 shows multiple views of the marking device. [Diagram 45] FIG. 45 shows multiple views of a tissue extraction bag with marking features. [Diagram 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] FIG. 48 shows a flow diagram 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. [Diagram 53] FIG. 53 shows a side view of an embodiment of a cutting wire. [Figure 54] FIG. 54 shows a partial cross-sectional side view of a dual retrieval bag with wire mesh and an inflation mechanism. [Figure 55] FIG. 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 rotating wire electrode with a sharp cutting edge. [Figure 58] FIG. 58 shows an embodiment of a single electrode wire. [Figure 59]FIG. 59 shows a bipolar device with active and return wires clamping a tissue specimen. [Figure 60] FIG. 60 shows a cutting and gripping loop in the retrieval bag. [Figure 61] FIG. 61 illustrates a stationary cutting mechanism and a moving tissue arrangement. [Figure 62] FIG. 62 shows the push / pull grid disconnect mechanism. [Figure 63] FIG. 63 shows a multi-stage rigid cutting mechanism. [Figure 64] FIG. 64 shows a stationary cutting electrode system. [Figure 65] FIG. 65 shows a skewer mechanism for tissue sectioning. [Figure 66] FIG. 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 a bipolar / bifilar wire pair. [Figure 69] FIG. 69 shows a square wire electrode. [Figure 70] FIG. 70 shows the harvest bag. [Figure 71] FIG. 71 shows the wire and bag construction. [Figure 72] FIG. 72 shows the bag and return electrode configuration. [Figure 73] FIG. 73 shows a dual bag design 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 cut device. [Figure 77] FIG. 77 shows another view of the device in FIG. [Figure 78]FIG. 78 shows a guide for a 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] FIG. 81 shows the shaft construction. [Figure 82] FIG. 82 shows an alternative shaft construction. [Figure 83] FIG. 83 shows a torsion spring for tensioning the wires / electrodes. [Figure 84] FIG. 84 shows wire activation using cams and lobes. [Figure 85] FIG. 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 a wraparound harvest bag. [Figure 88] FIG. 88 shows another extraction device. [Figure 89] FIG. 89 shows the wire details. [Figure 90] FIG. 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 several 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 several 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 PREFERRED EMBODIMENTS

[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 are increasingly directed to reducing the invasiveness of procedures. In particular, surgeons strive to perform "minimally invasive" procedures (meaning that incisions are limited to a certain size) whenever possible. However, many surgical procedures that can be performed almost entirely through very small incisions end up requiring a final step that is very difficult to perform through a small incision. This final step is the removal of the resected tissue. The removal of large tissue portions, 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 pieces of tissue inside a specimen while still within the patient's body. Current approaches allow for sectioning tissue into pieces small enough that they can be pulled out one by one through small incisions.

[0015] Several factors make this process time-consuming, difficult, 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 a lot of manpower and tools in the area. If the tissue and specimen bag must be manipulated and handled excessively, the opening of the bag may slip back into the incision site. If the tissue specimen is a cancerous tumor, this can be 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 containment component system is a flexible material that is rolled or folded by the surgeon, surgeon's assistant and / or scrub nurse in such a way that it can be inserted through a trocar or incision site and then opened once inside the patient's body. In this type of system, the surgeon first excises the tissue to be removed and then manipulates the bag opening with a laparoscopic tool to place the tissue specimen inside the bag. After capturing the tissue, the bag opening is elevated with a laparoscopic capture instrument and directed out of the incision site and secured externally by the surgeon either manually or with the addition of a Kelly clamp or clasp.

[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 so that it does not fall 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 through a trocar or incision site into the peritoneum, 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 aid the surgeon in placing the tissue specimen inside the bag. Such systems may include a molded metal ring with a spring bias attached to the top of the specimen bag such that the spring bias opens the top of the specimen bag when outside the cannula. Most systems that use 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 leaves the bag in 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, a string or suture material is used as a drawstring that closes the bag opening and tears the bag away from the metal ring, 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 then exposes the specimen bag. The tissue specimen extraction systems described in the patents referenced and incorporated above utilize tissue sectioning devices that include wires, return electrodes, and other components. The tissue specimen extraction systems of the present disclosure integrate 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 components" or simply "sectioning components" 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 or with the assistance of RF energy, or a combination of the two. However, any sectioning components described herein may include those referenced in each of the patents incorporated above, any referenced throughout this disclosure, or any other type of tissue cutting device known or to be created in the future. In many embodiments, these sectioning components may be integrated into the specimen bag of the present disclosure prior to deployment within the patient's body. 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. The "connector pins" may also be referred to as "connector parts." These connectors are attached at one end to the sectioning component inside the specimen bag. The connectors are configured to allow separate parts of the sectioning device to be connected at a later date. To facilitate distinction and reference between the tissue sectioning device component and the separate connectable part, the separate connectable part may be referred to herein as a "connectable (tissue sectioning) device" or a "part of the connectable device." For example, the connectable device 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. The connectable device, in embodiments, may apply the desired force and RF energy to the sectioning component and provide return current back 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 for 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 disclosed devices, 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 disclosed devices and systems 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. In particular, 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) when the collected tissue needs to be sectioned while being held inside the specimen bag. The ability to quickly activate and use the sectioning component can save valuable time at a critical moment after tissue mobilization. In an embodiment, the sectioning component includes multiple wire loops that are integrated with the bag. It is highly desirable to keep the ends of these sectioning wires managed and out of the way, yet readily accessible once they are 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 thus 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. The specimen bag and connector carrier assembly 10100 may simply be referred to as a "specimen bag assembly" since it is integrated in the illustrated embodiment. The specimen bag assembly includes a specimen bag 10101 with a flexible ring 10102 that may be attached to the bag opening. The flexible ring 10102 in the illustrated embodiment may be made of 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 a distal end with a flexible member 10103 and held securely at a 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] At an intermediate location between the specimen bag 10101 and the cannula assembly (not shown in FIG. 1-A), a connector carrier 10105 is shown. The connector carrier 10105 serves multiple functions shown and described in subsequent figures, including holding a connector configured to be attached to the sectioning device, providing a guide to run along the flexible ring 10102 to open and close the bag opening, providing a channel for the return electrode 10108 to extend outwardly 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 be plugged into a component of the sectioning device in embodiments where the sectioning device is powered by an RF power source. In such an embodiment, 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) and sectioning equipment inside the specimen bag 10101. 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 grip portion 10202 can be positioned anywhere between a fully extended position and a fully enclosed position. That is, the tubes may 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 open the bag as it extends beyond the distal edge 10205 of the outer tube 10203. As the connector carrier 10105 reaches the distal edge 10205, as shown and described in subsequent figures, 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 "fixing opening") in the outer tube 10203 to secure it in position within the cannula assembly 10201. The mechanical anchor 10802 can 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 secured within the outer tube fixation openings 10207, the user can control the opening and closing of the bag by advancing or retracting the inner tube handle 10206. A linking fitting 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 linking fitting 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 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 in relation 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 pushed in such a way that it is mostly located inside the outer tube 10203. The specimen bag 10101 and the 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 show that the top of the specimen bag 10101 includes a number 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 can be spread apart when the flexible ring 10102 is advanced, keeping the top of the bag open.

[0029] However, as shown in FIG. 1-C, the connector carrier 10105 remains inside the outer tube 10203, secured by the mechanical anchors 10802 and the fastening openings 10207. In this way, the tissue sectioning component and the connector of the connectable device are secured within the internal 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 placed inside an internal notch of 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 the 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 that makes up 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. The flexible loop 10310 therefore 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 and bunched bag opening can now easily slide 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. The open flexible ring 10102 forms a somewhat rigid circle, allowing 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, so the surgeon or surgeon's assistant does not need to hold the bag or add a Kelly clamp to secure it in place. The packed portion of the specimen bag remains inside the patient, so the surgeon can 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 the surgeon can save time and retrieve fewer instruments during critical moments in the surgery.

[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 advancement of the tube 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 an embodiment where the mechanical anchor is a spring 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 allow the handle to be advanced and the outer tube to release 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 the mechanical anchor, thereby releasing the mechanical anchor from the outer tube fixation opening 10207 and allowing removal of the outer tube 10203.

[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 enhances or overcomes the force required to maintain any type of latch feature in relationship 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 shown more clearly 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 cause disengagement.

[0036] 1-N, one embodiment of a fitting 10405 that can implement the described release is shown. Once the interface point between the inner tube 10206 and the fitting 10405 has stretched 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 a lower portion of the sample-loaded bag inside the patient, and leaving the opening of the bag and connector carrier assembly 10105 outside the patient's incision.

[0037] A person skilled in the art can easily envision other methods for creating a connection of the inner tube handle 10206 to the flexible ring guide 10406 ​​while within the outer tube 10203 that allows for decoupling 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 an 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 can freely access the connector and connection of the return electrode cable 10108 for subsequent sectioning steps without having the cannula assembly 10201 obstruct 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 one or more types of tissue sectioning instruments. The connector housing 10520 is housed within the connector carrier 10105 in such a way that the specimen bag assembly 10100 can be integrated with various types of tissue sectioning components inside the bag. In the illustrated embodiment, the connector housing 10520 manages a number of wire loops 10601, which is one particular type of cutting device for tissue sectioning. The wire loops can be implemented by those shown and described in U.S. Pat. Nos. 9,649,147 and 9,522,034. Any other type of cutting device can 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 exit 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 upwardly 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 components (e.g., wire loops). In other words, the wires can be pulled taut against the tissue specimen. The connector pins 10603 can move independently of one another, allowing the wires to 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 that a 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 in all the individual connections in one plug-in 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. Similarly, 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 instruments or not attached to any tissue sectioning instrument 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 an instrument assisted by the application of RF energy to the sectioning wires, as described in subsequent figures. The return electrode cable 10108 may be plugged into an RF sectioning instrument. However, the sectioning mechanism of the tissue specimen using these wires may be accomplished by mechanical, electrical, or any combination effect therein.

[0045] In the embodiment shown, 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 plugging 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 structure shown has the advantage that an audible click can provide the user with 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 a 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 that the housing is rotated (or moved) to provide an easier position for coupling of the tensioning mechanism assembly and removal from the connector carrier 10105.

[0047] 1-H and 1-I show the connector housing 10520 in one of two positions between which the connector housing 10520 can be rotated. In 1-H, the connector housing 10520 is in a flat position that aids in storage and protection of the connector housing 10520, and in 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 the connector housing. Once attached to the sectioning instrument, the connector housing 10520 can be pulled away from the connector carrier 10105. In the embodiment shown, the connector housing 10520, when pulled away, can expose the sectioning wire loop, which can then be placed in a specimen bag for the purpose of performing tissue sectioning.

[0048] 1-F and 1-G, a number of connector pins 10603 cover a number 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 sectioning 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 of the sectioning device and its subsequent use may require positioning the sectioning device over the center of the opening of the specimen bag. 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 folded 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 on a portion of the connector housing 10520 and / or the 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 upwards, 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 an embodiment, 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 the wires or other sectioning components inside the specimen bag 10101 from shifting when the tissue specimen is loaded. However, before sectioning begins, it is possible to remove the protective barrier 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 show steps to prepare the connector housing for coupling and / or tensioning. With the connector housing in an upright position, the surgeon can "stab" the sectioning instrument into the (4 pin) connector housing 10502 to achieve a one-step plugging process. The connector housing 10502, which was held within the connector carrier 10105, can be pulled away from the connector carrier 10105, and the surgeon can place the sectioning instrument directly above the tissue specimen and over the center of the opening of the bag. 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, and the surgeon can use each of the wire loops via an RF power source to separate the tissue specimen into pieces.

[0053] FIG. 1-M shows a side perspective view of the connector carrier 10105, fitting 10405, and inner tube handle 10206, and FIG. 1-N shows a cross section. 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 close the circuit.

[0054] FIG. 1-O shows the specimen bag assembly 10100 and the 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, at 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 to 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 an 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 an embodiment, the connector carrier may further include a mechanical anchor, and method 120000 may further include, at step 120003, releasing the mechanical anchor to move the connector carrier from a position within the cannula assembly to an exterior of said cannula assembly. In an embodiment, method 120000 may further include, at step 120004, pulling the top opening of the specimen bag out of the incision site of the patient. In an embodiment, method 120000 may further include, at step 120004, disengaging the cannula assembly from the specimen bag, the flexible ring, and the connector carrier. In an embodiment, method 120000 may further include, at step 120005, coupling at least one component of the tissue sectioning instrument to one or more connector portions. In an embodiment, method 120000 may further include, at step 120006, rotating at least one connector housing to an upright position. In an embodiment, the method 120000 may further include, in step 120007, sectioning the tissue specimen using at least one component of the tissue sectioning instrument.

[0057] (Bag return monitor) A common method of reducing alternate site burn 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 that is 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 in absolute and relative form.

[0058] In the previous disclosure, it has been 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 the bag to be manipulated to improve electrical contact between the return electrode and the tissue.

[0059] The present disclosure provides a method in which the contact quality system includes two separate return electrodes inside the specimen bag and has a known resistance across the two electrodes. This method may result in a reference resistance that is considered to be in parallel with the tissue. In this way, although the sensitivity of the tissue impedance may be reduced, it is believed that 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 realized with 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 can easily understand that a choice of known resistance values ​​can be selected to optimize the sensitivity of the parameters that are advantageous for the application. That is, for use in applications where a return pad is placed on the skin of the patient, other systems are designed to measure contact quality and site burn. However, the application of RF energy in this disclosure is directed to the sectioned tissue. The tissue that needs to be sectioned has a different resistance value that needs to 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 electrical impedance of the return electrode trace to dominate the measured impedance. This value can range from 0 ohms, a single electrode that is considered to only provide the electrical impedance of the return electrode trace, 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 the coated return electrode on a flexible substrate, the location of the resistance transition from the coated substrate to the cable poses a challenge under mechanical loading conditions due to differences in elasticity and the resulting shear forces. One aspect of the present disclosure provides a method to create this transition by using compression of the silver coating against the return cable. In this embodiment, a flat surface can be attached via soldering or crimping to the return electrode cable such that the flat surface is placed in close proximity to the silver coating. Compression can be applied to the silver coating against the flat surface to provide an electrical connection. 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 since the compression holds the substrate in place. The size and shape of the flat surface can be selected to provide an interface impedance to ensure proper electrical transition between the coated substrate and the cable. A method 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 an RF tissue specimen extraction device has the advantage of 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 a cryo-cut 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 with an axial mechanical load applied (e.g., the exemplary wire loop device shown in Figs. 50, 78 and 80), the combination of mechanical and electrical energy creates a cut that starts at the side of the tissue specimen, pulling the wire into the tissue towards the center of the specimen. This is due to the distribution of mechanical forces and electromagnetic fields along the wire. As the sectioning progresses, the cutting effect propagates into the tissue and down the surface of the tissue towards 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 forces 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 makes the cut. The axial force only advances the wire and does not contribute significantly 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 since it is 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 change in shape of the cut towards 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 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 the cut, the compression force starts at a nominal value determined by the tissue impedance and the vapor pocket created around the wire at the start. As the force increases, the compression of the tissue by the wire increases 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 discharge required 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 required to sustain the cut until the end of the cut can be challenging. It may be beneficial to take this effect into account in the selection of 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 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 the cut.

[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 geometry changes.

[0066] The 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 the measured tissue impedance. In this way, a maximum force is applied to the wire that also maintains the generator's delivery power capability to the tissue. The DC motor can also be selected with its inherent load characteristics that match the desired range of applied forces to allow the force delivered by the motor to be controlled with a constant current.

[0067] (Reusable sectioning device) In the previous disclosure, it has been explained that RF tissue sectioning can be easily adapted to create a reusable portion that works in conjunction with the disposable portion of the sectioning tool, which has the benefit of reducing the overall procedure cost while also reducing the amount of material disposed of per use.

[0068] One embodiment of the described reusable sectioning tool is to use a tensioning mechanism that utilizes a motor to apply the force. The use of a motor, such as a small DC motor, has an advantage in reusable applications in that the sectioning tool tensioning mechanism can be automatically advanced or retracted in position. This allows for easy repacking of the sectioning tool in preparation for the next use, which is much more difficult with coil spring embodiments. Additionally, the motor may incorporate an encoder to allow real-time position information of the wire during cutting and repacking in preparation for the sectioning tool for the next use. This allows for automatic tensioning for cutting and repositioning the tensioning mechanism to the pre-packing position after sectioning is completed. Using this embodiment, the reusable portion of the device may include the electronics required for communication between the sectioning tool and the controller, tensioning mechanism, and user control mechanism. The disposable portion may be limited to the interface between the sectioning tool and the sectioning wire.

[0069] The features and embodiments described above can be used as such 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, entitled "SYSTEM AND METHOD FOR REDUCING AND EXTRACTING VOLUMES OF TISSUE," filed July 21, 2015, having a priority date of July 22, 2014, the entire contents of which are incorporated by reference herein for all purposes as if set forth in its entirety 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 sectioning action or monopolar action.

[0072] In some embodiments, as illustrated in Figure 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 separate component 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 a safe tissue temperature.

[0074] In some embodiments, the tissue sectioning voltage parameter Vmin is defined as the minimum voltage required to initiate the initiation of a sectioning cut 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 a sectioning cut. 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 the sectioning cut of a control tissue.

[0075] In some embodiments, the tissue sectioning current parameter Imin is defined as the minimum current required to meet the current density required to create a tissue sectioning cut. In some embodiments, the tissue sectioning current parameter Imin is defined as the minimum current required to sustain a 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, the power factor angle PFAcut variable is measured during an electrosurgical procedure on a patient. The power factor angle PFAcut variable may 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 may 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 will dominate. 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 close to 90 degrees. Thus, 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, a direct impedance measurement for 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 PF activation while an open circuit condition is known to exist between the active and return electrodes. 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 to determine open and / or short circuits instead of the power factor angle PFA described above. 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 the apparent power. This ratio is 1.0 when the active and apparent powers are the same, as would be the case if a purely resistive load were applied. As more inductive or more capacitive loads are applied, the phase shift of these loads reduces the value of the ratio and approaches zero, since 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, thus providing or enabling the detection of the minimum power factor threshold PFcut for disconnection, the short circuit power factor threshold PFshort, and the open circuit power factor threshold PFopen.

[0080] In some embodiments, the average active power Preal may 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 may be connected to an analog multiplier. The output of the multiplier may 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 may also be measured using analog RMS voltage and RMS current sensing circuits that provide an RMS analog output. The RMS outputs of these sensors may also be connected to a multiplier to obtain the instantaneous apparent power, and the output of the multiplier may be connected to an analog circuit having a specific capacitance to provide a window for averaging the apparent power, as described above for the active power measurement. This circuit may be read using an A / D converter, and the power factor PF may then 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 comparators as threshold detectors 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 implement.

[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 properties of the active electrode wire, the tissue type and the amount of hydration of the tissue, and can be empirically determined by measuring a range of impedance values ​​during the cutting process in the 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 required to initiate or sustain the cutting effect, as described earlier herein. The maximum power parameter Pmax may be determined or defined as a value that will deliver the slicing or cutting effect without excessive charring, tissue desiccation and / or 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 may be provided to improve the efficiency of the power delivered from the generator to the tissue. In some embodiments, the controller may use power factor correction. Power factor correction may be achieved by using a variable capacitance that the controller (see, for example, FIG. 2) can adjust to offset the cable inductance of the system. 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 changed and the controller may control the phase to achieve a near 0 degree phase angle that results in maximum power efficiency for cutting. This technique may be used to maximize the power delivered to the tissue, thus providing faster cutting or allowing larger tissue specimens to be cut efficiently.

[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 may be deduced by accumulating the effective 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 may 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 may be compared to a maximum energy parameter Emax to ensure that the temperature of the tissue does not exceed an intended value and is not above a temperature deemed safe. The travel speed variable Rtravel is defined as the travel distance of the tensioning mechanism or cutting electrode or wire over a fixed time period and may be compared against a minimum travel speed parameter Rmin and a maximum travel speed parameter Rmax to ascertain 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 cryocut. 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 may 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 may be adjusted to a known mechanical force F equal to or greater than zero pounds force. In addition to varying the power and force, a vibration or other dynamic load may be applied to the wire upon sensing a low travel speed to accelerate its progress.

[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 applying no force against the tissue specimen, such as wire breakage.

[0089] Many methods can be used to measure or determine the running 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 translational motion. In some embodiments, the motion may be detected as motion within a plane.

[0090] In some embodiments, multiple motion sensors can be provided and configured to compare an image at time T0 to an image 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 has 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 that 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 changes rather than creating an image. The contrast changes can be surface irregularities in the spring or force application 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 moving components such as tensioning mechanisms, cutting electrodes or wires, and one or more optical sensors are configured to count the number of patterns moving past the focal area to determine travel speed and speed 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 the primary pattern or near the primary pattern as secondary patterns, thus providing additional information such as absolute distance traveled, start or end of travel markers and / or key points of travel distance.

[0093] In some embodiments, the device may be configured to adjust the 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 the spring or force application mechanism, and the measured rotation of the wheel provides an indication of the travel of the spring. Wheel rotation can be measured by including spokes of known width or angle in 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 that varies from a low impedance value to a high impedance value. 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 the capacitance change to determine the running speed or distance. In some embodiments, an electric plate is provided that does not cover the entire wheel surface, for example 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 running change of the spring can be calculated in a manner similar to the resistive film predecessor.

[0098] In some embodiments, an encoder is mechanically coupled to the spring or force application mechanism to indicate running speed or distance traveled. The encoder may provide waveforms that can be used to determine running 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 or not. 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 in response to information from one or more sensors only if, for example, the travel distance is outside of 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 the motion of the spring can be quantified in a traceable form that can be compared to external measurement equipment. An additional advantage is that correction algorithms can be applied if non-linearities are observed in the travel speed of the spring or force application mechanism through its full travel range.

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

[0102] In some embodiments, the signal is transmitted from the sectioning tool 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 in the electrosurgical device 102 and used for comparison against the pre-tension travel distance parameter Dpreten and the cut completion travel distance parameter Dcomplete. The pre-tension travel distance and the cut completion travel distance parameters Dpreten, Dcomplete are calculated by the design of the tensioning mechanism and active electrode assembly such that the pre-tension travel distance parameter Dpreten indicates the minimum distance achieved during pre-tensioning in the largest intended specimen, and the cut completion travel distance parameter Dcomplete indicates the maximum distance achieved when the active electrode wire finishes 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 pretension. 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 herein above can 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 above 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 the sectioning procedure complete, the speed of completion, the speed traveled, the absolute distance traveled, and / or the relative distance traveled.

[0105] In some embodiments, the sectioning device may 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 an expected range that would be associated with the sectioning power being applied to the electrodes. That is, an expected running speed range may be associated with a particular power level and / or sectioning force. If the actual running speed is outside the expected range, this may 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 the tissue sample, i.e., to bias the wire toward the tissue sample. Upon initiation 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 nested spring loaded tubes that freely extend out toward the specimen upon release of the mechanism. The extending 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 nested introducer tube with self-locking teeth to prevent the extended introducer tube from collapsing back on itself.

[0107] The expandable distal end portion of the sectioning instrument may be inserted into the 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, may 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., FIG. 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 getting 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 a larger 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 of the wire running through the tube and into the instrument, as illustrated in FIG.

[0110] Returning now to FIG. 4, introducer 400 may have more than one feature for maintaining pneumoperitoneum. The introducer may 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 may be adjusted downward toward the incision in such a way as to compress tissue between the inflatable ring 401 on the interior of the peritoneum and the mechanical sealer 402 on the exterior of the peritoneum. In some embodiments, inflation may be accomplished 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 to the inflatable ring.

[0111] 5, some embodiments include a flexible membrane 501 near the distal end of an introducer 500. A 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 outwardly, causing the flexible membrane 501 to expand outwardly, 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 the 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, as does 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 in the cross-sectional axis of the introducer such 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 the proper place.

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

[0115] In some embodiments (see, e.g., FIG. 4), a drawstring attachment to the distal portion of the introducer 403 can be included along with a sealing feature to provide multi-functionality to the introducer. This increases the efficiency of the procedure by minimizing the stress required to insert the bag, seal the peritoneum during tissue packing, and allowing 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 to control tissue sectioning variables, including, but not limited to, voltage, current, impedance, power, travel speed, travel distance and / or mechanical sectioning force to be adjusted or applied during a 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 a first, second and third lead, 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 the location of each wire.

[0121] The controller 108, 708 may be configured to switch PF power between each of the cutting wires intended to have RF power applied to complete the cut substantially simultaneously. This can be accomplished by switching RF energy in a sequence 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 in such a way that the cutting wires 122, 124 exhibiting different or lower impedance values ​​or lower travel lengths during the same period can receive more RF power on average than the remaining wire sets to maintain the cut. Those skilled in the art will recognize that when the electrode is not traveling, the vapor puddle collapses, resulting in a lower impedance, whereas when the cut is active, the vapor puddle can increase the impedance.

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

[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 advancing properly 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] Turning now to Figure 8, further details of the tissue sectioning method 800 will be described. As illustrated, the method 800 includes a step 802 of receiving a number 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 wires, such as energy, power, voltage, current, mechanical force, and / or feedback variables, such as impedance, resistance, travel speed, and distance traveled.

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

[0126] The 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 sample in response to the comparison step 804 or the comparison step 806.

[0127] Method 800 may be accomplished using the apparatus illustrated in any of Figures 1-Q-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 the preceding sections of this disclosure.

[0129] 1-Q, the system 100 and / or method 800 may 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 may 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 so that no electrosurgical effects occur.

[0130] For example, the system 100 may include current and voltage sensors to provide separate real and imaginary components of the complex load impedance applied by the system 100 to the tissue. Those skilled in the art will appreciate that the imaginary or reactive component of the cable impedance can make measuring the generator short circuit very difficult. However, by providing a 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 measurement of shorts, opens, and intermediate impedance values. In some embodiments, the 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 contribute significantly to the load resulting in a negative phase angle. Methods for calculating the phase include using an analog phase detector, comparing the zero crossing points and peak magnitudes, 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 a controlled outcome 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 with 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 keep the travel speed above a minimum value Rmin to ensure a low temperature cut, and / or to keep the power below a maximum value to reduce the power delivered when the cut is completed.

[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 is set on the generator 104 and has a separate power cord, or in some embodiments, the controller 108, 708 may be integral with and be a component of the generator 104 as illustrated in FIGS. 1-Q or 2, or may be integral with or be a component of the electrosurgical instrument 102. The controller 108, 708 may only have 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 for the transfer of information 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 prior to 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 prior to 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 separate tensioning mechanisms and wire sets within the electrosurgical device 102 such that the controller 108, 708 can selectively and / or sequentially energize the wires 122, 124.

[0140] 2, a user can select the appropriate sequence through a user interface 112 to the generator 104 or controller 108, although one skilled in the art will recognize that the user interface 112 can 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 can 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 controller 108, 708 or system 100 described previously herein. In some embodiments, method 900 includes one or more of steps 902 determining whether pretension has been applied to the tissue, (b) determining whether power applied to the tissue is acceptable, (c) determining whether impedance between wires 122, 124 and the tissue is acceptable, (d) determining whether voltage applied to the tissue is acceptable, (e) determining whether current applied to the tissue is acceptable, (f) determining whether power factor angle is acceptable, (g) determining whether minimum travel speed has been reached, (h) determining whether travel speed is acceptable, and / or (i) determining whether cutting is complete, (i) determining 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) step 920 of advising an operator to pretension the device 102; (b) step 922 of adjusting the power or suspending the power and advising the operator to modify the power; (c) step 924 of aborting the power activation and alerting the operator; (d) step 926 of determining whether a short circuit exists; (e) step 928 of determining whether an open circuit exists; or (f) step 930 of adjusting the power or advising the operator to modify the power.

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

[0146] The method 900 may include a step 932 of requesting to deliver power, a step 934 of applying power, and a step 936 of removing power. The step 934 of applying power may be responsive to the step 902 of determining that pretension has been applied. The step 936 of removing power may be responsive to the step 918 of determining that cutting is complete.

[0147] 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 herein above and may include some or all of method 900 described herein above 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 discontinued for all electrodes 1-N. In other words, system 100, 200 may be configured such that if one of the electrodes reaches the maximum off-time, the system will use that electrode next. If none of the electrodes has reached the maximum off-time, the system applies power to the electrode that is moving the slowest.

[0148] 11, various methods and systems are disclosed herein for detecting the distance traveled and the speed of travel of one or more wire electrodes 122, 124, such as electrodes 1-N associated with methods 3000, 4000, in some embodiments. In some embodiments, for example, a plurality of 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 time a spring mark 1102 is encountered, thereby inferring the distance traveled DTravelX and / or the speed of travel 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 modified relative to the distance along the spring 1104, such that a color optical sensor or other identification means can 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 illustrated) in 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 operation of the tool. 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 to test the deflection in the spring coils. Those skilled in the art will appreciate that a larger deflection means more spring material is deflected, which in turn means further runs 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 distance traveled (and speed of travel) of each spring and electrode or wire.

[0152] In some embodiments, a micro "radar" optical measurement can be provided of each connector block 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 and along the travel of the tensioning mechanism. Contacts can be attached to the tensioning mechanism or tensioning block near the distal end such that an electrical connection to the resistive strip or film is provided. As the tensioning mechanism moves, the contacts act in a manner similar to a "wiper" or variable resistor. By using an electrical circuit that applies 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 is related to the speed of travel.

[0154] In some embodiments, contacts and resistive strips are provided as previously described, but with a second conductive strip that is parallel to the resistive strip but not electrically coupled. The contacts provide electrical coupling to both the resistive strip and the conductive strip. 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 that would operate in close proximity for the duration of the run. 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 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 the desired travel speed of the electrode at a known power level in a 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 previously described herein and the device described in applicant's International Application 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 so that a disposable lumen 1303 can be attached. The disposable lumen 1303 can provide a guide 1306 for one or more tensioning mechanisms having a post 1316 that couples to a tensioning block 1318 on the proximal portion 1302 and can have a coupling point to allow the distal end 1308 to couple to an active electrode wire coupling (not illustrated). The disposable lumen 1303 may also include a means 1310 for advancing a tensioning spring (or tensioning mechanism) to a pretensioned position, a pretensioning mechanism 1312 that allows a user to pretension the tensioning mechanism, and an introducer 1314 for placement of the bag within the incision site (see, e.g., FIG. 1-Q).

[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 allow the spring and tensioning block 1318 of the proximal portion 1302 to be advanced 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 at the end of the tensioning mechanism in the proximal portion 1302 snaps / slides / locks into the receiving opening 1318a of the terminal block 1318. 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 in the proximal portion 1302 may 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 may 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 the 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 open or opened behind a movable, translatable or collapsible sleeve and / or punctured by a feature of 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 immediately recognize the many means of providing the reusable portion 1402 and the disposable portion 1404 and allowing the coupling of these portions. Any and all means now known and to be developed in the future 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 inside 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 areas that house 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 a user with the ability to tension only those wire sets that are to be activated with power, such as radio frequency (RF) energy. This ability 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 wire sets along with the introduction of power or RF energy. These "X" direction wires may be configured such that they do not overlap in physical space with one another, reducing the likelihood of the active and inactive wires electrically coupling. One of ordinary skill in the art will readily envision numerous ways of creating a mechanism 1502 that may selectively apply tensioning forces to only those wires that are 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, such as by a flange or tab 1506, prior to tensioning or power activation.

[0166] In some embodiments, referring to FIG. 23, the constant force spring 2302 is provided with a notch 2304 or additional engagement feature. One or more detent gates 2306 are configured to be temporarily inserted into the engagement feature or notch 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, for example, by rotating the slotted collar 2308. The slots 2310 can be oriented such that the rotational motion changes to linear or vertical motion at a preselected rotational location.

[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 rise at a defined rotational angle 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 in the patient's cavity, or in some embodiments, may be an attachment to the distal end of the tissue sectioning device, which may be removed after the bag 161 is placed, or may be a feature designed into 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 may 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 may have a means for mechanically coupling the drawstring 2405 to a semi-rigid ring around the bag opening. In some embodiments, the introducer 2404 may be pulled from the bag such that a user or a grasping instrument may 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 may be any means known to those skilled in the art, currently developed, or to be developed in the future, and may include tying, gluing, welding, fastening (e.g., threaded fasteners), or any other means.

[0171] Those skilled in the art will also appreciate that the drawstring 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 intended use within a surgical environment and to minimize the transfer of contaminants to the patient. In some embodiments, the drawstring 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 may be provided that is integrated with the tubing to form a secure tether to allow the user to expose the bag 161, as illustrated in FIG. 26. In some embodiments, the harvesting bag 161 includes multiple inflation areas 2604 inside the bag that can be inflated with low pressure air. These inflation areas 2604 are used to provide rigidity to the bag opening and / or side walls of the bag 161 to aid in loading of the tissue specimen into the bag 161. The inflation areas 2604, along with the return electrode cable 2602, may include or be coupled to a common inflation tube 2606 that protrudes outside the patient's body when the harvesting 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 mechanically supported together where they exit the harvesting bag 161 so that they can be used as a means to pull the bag 161 towards the incision site after it has been loaded with a tissue specimen. After the bag 161 has been deflated, 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 pull the remaining bag opening outside the patient's body. This integration of the return electrode cable 2602 and the tubing 2606 can be a molded assembly, a film applied around both components, laminated together as one 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 the system 100 may be provided. The bag 2700 may use a thin film layer 2702 containing perforations 2701 to secure the electrodes / wires against the interior surface of the bag 2700. These perforations 2701 may be designed to control the release of the electrodes / wires during a pretensioning step, or may be designed to partially release the electrodes / wires at selected locations and release the electrodes / wires at remaining locations during the travel of the electrodes / wires during cutting. In some embodiments, the 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 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 required 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 values ​​and patterns 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 (or less than about 0.200 inches). In some embodiments, the width is less than about 1.63 centimeters (or 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 one another 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, one can obtain progressive release of the electrode / wire as it advances during cutting and can guide the electrode / wire along the perforation channel 2707, resulting in a more predictable sectioning cut. This can be achieved by the same perforation per length value across some or all sections having perforations 2701, can be enhanced by using different perforation per length values ​​in different sections, can be linear, logarithmic or other patterns of increasing or decreasing perforation per length values, or can be 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 because multiple wires are used inside the bag, crossovers are created where wire sets intended to apply power, such as RF energy, to tissue meet in close proximity to wire sets that are not intended to carry power or RF energy. A certain amount of power tends to couple capacitively, inductively or conductively to the inactive wire sets. As the total surface area of ​​the active electrode increases, this can result in the cutting of unintended wire sets that can reduce the current density, and therefore the desired cutting performance is not achieved. Therefore, this coupling must be managed to avoid cutting of unintended wire sets.

[0179] Referring briefly to Fig. 99, in some embodiments, one or more electrode wires 9908 can be molded or housed within a portion of the bag wall 9906 or film 9910. Fig. 99 illustrates a top view of how some 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. This 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 the 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 where arcing begins, the arc path will be preferentially in the tissue and not through unintended wire sets.

[0182] Bonding can be mechanically managed by providing a higher mechanical load to the wire set intended for cutting versus the unintended wire set. This can be accomplished with separate pretension forces or with different forces applied for 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 the two as the intended wire set advances through the tissue. The increased separation will ultimately reduce the amplitude of bonding between the two wire sets to a non-significant level.

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

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

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

[0186] For example, if the electrosurgical device 102 is designed to have 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 laminated to the interior of the bag. Each of these inner layers may be an insulating layer with perforations running along the length of the layer 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 one opening in the bottom area of ​​each layer such that when the inner layer is in place, the return electrode is exposed to the tissue. A user may attach the connector of the active electrode wire set 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 by the surgeon, for example, by manually 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. In the same manner as previously described herein, a second electrosurgical device 102 can be connected to the tissue extraction bag, a device that can be repacked in a fully extended position. One skilled in the art can appreciate that this increases the number of sectioning cuts and reduces the likelihood of large tissue sections remaining after all sectioning steps have been completed. The layers of the bag can be constructed in such a way that each inner layer is slightly rotated from all the other layers to further reduce the likelihood of large tissue sections remaining after all sectioning steps have been completed.

[0188] 27, the film 2702 is separated into a number of different regions, in some embodiments, two regions. The bottom surface of the bag 2700a can include a bottom region 2706, which can be a hemispherical region as illustrated, although one skilled in the art will appreciate that a box shape or any other shape can be selected depending on the particular purpose of the bag 2700. The sides of the 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 the bottom region 2706 is less than the force in the side region 2704, which can bias the release of the wire from the side before the release from the bottom surface. To counter this tendency, one skilled in the art will appreciate that it may be desirable to provide the film 2702 with a first thickness T1 at the side portions that is different from, e.g., thicker than, the second thickness T2 at 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 (about 4.72 teeth per centimeter) perforations to provide a lower breaking force to separate perforations 2701. Side region 2704 can have a film 2702 that is about 0.0022 inches (about 55.88 μm) thick and 8 teeth per inch (about 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 manipulation and packing of the tissue specimen, allowing a lower perforation force to be used in bottom region 2700a without concern of failure during the packing process. This configuration also takes advantage of the higher side area forces to ensure that the electrode / wire does not release completely and / or prematurely with or during the pretension step, allowing the electrode / wire to release during cutting so that the perforations 2701 act 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. The methods may include providing a film 2702 having a first thickness T1 at a side portion 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 wires from the bag, as illustrated in Figure 27. These windows 2709 do not constrain the wires 151 and allow direct contact between the active electrode wires 151 and the tissue. The perforations or areas of perforated walls provide temporary attachment of the wires 151 to maintain alignment.

[0192] The ratio of window 2709 to perforation walls can be adjusted or selected in a manner similar to the perforation per length value to control the force required to release the wire 151 through the perforations. Additionally, the perforation walls can provide an isolation layer and / or the isolation layer can include perforation walls since the perforation walls cover 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 mechanical loading and electric field distribution of the wire 151, the active electrode wire can preferentially initiate initiation of the cut at a first portion of the side wall of the bag. By placing the window 2709 at or near the first portion, this initiation will be enhanced. In contrast, by placing a wall at or near the second portion, the initiation of the cut is moved 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 in such a way 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 to a second region of tissue.

[0195] 28, the perforations 801 or perforation walls 2883, in some embodiments, do not extend to the opening area of ​​the bag, thus allowing the proximal end of the electrode or wire to be easily terminated to the connector 2884 during manufacturing and / or to allow the user to easily guide the wire set connector, or termination of the wire to a corresponding receptacle in a sectioning tool or other device that the wire connector is intended to attach to. Having a portion of the electrode or wire that is not secured by the perforation walls 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 can include an outer bag 10002 and an apron 10004 to manage placement of the wires / electrodes 10006.

[0197] 28, an "apron" or additional film layer 2885 is provided within the bag to protect the wires from damage during stuffing. The apron may be attached at the proximal end to the bag opening or near the bag opening. The apron may have a continuous cylindrical shape or may be a series of segments that extend around the interior of the bag. The apron may be positioned such that the wires and / or connectors are between the apron and another feature within the bag. The apron may extend distally along the interior surface of the bag to a point near or beyond the perforations such that any wires not contained by the perforations remain below the apron. With the apron, tissue does not come into direct contact with the wires or wire connectors and may be more easily stuffed. The apron may also protect the wires during stuffing, manipulation and exposure of the bag.

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

[0199] One skilled in the art will appreciate that the apron may have advantages where any features located on the bag surface may impede loading of the specimen and / or may provide advantages for 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 meshes, 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 such that the tissue falls or rests below the distal-most edge of the apron as it is packed into the bag, or such that the distal-most edge of the containment flap may be elevated 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 positionable 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 positioned or positioned on the bottom or distal edge of the containment flap 2986 to allow the 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 packing of the tissue.

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

[0204] After loading of the tissue specimen, the containment flap 2986 can be used to help expose the bag opening. With a drawstring 2987 coupled to the distal edge of the containment flap along the periphery, pulling the drawstring through the incision site will lift the distal edge of the containment flap around the tissue specimen and draw the opening towards 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 incision. Once the bag reaches its intended exposure position, it can be secured with a semi-rigid member 2889 around the opening, inflated to secure, or held 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 so that the apron 2885 can remain in place until after exposure. The bag can be exposed by tying leads or sutures 2888 (see FIG. 28) to a semi-rigid member 2889 that helps guide the bag opening towards 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 a piercing feature 2890 that allows the user to pull it apart, thereby allowing access to the electrodes and / or bag features on the interior surface, such as wires or wire connectors 2884. This embodiment has the added benefit of reducing the chance of contact of the peritoneum or incision site with the portions of the apron layer that contacted the tissue specimen during packing and manipulation. The apron can collapse somewhat within the interior bag volume. This "curtaining" effect keeps the apron from remaining very close to the interior surface of the bag. A feature can be added at a corresponding location on the apron and the interior surface of the bag to help hold the distal most portion of the apron in place.

[0206] In some embodiments, a feature or tab 3092 on the apron 3085 can be provided in the bottom or distal portion of the apron, as illustrated in Figure 30. A corresponding feature or slot 3093 can be provided 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 a 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 inside surface of the bag is to weld or heat seal a small spot around the perimeter of the bag. This weld is designed to hold the bag in place but 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 inside 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 surface 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 location of the pocket 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 placed slightly below the proximal bag opening in a manner that remains below 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 stuffing. It is contemplated that multiple different aprons could be used to cover different wire sets, where one apron could be removed first to expose one or more connectors for connection to an instrument, and then a second apron is 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 avoid 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 may include additional guides to house the common wire set to maintain alignment over the perforations and near the bag opening. The guides may include heat shrink, tubing, and / or other means to hold the wires crimped together or attached in close proximity to a common wire connector. One or more guides may be used at locations along the wires where the wires will perform as intended if 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 stiff 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 the 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 inner surface as they exit the wire channel, and similarly should not interfere with the process of tissue packing or 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. This 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 made up 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 sidewalls of the bag up to the maximum tissue specimen height 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 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 prior to applying pretension, allowing unrestricted running of the pretension introducer tube into the incision site in preparation for the cutting procedure.

[0218] In some embodiments, the elongated wire channel is positioned under the apron with the 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 making the wire connection, or it may be a thin film that allows the user to "tear" the elongated wire channel from the inside surface of the bag, or it may be attached using a slot in the side of the bag into which the elongated wire channel will be installed during manufacture and / or other methods of attaching the channel to the inside surface of the bag. In some embodiments, the attachment may 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 manufacture that the user can remove during wire connection.

[0219] The shape of the elongated wire channel may be designed or configured to reduce the possibility of twisting the wire when released from the interior of the bag. In some embodiments, a relatively wide elongated channel may 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 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 allow the elongated wire channel to remain naturally aligned in the correct 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 tangling 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 long separation of the wire connector to 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 side wall of the bag out the bag opening. To ensure that the cut is not degraded, 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 into 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 affixing the cable to the inner side wall, 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 tool can include markings on the exterior surface that visually align the orientation of the tool with a particular feature on the exposed portion of the specimen bag. This allows the user to maintain proper alignment during connection of the wire connector of the specimen bag to the sectioning tool. The alignment feature can be a label, an inserted feature, an overmolded feature, a molded feature in the housing, a silk screened feature, a shape with a similar color, a registration number or other symbol or other identification means for the user. Some embodiments can include a contrasting line applied axially to the exterior housing of the distal tube such that when the line is placed in alignment with the return electrode cable, the tool is in proper alignment with the specimen bag to make the wire connection.

[0224] With the introducer tube extended into the specimen bag and against the tissue sample, any slack within the wires is removed and tension is applied to all of the wire sets. This tension aligns the wires from the distal end of the introducer tube to the wire attachment point inside the sectioning instrument. This alignment ensures that each wire set can advance inside the instrument 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 wire set that is being cut.

[0225] 31, a retrieval bag 3130 for the system 100 may be provided, which may include an expandable feature. Expansion of the bag 3130 may be accomplished with a honeycomb pattern of expanded or expandable cells 3132. The multiple expandable 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 expansion channels 3132, some or all of which may be accompanied by separate pressure retention means, such as separate syringes or stopcocks. In some embodiments, the bag 3130 may include small, isolated areas with still air trapped under pressure.

[0226] The inflated cells 3132 provide an additional insulating barrier between the tissue sample or electrodes and adjacent structures external to the exterior surface of the harvesting bag. In contrast, if the entire bag was inflated as a single cell, failure of one of the layers would result in a loss of expansion and insulation. By providing multiple independent expansion 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 layer and bottom layer 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 providing a vibrational motion to the electrodes or wires using ultrasonic energy in combination with or independent of the voltage and current applied to the tissue through the electrodes or wires. As explained above, the mechanical load F (see also FIG. 2) on the wires 122, 124 is crucial and may be a constant force or may be dynamically applied. Dynamic loading includes the use of vibrations, where a transducer may be used to generate high frequency vibrations on the wires or wire ends. The use of ultrasound to create vibrations may be used alone or with RF energy. In some embodiments, the ultrasonic transducer is on the sectioning tool. When the wire connector on the bag is coupled to the sectioning tool, ultrasonic or high frequency vibrations are transmitted to the wires in 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, an active electrode wire 3208 may be mechanically coupled 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 such a way that a 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 vibration at an optimal frequency. The control system can utilize a phase-locked loop to control the optimized frequency that provides 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 vibration from the lowest to highest force applied by the tensioning device. Other control systems can be used that do not maintain a constant displacement, such as a fixed oscillation or Wien bridge oscillator, used as a complement to RF energy cutting.

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

[0233] 33, a tissue sectioning device 102, 200 (see, e.g., FIG. 1-Q or FIG. 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 may be initiated by applying power to the wire electrode 3302 and causing the film 3306 to break, 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 appreciate that generally, activation of the wire to initiate the cutting effect results from a 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 a 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 pre-tensioning the tissue sample and an insulating layer between the wire electrode 3302 and the tissue is 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 could serve the alternative function of applying tension to the tissue sample, or could be achieved with a design of the bag, wire attachment and pre-tensioning mechanism that results in a gap in the tissue wire / bag interface during operation. The desired wire set to be activated can have power applied, such as RF energy, and after sufficient power with voltage is applied, the wire set can be pulled to the surface of the tissue or can be mechanically, electrically or using temperature to break through the separation layer and initiate the cutting effect. Generally speaking, any easily electrically removable (or degradable) adhesive or holding volume to hold the wire electrode in place can be provided, 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 the 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. Thus, one skilled in the art would 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 may include multiple conductive elongated or extension portions 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 the incision site.

[0238] In some embodiments, as illustrated in FIG. 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 an inner surface of a 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 about five extension portions 3548 and the second portion 3546 of the dual return electrode 3540 has about five extension portions 3548. In some embodiments, the first and second portions 3544, 3546 are mirror images of one another.

[0239] The dual return electrode 3540 may 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 collapsibility during insertion of the bag into the incision site.

[0240] Methods of manufacturing return electrodes such as those described herein can include adhering the return electrode and cable to the bag or forming the electrode on the surface of the bag using 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 may be made from an adhesively attached flexible circuit or may be 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, for example, providing a different power setting or waveform to leave a distinctive dry layer or pattern as part of the sectioning cut. The different power setting or waveform can be a modulated higher frequency waveform combined with a basic waveform that delivers RF power to the tissue. Thus, the primary function of controlling the RF power delivered to perform the cut can be relatively unaffected by the modulated waveform by using analog or digital low-pass or band-pass filters in a control system feedback loop. That is, the method 10000 can include adjusting the power setting to cause the wires to leave an identification pattern in the cut associated with each of the wires 1-N. 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 the direction, or which wire is first or last, etc.).

[0242] 36, the electrodes / wires can have a color coded powder applied to them such that each electrode / wire has a different color and when the wires are pre-tensioned against a tissue specimen the distal end of the tissue specimen becomes marked. 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 pieces of the sectioned tissue specimen.

[0243] Now referring to FIG. 37, in some embodiments, the electrodes or wires can be provided with insulating or highly conductive sections that provide a "signature" or orientation mark on 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 the first active electrode 3712 to define the 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 areas. As a result, the current concentration at the interface of the tissue and insulation 3704 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 section has 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 the section plane cut from each active electrode 3712, 3714, 3716 from the 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 are more conductive than the remainder of the coating 3702. In some embodiments, the rings of material 1006, 3708 are relatively less conductive. 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 for a given length, and / or the spacing of the bands 3704 can be modulated to adequately distinguish the 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 normal coating 3702 on the active electrode surface. That is, generally speaking, the identification band 3704 can be more or less conductive than the coating 3702.

[0247] In the tissue sectioning method, 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 proximal tissue specimen surface, 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] Returning briefly to FIG. 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 to have 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 predefined sequence of operation selected by the 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. The corresponding active electrode wire connectors can have the same color or shape, allowing the user to couple similar colors or shapes together to ensure that the proper coupling sequence is maintained. In some embodiments, a method for ensuring that the proper coupling sequence is maintained includes giving each tensioning rod receptacle a unique shape so that it will only receive a corresponding active electrode wire connector with a unique mating shape. Alternatively, each wire can have an increasing amount of coating impedance from one wire to the next. Energy can then be applied to all the wires, but the coating variations will force the wires to fire or break 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 such that when the spring is in a fully extended or pretensioned position, the insulating coating is positioned at the contact point of the electrical interface of the spring with the power or RF energy. When the device is pretensioned and the spring advances to apply tension on the tissue sample, the insulating coating advances to the coils of the spring and the conductive portion of the spring is now in contact with the electrical interface of the RF and spring. 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 cutting include, but are not limited to, uterus, ovaries, kidneys, colon, spleen, liver, gallbladder, and lungs. For some organs, a non-circular distal instrument end is beneficial for minimally invasive access to and resection of the specimen, such as in video-assisted thoracic surgery (VATS) for the lungs. In this case, the incision may be wider than it is tall because of the spacing between the ribs. In this case, the sectioning instrument may be advantageously non-circular to accommodate or optimize the use of the available space. For example, typically three or more tensioning mechanisms may be arranged in a line within an elongated oval instrument end. The shape of the bag may also be modified to better align the electrode wire assembly with the shape and size of the tissue specimen. This may also require a different number of active electrode assemblies or different active electrode wire lengths.

[0253] In some procedures, the specimen is likely to contain residual staple lines or clips from the resection. This is particularly common in pulmonary and colonic procedures. It may be desirable to utilize stronger wires that are more likely to penetrate the staple line during cutting without fracturing the active electrode. This may be accomplished through the use of stronger materials, such as titanium. Similarly, it may be accomplished through the use of larger diameter wires or strands 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 that are routinely extracted using currently available methods becomes more challenging. In addition to the aforementioned organs that are candidates for specimen sectioning for extraction, smaller portions and chunks of these organs that are not deemed necessary for tissue sectioning prior to extraction will also be candidates for extraction in the future. An example would be the appendix or gallbladder, which can be easily extracted through a 5 mm trocar today, but as the use of 3 mm or smaller devices becomes more common, device sectioning becomes one obvious solution for extraction.

[0255] In some embodiments, a pressure contact connector may be provided that includes a resistor, optical feedback, or RFID with corresponding circuitry in the tissue sectioning device 100 or controller 108, 708 that can implement the identification method. In some embodiments, the identification method includes (a) identifying a particular 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 differentiating 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 accomplished using resistor values, optical signatures, or RFID as an index to a lookup table preprogrammed in the controller 108 or data store 110 of the device 102. The index may point to stored parameters that update the parameters for the particular type of bag or the particular active electrode wire set coupled to the connector that houses the resistor. In some embodiments, the information programmed in the optical encryption or RFID content is used to update the parameters with the information passed to the controller 108. This information, in some embodiments, may include a sequence number such 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 contact 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 type material. The contacts or end cap 3803 is constructed of a highly conductive material, such as tinned copper or aluminum, and is attached to the resistive element in a manner such that the desired resistance provided by the resistive element 3802 can be electrically measured between the two contacts 3803.

[0257] 39 illustrates one embodiment of integrally coupling resistor 3901 within insulation displacement connector 3905 and insulation displacement ferrule 3906. The insulation displacement 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 insulation displacement ferrule 3906 and are insulation displacement to mechanically secure the wires while simultaneously providing an electrical coupling between the active electrode wires 3907 and the insulation displacement ferrule 3905. One skilled in the art will recognize that these wires can be welded, secured or captured inside the insulation displacement ferrule by means other than insulation displacement, so long as that method provides an electrical coupling from the wires 3907 to the insulation displacement ferrule 3906.

[0258] In some embodiments, the insulation displacement ferrule 3906 has a stepped feature at the proximal end such that the insulation displacement ferrule 3906 is secured within or relative to the insulation displacement connector 3905. This provides 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 end 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 accomplished by creating an isolation barrier 3908 which may be provided, for example, by an insulating film between the resistor 3901 body and the interior surface of the insulation displacement connector 3901. This may be a physical separation provided by an insulating film or coating applied to a top portion of the interior surface of the insulation displacement connector, an insulating film or coating applied to the side 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 electrically measured between the proximal end cap 3910 and the outer surface of the insulation displacement connector 3905 .

[0261] 39, the components within the tensioning tool that interface with the insulation displacement connector include a central axial component (not shown) that is electrically isolated from the outer portion. The axial component may have a spring or other means that ensures 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 include 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 previously described 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 resulting other, i.e., current or voltage.

[0264] The step of measuring the resistance can be accomplished using analog circuitry, such as an op-amp or other means to apply a reference voltage and an A / D converter to measure the resulting electrical parameter. This circuitry can be located within the tensioning tool or can be located within the controller.

[0265] Each side of the resistor 501, 4020 can be provided with a separate electrical trace, which can be accomplished by applying a thin conductive trace onto the surface of the spring, isolated from the spring with an isolation 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 coil of the spring 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 of the termination block to perform a resistance measurement prior to applying the instrument pretension. In some embodiments, the measured resistor values ​​for each insulation displacement connector are stored in a data store that may be located on the tensioning instrument or in the controller itself.

[0267] Returning now to FIG. 1-Q, in some embodiments, a system 100 may be provided having a bag 161. The bag 161 may have multiple active electrode sets 153, 155, 157, 159, each having a resistor (not illustrated). The first electrode set 153 may have a resistor having a first resistance, such as 100 ohms. The second electrode set 155 may have a resistor having a second resistance, such as 200 ohms, the third electrode set 157 may have a resistor having a third resistance, such as 300 ohms, and the fourth electrode set 159 may have 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 particular sequence. 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 it is paramount to have good contact between the return electrode of the device and the tissue specimen in order to maintain cryo-cutting. One method for ensuring this contact is described in the open-wire check described earlier in this specification. Another method is to utilize two sections 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 sections of the return electrode. This signal is used by many currently available generators to calculate the impedance between the two return electrode sections. As the tissue simultaneously contacts the two sections, the impedance of the tissue between the sections will offer a low resistance. This is continuously monitored by the generator, and if the tissue loses contact with the return electrode, a change in impedance can be observed and an alarm condition can be triggered so that the user can 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 location of pretension. A travel stall condition can be identified and indicated by a travel speed lower than acceptable.

[0271] 41, as illustrated, a method 4100 for identifying an active electrode connector 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 if the resistance value has a corresponding lookup table index 4106, (d) determining if the active electrode index value is consistent with other previously performed couplings 4108, (e) determining if 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 the system 100, the tissue structure may weaken and the tissue may "flow" or change shape, resulting in irregular or non-repeatable section sizes. Methods can be provided to reduce this tissue flow, including holding the tissue during sectioning to inhibit flow.

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

[0274] FIG. 42 illustrates a plan view and a side view 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 pre-tensioned 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 make 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 completed, the inflation channel 4204 may be deflated to allow removal of the specimen. This inflation and deflation may be performed using a syringe. In some embodiments, the controller 108 or the second device may be configured to automatically adjust the pressure. Feedback on successful pressure application can be provided by observing the acceptable volume range applied for inflation with a syringe and the resistance of pressure increase with a pressure sensor, either manually or in an automated pressure delivery device, with automated syringe application.

[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) packing 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 4310 into a patient as pretension is applied to a tensioning mechanism, (f) sectioning tissue for all active electrode wire sets 4312, and (g) contracting an expansion channel 4314.

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

[0277] Some methods and / or systems improve the reliability of the cut by pretreating the tissue sample prior to cutting, for example by applying low temperature to freeze the tissue. This can result in a more rigid specimen and reduce the thermal consequences of the cut. Some methods include injecting an anchoring 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 mechanism with a rotational coupling such as a gear or contact coupling, a linear drive mechanism with a magnetic coupling, a linear drive mechanism with manual control, and / or an electromechanical drive mechanism such as a servo or stopper motor drive mechanism or linear actuator as previously described.

[0279] In some embodiments, a method of preparing or examining a tissue specimen is provided. One method of marking and reassembling a tissue specimen for later 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 portion from the bag. Once removed, the specimen can be reassembled or otherwise identified and examined for pathological assessment. The marked specimen can be identified through visual inspection or can include a fluorescent or similar chemical marker to allow the user to identify the 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 of a specimen prior to sectioning. The marking tool 4400 may include a shaft 4402 configured to pass through a laparoscopic opening or trocar. In some embodiments, the shaft 4402 of the marking tool 4400 has a small diameter of 2-20 millimeters, although one skilled in the art would understand that other sizes may be suitable. The marking tool 4400 may include a marking ink present on a surface of its distal end 4400. In some embodiments, when placing the marking tool 4400 in 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 the distal end 4404 can be determined by the user based on how far the sheath 4406 is retracted. In some embodiments, the ink can only be released by the user in such a way that it is on the marking end of the device only after the device is placed inside the patient's body.

[0281] In some embodiments, the 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 of 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 the placement of ink in more refined or selective areas. One skilled in the art will appreciate that the length of the exposed portion 4408 may 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 the patient's body, reducing the diameter before removal from the patient, and in some embodiments returning to the 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 expanding member prior to insertion into the patient's body, or can be present in a small pouch inside the instrument, allowing the user to expand the marker and then break open the pouch or release the ink to apply the ink with the expanded member.

[0284] Continuing with reference to FIG. 44, the distal end may be configured to expand within the 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 may be provided to allow expansion after insertion into the patient. That is, an expandable marking end 4414, 4416, 4418 may be provided that can be minimized prior to removal from the patient, such as by retracting the expandable marking end 4414, 4416, 4418 back into the shaft 4402 of the instrument or by extending the sheath 4406 back over the marking end. One of ordinary skill in the art would 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, inks or markers can be used to help identify the specimen pieces while in the bag or once extracted 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 containing ink on the return portion 4504 of the bag 4500. The ink 4502 can be a heat sensitive ink (or a small pouch that opens with enough heat and releases the ink) or similar 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 the ink 4502 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 and ink may be 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 tool may be provided with a distal end 4600. The distal end 4600 may include ink 4602 attached to or coated on one or more expansion valves 4604 or other sectioning tool features that expand the wires / electrodes 4608. In some embodiments, the distal end 4600 of the sectioning tool may have ink 4602 positioned on one or more distal surfaces 4606 of the tube and / or one or more valves 4604 intended for contact with tissue. Once the sectioning tool 102 (see, e.g., FIG. 1-Q) is pre-tensioned, 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 packing the specimen into the bag, the surgeon can mark the surface or portion of the specimen that requires pathological evaluation of the 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 the section that contains this surface and assess the margins or any cancer cells that may be found on this surface.

[0292] Some embodiments include using imaging recognition, including but not limited to digital cameras and / or ultrasound, to image the specimen prior to sectioning, extraction, or during extraction 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 to reorient 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 excision 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 interventions required.

[0294] In some embodiments, the 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 that contains 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 pathology, 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 assembled section structure (i.e. vasculature, tumor, etc.) that can be compared to the section itself.

[0296] In some embodiments, methods of handling cancerous tissue are provided. During removal of sectioned tissue known or suspected to be cancerous from the sectioning bag, great care may be desired to ensure that no fluid or tissue leaks 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 placed above, below, or around the exposed bag opening 4710 to absorb any fluid that may leak out (see, for example, FIG. 47).

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

[0298] In some embodiments, as illustrated in FIG. 47, an expandable or elongated bag 4700 can be provided to capture the 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 can have a first width W and a first depth D, the elongated bag 4700 can have a first width W that is the same 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 section 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 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 section 4704 placed within the bag 4700 (note that this twisting process also applies to secondary bags 4700). One of ordinary skill in the art will appreciate that even when an elongated or secondary bag 4700, 4700 is provided to allow a user to twist the tissue sections 4704 to separate them, the user need not necessarily perform this step, and optionally all of the tissue sections 4704 are captured within a single cavity. One of ordinary skill in the art will also appreciate that a user can optionally seal, tie, clamp, or otherwise fasten the twist regions 4706 to semi-permanently separate the individual 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 has been sectioned, the surgeon can view the bag and see if there are any signs of cancer in the sample. For example, in a method similar to fluorescence-guided surgery using contrast agents and a cancer cell "auto-guide" created by researchers at Purdue University, it is believed that the new contrast agents can be injected prior to surgery and can be seen in the specimen at the time of extraction. Relatedly, in a manner substantially as described herein above with respect to Figures 41-46, similar contrast agents can 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 the section is extracted from the bag.

[0301] 48, a novel tissue sectioning method 4800 is further described herein. 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 tool), and sectioning 4810 the tissue (and optionally removing the tool). The method 4800 may include step 4812 of extracting the sectioned tissue from the patient and / or the bag.

[0302] As explained above, a coating on the wire or electrode can be provided to provide a relatively quick initiation of tissue sectioning cutting and to allow 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 impedance of the tissue being cut. For example, the lung is a high impedance tissue compared to many other tissues found in the human body. Thus, 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 tissues with relatively low impedance such as uterus or ovarian cysts. It is believed that a user may 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 may be provided to indicate to the user which bag has been selected and / or to confirm whether the selected bag does indeed have a wire / electrode with a coating with an impedance that matches the impedance of the tissue being cut.

[0304] 49, systems and methods are disclosed herein for providing an emergency release, interruption or release of a wire connector of an electrosurgical instrument. In some embodiments, the emergency release device 4900 has a plunge cutter 4902 in 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 more 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, causing the wire to break.

[0306] The emergency release may include pressing the insertion tube against the tissue, causing it to extend beyond the reach of the wire and cause higher forces on the wire that ultimately break the wire or the link. The emergency release may include the use of a Nitinol spring or clip in the wire crimp barrel that releases the crimping of the wire from the connector barrel. The emergency release may include a member or release feature configured to apply a force from the rear that re-extends the spring to its pre-tensioned position so that the user can remove the connector, retract the distal insertion tube, and insert a component that couples to the springs and pulls them forward to allow the user to uncouple. The emergency release may include an opening that clamps around the wire to break the link when crushed. The emergency release may include a connector system where 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 by rotation and then stretch the spring back to its original position.

[0307] In some embodiments, the emergency release device includes a tensioning rod that is 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 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, such as when this higher force reaches the trip threshold or maximum range of intended use.

[0308] In some embodiments, a locking feature is provided on the tension rod that releases the jaws that hold 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 brake and force relief by pressing the device into the patient's body to release the connector.

[0309] In some embodiments, a cutting feature is provided on the tensioning rod and is configured to cut the wire when actuated 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 a user, ejects the connector and is configured to lift and melt the gate that disconnects the wires at the distal end of the tray, electrical excitation, e.g., at a different resonant frequency or energy level, 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 device" is provided, as illustrated in FIG. 50, where the tension rod has a pin attached to a loop captured by a collar 5002, with a loop 5006 attached to the end of the tension rod. When the collar 5002 is moved so that it no longer captures the pin, the pin flips and the end of the tension rod can be released. 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 as there is not enough free space to allow pin flipping, but when the tube is aligned with the slot, the pin flips and the connector releases the wire 5008 from the spring 5004.

[0312] Turning now to some embodiments of Figure 51, there is provided a release device similar to a "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 an open portion of a 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 inner surface of the lumen, or can be provided by a strip of the inner tube that only obstructs the spring when rotated to a "release" position, thus allowing release only if the user actively activates this 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 insulation features will now be described in more detail with reference to Fig. 52. As illustrated in Fig. 52, selective insulation regions 5202 can be provided to prevent electrical flow (only the "drag strip" contacts the insulation) and to control when the electrode / wire can be energized.

[0316] Additionally, parallel sections of springs that are conductive but not electrically coupled can be incorporated onto the spring surface. In some embodiments, this effect is created by applying a thin conductive layer with an insulated backing. By adding these electrical "traces", separate contact members can be provided 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 provided to circuitry within the fixed portion of the electrosurgical instrument 102, for example to identify the type of electrode as previously described 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, sectioning the specimen.

[0318] As illustrated in FIG. 54, some embodiments include a dual bag, with an outer bag 5402 and an inner bag containing 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 as previously described herein) to cut the sample into smaller pieces while retracting the mesh into the shaft. A balloon 5404, for example, in or coupled to the outer or inner bag 5402, 5406, may be used to help push the sample or pieces of the sample into the shaft by sealing the bags against the shaft. The resulting sectioned pieces may be elongated pieces.

[0319] As illustrated in Fig. 55, some embodiments include a collapsible basket 5502, such as a cutting mesh or basket 5502 of electrodes 5504 oriented perpendicular to an open specimen bag. The bag can then be closed around the shaft and reoriented to be parallel to the axis of the shaft and the 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 Fig. 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. The rotating wire can have sharp corners to maximize electrical density and / or bend to expand the cutting structure.

[0322] As illustrated in Fig. 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 into different orientations. The resulting tissue section has a substantially cylindrical shape.

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

[0324] As illustrated in FIG. 60, in some embodiments, a cutting / grasping loop in 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 outside of the specimen and "scrapes" the specimen and severs it into smaller, more manageable pieces. A linking operation may be provided. The electrode wire loop 6002 is crushed or crushable on each sectioned piece 6004, which can be pulled out of the patient's cavity. The tissue sections 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 may be pulled into the bipolar RF electrode wire 6102. The specimen may be captured in a collection bag portion of the device. The bag may then be pulled into the device shaft, partway through an activated wire electrode. There may be another bag 6106 or electrode mesh outside the specimen to encapsulate the specimen as it is being cut. The mesh may also serve as a return electrode. The bag / cutter may be rotated by hand to obtain multiple cuts in the tissue.

[0326] As illustrated in Fig. 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 in the shaft as the collection bag is retracted. The shaft / cutter can be rotated by hand to obtain multiple cuts.

[0327] As illustrated in Fig. 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 the 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 may also be the return electrode are used to draw the specimen into the electrode wire. Sectioned tissue can be extracted through the shaft or incision. A funnel 6202 as illustrated in Fig. 62 may be included here as well.

[0329] As illustrated in Fig. 65, some embodiments may provide a rotating edge peeling / cutting action. For example, rather than just 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 may be provided, as illustrated in Fig. 66. In some embodiments, a rotating skewer or a rotating bag imparts rotation to the enclosed specimen. One or more bipolar electrode cutting wires may then be used to peel or slice the tissue as it is pulled through or against the wire. The skewer and / or bag may 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 may provide an electrode structure 6800. In some embodiments, a series of bifilar wire pairs may be provided to enable bipolar RF energy to create cutting. Each wire pair 6800 may include an active electrode 6802 and a return electrode 6804. The wires 6802, 6804 may 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] As illustrated in FIG. 69, most of the wire electrodes illustrated herein are shown as being substantially circular, however, one skilled in the art will recognize that wire electrodes 6900 having other wire electrode shapes are envisioned, such as square wire electrodes 6900. A rectangular wire electrode 6900 may maximize current density at the corners, thus 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 of concentrated current density, which may make cutting or initiating a cut more efficient.

[0334] As illustrated in Fig. 70, some embodiments of the bag structure 7000 can include a bag 7002 incorporating 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 prior to welding the flat pattern into the bag shape.

[0335] As illustrated in Fig. 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] As illustrated in Fig. 72, some embodiments provide a bag structure 7200 having active and return electrodes. In some embodiments, the active electrode wires can be incorporated into the specimen bag by providing a multi-layer structure. An outer layer 7202 can include nylon or 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 wires, and the next or innermost layer 7210 can include a perforated bag material.

[0337] As illustrated in Fig. 73, some embodiments include a dual bag structure 7300 for pretensioning the 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 illustrated) used to sever the specimen. A return electrode (not illustrated) may be housed within the outer bag 7304 as well.

[0338] As illustrated in Fig. 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 contains the return electrode. The inner bag 7404 can house an active electrode (not illustrated) for cutting.

[0339] As illustrated in Fig. 75, some embodiments provide a cryptographic signal controller (multiplexing). To accommodate the potential use of various generators for power (e.g., RF energy) to perform the 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 be equipped with 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 illustrated) can aid in reorienting the retrieval bag 7602. In some embodiments, providing two or more drawstrings 7608 can improve control of bag closure and can increase the tendency of the bag 7602 to close onto the device shaft (not illustrated).

[0341] As illustrated in FIG. 77, in some embodiments, a method of use of 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 a shaft (not illustrated), as illustrated in FIG. 76, and then may be rotated on the shaft or through an incision to apply a cut to the specimen therein with one or more electrodes 7610, as illustrated in FIG. 73. An external drawstring 7612 may aid in positioning the bag 7602.

[0342] Some embodiments provide guides for the wire loops, as illustrated in Fig. 78. For example, the shaft tip 7802 or distal portion of the shaft can include a guide 7804 for each wire electrode 7806. The guides 7804 can 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 the 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 down the pull rate near the end of the cut, electrode sparking or flashing is reduced.

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

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

[0347] Alternatively, manual wire retraction may 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 pulls 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. The cam can be rotated to 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 this point, 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 delivered initially to the tensioned wire cutter to delay cut initiation and allow tissue coagulation prior to cutting. It is believed that the energy delivery can be modified such that at a predefined time point or until a predefined parameter threshold is met, wire cutting is then initiated through an increase in voltage. Another means of achieving this would be to apply a non-sinusoidal waveform initially 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 pure 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 damping characteristics by adding or subtracting loads to the RF output stage, or other means.

[0353] Parameters that may be advantageous 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 can be applied to the wire during coagulation than would be required for cutting alone, with pressures as high as 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 , a suitable device 8610 is illustrated for maintaining pneumoperitoneum during packing of the bag 8611. 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-like feature that surrounds or encircles the introducer shaft and has flexibility in the introducer shaft to allow movement of the introducer with minimal movement of the cup-like 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 onto 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 easier and more reliable sealing. In some embodiments, a large clip or tie may be provided to allow for reliable closure. Here, a user may apply a clip or tie on or around a malleable material (e.g., wax and / or adhesive) area or strip that is permanently attached to the bag opening to provide a fluid-impermeable barrier between the contents and the exterior of the bag. The malleable material may be provided on the interior or exterior walls of the bag. Providing a malleable material on the exterior of the bag may reduce potential or accidental pre-engagement, which may be possible after the user inverts the end of the bag in, for example. In a variation, a removable strip may be provided on the malleable material to prevent pre-engagement.

[0356] Turning now to Fig. 87, means for assisting in the removal of a section using a bag will now be detailed. 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 may include a segment clamp 8726 that compresses and / or reorients the segment 8722 simultaneously with the application of a force to remove the bag 8724. Specifically, the segment clamp 8726 may be configured such that as a user pulls the segment clamp 8726 proximally, the segment 8722 is compressed simultaneously or substantially simultaneously as the bag 8724 is withdrawn from the patient's body (see, for example, FIG. 87(c)). In some embodiments, the segment clamp 8726 is integrated onto the interior of the bag 8724 to facilitate reorientation of the tissue segment 8722 through direct contact. The segment clamp 8726 may be a string or strap-like feature. In some embodiments, the segment clamp 8726 may 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 effectively "grip" the segment 8722 as a user or instrument pulls proximally.

[0358] In some embodiments, as illustrated in FIG. 87(c), the segment clamp 8722 is configured to apply a 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 allow 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 may 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 example approach to enable robot-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 between the trocar or incision site. In some embodiments, the robotic grasper 8832 is configured to travel between the incision site and another location, such as 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 may 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 the 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 the 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) applying an external compressive force on the tissue section at an angle of 15-90° to the direction of the cutting or wire retraction pulling 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 extraction methods disclosed herein include the following steps (not necessarily in this order): (1) marking or identifying areas or margins 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 the wire connector to the instrument, (6) inserting the distal end of the instrument into the thoracic cavity, (7) pre-tensioning the wire before cutting, (8) sectioning the tissue using either mechanical or mechanical / electrical cutting, (9) removing the instrument, (10) extracting the specimen section, and (11) removing the bag.

[0364] Temporary retention of the wire to the bag can be accomplished in a number of ways. The bag may include multiple layers, or a single layer with additional features attached to temporarily hold the wire in place. The bag may include multiple film pieces welded or glued together, or may 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 to ensure that the wire is held against the sidewall of the bag as illustrated. By keeping the wire attached against the sidewall of the bag, the specimen can be packed without inadvertently shifting the wire or catching it and causing the specimen to be completely packed. To this end, the wire can be held in place with a loop, perforation or similar bag feature that releases with tension applied to the wire. Additionally, the retaining feature may release in response to the application of energy to the wire that melts or softens the retaining feature. An additional approach is to have a mechanical pull tab or feature that the user can pull that releases the wire from the retaining feature. The mechanical pull tab or feature could be a separate string attached to the retaining feature that is accessible to the user near the opening of the bag when exposed. An inflatable feature inside the bag itself could be used to rupture the retaining feature as well.

[0366] One potential risk of temporarily attaching a wire to the bag is that the bag will burst during removal of the wire. 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 impermeable.

[0367] Additional features may be added that provide feedback to the user regarding the safety of the bag. The bag may 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 may be used to detect any pressure drop. The pressure valve and / or means for inflating the bag or inflatable channel may be coupled into the bag or, alternatively, 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 if 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 that is separated to the outer layer by inflation. The capacitance between the two conductive layers can be monitored in such a way that a pressure drop changes the capacitance reading, similar to pressing a capacitive touch screen. Capacitance can be measured at regular intervals, on command, or continuously, or a threshold can be pre-determined such that if pressure is lost the system can identify the condition and issue an alert. The two conductive layers can also be used in a manner similar to a resistive touch screen 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 a sterile fluid, allowing the user to be confident of the safety of the bag if the fluid level does not drop as the procedure progresses.

[0368] If the user visually determines there is a gap in the bag, an adhesive patch can be applied to reduce the risk of losing fluid or tissue from the contents of the bag. The user can also make the decision 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 be accomplished in some embodiments using a sectioning device that does not have an electrosurgical component. In particular, a surgical device may be provided having one or more wires that mechanically section the 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. In a similar manner, a robotic system may provide cutting functions that are not electrosurgical in nature. As in the case of an electrosurgical sectioning procedure, the extraction bag may provide a means for keeping the cutting wires in place (and not entangled with each other) while the tissue sections are placed in the extraction bag, and 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 less 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, the tissue extraction 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 extraction device without an electrosurgical cutting element requires fewer instrument connections to be completed by the user. This, in turn, may reduce the production costs of the product. In some embodiments, an extraction device without an electrosurgical cutting feature may allow for cutting of tissue at lower temperatures and may be a safer alternative for fragile patients. Those skilled in the art will appreciate that the mechanical pull forces in an extraction device without electrosurgical cutting will be significantly greater than those with electrosurgical cutting features.

[0370] As previously mentioned in U.S. Patent Application Serial No. 14 / 805,358, there may be some merit in bipolar applications of RF energy. 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, 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 such a way 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 point across the tissue specimen. Initiation of the cut occurs at a 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 explained earlier in this specification, 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 simply an extraction device that does not section tissue.

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

[0374] In some embodiments, the pressure in the space 9106 between the 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, it provides a visual indication of failure when the outer bag layer 9104 no longer appears to be pulled towards 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 out of the holes (especially if the holes are small). That is, the vacuum in the space 9106 between the layers 9102, 9104 may tend to bias 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] In some embodiments, as illustrated in Fig. 92, the extraction device 102 may include a CO2 and / or N2O 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 with a vacuum or with atmospheric air inside, the gas used for insufflation, for example carbon dioxide or nitrous oxide, will tend to enter the interior space 9204 of the bag 161, and the 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 does not necessarily have to be inside the extraction device 102, but merely needs to be exposed to the interior space 9204 for sampling using any suitable means known or yet to be developed in the art.

[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 such that the sensor 9202 can 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 content 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 towards 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 to sample the contents of the intermediate space 9406, as previously described. A second channel 9412 can be provided to resupply air drawn from the space 9406 or other air 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 as previously described.

[0380] This monitoring can establish a baseline and / or provide a more accurate indication of the starting levels of CO2 and / or N2O. The sensor 9202 can, in some embodiments, monitor for differential or changing levels of CO2 and / or N2O 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 inside the bag area 9204.

[0381] The sensor 9202 may be used independently and / or may include a visual or audible indication when CO2 and / or N2O are detected. The sensor 9202 may also be electrically coupled to a processing unit, such as the controller 108, 808, that may create an audible or visual indication to a user when CO2 and / or N2O 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 CO2 and / or N2O 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 and 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. The leak detection method may include comparing one or more fluid quality values ​​detected at a first time point to one or more fluid quality values ​​detected at a second time point.

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

[0385] With continued 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. An acoustic transducer (not illustrated) can be provided to monitor the acoustic emissions of the structure and detect changes in the 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 method of post-operative leak detection 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 be provided as well to determine if a leak has occurred.

[0387] The detection system may 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 may have a fitting that allows easy attachment of the leak detection system by the user. For embodiments using a bag opening, an interface fits into the bag opening, allowing the user to clamp the opening onto the interface to create a seal. The bag may 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, prior to completing the surgery.

[0389] In some embodiments, the leak detection method may include flushing the bag between layers with a fluid (e.g., sterile saline) after use. The fluid contents can then be evaluated for biological material 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 leakage. For example, the operating room air supply can be used to fill the interior of a used specimen bag 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 the specimen bag was shipped in) to visually view any air bubbles escaping from any breaks in the specimen bag. Surfactants can be added to the surface of the bag or to the water to modify the surface tension of the water and enhance the visible bubbling 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 adding pressurized air to a predetermined pressure to accelerate any leaks through any breaks in the bag or bag layers.

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

[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. Methods for determining leakage may include visually determining a perceived color change at one or more contact points 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 contact area 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 indicated as well.

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

[0400] 96 illustrating a side cross-sectional view and partial top view, a method for detecting leaks in an inner layer, for example, 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 an outer surface of the inner bag layer 9604 and / or an 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 inner surface of the bag layer, or may be pairs placed 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 the 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 the electrodes and the current measured between the electrodes may provide the impedance across the electrodes. If the intermediate space is dry, the impedance approaches an open circuit and is 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 provides a change in impedance due to the conductivity of blood, tissue or other body 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 in the bag or other means 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 chance 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 the electrodes to contact the same electrode and not the opposing electrode.

[0404] Since 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 electrodes or circuitry. The electrodes can sense resistance or capacitance. For example, the electrodes can have a fluid absorbing gel on the bottom of the bag that changes capacitance when liquid is added.

[0405] Some embodiments of detecting leaks in the bag may include applying a constant amount of helium (He) or inert gas into the intermediate space contained 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 so that the sensor is located inside the introducer tube or outside the tube, where the lumen is connected to the introducer tube so that the sensor can sample the contents of the air flowing from the inside of the bag, such as in a smoke evacuation system. Any traces of helium or inert gas indicate the movement of gas from the intermediate space to the inside 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 such that any detection of helium or inert gas inside the abdominal cavity will indicate a leak between the mid-bag space and the outer bag layer. The method may include the step of pausing 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. It is contemplated that the camera may be inserted through a separate port and may be an endoscopic camera used during laparoscopy, or may be a separate camera intended to detect leaks. The camera image may be sent to a processing unit, such as the controller described earlier in this specification, or a different unit that can digitize the image in real time. The processing unit may 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 geometry of the bag as the procedure progresses, such as the thickness of the intermediate space, which may provide an indication of a leak in the bag. The visual image may also look for fluid accumulation on the surface or bottom of the bag, and may look for droplets that form or fall from the bag, and may 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 particular color, the processor may use a filtering algorithm to identify changes in the amplitude of this color on the outer surface of the bag.

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

[0410] 97, some embodiments of leak detection include providing or using an audible or visual indicator 9708 that expands or "sniffs" 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 break occurs in either the inner or outer bag 9702, 9704, the vacuum loss indicator 9708 feature will sniff, stretch or change from a first tensioned state to a second state, indicating to the surgeon that a break in either layer of the bag has caused a vacuum loss in the interstitial space between the two layers of the specimen bag.

[0411] Some embodiments of leak detection can include providing or using a color-changing moisture indicator between the bag layers. For example, the specimen bag layer can be constructed of two layers of polyurethane welded together to create a sealed interior space between the two layers. Compromise or leakage 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 that would be observable from an endoscopic camera in the body cavity or by the surgeon after removal of the bag. The agent can be sprayed onto either or both of the polyurethane interior walls during assembly of the bag. The agent may also be inserted into the construction as a loose powder or as a liquid film. Strips of colored paper or fabric can hold the color-changing agent.

[0412] In some embodiments, liquid agents may be inserted through the port after placement of the bag in the body. Since 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 inner surface of the outer bag may be provided and configured to chemically bond to the liquid. After the procedure, visual inspection of the outer surface of the inner bag and / or the inner 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 leakage of fluid from a damaged 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 instrument such as a black light. Inspection for breaks in the inner bag layer can be incorporated as a routine with every specimen extraction procedure by scanning each post-operative bag for the presence of this break 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, a coating similar to dry watercolor pigments can be applied to the gap between the inner and outer bags during specimen bag manufacture to visually indicate a breach in the inner bag layer. If a breach occurs in this gap and bodily fluids infiltrate the gap, the dry pigment will become saturated, providing a 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 may 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 would allow 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 damaged, the color-changing material could change color as a visual indication of the damage. For example, the material between the layers could change color when CO2 or N2O, 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 the biological fluid.

[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 within the inner bag, the outer bag layer may be manufactured of a white or similarly contrasting material, allowing the surgeon to probe for blood on the inside of the outer white layer, such as with a camera during or after use of the instrument. A discoloration of the outer bag inner surface 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 extension members 9708 may be positioned at locations around the periphery of the outer layer 9702 of the bag assembly. The one or more extension members 9708 will not be noticeable in a normal relaxed state, and under normal conditions, with a fully retracted and pressurized bag assembly, the geometry will remain in the relaxed state. However, if a leak occurs within the inner bag layer 9702, the extension members 9708 on the outer layer 9702 will 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, leakage management embodiments are described herein as well. 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 agents in the space between the bag layers can be configured to kill cells that they come into contact with. The agents can be specific agents 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] Chemotherapy agents may be selected based on the procedure and / or the patient's medical 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 space between the layers of the bag.

[0425] For colectomy, the agent required for the 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 the bag layers or within the bag during manufacture. The agents may be applied in liquid form in safe quantities or may be applied as a film to either the exterior layer of the inner bag or the interior layer of the outer bag.

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

[0429] Some embodiments of leak mitigation 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 a certain 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 embodiments of leak mitigation include providing or using an absorbent material that changes hardness or phase when in contact with fluid. The material may be placed between the bag layers. This may be a dry material that in some embodiments changes to a gel. In some embodiments, the material may change to become harder or softer, may be a powder or film that changes to a gel, or may even change color as a result of a chemically activated change. The material changes phase and may be detected in any manner, such as visually, through physical palpation of the bag, etc.

[0431] Some embodiments of leak mitigation may include the use or placement of a viscous gel material layer between the inner and outer bag layers such that if a leak does occur, the gel is configured to minimize the effects of the leak. The gel may, in some embodiments, close the leak. In some embodiments, the thickness of the bag may be increased in such a way that the leak is less likely to 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 manufacture 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 may contain many internal spaces that help reduce the volume of fluid that could potentially leak if the inner layer is compromised. For example, the many walls joining the inner and outer layers may create many smaller fixed volumes of air, fluid, gel, or other leak mitigation or management means 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 may include multiple sealed pockets of fluid or leakage mitigation means. The multi-cell layer may be positioned between the inner layer and the outer layer. The multi-cell layer may limit the passage of contaminated material and reduce the probability that contaminated material, such as a portion of a sectioned cancerous tissue sample, will damage the bag assembly. The multi-cell layer may be positioned on the exterior of both bag layers in some embodiments.

[0436] Some embodiments of leak mitigation may include the use of a material that solidifies when in contact with bodily fluids. For example, an epoxy or any thermosetting material may be provided in 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 intermediate space. 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. 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 in some embodiments.

[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 crush the hardened materials and extract them through the incision site after the sectioning procedure is completed. Crushing of the hardened materials can be accomplished in some embodiments without destroying the outer bag layer.

[0438] In some embodiments, a material that is reactive with carbon dioxide and / or nitrous oxide may be used or placed in the space between the outer and inner layers. The reactive material 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 accomplished in a variety of ways. The disclosure should be understood to encompass each of these variations, whether it be a variation of an embodiment of any of the apparatus, method, or process embodiments, or simply a variation of any of these elements. In particular, it should be understood that the language for each element can be expressed by 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 within the description of each element or action. Such terms can be substituted, if desired, to make explicit the implicitly broad coverage to which the invention is entitled.

[0440] Merely by way of example, it should be understood that any action may be expressed as a means for taking that action or as an element that causes that action. Similarly, each physical element disclosed should be understood to encompass a disclosure of the action that the physical element facilitates. With respect to this last aspect, a disclosure of a "mechanism for cutting" should be understood to encompass a disclosure of the act of "cutting" (whether or not explicitly discussed), and conversely, if there were a disclosure of only the act of "cutting," such disclosure should be understood to encompass a disclosure of the "mechanism for cutting." 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: [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 within the connector carrier and movable from a position within the cannula assembly to an exterior of the cannula assembly; 1. A tissue sample 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 within the specimen bag. [Reference Example 3] The tissue specimen extraction device of 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 Example 1, wherein the specimen bag is configured to be rolled up and stored within the cannula assembly in a first retracted position. [Reference Example 5] The tissue specimen extraction device of Reference Example 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 disposed in a collapsed position with the specimen bag within the cannula assembly in a first retracted position. [Reference Example 7] The tissue specimen extraction device of 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 a top portion of the specimen bag in an open position. [Reference Example 8] The tissue specimen extraction device of reference embodiment 1, wherein in a first retracted position, the specimen bag, the flexible ring and the connector carrier are retained within 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 embodiment 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] The tissue specimen extraction device of 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 embodiment 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 within the connector housing are removable. [Reference Example 15] The tissue sample extraction device of 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 Example 15, wherein the one or more mechanisms for pulling the connector housing include a pull tab and a cartridge. [Reference Example 17] The tissue specimen extraction device of reference embodiment 1, wherein the connector carrier is positioned in a protective position inside the cannula assembly and is configured to be secured by a mechanical anchor when the specimen bag is open. [Reference Example 18] The tissue specimen extraction device of 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 Example 3, wherein the at least one component of the tissue sectioning instrument includes a tensioning mechanism assembly. [Reference Example 21] The tissue specimen extraction device of Reference Example 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 being configured to advance and retract the flexible ring; a connector carrier having one or more connector pins and carrying at least one connector housing internal to the connector carrier, the connector carrier being movable from a position internal to 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 an 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] 1. A method for extracting a tissue sample, comprising: 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; 1. A connector carrier comprising: a connector carrier including one or more connector portions and configured to hold at least one connector housing present within the connector carrier, the connector carrier including one or more connector portions and configured to hold at least one connector housing present 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 within 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; 23. 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 within the cannula assembly to an exterior of the cannula assembly. [Reference Example 25] The tissue specimen extraction method of reference embodiment 23, further comprising the step of pulling the top opening of the specimen bag out from the incision site on the patient. [Reference Example 26] The tissue specimen extraction method of reference embodiment 23, further comprising the step of detaching the cannula assembly from the specimen bag, the flexible ring and the connector carrier. [Reference Example 27] The tissue specimen extraction method of 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 sample extraction method of reference embodiment 23, further comprising 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 comprising the step of moving the at least two connector portions independently of each other. [Reference Example 30] A method for extracting a tissue sample as described in Reference Example 27, comprising the step of sectioning the tissue sample using at least one component part of the tissue sectioning device.

Claims

[Claim 1] 1. A method of manufacturing a tissue specimen extraction device, comprising: providing a specimen bag having a flexible ring configured to form a top opening of the specimen bag; Providing a cannula assembly; providing a connector carrier, the connector carrier holding at least one connector housing, the at least one connector housing having one or more connector portions, the at least one connector housing residing within the connector carrier, the connector carrier being movable from a position within the cannula assembly to a position exterior to the cannula assembly; and rolling the specimen bag to conceal the specimen bag within the cannula assembly. the specimen bag, the cannula assembly and the connector carrier are configured to cooperate to permit insertion and deployment of the tissue specimen extraction device within an incision site of a surgical patient; The expansion is advancing the cannula assembly through the incision site and into the surgical patient; opening the specimen bag; securing the connector carrier at a distal edge of the cannula assembly; closing the top opening of the specimen bag; 23. A method of manufacturing a tissue sample extraction device, comprising:

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