Tissue removal systems and methods
By utilizing the conductive layer and contact detection technology of the tissue containment and removal system, the risk of hidden cancer spread during minimally invasive surgery has been eliminated, enabling safe tissue sample fragmentation and removal, and reducing surgical complications and recovery time.
Patent Information
- Application Number
- CN202080063797.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-04-07
- Filing Date
- 2020-08-13
- Publication Date
- 2025-11-11
- Estimated Expiration
- 2040-08-13
AI Technical Summary
In minimally invasive surgery, especially hysterectomy, there is a risk that hidden cancers cannot be detected in advance and may spread during the operation. Traditional open surgery has the problems of high complication rate and long recovery time.
The tissue containment and removal system includes a conductive tissue container and a bulk tissue reducer. The impedance value is monitored by a contact detection system to ensure a safe distance between the tissue cutting blade and the container wall, preventing perforation of the tissue container. Combined with optical observation and a mechanical unfolder assembly, the system enables the safe pulverization and removal of tissue samples.
It enables the safe pulverization and removal of tissue samples during minimally invasive surgery, reducing the risk of hidden cancer spread, minimizing surgical complications, and shortening recovery time.
Smart Images

Figure CN114760933B_ABST
Abstract
Description
[0001] This application claims the benefit of U.S. Provisional Application No. 62 / 886,473, filed August 14, 2019, entitled “TISSUE REMOVAL SYSTEMS AND METHODS”, which names Joseph N. Jones et al. as inventors, and U.S. Provisional Application No. 63 / 006,360, filed April 7, 2020, entitled “TISSUE REMOVAL SYSTEMS AND METHODS”, both of which are incorporated herein by reference in their entirety. Background Technology
[0002] In the fields of human and veterinary healthcare, the removal of tissue from a patient's body is often desired or even necessary. Such tissue typically takes the form of clumps, tumors, or organs, some of which may be benign, cancerous, precancerous, or suspected to be cancerous or precancerous, and can be removed using traditional surgical techniques, including open surgery as well as minimally invasive methods.
[0003] Laparoscopic surgery is a well-known minimally invasive approach, in which tissue samples are removed through small incisions using specialized instruments. Minimally invasive surgeries such as laparoscopic surgery and microsurgical laparotomy can also employ robotic-assisted techniques. Surgeries performed using minimally invasive methods include those performed in the abdominal cavity, pelvic cavity, and thoracic cavity. Cholecystectomy, nephrectomy, colectomy, hysterectomy, myomectomy, oophorectomy, and other gastrointestinal, gynecological, and urological surgeries are common with minimally invasive arthroscopy, cystoscopy, and thoracoscopic surgery. The documented advantages of minimally invasive surgery include: increased safety, reduced pain, reduced risk of infection, shorter recovery time, shorter hospital stays, increased patient satisfaction, and lower costs.
[0004] Typically, tissue samples removed via minimally invasive surgery are larger than the incisions used to obtain them. Therefore, techniques have been developed to safely remove such samples while maintaining the advantages of minimally invasive methods. One such technique is fragmentation, in which the tissue sample is cut or processed into fragments while still inside the patient, at the skin level, or just outside the patient, so that the fragments can be more easily removed. The earliest forms of fragmentation involved cutting the uterus with scissors or a scalpel during a vaginal hysterectomy to allow the sample to be removed through the vagina. Similar manual cutting techniques can be used when removing many types of tumors or organs through an abdominal incision. Later, electromechanical powered fragmenters were developed that could be deployed through a laparoscopic port, allowing tissue fragments to be removed through said port.
[0005] In gynecology, hysterectomy is a common surgical procedure, performed on approximately 500,000 women annually in the United States alone. A hysterectomy involves removing a woman's uterus, which may be necessary for any of a variety of reasons, the most common of which (accounting for over 50% of cases in the United States) is due to the presence of uterine fibroids. Uterine fibroids (also known as leiomyomas) are benign tumors that tend to grow to a size that often becomes unremovable through the vaginal opening or a minimally invasive surgical incision without some form of fragmentation. Such hysterectomies can be performed using traditional open surgical techniques or minimally invasive techniques, such as laparoscopy with fragmentation or large-scale tissue reduction. Hysterectomies can be partial, for example, involving the removal of only the uterus, or total, in which both the uterus and cervix are removed. In either case, the ovaries and / or fallopian tubes may or may not be removed simultaneously.
[0006] For many years, powered fragmentation has been used in gynecological surgery to remove large uteruses from patients through small incisions, which is essential in minimally invasive procedures. The most common application of powered fragmentation in gynecological surgery typically involves fragmenting large, fibrous uteri to remove them from the patient during laparoscopic or robot-assisted laparoscopic hysterectomy, although there are some other applications—particularly myomectomy—where the fibroids are removed, but the uterus itself is left inside the patient in case the patient wishes to conceive in the future.
[0007] Because hysterectomies involving an enlarged uterus are so common, and because minimally invasive surgery offers numerous benefits to patients, surgeons, hospitals, and payers, the use of powered fragmentation has become widespread. However, the possibility that occult cancers hidden within the uterus cannot be detected preoperatively and may spread during fragmentation, causing serious consequences, remains a source of concern. Therefore, even though most hysterectomies involve a uterus without any actual or suspected cancer, traditional open surgery is still prevalent, carrying increased risks, complication rates, longer hospital stays, and more difficult recovery. Therefore, there is a need for techniques and systems that can safely remove and manage tissue samples, even in cases where occult malignancies may be present. Summary of the Invention
[0008] Some embodiments of such tissue containment and removal systems may include a tissue container with a conductive layer, the tissue container comprising a conductive element, an internal volume, and an opening. The tissue containment and removal system may also include a bulk tissue reducer with a tissue cutter having a tissue cutting blade configured to be conductive. A motor is operatively coupled to the tissue cutting blade of the bulk tissue reducer to provide prime force to the tissue cutting blade upon actuation. The tissue containment and removal system may further include a contact detection system with detection circuitry operatively coupled to the tissue cutting blade and the conductive element and configured to generate a continuous signal between the tissue cutting blade and the conductive element and to measure the impedance value between the tissue cutting blade and the conductive element. A controller may be operatively coupled to the motor and may be configured to stop actuation of the motor and the tissue cutting blade whenever the impedance between the tissue cutting blade and the conductive element is at or below a predetermined impedance threshold.
[0009] In some embodiments of methods for containing and obtaining tissue samples within a patient's body, a tissue container may be inserted into the patient's body cavity. Once the tissue container is positioned within the patient's body cavity, the tissue sample can be manipulated or otherwise inserted through the opening of the tissue container and into its internal volume. For such manipulation of the tissue sample, any suitable instrument, such as a grasper, holding hook, cannula, camera, etc., can be used, all of which can optionally be inserted into the body cavity through a small, minimally invasive incision in the patient's skin and underlying fascia. Once the tissue sample is positioned within the internal volume of the tissue container, the entire edge of the opening of the tissue container, or the circumference of the opening, can be withdrawn from within the body cavity to a position outside the patient's body. This effectively contains the tissue sample of interest within the internal volume of the tissue container and isolates the tissue sample from the surrounding tissues of the patient's body positioned outside the tissue container. The distal end of a bulk tissue reducer can then be inserted into the internal volume of the tissue container. In some cases, the distal end of the bulk tissue reducer may be inserted into the internal volume of the tissue container until it is adjacent to the tissue sample. Before, during, or after inserting the distal end of the bulk tissue reducer into the internal volume, a continuous signal can be transmitted between the tissue cutting blade of the tissue cutter and the conductive element of the tissue container, and the impedance between the tissue cutting blade and the conductive element is monitored by the detection circuit of the contact detection system. The tissue cutter of the bulk tissue reducer can be actuated when the detection circuit is monitoring the impedance between the tissue cutting blade and the conductive element. Subsequently, when the monitored impedance between the tissue cutting blade and the conductive element is at or below a predetermined impedance threshold, the tissue cutter can be deactivated by a deactivation signal from the detection circuit or a similar device.
[0010] Some tissue container embodiments may include an internal volume, an opening, and a conductive layer, the conductive layer comprising a composite braid having conductive and non-conductive strands. Some related embodiments of methods for containing and isolating tissue samples within a patient may include inserting a tissue container into a patient's body cavity, the tissue container including an internal volume, an opening, and a conductive layer comprising a composite braid having conductive and non-conductive strands. A tissue sample may then be inserted through the opening into the internal volume of the tissue container, and the entire edge of the opening may be withdrawn from the body cavity back to a position outside the patient's body.
[0011] Some embodiments of such tissue containment and removal systems may include a tissue container comprising a conductive layer, the tissue container including a conductive element, an internal volume, and an opening. The tissue containment and removal system may also include a surgical instrument configured for use within the internal volume of the tissue container and including a conductive portion. The system may further include a contact detection system with detection circuitry operatively coupled to the conductive portion and the conductive element. The detection circuitry may be configured to generate a continuous signal between the conductive portion and the conductive element and to measure the impedance value between the conductive portion and the conductive element. The contact detection system may also include a controller configured to actuate or otherwise issue a warning signal whenever the impedance between the conductive portion and the conductive element is at or below a predetermined impedance threshold. For some such embodiments, the surgical instrument may include a gripping hook having a body portion made of metal, the body portion including the conductive portion.
[0012] Some embodiments of the tissue containment and removal system may include a tissue container with a translucent wall structure and a bulk tissue reducer. A bulk tissue reducer embodiment may include a tissue cutter having a hollow structure with an inner lumen extending its length and a tissue cutting blade disposed at the distal end of the tissue cutter. The bulk tissue reducer may also include a light energy source configured to emit light energy in a distal direction through the inner lumen and from the distal end of the tissue cutter.
[0013] Some embodiments of a method for containing and removing tissue samples from a patient's body may include inserting a tissue container into the patient's body cavity, inserting the tissue sample through an opening in the tissue container and into its internal volume, and withdrawing the entire edge of the opening from the body cavity back to a position outside the patient's body. This method may also include inserting the distal end of a bulk tissue reducer into the internal volume of the tissue container until the tissue cutting blade of the bulk tissue reducer contacts the tissue sample. Light energy is then emitted from the distal end of the tissue cutter in a distal direction toward the tissue sample in contact with the tissue cutting blade. Light energy leakage can then be observed between the distal end of the bulk tissue reducer and the tissue sample. The intensity and orientation of the observed light energy leakage can be used to manipulate the alignment between the distal end of the bulk tissue reducer and the tissue sample to minimize the amount of light energy leakage between them.
[0014] Some embodiments of the tissue container deployer assembly may include a tissue container deployer with a sheath having an inner lumen and a circular distal end, the circular distal end including longitudinal slits converging and forming a petal-like structure within the distal end of the sheath, the petal-like structure being configured to open upon application of distal axial pressure from within the inner lumen. The tissue container deployer may also include a push rod having an elongated configuration, the outer surface of which is dimensionally set to fit and axially translate within the inner lumen of the sheath, and its axial length being equal to or greater than the axial length of the inner lumen of the sheath. Tissue container embodiments are arranged in a contracted state within the inner lumen of the sheath, the tissue container including walls having a thin, flexible configuration, an internal volume, and an opening communicating with the internal volume.
[0015] Some embodiments of the method for deploying a tissue container may include inserting the distal end of a sheath of a tissue container deployer assembly through a body opening into a desired location within the patient's lumen. A pusher of the tissue container deployer assembly is axially advanced distally relative to the sheath, simultaneously advancing the tissue container, which is arranged in a retracted state within the inner lumen of the sheath. The tissue container is advanced axially such that the distal end of the pusher abuts the proximal end of the tissue container. As the pusher and tissue container are axially advanced, the method further includes opening a flexible flap formed by a longitudinal slit on the distal end of the sheath, together with the distal end of the tissue container, to form a distal port on the sheath for ejecting the tissue container from the distal end of the inner lumen of the sheath. The method further includes continuing to axially advance the tissue container with the pusher until the tissue container is completely ejected from the distal port of the sheath and enters the patient's lumen.
[0016] Certain embodiments are further described in the following description, examples, claims, and drawings. These features of the embodiments will become more apparent from the following detailed description when taken in conjunction with the accompanying exemplary drawings. Attached Figure Description
[0017] Figure 1 This is a front view of an embodiment of the organization containment and removal system.
[0018] Figure 2 It is a top view of a part of the patient's body, with large tissue reducers and tissue containers arranged within the patient's body cavity.
[0019] Figure 3 It unfolds inside the patient's body cavity. Figure 1 A cross-sectional front view of an embodiment of an organization containment and removal system.
[0020] Figure 4 yes Figure 1 A top view of an embodiment of a tissue containment and removal system, wherein the distal end of a bulk tissue reducer is arranged within the internal volume of a tissue container.
[0021] Figure 5 yes Figure 4 A front view of an embodiment of the organization containment and removal system.
[0022] Figure 6 This is a perspective view of an embodiment of the drive box.
[0023] Figure 7 It is for removing the top cover. Figure 6 A top view of the drive box.
[0024] Figure 8 It is used for Figure 1 A schematic diagram of the console of an embodiment of the organization containment and removal system.
[0025] Figure 9 It is along Figure 1 The line 9-9 was cut off Figure 1 A cross-sectional view of the tissue container.
[0026] Figure 10 yes Figure 9 The part indicated by the surrounding portion 10-10 Figure 9 An enlarged view of the wall portion of the tissue container.
[0027] Figure 11 It is along Figure 10 The line 11-11 cut Figure 10 An enlarged view of the conductive layer of the tissue container wall.
[0028] Figure 12 An enlarged perspective view of an embodiment of the mesh is shown.
[0029] Figure 13 This is a schematic diagram of an embodiment of the detection circuit.
[0030] Figure 14 This is a front view of an embodiment of a tissue container including conductive ink disposed on its surface.
[0031] Figure 15 It is along Figure 14 The line cut at 15-15 Figure 14 An enlarged view of the wall portion of the tissue container.
[0032] Figure 16 This is an exploded view of an embodiment of the bulk tissue reducer.
[0033] Figure 17 This is a cross-sectional front view of an embodiment of the bulk tissue reducer.
[0034] Figure 18 It is along Figure 17 The line cut from 18-18 Figure 17 Cross-sectional view of the bulk tissue reducer.
[0035] Figure 19-21 The illustration shows the sequence of tissue placement within the body cavity of the patient's pelvic region.
[0036] Figure 22 This is a front view of a bulk tissue reducer embodiment in use, showing the reduction of isolated tissue samples from the internal volume of a tissue container embodiment.
[0037] Figure 23 The surrounding portion 23 represents and illustrates both the light energy embodiment and the light guide embodiment. Figure 17 Enlarged view of an embodiment of the bulk tissue reducer.
[0038] Figure 24 It is a frontal view of the body cavity in the patient's pelvic region, in which light energy from the light energy source of the bulk tissue reducer embodiment leaks from the gap between the distal end of the bulk tissue reducer and the outer surface of the tissue sample.
[0039] Figure 25 yes Figure 1 An exploded view of the tissue cutter and housing portion of an embodiment of the bulk tissue reducer.
[0040] Figure 26 yes Figure 25 A perspective view of a tissue cutter.
[0041] Figure 27 yes Figure 26 A perspective view of a tissue cutter, in which the light cone is removed to expose the light energy embodiment of the bulk tissue reducer embodiment.
[0042] Figure 28 yes Figure 1 A partially cut rear view of the housing of an embodiment of the bulk tissue reducer.
[0043] Figure 29This is a front view of an embodiment of the organization container expander component.
[0044] Figure 30 It is along Figure 29 The line is cut at 30-30. Figure 29 A cross-sectional view of an embodiment of an organization container expander component.
[0045] Figure 31 It is along Figure 30 The line 31-31 is cut off Figure 30 A cross-sectional view of an embodiment of an organization container expander assembly.
[0046] Figure 32 yes Figure 29 An end view of an embodiment of the sheath of the organization container expander component.
[0047] Figures 33 to 35 The diagram shows Figure 29 The unfolding order of the organization container unfolder components.
[0048] The accompanying drawings are intended to illustrate certain exemplary embodiments and are not restrictive. For clarity and ease of illustration, the drawings may not be made to scale, and in some cases, aspects may be enlarged or amplified to aid in understanding a particular embodiment. Detailed Implementation
[0049] As discussed above, devices and methods for the safe handling and removal of tissue samples from locations within a patient's body, even in cases where occult malignancies may be present, can be useful. Certain embodiments of devices and methods for containing and removing tissue samples from within a patient's body, as well as related devices and methods, are discussed in U.S. Patent Application No. 16 / 169,884, filed October 24, 2018, entitled "Systems and Methods for Tissue Capture and Removal," and in U.S. Patent Application No. 16 / 758,358, filed April 22, 2020, also entitled "Systems and Methods for Tissue Capture and Removal," both of which are incorporated herein by reference in their entirety. Such devices and methods for the safe removal of tissue samples from within a patient in a minimally invasive manner can be particularly useful. Any feature, size, or material of the tissue capture and removal systems and methods discussed in any of these incorporated references may be used in any suitable embodiment of the tissue containment and removal system or any related apparatus or method discussed herein.
[0050] Figure 1-3An embodiment 10 of a tissue containment and removal system is shown, configured to contain and isolate a tissue sample 15 in situ within a body cavity 18 of a patient's body 20, and to reduce or otherwise pulverize the tissue sample 15 while maintaining its arrangement within the patient's body 20 and isolated from surrounding tissue 22 within the body cavity 18, such as... Figure 2 and 3 As shown. In some cases, the tissue containment and removal system 10 may include means and related method embodiments for removing fragmented tissue samples 15 from a location within a patient's body 20 that enters through a body opening such as the vagina 24, as illustrated. Figure 3 As shown. Other body openings 24 suitable for this type of access may include surgical incisions or other natural body openings created in the patient's skin, fascia, internal organs, etc., including the mouth, nostrils, or anus. The tissue containment and removal system embodiment 10 shown may include a bulk tissue reducer embodiment 30 (which may also be referred to herein as a tissue shredder embodiment) and a tissue container embodiment 40. Figure 4 and 5 It shows Figure 1 The tissue containment and removal system 10 includes a bulk tissue reducer 30, wherein the distal end 32 of the bulk tissue reducer 30 is disposed within the internal volume 42 of the tissue container 40. To facilitate the introduction of the distal end 32 of the bulk tissue reducer 30 into the internal volume 42 of the tissue container 40, a stopper 31 may be disposed within the inner lumen or orifice 37 of the tissue cutter 34, such as... Figure 1 As shown. In some cases, the occluder 31 may be generally cylindrical, with its external lateral dimensions slidingly fitted into the orifice 37 of the tissue cutter 34, its length being at least as long as the tissue cutter 34, and its distal end 28 having a circular, non-invasive bullet shape, configured to extend beyond the distal end 33 of the tissue cutter 34 beyond the bulk tissue reducer 30 and to facilitate the introduction of the associated structures of the tissue cutter 34 and the bulk tissue reducer 30 into the tissue container 40. Once the distal end 32 of the tissue cutter 34 is properly positioned within the internal volume 42 of the tissue container 40, the occluder 31 can be withdrawn proximal to the orifice 37 and removed from the bulk tissue reducer 30.
[0051] Figure 6 An embodiment of an optional drive box 50 is depicted, which can be used in some tissue containment and removal system embodiment 10 to the tissue cutter 34 of bulk tissue reducer embodiment 30 (see...). Figure 3 and 5 It provides rotational energy. Figure 7A drive housing embodiment 50 without a top cover is depicted, and embodiments of the internal components of the drive housing embodiment 50 are illustrated. In some embodiments, the drive housing 50 may include a motor 51, a power supply 52, a circuit board 53, and a connector 54, which may be configured to be operatively coupled to the bulk tissue reducer 30. These components of the optional drive housing embodiment 50 may also include... Figure 1 and 8 The control console of embodiment 60 of embodiment 10 of the tissue containment and removal system is shown.
[0052] For some tissue containment and removal system embodiments 10, the tissue cutter 34 of the bulk tissue reducer 30 can operate within the internal volume 42 of the tissue container 40. Because some tissue container embodiments 40 may have a thin, flexible wall structure 44, it may be important to prevent contact between the wall 44 of the tissue container 40 and the tissue cutting blade 36 of the tissue cutter 34, which could result in damage or puncture of the wall 44 of the tissue container 40. Therefore, some tissue containment and removal system embodiments 10 may include a contact detection system 70, which may be configured to issue a warning signal and may optionally include an automatic shut-off feature to prevent contact between the tissue cutting blade 36 and the wall 44 of the tissue container 40 or some other component thereof. Figure 9 and 10 The conductive element 46 shown is used when it comes into contact or is about to come into contact. More specifically, in such cases, embodiments of such a contact detection system 70 can be configured to warn the user of the system when the tissue cutting blade 36 comes into contact with or is in close proximity to the wall 44 of the tissue container 40, or to shut off the power to the motor 51 used to rotate or otherwise actuate the tissue cutter 34.
[0053] While the impedance 77 between the conductive element 46 of the tissue cutting blade 36 and the tissue container 40 is typically used to determine proximity or contact between the tissue cutting blade 36 and the wall 44 of the tissue container 40, other forms and energy types are available that can be used in contact detection system embodiments. For example, a time-of-flight optical sensor (not shown) can be used to detect the distance between the tissue shredder / bulk tissue reducer 30 and the tissue container 40. In such embodiments, a light energy source (not shown) can emit light energy, such as, for example, infrared light energy, and an infrared light sensor and associated controller (not shown) can be configured to measure how long it takes for the infrared light energy to return to the infrared light sensor. Such system embodiments use the speed of light and the time it takes for the infrared light energy to return to detect how close the bulk tissue reducer is to the inner surface 48 of the internal volume 42 of the tissue container 40. In such configurations, the longer the time delay, the farther the wall 44 of the tissue container 40 is from the distal end of the tissue cutter 34 of the bulk tissue reducer 30. In some embodiments, multiple types of sensors can be used with multiple types of emitted and received light energy.
[0054] Another method for optically detecting proximity or contact between the tissue cutting blade 36 and the conductive element 46 of the tissue container 40 may include emitting light energy from a light energy source (not shown), such as an emitting diode, from the distal end 32 of the bulk tissue reducer 30 or a component thereof, and measuring the amount or amplitude of the light energy returned to the phototransistor detection sensor. As the tissue cutter 34 of the bulk tissue reducer 30 gets closer to the inner surface 48 of the wall 44 of the tissue container 40, such a phototransistor sensor will detect a larger amplitude light energy or a larger amplitude returned light energy signal, and can be configured to increase the voltage output of the phototransistor detector. Some embodiments of such a contact detection system 70 may be configured to issue a warning or shut off the power to the motor 51 of the bulk tissue reducer 30 if the returned light energy signal exceeds a predetermined threshold.
[0055] Optical fiber (not shown) can also be used to extend the range of the detector sensor and transmitter diode, allowing the sensor to be placed at an optimal location at the distal end 32 of the tissue cutter 34, or directly inside or outside the tissue cutter 34. In some cases, the inner surface 48 of the tissue container 40 may be made of a reflective material to enhance the effect of the reflected light energy signal from the inner surface 48 of the tissue container 40 and to facilitate the reduction of bulk tissue 30 or associated sleeve 38 (e.g., Figure 5 (As shown) Proximity detection of tissue container 40.
[0056] The reflective inner surface 48 of the tissue container 40 can also be used to distinguish the target tissue sample 15 from the tissue container 40. Much more light energy is reflected from the inner surface 48 of the tissue container 40 compared to when detecting tissue, which allows this type of contact detection system embodiment 70 to identify two different surfaces or their materials. An optical proximity sensor can then trigger an embodiment of the contact detection system 70 to determine whether the tissue cutter 34 has come into close proximity to or contacted a designated layer of the tissue container 40, such as the conductive layer 47.
[0057] In some cases, an ultrasonic proximity sensor (not shown) can be used to detect sound waves to detect proximity to a conductive, acoustic, or visible layer of the wall structure 44 of certain tissue container embodiments 40. This can, in turn, be used to trigger embodiments of the contact detection system 70 to determine that the tissue cutter 34 has come into close proximity to the wall structure 44 of the tissue container 40 or has made contact with a designated layer of the tissue container 40, such as the conductive layer 47.
[0058] A capacitive sensor (not shown) can also use capacitance to detect proximity of the tissue cutting blade 36 to the conductive element 46 or conductive layer 47 of the tissue container 40. The capacitive sensor may include a conductive plate and use the sensed object (such as the tissue cutting blade 36 or a separate plate structure) as a second plate to generate a capacitor function. In some embodiments of the bulk tissue reducer 30, the capacitance value changes as it approaches such a capacitive sensor, and some embodiments of the contact detection system 70 may use these changes to determine proximity to the sensor and ultimately contact with the tissue container 40. Alternatively, a capacitive sensor may be built into embodiments of the bulk tissue reducer 30 and may use the tissue cutting blade 36 as its plate. When the bulk tissue reducer 30 approaches the tissue container 40, the sensor may detect the conductive layer 47 of the tissue container 40 as a second plate of the detection capacitor. The sensor may also be calibrated to distinguish between metal and tissue sample 15 in the bulk tissue reducer 30 or the tissue container 40. This, in turn, can be used to trigger embodiments of the contact detection system 70 to determine whether the tissue cutter 34 or its tissue cutting blade 36 has come into close proximity to or contacted a designated layer of the tissue container 40.
[0059] Preventing perforation of the wall 44 of the tissue container 40 can also be enhanced by properly aligning the tissue cutting blade 36 of the bulk tissue reducer 30 with the tissue sample 15 during use. Therefore, in some cases, certain embodiments of the bulk tissue reducer 30 may include a light energy source (such as a light-emitting diode or any other suitable light energy source) and a light-guiding assembly to provide light within the orifice or inner lumen 37 of the tissue cutter 34 (see [link to original text]). Figure 5 The light guide can illuminate the tissue sample 15 by traveling distally to the adjacent structure of the bulk tissue reducer 30. In some cases, the light guide can be configured to prevent rotation with the tissue cutting blade 36 of the tissue cutter 34 of the bulk tissue reducer 30, thereby preventing rotation of the reduced portion of the tissue sample 15 disposed within the inner lumen 37 of the bulk tissue reducer 30 during extraction of the tissue sample 15 (or fragments thereof).
[0060] In order to contain and isolate the tissue sample 15 before it is reduced in size or pulverized, in some cases it may be necessary to reliably and consistently deploy a suitable tissue container embodiment 40 around the tissue sample 15. This process can typically be performed within the confined space of the body cavity 18 within the patient's body 20. In some cases, this process can be facilitated by using a suitable container deployer or container deployer assembly, which will be discussed and shown in more detail below. Figures 29 to 35In some cases, such container deployer assembly embodiments can be configured to perform the deployment of the tissue container 40 while maintaining some degree of control over the orientation of the tissue container 40 during deployment. Some embodiments of such container deployer assemblies can be configured to operate in a manner similar to a rivet gun. This type of configuration can be actuated using a spring-loaded mechanism, compressed air, or other mechanical or electrical actuators to deploy the tissue container 40 from the sheath of the tissue container deployer assembly.
[0061] Figure 3 It shows Figure 1 Embodiment 10 of a tissue containment and removal system includes an embodiment of a contact detection system 70 with an automatic shut-off feature. The tissue containment and removal system 10 is shown with its distal end 32 of a bulk tissue reducer 30 disposed within the internal volume 42 of a tissue container 40 and adjacent to a tissue sample 15 within the pelvic cavity 18 of a patient 20. For this embodiment 10 of the tissue containment and removal system, a circuit can be closed when there is physical and electrical contact between the tissue cutting blade 36 and the conductive layer 47 or conductive element 46 of the tissue container 40, and when current flows from one to the other, by attaching a container conduit 72 (first electrode) electrically connected to the conductive layer 47 or conductive element 46 of the tissue container 40. In some cases, this circuit can be completed by, for example... Figure 8 The block diagram shows the controller 80 or as shown. Figure 8 and 13 The detection circuit 75 shown is used to identify generally undesirable situations that occur when the tissue cutting blade 36 of the bulk tissue reducer 30 has come into contact with or is close to the wall 44 of the tissue container 40.
[0062] In some cases, such contact may result in perforation of the wall 44 of the tissue container 40. Perforation of the wall 44 of the tissue container 40 may, in some cases, disrupt the isolation of the tissue sample 15 or a portion thereof disposed within the internal volume 42 of the tissue container 40 from the surrounding tissue 22 of the patient 20. Figure 13As shown, conditions of mutual electrical contact with amplitude at or above a predetermined threshold, i.e., the transmission of a continuous signal 76, or a measured effective impedance 77 measured between the conductive element 46 and the tissue cutting blade 36 falling below a predetermined threshold, can be detected by the controller 80 or its contact detection system 70, which can be configured to subsequently issue a warning signal to the user, shut off the power to the motor 51 of the tissue cutter 34 or both connected to the bulk tissue reducer 30, or initiate any other useful process during detection. In some embodiments, the conductivity of the tissue container 40 can be achieved by including conductive elements 46 in its wall structure 44. Such conductive elements 46 can include a layer of metal mesh, conductive plastics such as PEDOT or other similar materials, conductive plastic mesh, or plastic layers in the container construction. Furthermore, conductive ink 95 including materials such as silver, carbon, etc., can be used to produce... Figure 14 The conductive layer 47 or conductive element 46 of the tissue container 40 shown. For some tissue container embodiments 40, the conductive layer 47 may include, for example... Figure 10 The woven mesh 100 shown has the following characteristics: Figure 10 The illustrated composite mesh structure comprises both conductive and non-conductive material strands. Generally, the conductive layer of Tissue Container Example 40 and the non-conductive layer of Tissue Container Example 47 (discussed below) discussed herein may comprise materials such as any suitable biocompatible material, including plastics such as polyethylene, polyurethane, polypropylene, PET, PETG, aromatic polyamides, and para-aromatic polyamides, including, for example, poly(p-phenylene terephthalamide). Aliphatic or semi-aromatic polyamides Fibers, rubber, thermoplastics, etc.
[0063] In some cases, although typically observed as a stepwise function, the decrease in measured impedance 77 and the associated reduction in physical separation between the conductive element 46 of the tissue container 40 and the tissue cutting blade 36 of the bulk tissue reducer 30 may include a predetermined range, such that the contact detection system 70 is sensitive enough to quickly stop the tissue cutter 34 of the bulk tissue reducer 30, but not sensitive enough to falsely trigger in conductive or aqueous environments. For some embodiments, the non-conductive insulating layer 102 of the tissue container 40 may be disposed between the conductive layer 47 and the bulk tissue reducer 30, such as... Figure 10 As shown. A continuous signal 76, transmitted between the tissue cutting blade 36 and the conductive element 46 of the tissue container 40, which can be used to determine the impedance value 77 between them, may include a direct current (DC) or alternating current (AC) continuous signal 76 with a frequency range of about 1 Hz to about 1 MHz. For example... Figure 3As shown, a snap-fit connector 104 can be used, which allows the container conduit 72 (first electrode) to be attached to the conductive element 46 of the tissue container 40 for electrical communication after the tissue sample 15 has been captured and placed within the internal volume 42 of the tissue container 40. In some cases, the container conduit 72 (first electrode) can be thus secured to electrical communication at any time during the entire tissue sample capture process.
[0064] For some tissue containment and removal system embodiments 10, portions of various instruments other than the bulk tissue reducer 30 may be electrically insulated to prevent accidental triggering of the contact detection system. For example, in the case where the bulk tissue reducer 30 is used as an antenna, contacting the tissue cutting blade with the metal grip hook instrument 106 may accidentally trigger the contact detection system, while by making the grip hook instrument 106 electrically insulated, it may be possible to interact with the bulk tissue reducer 30 without triggering the contact detection system 70.
[0065] As discussed above, the contact detection system 70 of the tissue containment and removal system 10 can include various embodiments. In some cases, the entire bulk tissue reducer 30, or tissue container 40, or conductive layer 47, or conductive element 46 can be configured as an antenna that can detect changes in its shape, proximity to other metal elements, or other antennas. Additionally, the conductive layer 47 of the tissue container 40, which may include metal, can be fabricated as a printed flexible circuit and a metal mesh 100. Impedance detection characteristics can be used to detect the proximity of an object such as the tissue cutting blade 36 to the conductive element 46. This configuration enables the contact detection system 70 to function such that it shuts off power and alerts the user not only when the tissue cutting blade 36 contacts the conductive layer 47 of the tissue container 40, but also when the tissue cutting blade 36 is near the conductive layer 47 or its conductive element 46. This proximity or physical separation between the tissue cutting blade 36 of the bulk tissue reducer 30 and the conductive element 46 of the tissue container 40, which can be indicated by an associated effective impedance value 77 and can be used to trigger a detection event, can include, for example, Figure 5 The approach value 108 shown is up to about 10 mm, up to about 1 mm, about 0.001 mm to about 10 mm, more specifically, about 0.01 mm to about 1 mm, and even more specifically, about 0.025 mm to about 0.075 mm.
[0066] Reference Figure 8 and 13An embodiment 70 of a contact detection system is shown, which can be incorporated into a console printed circuit board (PCB) 82 and coupled to a conductive element 46 of a tissue container 40 and a tissue cutting blade 36 of a bulk tissue reducer 30. In some embodiments, detection can be performed by outputting a square wave embodiment of a continuous signal 76 electrically connected to the tissue cutting blade 36 of the bulk tissue reducer 30, having a frequency of at least about 20 kHz and an amplitude of about +3.3V to -3.3V. In some cases, some such continuous signal embodiments 76 may also have a voltage up to about 5V. When the tissue cutting blade 36 contacts the conductive element 46 in the wall 44 of the tissue container 40, the resulting decrease in the effective impedance 77 and the corresponding increase in the transmission of the continuous signal are received back at the console PCB 82 via conductive conduits 72 (such as wires connected between the console PCB 82 and the conductive element 46 of the tissue container 40).
[0067] In some configurations, the continuity signal 76 can be output to the conductive element 46 of the tissue container and then received by the handheld part 35 of the bulk tissue reducer 30. In some cases, a sine wave, a triangle wave, or other waveform can be used instead of a square wave. In some cases, a sine wave may produce less electrical noise and less signal to detect. In some cases, the contact detection system 70 can be configured to generate a continuity signal 76 with a high-frequency alternating current, the frequency of which may be approximately 20 kHz in some cases, as lower frequencies may be more likely to induce arrhythmias. By increasing the frequency to approximately 20 kHz or higher in some cases, the contact detection system 70 can safely transmit embodiments of the continuity signal 76 with a current up to approximately 10 mA through the body 20 of a human patient. In some cases, for reference, when using DC current, the safe current limit according to electrical safety standard IEC 60601-1 may be up to approximately 50 µA. For some embodiments, Figure 8 The detection circuit 75 shown is designed to limit the current amperes of the continuity signal 76 to a maximum value of up to about 6.6 mA at a frequency of at least about 20 kHz or higher.
[0068] for Figure 13In the illustrated embodiment of the detection circuit 75, the impedance 77 between the conductive element 46 of the tissue container 40 and the tissue cutting blade 36, measured by the detection circuit 75, is effectively processed by the detection circuit 75 and converted into a Vout signal at the Vout terminal 110. This Vout signal generates a voltage output with an amplitude inversely proportional to the measured impedance 77. That is, the lower the measured impedance 77, the higher the Vout signal generated by the detection circuit 75 at the Vout terminal 110. Therefore, empirically, in some embodiments of the contact detection system 70, when the tissue cutting blade 36 of the bulk tissue reducer 30 is arranged in the middle of the internal volume 42 of the tissue container 40 and surrounded by air, the Vout signal measured by the detection circuit 75 of the contact detection system 70 at the Vout terminal 110 is <50mV, which is essentially a Vout signal associated with an open circuit or almost infinite impedance 77 measured between the conductive element 46 of the tissue container and the tissue cutting blade 36.
[0069] When the tissue cutting blade 36 of the bulk tissue reducer 30 is in direct contact with the stainless steel conductive element 46 in the wall 44 of the tissue container 40, the Vout measurement at the Vout terminal 110 is approximately 2.1V to approximately 2.2V, which represents a Vout signal consistent with the very low or near-zero impedance measured between the conductive element 46 and the tissue cutting blade 36 in the tissue container 40. When the tissue cutting blade 36 of the bulk tissue reducer 30 is placed in contact with the non-conductive inner layer 102 of the container wall 44, the measured value is approximately 500mV. This is generally interpreted as indicating some capacitive coupling between the conductive element 46 of the container wall 44 and the tissue cutting blade 36 of the bulk tissue reducer 30, even without direct electrical contact with the conductive element 46 throughout the tissue container 40.
[0070] In another test, the non-conductive inner wall 44 of the tissue container 40 was scratched to expose some of the conductive stainless steel mesh 100 of the conductive elements 46. The internal volume 42 of the tissue container 40 was filled with tap water and saline solution, and the tissue cutting blade 36 of the bulk tissue reducer 30 was immersed in the water. On the detection circuit embodiment 75, the Vout reading at the Vout terminal 110 was approximately 1.2V to approximately 1.6V. This reading reflects the current flowing from the continuity signal 76 of the tissue cutting blade 36 of the bulk tissue reducer 30 through the saline solution and into the conductive stainless steel mesh 100 of the conductive elements 46 of the container 40 wall 44. Different readings generally appear to indicate that the tested contact detection system embodiment 70 can be used to distinguish the electrical contact (approximately 2.1V) between the tissue cutting blade 36 of the bulk tissue reducer 30 and the conductive element 46 of the container wall 44, and the contact (approximately 1.4V) between the tissue cutting blade 36 of the bulk tissue reducer 30 and the tissue / saline / fluid in the tissue container 40 with exposed conductive elements 46 (e.g., from previous contact with the blade).
[0071] In some embodiments, the contact detection system 70 may have four main subsystems, including a power supply 112, a patient interface 114, a receiver / rectifier 116, and a signal filtering unit 118. (See also...) Figure 13 In some embodiments, power supply 112 may include power supply circuitry including positive and negative output charge pumps and evaluation module 113, such as a Texas Instruments LM27762EVM, which can be configured to convert a 5V input voltage into +3.3V and -3.3V outputs for powering the remainder of detection circuitry 75 of contact detection system 70. Detection circuitry 75 may also include signal generator 120, which may include analog device 121, such as an Analog Devices DC20738-H manufactured by Analog Devices Corporation in Norwood, Massachusetts, which can be configured to generate a square wave signal at a frequency of approximately 20kHz and use it as a signal generator for detection circuitry 75. In some cases, such analog devices may generate continuous signals at frequencies from approximately 10kHz to approximately 30kHz. The square wave output can be fed into comparator 122, which is powered by the +3.3V and -3.3V rails of charge pump 113, causing the output to swing between +3.3V and -3.3V at 20kHz. Resistors R1 124 and R2 126 can be selected to provide a threshold for switching at half of the nominal +3.3V supply. For the exemplary embodiment shown, resistors 124 and 126 can each have a resistance of approximately 10 kiloohms.
[0072] The patient interface portion 114 of the detection circuit may include resistors R3 128 and R4 130, which can be selected according to the requirements of the body-floating (BF) type in Table 3 of IEC 60601-1 to limit the patient assist current. In some embodiments, resistors 128 and 130 may each have a resistance of approximately 499 ohms. In some cases, the 100μA limit for low-frequency AC current may be increased based on an increased transmitter / signal generator frequency of 20kHz or higher. In some cases, the low-frequency AC current limit may increase by two orders of magnitude, becoming a limit of approximately 10mA. In some cases, the maximum voltage between the transmit terminal or blade terminal 135, which can be coupled to the blade conduit 74, and the receive terminal or container terminal 137, which can be coupled to the container conduit 72, may be set to approximately 6.6V (i.e., the difference between a 3.3V negative output and a 3.3V positive output). The leakage current value may include 6.6V divided by the series resistors including resistors R3 128 and R4 130: 泄漏=6.6V / (499+499) = 6.6mA. This configuration can be used to achieve compliance within safe physiological boundaries without including a resistor R5 140 for further current limiting. For some exemplary embodiments, resistor R5 140 may have a resistance of approximately 249 ohms. Capacitors C1 142 and C2 144 can be used to block DC current from flowing to the patient's body. The capacitance values of capacitors C1 142 and C2 144 can also be selected to minimize drop-off at square wave high or low. For the exemplary embodiments shown, capacitors 142 and 144 may each have a capacitance of approximately 10μF.
[0073] The receiver / rectifier circuit section 116 of the detection circuit 75 of the contact detection system 70 may include amplifiers, such as operational amplifier U1B 146, which can be configured to act as a buffer / follower 148 that simply passes the voltage from the top of resistor R5 140 to the next stage. Resistors R3 128, R4 130, R5 140, and measuring resistor 77 (Rmeas) can be configured to form a resistive voltage divider. Amplifiers such as operational amplifier U2A 150 and operational amplifier U2B 152 can be configured to form a rectifier that flips the negative portion of a continuous signal to positive, making it appear more like a DC output except for the square wave edges. This rectifier may have the ability to add gain to the output of the resistive voltage divider discussed above. For example, if resistors R7 154, R8 156, R9 158, and R10 160 have the same resistance, then the equation from Rmeas 77 to Vout 110 might be as follows:
[0074] Vout=0.5*6.6*(R5 / (R3+Rmeas+R4+R5))*(R7 / R6)
[0075] In some embodiments, the resistance values of resistors 154, 156, 158, and 160 can be equal to each other and approximately 2.2 kiloohms. In some cases, resistor values can be selected based on usage under certain conditions, such as when the non-conductive liner 102 of the tissue container 40 has been scored and there is tissue between the bulk tissue remover 30 and the conductive element 46 exposed by the scoring. In such cases, the resistance between the bulk tissue remover 30 and the conductive layer 47 of the tissue container 40 can be approximately 1 kiloohm. In some such cases, it may be useful to maximize the difference in Vout 110 between 0 ohms and 1 kiloohms Rmeas 77, depending on two design considerations, including rail voltage. More specifically, high gain (large resistance values of resistors R7 154 and R6 162) can allow a large voltage difference between 0 ohms and 1 kiloohms Vout 110, but rail prevents unlimited use of gain. In some embodiments, the resistance value of resistor 162 can be approximately 687 ohms. Under these parameters, operational amplifier performance at high gain may also need to be considered. Another design consideration includes noise immunity. With a fixed voltage rail, using a relatively small resistor R5 140 allows for greater gain, but it also results in a smaller divider input voltage relative to potential sources of interference. Certain values for some detection circuit embodiments 75 can be selected as follows: Vout 110 = 2.1V for 0 ohms, Vout = 1.2V for 1 kΩ, and Vout 110 < 50mV for high Z.
[0076] Embodiments of the filter circuit of signal filtering circuit 118 may include amplifiers, such as operational amplifier U3A164, which can be configured as an inverting active low-pass filter having an attenuation frequency determined by resistor R12 166 and capacitor C4 168, and a gain configured by resistors R11 170 and R12 166. For such filter circuit embodiments, a filter value of F3db = 1 / (2*pi*R12*C4) and a gain of -R12 / R11 can be achieved. Amplifiers such as operational amplifier U3B172 can also be configured as inverting active low-pass filters. A filter value of F3db = 1 / (2*pi*R14*C5) can be achieved, which is also a function of capacitor C5 182 with a capacitance of approximately 10nF, and a gain of -R14 / R13, each being a function of resistor R13 174 and / or resistor R14 176. Finally, resistor R15178 and capacitor C6180 can be configured to form a low-pass filter with the following attenuation frequency: F3db = 1 / (2*pi*R15*C6). In some embodiments, capacitor 180 can have a capacitance of approximately 10nF. If all three filters are configured with the same resistance-capacitance (RC) value, the filter may be configured for active attenuation. In such circuit embodiments, the attenuation frequency can be approximately 15.9kHz. Another design consideration for setting an extremely low cutoff frequency is delay. In some cases, the delay can be approximated by approximately 63 microseconds by approximately three time constants; for this particular exemplary embodiment, the total delay is approximately 189 microseconds. For the illustrated embodiment, resistors 166, 170, 174, 176, and 178 can all have the same resistance value of approximately 1 kiloohm. The exemplary embodiment of the detection circuit 75 discussed above also includes the pair of diodes D1 and D2 shown, and capacitor C3184, which can have a capacitance of approximately 100pF. In addition, the operational amplifier embodiments 146, 150, 152, 164 and 172 and the amplifier of comparator section 122 may include operational amplifier model OPA2192 manufactured by Texas Instruments in Dallas, Texas.
[0077] Some embodiments of the tissue containment and removal system 10 may include a tissue container 40 having a conductive layer 47, the tissue container including a conductive element 46, an internal volume 42, and an opening 43. The tissue containment and removal system 10 may also include a bulk tissue reducer 30 having a tissue cutter 34 with a tissue cutting blade 36 configured to be conductive. A motor 51 is operatively coupled to the tissue cutting blade 36 of the bulk tissue reducer 30 to provide prime force to the tissue cutting blade 36 upon actuation; in some cases, the prime force may be a rotational prime force. The tissue containment and removal system 10 may further include a contact detection system 70 having a detection circuit 75 operatively coupled to the tissue cutting blade 36 and the conductive element 46 and configured to generate a continuous signal 76 between the tissue cutting blade 36 and the conductive element 46 and to measure an impedance value 77 between the tissue cutting blade 36 and the conductive element 46. The controller 80 is operatively coupled to the motor 51 and can be configured to stop the actuation of the motor 51 and the operatively coupled tissue cutting blade 36 whenever the impedance 77 between the tissue cutting blade 36 and the conductive element 46 is at or below a predetermined impedance threshold. Once the controller 80 stops the actuation of the motor 51 due to the impedance 77 between the tissue cutting blade 36 and the conductive element 46 being at or below the predetermined impedance threshold, the controller 80 can set a latch for the interrupted power state, which will remain in place regardless of changes in the impedance value 77 measured after power-off, until a reset command is issued by the user of the system 10.
[0078] In some embodiments, the controller 80 may optionally be configured to actuate or otherwise issue a warning signal via the indicator 190 whenever the impedance 77 between the tissue cutting blade 36 and the conductive element 46 is at or below a predetermined impedance threshold. In some embodiments, an audible warning signal may be emitted from an audible signal transmitter, in which case the indicator 190 may include a speaker. In such cases, the controller 80 may be configured to actuate an audible warning signal from the audible signal transmitter whenever the impedance 77 between the tissue cutting blade 36 and the conductive element 46 is at or below a predetermined impedance threshold. In some embodiments, a visual warning signal may be emitted from a visual signal transmitter. In such cases, the indicator 190 of the contact detection system 70 may include a light source, such as an LED or any other suitable source. In such cases, the controller 80 may be configured to actuate a visual warning signal from the visual signal transmitter of the indicator 190 whenever the impedance 77 between the tissue cutting blade 36 and the conductive element 46 is at or below a predetermined impedance threshold.
[0079] Reference Figure 8 and 13In some embodiments, the contact detection system 70 may include a blade terminal 135 operably coupled to the controller 80 and the tissue cutting blade 36 via a conductive blade conduit 74, and a container terminal 137 operably coupled to the controller 80 and the conductive element 46 of the tissue container 40 via a conductive container conduit 72. For some of these embodiments, the conductive blade conduit 74 operably coupled to the blade terminal 135 and the tissue cutting blade 36 may have a snap-fit connector 105 configured to provide a releasable electrical connection therebetween. For some of these embodiments, the conductive container conduit 72 operably coupled to the container terminal 137 and the conductive element 46 of the tissue container 40 may also have a snap-fit connector 104 configured to provide a releasable electrical connection therebetween. In addition to snap-fit connectors 104 and 105, the contact detection system may also include a communicating container connection interface 192 disposed between the container conduit 72 and the controller 80, and a communicating bulk tissue reducer connection interface 194 disposed between the blade conduit 74 and the controller 80.
[0080] The controller may include a console printed circuit board 82 and a motor driver 84 operatively coupled to the motor 51. The controller 80 may further include a signal generator 120, a processor 86, and a memory 88 operatively coupled to the processor 86. The contact detection system 70 may also include a main power supply 90 operatively coupled to the controller 80 and / or any other suitable component of the contact detection system 70, and a cooling fan 91 for holding the component within the console 60 at an appropriate operating temperature. The motor 51 may be operatively coupled to the tissue cutting blade 36 of the bulk tissue reducer 30 via a flexible shaft 56 configured to transmit rotational torque from the motor (or a suitable gear system coupled thereto) to the tissue cutter 34 of the bulk tissue reducer 30.
[0081] Reference Figure 9 and 10 In some tissue containment and removal system embodiments 10, the tissue container 40 may include a second non-conductive layer 102 disposed on the inner surface 196 of the conductive layer 47. The tissue container 40 may also additionally include a third non-conductive layer 198 disposed on the outer surface 200 of the conductive layer 47. The conductive layer 47 disposed between the second layer 102 and the third layer 198 may include a composite braid having non-conductive and conductive strands interwoven, the conductive strands constituting conductive elements 46 of the tissue container 40. In some embodiments, the conductive layer 47 disposed between the second layer 102 and the third layer 198 may also include a thin, flexible layer of non-conductive polymer material with a pattern of conductive ink 95, such as... Figure 14As shown. The conductive ink 95 can be flexible after printing, which can create a wall structure 44 with a flexible configuration. For such embodiments, the conductive ink 95 can be printed onto the inner surface of the wall 44, the outer surface of the wall 44, or any other suitable location. For some embodiments, the printed pattern of the conductive ink 95 can include a pitch that ensures the tissue cutting blade 36 of the bulk tissue reducer 30 contacts the conductive ink 95 before perforating the thin polymer layer printed with the conductive ink 95. For such tissue container embodiments, the conductive ink 95 can be used as a conductive element 46 of the tissue container 40. For some other embodiments, the conductive layer 47 disposed between the second layer 102 and the third layer 198 and its conductive element 46 can include, for example, Figure 12 The metal mesh 100 shown is made entirely of conductive strands 230. In some cases, the conductive strands 230 of the metal mesh 100 may include or be made of metal, such as stainless steel.
[0082] Reference Figures 16 to 18 The illustrated tissue cutter embodiment 34 includes an elongated tube 202 having an inner lumen 37 extending its length. In some embodiments, the tissue cutting blade 36 includes a sharp distal end of the elongated tube 202 of the tissue cutter 34 with a beveled configuration, although alternative configurations may be used. In the illustrated embodiment, the tissue cutting blade 36 is circular in shape in its cross-sectional profile, and the entire tissue cutting blade 36 lies in a plane perpendicular to the longitudinal axis 204 of the elongated tube 202 of the tissue cutter 34. The elongated tube 202 of the tissue cutter 34 can be made of any suitable high-strength material, which may also optionally be conductive. In some cases, metals such as nickel-titanium alloys, stainless steel, etc., may be used. In the illustrated embodiment, the bulk tissue reducer 30 includes a housing 206 operatively coupled to the tissue cutter 34 and a sleeve 38 fixed to the housing 206. Such a sleeve embodiment 38 may have an elongated, hollow configuration and include an inner lumen 39 extending its length. As shown, a sleeve 38 is arranged on the elongated tube 202 of the tissue cutter 34, with a tight fit between the outer surface 208 of the elongated tube 38 and the inner surface 210 of the sleeve 38. For some bulk tissue reducer embodiments, a manual start switch 207 may be arranged on the housing 206 and operably coupled to the controller 80 to manually actuate the motor 51 and the tissue cutter 34 of the bulk tissue reducer 30. The system 10 may also include a foot switch 209 operably coupled to the controller 80 to actuate the motor 51 and the tissue cutter 34 of the bulk tissue reducer 30, such as... Figure 8 As shown.
[0083] As discussed above in detail with respect to exemplary detection circuit embodiment 75, the proximity value 108 of the tissue cutting blade 36 relative to the conductive element 46 of the tissue container 40 can be represented by various corresponding measurement parameters, such as impedance 77, the measurement current of the continuity signal 76, the Vout signal from the Vout terminal 110, etc. For some embodiments, an impedance threshold can be selected to correspond to the proximity value 108, which indicates the separation distance between the tissue cutting blade 36 and the conductive element 46, said distance being up to about 1 mm. To provide a clinically safe continuity signal, in some cases, the detection circuit 75 can be configured to generate the continuity signal 76, including an alternating current with a frequency of about 10 kHz to about 30 kHz, more specifically about 20 kHz, a maximum current of up to about 10 mA, a square wave continuity signal, or any suitable combination of these parameters.
[0084] For some tissue sample removal procedures, the tissue container 40 can be inserted as follows: Figure 19 The patient 20 is shown in body cavity 18 and as indicated by arrow 220. In some embodiments, a tether 49 distally attached to the edge 41 of a tissue container allows the proximal end 222 to remain outside the patient's body cavity 18. In some embodiments, the tether 49 may also include a conductive conduit to serve as a container conduit 72. In such embodiments, a snap-fit connector 104 may be operatively coupled to the proximal end 222 of the tether 49.
[0085] Once the tissue container 40 is placed within the patient's body cavity 18, the tissue sample 15 can be manipulated or otherwise inserted through the opening 43 of the tissue container 40 into its internal volume 42, such as... Figure 20 As shown. For such manipulation of tissue samples, any suitable instrument can be used, such as a gripper 224, a camera 226, a holding hook 106, a cannula (not shown), etc., all of which can optionally be inserted into the body cavity 18 through a small, minimally invasive incision in the patient's skin and the underlying fascia. Once the tissue sample 15 is positioned within the internal volume 42 of the tissue container 40, the entire edge of the opening 43, defined by the circumferentially arranged edge 41 surrounding the opening 43, can be withdrawn proximally from within the body cavity 18 to a position outside the patient's body 20, while the tissue sample 15 remains simultaneously within the internal volume 42 and the patient's body cavity 18. This arrangement of the tissue sample 15, the tissue container 40, and the body opening 24 effectively accommodates the tissue sample of interest 15 within the internal volume 42 of the tissue container 40 and isolates the tissue sample 15 from the surrounding tissue 22 of the patient's body 20 positioned outside the tissue container 40, as... Figure 21 As shown. At this time, the snap connector 104 of the tether 49 is operably connected to the container terminal 137.
[0086] The distal end 32 of the bulk tissue reducer 30 can then be inserted into the internal volume 42 of the tissue container 40 and the lumen 18 of the patient's body 20. In some cases, the distal end 32 of the bulk tissue reducer 30 can be inserted into the internal volume 42 of the tissue container 40 until it is adjacent to the tissue sample 15, such as... Figure 3 As shown. During, before, or after the insertion of the distal end 32 of the bulk tissue reducer 30 into the internal volume 42, a continuity signal 76 can be transmitted between the tissue cutting blade 36 of the tissue cutter 34 and the conductive element 46 of the tissue container 40, and the impedance 77 between the tissue cutting blade 36 and the conductive element 46 is monitored by the detection circuit 75 of the contact detection system 70. While monitoring the impedance 77 between the tissue cutting blade 36 and the conductive element 46 by the detection circuit 75, the tissue cutter 34 of the bulk tissue reducer 30 can be actuated. Subsequently, when the monitored impedance 77 between the tissue cutting blade 36 and the conductive element 46 is at or below a predetermined impedance threshold, the tissue cutter 34 can be deactivated by a deactivation signal from the detection circuit 75 or a similar arrangement.
[0087] In some embodiments, in addition to deactivating the tissue cutter 34 when the monitoring impedance 77 between the tissue cutting blade 36 and the conductive element 46 is at or below a predetermined impedance threshold, the detection circuit 75, controller 80, or any other suitable component may also issue an audible warning signal when the monitoring impedance 77 between the tissue cutting blade 36 and the conductive element 46 is at or below the predetermined impedance threshold. In some cases, issuing an audible warning signal may include issuing a single beeping tone. In some embodiments, the beeping tone may be configured to conform to IEC 60601-1-8 in terms of maximum and minimum volume, frequency, or any other applicable parameters. Furthermore, in addition to deactivating the tissue cutter 34 when the monitoring impedance 77 between the tissue cutting blade 36 and the conductive element 46 is at or below the predetermined impedance threshold, the system 70 may also issue a visual warning signal when the monitoring impedance 77 between the tissue cutting blade 36 and the conductive element 46 is at or below the predetermined impedance threshold. In some embodiments, the issued visual warning signal may include a light signal. Furthermore, for some continuous detection methods, the impedance threshold can be determined as a value close to 108 corresponding to the physical distance between the indicative tissue cutting blade 36 and the conductive element 46, such as... Figure 5As shown. In some embodiments, this corresponding proximity value 108 can be as high as about 1 mm. Therefore, with this type of configuration, the tissue cutter 34 of the bulk tissue reducer 30 can be deactivated when the proximity value 108 between the tissue cutting blade 36 and the conductive element 46 is as high as about 1 mm. In some cases, other proximity values 108 corresponding to the respective impedance thresholds may include proximity values 108 as high as about 10 mm, as high as about 1 mm, about 0.001 mm to about 10 mm, more specifically about 0.01 mm to about 1 mm, and even more specifically about 0.025 mm to about 0.075 mm.
[0088] In some cases, before the tissue cutter 34 is deactivated, the tissue sample 15 may come into contact with the tissue cutting blade 36 of the tissue cutter 34, and the tissue sample 15 may be reduced in size by the actuated tissue cutter 34, such as... Figure 22 As shown. During this reduction of tissue sample 15, the distal end 107 of the holding hook 106 can be secured to tissue sample 15, and tissue sample 15 or its grasping reduction portion can be pulled proximally through the inner lumen 37 of tissue cutter 34 (as indicated by arrow 228) while tissue sample 15 is reduced using the actuated tissue cutter 34. The reduced tissue sample 15 can continue to be withdrawn through the inner lumen 37 of tissue cutter 34 until at least a portion of tissue sample 15 is disposed outside the bulk tissue reducer 30 and the patient's body 20. In some cases, this process can continue until the entire tissue sample 15 has been removed from the internal volume 42 of tissue container 40.
[0089] Regarding the use of the distal end of the gripping hook 106 to grasp the tissue sample 15, in some cases, the tissue 15 to be grasped may be positioned within the hole 37 of the tissue cutter 34 or distally adjacent to the distal end 32 of the tissue cutter 34. More specifically, see... Figure 3 and 5Example 10 of the tissue containment and removal system shows a gripping hook embodiment 106 with an axial length substantially similar to that of the bulk tissue reducer 30. In this embodiment, when the distal ends of the gripping hooks 106 are fully advanced into the aperture 37 and at their maximum distal extension within the aperture 37, the distal ends of the gripping hooks 106 can extend substantially co-existingly with the distal end 32 of the tissue cutter 34, as shown. In this system embodiment 10, to grip the tissue sample 15 with the distal ends of the gripping hooks 106, the tissue sample 15 can be pressed against the distal end 32 of the tissue cutter 34, such that at least a portion of the tissue sample 15 extends proximally into the aperture 37 to form a “tissue meniscus” (not shown), which can be gripped by the distal ends of the gripping hooks 106 while remaining within the aperture 37. In other cases, the gripping hooks 106 may have an axial length that allows the distal ends of the gripping hooks 106 to extend distally from the distal end 32 of the tissue cutter 34. In some embodiments, the gripping hook 106 may have an axial length that allows the distal end of the gripping hook 106 to extend distally from the distal end 32 of the tissue cutter 34 by up to about 25 mm or more. In such embodiments, a tissue sample 15 disposed outside the hole 37 but distally adjacent to the distal end 32 of the tissue cutter 34 can still be gripped by the distal end of the gripping hook 106.
[0090] In some cases, transmitting a continuity signal 76 between the tissue cutting blade 36 of the tissue cutter 34 and the conductive element 46 of the tissue container 40 may include transmitting a continuity signal 76, which includes alternating current having a frequency of about 10 kHz to about 30 kHz, more specifically about 20 kHz, a maximum current of up to about 10 mA, a square wave continuity signal, or any combination of these or other suitable parameters.
[0091] In some tissue container embodiments, the stainless steel mesh 100 can be used as a reinforcing layer of the tissue container 40, and this reinforcing layer can be used as a conductive element 46 in the wall 44 of the tissue container 40 for completing the electrical detection circuit 75 of the contact detection system 70, such as... Figures 9 to 11 As shown. If it can also be used as a liquid-tight or sealing layer (polyester woven fabric, woven fabrics If a generally non-conductive reinforcing layer 102 (either a braided fabric or a tough polymer layer) is used for the tissue container 40, then additional conductive elements 46 and / or conductive layers 47 may be included in the walls 44 of the tissue container 40 to facilitate detection by the detection circuit 75 performed by the contact detection system 70. The conductive elements 46 may include conductive strands 230, which in some cases may be braided with non-conductive strands 232 to form a composite braid 234 that can be used as the conductive layer 47 of the container 40. In such composite braid embodiments, the conductive strands 230 may form an interlaced, overlapping grid pattern, wherein adjacent and overlapping conductive strands 230 are electrically in contact with each other, such that all portions of all conductive strands are electrically continuous with each other. In this way, a continuity signal 76 transmitted to any portion of any conductive strand 230 will be transmitted to all portions of all other conductive strands 230 of the composite braid 234. For these embodiments 234, the container conduit 72 can be electrically connected to any portion of any conductive strand 230 and achieve electrical continuity with all other portions of the composite braid 234 conductive strands 230.
[0092] In some cases, the conductive element 46 may also include one or more stretchable conductive materials that can be screen-printed, stamped, or pad-printed onto the surface of the polymer layer or other otherwise non-conductive layer of the tissue container 40. The conductive element can also be manufactured in a manner similar to that of a flexible circuit board. As an example, such as Figure 14 The conductive ink 95 shown can be screen-printed onto the outer surface of the inner layer, first layer, or any other suitable layer in some container embodiments. In some container embodiments 40, the material of the conductive ink 95 can be positioned such that it is disposed on the outer surface of the conductive ink material 95. The woven fabric or another polymer film layer is in contact. In some cases, such multilayer configurations can be laminated together.
[0093] In some cases, the conductive intermediate layer 47 of the multilayer tissue container wall 44 can be made of a composite braid 234 of strands of different materials as discussed above. Such a composite braid 234 can, in some cases, be made of non-conductive polyester strands, polyethylene strands, and conductive metal strands including stainless steel strands, or any combination of metal strands and polymer strands. In such a composite braid embodiment 234, the ratio of non-conductive polymer strands 232 to conductive metal strands 230 can range from about 20% to about 80%, or from about 10% to about 90%, or from about 1% to about 99%. For some exemplary embodiments, the ratio of conductive metal strands 230 to non-conductive polymer strands 232 can be about 1% metal to about 99% polymer, about 10% metal to about 90% polymer, about 20% metal to about 80% polymer, about 30% metal to about 70% polymer, about 40% metal to about 60% polymer, about 50% metal to about 50% polymer, about 60% metal to about 40% polymer, about 70% metal to about 30% polymer, about 80% metal to about 20% polymer, about 90% metal to about 10% polymer, about 99% metal to about 1% polymer, or any other ratio between these ranges. For some composite braid embodiments 234, the ratio of the number of conductive strands to the number of non-conductive strands can be about 5% to about 20%, more specifically, about 8% to about 12%.
[0094] Compared to a mesh layer made entirely of metal strands 230, using synthetic polymer strands 232 instead of steel / metal strands 230 can improve the flexibility and potential cut resistance of the braided composite layer 234 without increasing weight. The conductive fibers 232 can also be woven into a largely non-conductive material to enhance the functionality of the contact detection system embodiment 70, including the automatic shut-off feature in the tissue containment and removal system embodiment 10 discussed herein.
[0095] Figure 14 A stretchable conductive ink 95 is depicted printed onto a portion of the tissue container 40. The conductive ink 95 can serve as a conductive element 46 of the tissue container 40 to detect contact with the bulk tissue reducer 30 and trigger a detection circuit 75. The conductive ink 95 can be printed at a location disposed between two layers 102, 198 of a non-conductive polymer material such as plastic, such that the conductive ink 95 is not exposed on the inner or outer surface of the tissue container 40.
[0096] For some embodiments, Figure 10The diagram illustrates how the intermediate layer 47 of the layered wall 44 of the tissue container 40 can be made of a composite braid 234. This composite braid 234 may include or otherwise be made of strands 230, 232, which include materials such as polyester, polyethylene, metal, stainless steel, or any combination of metal and plastic or polymer. For some composite braid embodiments 234, the ratio of polymer strands 232 to metal strands 230 in the composite braid 234 may range from about 20% to about 80% in some cases, or from about 10% to about 90% in others, or from about 1% to about 99% in still others.
[0097] Some tissue container embodiments 40 may include an internal volume 42, an opening 43, and a conductive layer 47, said conductive layer comprising a composite braid 234 having conductive strands 230 and non-conductive strands 232. For some of these tissue container embodiments 40, the non-conductive strands 232 may comprise a polymer, such as polyester, polyethylene, etc. Or nylon. For some of these tissue container embodiments 40, the conductive strands 230 may include metals such as stainless steel, nickel-titanium alloys, etc. In some cases, the conductive strands 230 and the non-conductive strands 232 may have an external lateral dimension of about 0.01 mm to about 0.5 mm. For tissue container embodiments 40 having a composite braid 234, various ratios of non-conductive strands 232 to conductive strands 230 can be used. For some embodiments, the ratio of non-conductive strands 232 to conductive strands 230 may be about 10% to about 90%, more specifically, about 20% to about 80%, and any other suitable ratio as discussed herein. (Refer to...) Figures 9 to 11 In some embodiments, the tissue container 40 may optionally further include a second non-conductive layer 102 disposed on the inner surface 196 of the conductive layer 47, a third non-conductive layer 198 disposed on the outer surface 200 of the conductive layer 47, or both of these additional layers.
[0098] Reference Figures 19 to 21 Some embodiments of a method for containing and isolating a tissue sample 15 within a patient's body 20 using a tissue container 40 with the configuration discussed above may include inserting the tissue container 40 into a body cavity 18 of the patient 20. The tissue container 40 includes an internal volume 42, an opening 43, and a conductive layer 47 comprising a composite braid 234 comprising conductive strands 230 and non-conductive strands 232. The tissue sample 15 may then be inserted through the opening 43 into the internal volume 42 of the tissue container 40, and the entire edge of the opening 43 may be withdrawn from within the body cavity 18 to a position outside the patient's body 20.
[0099] An embodiment of the contact detection system 70 of the tissue containment and removal system embodiment 10 can also be coupled to various instruments other than the bulk tissue reducer 30, which may contact or be adjacent to the conductive element 46 of the tissue container 40. Exemplary embodiments of such instruments may include a gripping hook 106, a non-invasive gripper 224, a camera 226, a Lahey gripping hook, a ring clamp, a speculum, a vaginal cannula, a needle, or any other object that may contact the conductive layer 47 of the tissue container 40. Any of these types of instruments can be configured such that if any of these types of instruments contacts or approaches the conductive element 46 of the conductive container layer 47, an alarm can be sent to the user and / or power to the motor 51 of the tissue cutter of the bulk tissue reducer can be terminated.
[0100] Refer again Figure 3 An optional conductive gripping hook conduit 236 is shown, which is used to electrically connect the gripping hook 106 to the contact detection system 70 and its detection circuit 75 in a manner similar to that of connecting the tissue cutting blade 36 of the bulk tissue reducer 30 to the contact detection system 70. Therefore, Figure 3 A contact detection system embodiment 70 is also shown, operatively coupled between a surgical instrument in the form of a gripping hook embodiment 106 and a conductive element 46 of a tissue container embodiment 40. This contact detection system embodiment 70 can thus detect when the gripping hook 106 or any other suitable connecting surgical instrument breaks through the non-conductive layer 102 and comes into contact with or is adjacent to the conductive element 46 of the tissue container 40. This configuration can be used to alert the user that the tissue container 40 has been damaged, compromised, or is about to come into contact with the gripping hook 106 or any other suitablely configured instrument available when positioned within the internal volume 42 of the tissue container 40 during a tissue removal procedure.
[0101] Some embodiments of this tissue containment and removal system 10 may include a tissue container 40 having a conductive layer 47, the tissue container including a conductive element 46, an internal volume 42, and an opening 43. The tissue containment and removal system 10 may also include a surgical instrument configured for use within the internal volume of the tissue container 40 and including a conductive portion 106', which, for the case of a stainless steel grip hook 106, constitutes the entire instrument 106. The system 10 may further include a contact detection system 70 having a detection circuit 75 operatively coupled to the conductive portion 106' and the conductive element 46 of the tissue container 40. The detection circuit 75 may be configured to generate a continuity signal 76 between the conductive portion 106' and the conductive element 46 and to measure an impedance value 77 between the conductive portion 106' and the conductive element 46. The contact detection system 70 may also include a controller 80 configured to actuate and issue a warning signal whenever the impedance 77 between the conductive portion and the conductive element is at or below a predetermined impedance threshold. In some such embodiments, the surgical instrument may include a gripping hook 106 having a body portion made of metal, the body portion including a conductive portion 106'.
[0102] Some embodiments of this tissue containment and removal system 10 may include an auditory signal transmitter 190. In such embodiments, a controller 80 may be configured to actuate an audible warning signal from the audible signal transmitter 190 whenever the impedance 77 between the conductive portion 106' and the conductive element 46 of the tissue container 40 is at or below a predetermined impedance threshold. Furthermore, some embodiments of this tissue containment and removal system 10 may include a visual signal transmitter 190. In such embodiments, a controller 80 may be configured to actuate a visual warning signal from the visual signal transmitter 190 whenever the impedance 77 between the conductive portion 106' and the conductive element 46 is at or below a predetermined impedance threshold.
[0103] In some cases, contact detection systems can have, for example... Figure 13 The instrument terminal 238 and container terminal 137 are shown. The instrument terminal is operatively connected to the controller 80 and the conductive portion 106' via a conductive grip hook conduit 236. The container terminal is operatively connected to the controller 80 and the conductive element 46 of the tissue container 40 via a conductive conduit 72. Furthermore, the conductive conduit 236 operatively connecting the instrument terminal 238 and the conductive portion 106' may include a snap-fit connector 240 configured to provide a releasable electrical connection, and the conductive conduit operatively connecting the container terminal 137 and the conductive element 46 of the tissue container 40 may include a snap-fit connector 104 configured to provide a releasable electrical connection.
[0104] The features, dimensions, and materials of the contact detection system 70 used in this type of tissue containment and removal system embodiment can be the same as those of the contact detection system 70 in the tissue containment and removal system embodiment 10 discussed above with respect to monitoring the contact of the conductive element 46 via the bulk tissue reducer 30, as... Figure 8 and 13 As shown. More specifically, controller 80 may have a console printed circuit board 82 and a motor driver 84 operatively coupled to motor 51. Controller 80 may further have a signal generator 120, a processor 86, and a memory 88 operatively coupled to processor 86. Contact detection system 70 may include a power supply 112 operatively coupled to controller 80.
[0105] Furthermore, for these same tissue containment and removal system embodiments 10 that monitor the impedance value 77 between the surgical instrument, including the gripping hook 106, and the conductive element 46, the tissue container 40 may include a second non-conductive layer 102 disposed on the inner surface 196 of the conductive layer 47, such as Figure 9 and 10 As shown. The tissue container 40 may also additionally include a third non-conductive layer 198 disposed on the outer surface 200 of the conductive layer 47. The conductive layer 47 disposed between the second layer 102 and the third layer 198 may include a composite braid 234 having non-conductive strands 232 interwoven with conductive strands 230, the conductive strands constituting conductive elements 46 for such container embodiment 40. For some embodiments, the conductive layer 47 disposed between the second layer 102 and the third layer 198 may also include a thin, flexible layer of non-conductive polymer material patterned with conductive ink 95, the conductive ink having a flexible configuration, being printable onto the outer surface of the thin, flexible layer and being used as conductive elements 46 for such tissue container embodiment 40, such as... Figure 14 As shown. Refer again. Figure 12 For some tissue container embodiments 40, the conductive layer 47 and its conductive elements 46 disposed between the second layer 102 and the third layer 198 may include a wire mesh 100, all strands of which include conductive metal strands 230. In some cases, the wire mesh 100 may include stainless steel or be made of stainless steel.
[0106] Reference Figures 16 to 18The tissue cutter embodiment 34, which can be used with system embodiment 10 for monitoring the impedance value 77 between a surgical instrument including a gripping hook 106 and a conductive element 46, includes an elongated tube 202 having an inner lumen 37 extending its length. In some embodiments, the tissue cutting blade 36 includes a sharp distal end of the elongated tube 202 of the tissue cutter 34 with a beveled configuration, although alternative configurations may be used. In the illustrated embodiment, the shape of the tissue cutting blade 36 is circular in its cross-sectional profile, and the entire tissue cutting blade 36 lies in a plane perpendicular to the longitudinal axis 204 of the elongated tube 202 of the tissue cutter 34. The elongated tube 202 of the tissue cutter 34 can be made of any suitable high-strength material, which may also optionally be conductive. In some cases, metals such as nickel-titanium alloys, stainless steel, etc., may be used. In the illustrated embodiment, the bulk tissue reducer 30 includes a housing 206 operatively coupled to the tissue cutter 34 and a sleeve 38 fixed to the housing 206. Cannula embodiment 38 may have an elongated hollow configuration and include an inner lumen 39 extending its length. As shown, cannula 38 is arranged on the elongated tube 202 of tissue cutter 34, with a tight fit between the outer surface 208 of the elongated tube 38 and the inner surface 210 of cannula 38.
[0107] Furthermore, as discussed above in detail with respect to the exemplary detection circuit embodiment 75 that can be used with system embodiment 10 for monitoring the impedance value 77 between a surgical instrument including a gripping hook 106 and a conductive element 46, the proximity value 108' (not shown) of the conductive portion 106' of the gripping hook 106 relative to the conductive element 46 of the tissue container 40 can be represented by various corresponding measurement parameters, such as impedance 77, a measurement current of the continuity signal 76, a Vout signal from the Vout terminal 110, etc. For some embodiments, an impedance threshold can be selected corresponding to the proximity value 108', which indicates a separation distance of up to about 1 mm between the conductive portion 106' and the conductive element 46. To provide a clinically safe continuity signal, in some cases, the detection circuit 75 can be configured to generate a continuity signal 76, including an alternating current with a frequency of about 10 kHz to about 30 kHz, more specifically about 20 kHz, a maximum current of up to about 10 mA, a square wave continuity signal, or any suitable combination of these parameters.
[0108] As briefly discussed above, in some cases it may be useful to keep the bulk tissue remover 30 aligned with the tissue sample 15 during the pulverization or reduction of the tissue sample 15 within the internal volume 42 of the tissue container 40. To maintain such alignment, even if the tissue container 40 is partially opaque and not completely transparent, such as... Figure 17 and 23The hole 37 of the tissue cutter 34 of the bulk tissue reducer 30, which is illuminated downwards by the light energy 250 emitted from the light energy source 252, can also be visualized through the wall 44 of the tissue container 40. In such embodiments, if the wall structure 44 of the tissue container 40 is at least semi-transparent, visualization of the light energy emitted from the gap between the distal end 33 of the tissue cutter 34 of the bulk tissue reducer 30 and the tissue sample 15 itself can serve as an indication of certain types of misalignment between the tissue cutter 34 and the tissue sample 15.
[0109] Figure 17 , 23 Figures 252 and 24 illustrate how a light source 252 or a camera 227, arranged near the edge of the bulk tissue reducer 30 itself, can be used to illuminate or observe the orifice 37 of the tissue cutter 34 of the bulk tissue reducer 30 downwards. In some cases, the connection between the light source 252 and the orifice 37 or the light guide 254 can be enhanced by a light cone 255, which is a conical structure arranged above the light source 252, such as... Figure 26 As shown and in Figure 27 The image is omitted for illustrative purposes. The light source 252 or camera 227 can be positioned to not interfere with the extraction of tissue sample 15 and the operation of the holding hook 106 for extracting tissue sample 15 through orifice 37 (e.g., Figure 22 (As shown). Figure 24 This illustrates how light energy 250, transmitted through the walls 44 of tissue container 40 and observed or monitored by a camera 226 disposed in the body cavity 18 of patient 20, can indicate whether a schematically reduced or pulverized tissue sample 15 is in firm and complete 360-degree contact with the tissue cutting blade 36 of bulk tissue reducer 30. In some embodiments, light energy 250 may include colored light energy, such as red light energy. Any leakage of this colored light energy 250 into the internal volume 42 of tissue container 40 can be detected by camera 226 through the walls 44 of tissue container 40 as an indication of insufficient tissue contact between the tissue cutting blade 36 of tissue cutter 34 and the tissue sample 15. Tissue container 40 may be designed such that light energy 250 is transmitted through container 40 and its wall structure 44, which may be translucent, transparent, or otherwise not entirely opaque. Light energy 250 may also include white light energy, or any other type of electromagnetic energy within or outside the visible light spectrum, such as infrared, near-infrared, ultraviolet, radio waves, microwaves, X-rays, etc.
[0110] like Figures 25 to 28 As shown, light energy 250 and its light energy source 252 can be incorporated into the housing 206 of the bulk tissue reducer 30 to aid in visualization of the tissue sample 15 through the aperture 37 of the tissue cutter 34 of the bulk tissue reducer 30. In some cases, light energy 250 can be directed down to the handpiece 35 and / or housing 206 of the bulk tissue reducer 30.
[0111] Refer again Figure 17 , 23 In embodiments 24 to 28, some embodiments of the tissue containment and removal system 10 may include a tissue container 40 having a translucent wall structure 44 and a bulk tissue reducer 30. The bulk tissue reducer embodiment 30 may include a tissue cutter 34 having a hollow structure with an inner lumen 37 extending its length and a tissue cutting blade 36 disposed at a distal end 33 of the tissue cutter 34. The bulk tissue reducer 30 may also include a light energy source 252 configured to emit light energy 250 through the inner lumen 37 and from the distal end 33 of the tissue cutter 34 in a distal direction. In some embodiments, the bulk tissue reducer 30 may further include a housing 206 fixed in a fixed relationship with an optional light guide 254. Typically, in such embodiments, the tissue cutter 34 is operatively coupled to the housing 206 to allow the tissue cutter 34 to revolve around its longitudinal axis 204 (see...). Figure 16 Rotation relative to the outer shell 206. In some cases, the translucent wall structure 44 of the tissue container 40 may include a thin layer 102 of polymeric material, including polyester, polyethylene, polyurethane, polypropylene, PET, PETG, aromatic polyamides and para-aromatic polyamides, and poly(p-phenylene terephthalamide). and aliphatic or semi-aromatic polyamides The wall 44 of the tissue container 40 used in this embodiment can also be made of any other suitable material or construction, including the conductive element embodiment 46 discussed herein.
[0112] For some such system embodiments 10, a light energy source 252, such as an LED light source 252, may be arranged near the proximal end of the inner lumen 37 of the tissue cutter 34 within the housing 206. In some cases, the bulk tissue reducer 30 may further include an optional light guide 254 operatively coupled to one or more light energy sources 252, such that at least some of the light energy 250 emitted from the light energy sources 252 is transmitted to and conducted by the light guide 254. The light guide 254 may be arranged within the inner lumen 37 of the tissue cutter 34 and configured to transmit the light energy 250 from the light energy sources 252 in a distal direction through the light guide 254 to emit it beyond the distal end 33 of the tissue cutter 34. For some embodiments, the light guide 254 may include an elongated hollow configuration having an inner lumen 256 extending its length. Optional embodiments of the light guide 254 may include a translucent polymer material configured to transmit light energy 250 from the proximal end 257 to the distal end 258 of the light guide 254. In some cases, the translucent polymer material of the light guide 254 may include polycarbonate. Furthermore, in some cases, the inner surface of the light guide 254 may be reflective to facilitate partial or total internal reflection of the light energy 250 propagating within the inner lumen of the light guide 254 in a distal direction. For such embodiments, the light guide 254 may be made of an opaque material, including metals such as stainless steel. As described above, the tissue cutter 34 is configured to rotate relative to the housing 206; however, the elongated hollow structure of the light guide 254 may be fixed to the housing 206 so that the tissue cutter 34 remains stationary relative to the housing 206 as it rotates about its longitudinal axis 204 during actuation.
[0113] As discussed above, in some cases, the light energy source 252 may include multiple light energy sources 252, which are arranged proximal to the inner lumen 37 of the tissue cutter 34 and operatively coupled to the light guide 254, such as... Figure 23 As shown. Some embodiments of the multiple light energy sources 252 may include light-emitting diodes (LEDs) capable of emitting light energy of any suitable wavelength. In some cases, the LED may be a red LED configured to emit red light. Typically, the light energy sources 252 will be configured to emit light energy 250, which is bright enough to be visible through the translucent wall structure 44 of the tissue container 40. Some bulk tissue reducer embodiments 30 may include 1, 2, 3, 4, 5 or more of these light energy sources 252.
[0114] Some embodiments of a method for receiving and removing a tissue sample 15 from a patient's body 20 may include inserting a tissue container 40 into a body cavity 18 of the patient 20, inserting the tissue sample 15 through an opening 43 into the internal volume 42 of the tissue container 40, and withdrawing the entire edge of the opening 43 of the tissue container 40 from within the body cavity 18 back to a position outside the patient's body 20, such as... Figures 19 to 21 As shown. This method may also include inserting the distal end 32 of the bulk tissue reducer 30 into the internal volume 42 of the tissue container 40 until the tissue cutting blade 36 of the tissue cutter 34 of the bulk tissue reducer 30 contacts the tissue sample 15. Then, light energy 250 can be emitted from the distal end 33 of the tissue cutter 34 in a generally distal direction toward the tissue sample 15 in contact with the tissue cutting blade 36. Although the light energy 250 emitted from the distal end 33 of the tissue cutter 34 is transmitted in a generally distal direction, the light energy 250 is emitted at various angles into the inner lumen 37 of the tissue cutter 34 and the wall structure of the hollow tubular light guide 254, and therefore, when the light energy 250 is emitted from the distal end 33 of the tissue cutter 34, it is emitted at various angles, forming a very wide emission solid angle. Leakage of the light energy 250 can then be observed between the distal end 33 of the tissue cutter, the distal end 32 of the bulk tissue reducer 30, and the tissue sample 15, as shown. Figure 24 As shown. The intensity and orientation of the light energy leakage 260 observed by the user through camera 226 or any other suitable instrument can be used to manipulate the alignment between the distal end 32 of bulk tissue reducer 30 and tissue sample 15 to minimize the amount of light energy leakage 260 between the distal end 32 of bulk tissue reducer 30 and tissue sample 15.
[0115] In some cases, the method may further include actuating the tissue cutter 34 of the bulk tissue reducer 30 and deactivating the tissue cutter 34 of the bulk tissue reducer 30 when light energy leakage 260 is observed between the distal end 32 of the bulk tissue reducer 30 and the tissue sample 15. In some cases, the method may further include actuating the tissue cutter 34 of the bulk tissue reducer 30 to contact the tissue sample 15 with the tissue cutting blade 36 of the tissue cutter 34, and reducing the tissue sample 15 with the actuated tissue cutter 36. In some cases, the method may further include securing the distal end 107 of the holding hook 106 to the tissue sample 15 and pulling the reduced portion of the tissue sample 15 through the inner lumen 37 of the tissue cutter 34 while reducing the tissue sample 15 with the actuated tissue cutter 34 until at least a portion of the tissue sample 15 is positioned outside the bulk tissue reducer 30 and the patient's body 20, such as... Figure 22 As shown.
[0116] As discussed above, in order to contain and isolate the tissue sample 15 before it is reduced in size or pulverized, in some cases it may be necessary to reliably and consistently deploy a suitable tissue container, embodiment 40, around the tissue sample 15, such as... Figures 19 to 21 As shown. This process can typically be performed within a confined space or cavity 18 within the patient's body 20. In some cases, this process can be facilitated by using a suitable container deployer assembly 270 or its container deployer 272. In some cases, such a container deployer assembly embodiment 270 can be configured to perform the deployment of the tissue container 40 while maintaining some control over the orientation of the tissue container 40 during deployment. Some embodiments of such a container deployer assembly 270 can be configured to operate in a manner similar to a rivet gun. This type of configuration can be actuated using a spring-loaded mechanism, compressed air, or other mechanical or electrical actuators to deploy the container from the sheath of the tissue container deployer assembly (not shown).
[0117] Reference Figures 30 to 31 In some cases, such a container deployer assembly 270 may include a sheath 274, which may have an elongated, hollow configuration made of a rigid polymer or other suitable material. The sheath 274 may be placed through the skin of the patient 20 to access the internal portion 18 of the patient's body 20. The sheath 274 may have dimensions corresponding to the size of the corresponding bulk tissue reducer 30, or dimensions corresponding to the length of a conventional laparoscopic cannula incision, such as a cannula incision length of about 5 mm, about 8 mm, about 10 mm, about 12 mm, or other suitable length. Furthermore, the container deployer assembly embodiment 270 can be used to place the sheath 274 through a natural body opening such as the rectum or vagina 24.
[0118] Figures 29 to 32 An embodiment 270 of a container deployer assembly for a tissue container 40 is shown, the tissue container being configurable for use with a number of different procedures. One possible use may include placing the tissue container 40 within the abdominal cavity 18 of a patient 20 to capture and isolate tissue samples 15, such as the uterus of the patient 20, to perform a hysterectomy. Figures 29 to 32 The illustrated container deployer assembly embodiment 270 can typically be configured to fit into the vaginal cavity 24 and protrude precisely before or after the vaginal stump after the uterus has been separated from the vagina 24 via a vaginoplasty. Such a container deployer assembly embodiment 270 may have features that facilitate control of the orientation of the tissue container 40 during deployment. Exemplary features that can be used to provide such control may include, for example... Figure 31The stabilizer ridge (rail) 276 shown, or other asymmetrical features, engage the tissue container 40 and ensure its placement on the abdominal floor, which may be useful for some tissue removal procedures. In some cases, the tissue container 40 can be deployed to a position between the uterus and the abdominal floor.
[0119] Figure 30 An embodiment 270 of a container deployer assembly is shown, which includes a push rod 278 that can be used to push a tissue container 40 out of the inner lumen 280 of a sheath 274 to assist in deploying the tissue container 40 into the abdomen or other body cavity 18 of a patient 20. (See reference...) Figure 30 The tether 282 is shown extending from the tissue container 40 to a position disposed outside the sheath 274. The tether 282 can also be disposed inside the sheath 274, such as... Figure 30 As shown. The push rod 278 may also include an elongated slot or groove 284 extending longitudinally along its outer surface for assembling the tether 282 between the push rod 278 and the sheath 274 in a tight fit between the inner surface 286 of the sleeve 274 and the outer surface 288 of the push rod 278. In some embodiments, the tether 282 may also include a conductive conduit and serve as a container conduit 72 electrically connected to the conductive element 46 of the container 40. Thus, in some cases, the tether 282 may include a snap-fit connector 104, which may be configured to be releasably and operably coupled to the container terminal 137 of the detection circuit 75.
[0120] Some embodiments of the container deployer assembly 270 include a container deployer 272 and a tissue container 40 disposed therein and prepared for deployment. Embodiments of the container deployer 272 may include a sheath 274 and a pusher 278 configured to slide axially within an inner lumen 280 of the sheath 274 to deploy the tissue container 40. Some sheath embodiments 274 may be shaped to include a rounded, non-traumatic distal end 290, allowing them to be easily introduced into the vagina, rectum, port, or other natural orifice 24 or surgically created orifice without trauma to surrounding tissue. Such embodiments of the container deployer assembly 270 may have a variety of uses, including placing the tissue container 40 into an abdominal cavity 18 to capture the uterus for hysterectomy when removal of the uterus is required. Container deployer assembly embodiment 270 in... Figure 33 The procedure is shown as an insertion into the vagina 24 of the patient 20, as indicated by arrow 292, to accommodate and remove the patient's uterus 15 for hysterectomy. Figure 33 The illustration shows the sheath 274 of the container unfolder assembly 270 and the tissue container 40 being introduced into the vagina 24, wherein the tissue container 40 has been preloaded into the sheath embodiment 274. In some cases, during such procedures, the uterus 15 may be separated from the vagina by a vaginoplasty, and the sheath 274 may be inserted before or after the vaginal stump, as shown.
[0121] Once the sheath 274 and the tissue container disposed therein are optimally positioned within the vagina 24, the push rod 278 can be pushed distally relative to the sheath 274. This can be used to effectively unfold the tissue container 40 from the distal end 290 of the sheath 274 and into the cavity 18 within the patient's abdomen or pelvis, as... Figure 34 As shown. Figure 33 A tether 282 is shown extending from the tissue container 40 to the outside of the sheath 274. Some portions of the tether 282 may also be arranged inside the sheath 274, such as... Figure 30 As shown, the push rod 278 may have a notch or groove 284 to accommodate the tether 282 below the nominal outer surface 288 of the push rod 282, provided that the sheath 274 and the push rod 278 are in close fit.
[0122] Some sheath embodiments 274 may include Figure 31 The features shown ensure that the orientation of the tissue container 40, such as circumferential orientation, can be controlled during the deployment of the tissue container 40. Such features may include stabilizing ridges 276 extending inwardly from the inner surface 286 of the inner lumen 280 of the sheath 274 or other symmetrical or asymmetrical features, such as... Figure 31 As shown. This feature 276 can be used to ensure that the tissue container 40 is positioned under the abdomen when unfolded through the vagina 24 to accommodate and remove the tissue sample 15. In some cases, the tissue container 40 can be unfolded between the uterus and the abdomen. Some sheath embodiments 274 may also have an orientation indicator 292, such as circumferential orientation, as shown. Figure 29 , 30 As shown in Figure 32, this allows the user to know the orientation of the opening 43 of the tissue container 40 once the tissue container 40 of such an embodiment is positioned in the desired location within the patient's body 20 and is ready to be deployed. For example, in some embodiments, if the orientation indicator 292 points towards the operating room ceiling during insertion and subsequent deployment, then once deployed, the opening 43 of the tissue container 40 will also point in that direction, as shown in Figure 32. Figure 34 As shown.
[0123] In some embodiments, the tissue container 40 can be partially deployed outside the sheath 274, such that the opening 294 at the distal end 290 of the sheath 274 can be configured to spring open, similar to a hoop, but a portion of the hoop remains within the sheath 274. In such embodiments, full deployment can be prevented by maintaining a small tension on the tether 282. In some cases, the edge 41 of the container 40 can be connected to a rigid member (not shown) for controlling the hoop or opening 43 of the edge 41. The rigid member can be a rigid bar in both handheld and robot-controlled embodiments. A rigid member that guides or is part of the tissue container 40 can also be configured as part of the container deployer 272. In practice, an operator of an embodiment of the container deployer 272 can have the tissue container 40 open on a rigid control bar, and the operator can work in a team with a laparoscopic surgeon to achieve the containment of the target tissue sample 15 within the internal volume 42 of the tissue container 40.
[0124] Some embodiments of the tissue container deployer assembly 270 may include a tissue container deployer 272 having a sheath 274 having an inner lumen 280 and a circular distal end 290 including a longitudinal slit 296, the longitudinal slits converging to form a flap 298 in the distal end 290 of the sheath 274, the flap being configured to open upon application of distal axial pressure from within the inner lumen 280. The tissue container deployer 272 may also include a push rod 278 having an elongated configuration, the outer surface 288 of which is sized to fit within and axially translate within the inner lumen 280 of the sheath 274, and its axial length being equal to or greater than the axial length of the inner lumen 280 of the sheath 274. Tissue container embodiment 40 is arranged in a contracted state within the inner lumen 280 of the sheath 274. Tissue container 40 includes a wall 44 with a thin, flexible configuration, an internal volume 42, and an opening 43 communicating with the internal volume 42.
[0125] In some embodiments, the sheath 274 may further include a plurality of stabilizer ridges 276, each stabilizer ridge being fixed to the inner lumen 280 and extending radially inward from the inner surface 286 of the inner lumen 280, and each stabilizer ridge having an elongated configuration with its longitudinal axis substantially parallel to the longitudinal axis 300 of the sheath 274 and the push rod 278. In some embodiments, the opening 43 of the tissue container 40 includes an edge 41 disposed around the opening 43, said edge engaging the tissue stabilizer ridges 276 of the sheath 274 to prevent the tissue container 40 from rotating within the inner lumen 280 of the sheath 274 and to position the tissue container 40 with the opening 43 facing a fixed and known circumferential orientation. In some embodiments, the edge 41 of the tissue container 40 may have a resilient configuration that opens in an unrestrained state.
[0126] In some embodiments, a plurality of stabilizer ridges 276 may be uniformly spaced circumferentially around the inner cavity 280, and the plurality of stabilizer ridges 276 may include two, three, four or more stabilizer ridges 276. In some cases, the longitudinal length of the stabilizer ridge 276 may be at least twice the lateral external dimension of the sheath 274, and may extend radially inward from the inner surface 286 of the inner cavity 280 by about 0.05 inches to about 0.4 inches.
[0127] Some sheath embodiments 274 may be made of polymeric materials, including ABS plastic, polycarbonate, PEEK, or PVC. Some sheath embodiments 274 may have an axial length of about 15 cm to about 35 cm, a lateral dimension of about 0.4 inches to about 1.5 inches, and a wall thickness of about 0.02 inches to about 0.1 inches. In some cases, such sheath embodiments 274 may further include an orientation indicator 292, which in some cases can be used to indicate to a user of the container unfolder assembly 270 the circumferential orientation of the opening 43 of the tissue container 40. Some sheath embodiments 274 may further include a flange 302 disposed on its proximal end, wherein the orientation indicator 292 includes an arrow-shaped body fixed to the flange 302, the arrow 304 pointing in the same direction as the opening 43 of the tissue container 40 facing when disposed within the sheath 274.
[0128] Some embodiments 270 may include a tether 282 having a thin, flexible configuration and secured to the distal end 306 of the edge 41 arranged around the opening 43 of the tissue container 40 (e.g., Figure 35 (as shown), and the proximal end 308 of the inner lumen 280 extending from the sheath 274 before unfolding. Figure 35 A tissue container 40 is shown fully ejected from the distal port 294 of the sheath 274 and positioned within a body cavity 18, with a tether 282 extending from the cavity 18 to a location outside the patient's body 20. In some embodiments, the push rod 278 may include a longitudinal groove 284 arranged along its outer surface 288, with the tether 282 disposed within the longitudinal groove between the outer surface of the longitudinal groove 284 and the inner surface 286 of the sheath 274.
[0129] Some method embodiments of deploying the tissue container 40 may include inserting the distal end 290 of the sheath 274 of the tissue container deployer assembly 270 through the body opening 24 into a desired location within the lumen 18 of the patient 20, such as... Figure 33 As shown. The push rod 278 of the tissue container deployer assembly 270 is axially advanced distally relative to the sheath 274, while simultaneously advancing the tissue container 40, which is arranged in a retracted state within the inner lumen 280 of the sheath 274, as shown. Figure 34As shown. The tissue container 40 is advanced axially such that the distal end of the push rod 278 abuts the proximal end of the tissue container 40. As the push rod 278 and the tissue container 40 are advanced axially, the method further includes opening a flexible flap 298 formed by a longitudinal slit 296 on the distal end 290 of the sheath 274 together with the distal end 310 of the tissue container 40 in the contracted state to form a distal port or opening 294 on the sheath 274 for ejecting the tissue container 40 distal to the inner lumen 280 of the sheath 274. The method further includes continuing to advance the tissue container 40 axially with the push rod 278 until the tissue container 40 is completely ejected from the distal port 294 of the sheath 274 and enters the inner lumen 18 of the patient 20, as shown. Figure 35 As shown.
[0130] As discussed above, the sheath 274 may include a plurality of stabilizer ridges 276, and some method embodiments include stabilizing the circumferential orientation of the tissue container 40 with the stabilizer ridges 276 during axial advancement of the tissue container 40 with the push rod 276. In some cases, the method may also include retracting the edge 41 of the tissue container 40 proximally from the inner lumen 18 of the patient 20, beyond the body opening 24, to a position outside the patient's body 20, such as... Figure 21 As shown. In some embodiments, the method may further include using a tether 282 to retract the edge 41 of the tissue container 40 from inside the body cavity 18 of the patient 20 proximally back to a position outside the patient's body 20.
[0131] The features described herein with respect to different methods of use or different characteristics, instruments, parts, or their order of use may be used interchangeably between various methods without departing from the spirit of the methods and apparatus disclosed herein. The presence or absence of a particular step or component should not be construed as limiting the methods described herein.
[0132] In the above detailed description, the same reference numerals used may refer to the same elements that may have the same or similar dimensions, materials, and configurations. Although specific forms of embodiments have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the embodiments discussed. Therefore, the present invention is not intended to be limited to the foregoing detailed description.
[0133] The entire contents of each patent, patent application, publication, and document cited herein are incorporated herein by reference. Reference to the foregoing patents, patent applications, publications, and documents does not constitute an admission that any of the foregoing content is applicable prior art, nor does it constitute any admission of the content or dates of such documents.
[0134] The entire contents of each patent, patent application, publication, and document cited herein are incorporated herein by reference. Reference to the foregoing patents, patent applications, publications, and documents does not constitute an admission that any of the foregoing content is applicable prior art, nor does it constitute any admission of the content or dates of such documents.
[0135] Modifications may be made to the foregoing embodiments without departing from the basic aspects of the present technology. Although the present technology has been described in considerable detail with reference to one or more specific embodiments, changes may be made to the embodiments specifically disclosed herein, but such modifications and improvements are within the scope and spirit of the present technology. The technology exemplarily described herein may be practiced without any elements not specifically disclosed herein. Thus, for example, in each instance herein, any one of the terms “comprising,” “substantially consisting of,” and “consisting of” may be replaced by any of the other two terms. The terms and expressions used are used as descriptive terms rather than restrictive ones, and the use of such terms and expressions does not exclude any equivalents of the features shown and described or portions thereof, and various modifications may be made within the scope of the claimed technology. The term “a” or “an” may refer to one or more elements it modifies unless the context clearly describes one or more elements. Although the present technology has been specifically disclosed by way of representative embodiments and optional features, modifications and variations may be made to the concepts disclosed herein, and such modifications and variations may be considered within the scope of the present technology.
[0136] Some embodiments of this technology are set forth in the appended claims.
Claims
1. A tissue containment and removal system comprising: An organization container comprising a conductive layer containing conductive elements, internal volume, and openings; A bulk tissue reducer, comprising a tissue cutter having a tissue cutting blade configured to be conductive; A motor operatively coupled to the tissue cutting blade of the bulk tissue reducer; as well as Contact detection system, comprising: A detection circuit, operably coupled to the tissue cutting blade and the conductive element, and configured to generate a continuous signal between the tissue cutting blade and the conductive element and to measure the impedance value between the tissue cutting blade and the conductive element, and A controller, operably coupled to the motor, is configured to stop actuation of the motor and the tissue cutting blade whenever the impedance between the tissue cutting blade and the conductive element is at or below a predetermined impedance threshold. The detection circuit includes an operational amplifier configured as a low-pass filter, and the low-pass filter is an inverting active low-pass filter; or The detection circuit includes resistors and capacitors configured to form a low-pass filter.
2. The tissue containment and removal system of claim 1, wherein the controller is configured to actuate a warning signal whenever the impedance between the tissue cutting blade and the conductive element is at or below the predetermined impedance threshold.
3. The tissue containment and removal system of claim 2, comprising an auditory signal transmitter, wherein the controller is configured to actuate an auditory warning signal from the auditory signal transmitter whenever the impedance between the tissue cutting blade and the conductive element is at or below the predetermined impedance threshold.
4. The tissue containment and removal system of claim 2, comprising a visual signal transmitter, wherein the controller is configured to actuate a visual warning signal from the visual signal transmitter whenever the impedance between the tissue cutting blade and the conductive element is at or below the predetermined impedance threshold.
5. The tissue containment and removal system of claim 1, wherein the contact detection system comprises a blade terminal operably coupled to the controller and the tissue cutting blade via a conductive conduit, and a container terminal operably coupled to the controller and the tissue container via a conductive conduit.
6. The tissue containment and removal system of claim 5, wherein the conductive conduit operatively connecting the blade terminal and the tissue cutting blade includes a snap-fit connector configured to provide a releasable electrical connection.
7. The tissue containment and removal system of claim 5, wherein the conductive conduit operatively connecting the container terminal and the conductive element of the tissue container includes a snap-fit connector configured to provide a releasable electrical connection.
8. The tissue containment and removal system of claim 1, wherein the controller comprises a console printed circuit board and a motor driver operatively coupled to the motor.
9. The tissue containment and removal system of claim 8, wherein the controller comprises a signal generator, a processor, and a memory operatively coupled to the processor.
10. The tissue containment and removal system of claim 1, wherein the contact detection system includes a power supply operatively coupled to the controller.
11. The tissue containment and removal system of claim 1, wherein the tissue container comprises a second non-conductive layer disposed on the inner surface of the conductive layer.
12. The tissue containment and removal system of claim 11, wherein the tissue container comprises a third non-conductive layer disposed on the outer surface of the conductive layer.
13. The tissue containment and removal system of claim 1, wherein the conductive layer comprises a composite braid comprising non-conductive strands interwoven with conductive strands constituting the conductive element.
14. The tissue containment and removal system of claim 1, wherein the conductive layer comprises a thin, flexible layer of non-conductive polymer material and a conductive ink pattern printed on its outer surface.
15. The tissue containment and removal system of claim 1, wherein the conductive layer and its conductive elements comprise a metal mesh.
16. The tissue containment and removal system of claim 15, wherein the wire mesh comprises stainless steel.
17. The tissue containment and removal system of claim 1, wherein the tissue cutter comprises an elongated tube having an inner lumen extending therefrom, and the tissue cutting blade comprises a sharp distal end of the elongated tube.
18. The tissue containment and removal system of claim 17, wherein the sharp distal end of the tissue cutting blade is located in a plane perpendicular to the longitudinal axis of the elongated tube.
19. The tissue containment and removal system of claim 1, wherein the impedance threshold corresponds to a proximity value, the proximity value indicating a spacing distance of up to 1 mm between the tissue cutting blade and the conductive element.
20. The tissue containment and removal system of claim 1, wherein the detection circuit is configured to generate a continuous signal comprising alternating current at a frequency of 10 kHz to 30 kHz.
21. The tissue containment and removal system of claim 20, wherein the detection circuit is configured to generate a continuous signal having a maximum current of up to 10 mA.
22. The tissue containment and removal system of claim 20, wherein the detection circuit is configured to generate a square wave continuity signal.
23. The tissue containment and removal system of claim 1, wherein the bulk tissue reducer includes a housing operatively coupled to the tissue cutter.
24. The tissue containment and removal system of claim 23, comprising a sleeve fixed to the housing, the sleeve comprising an elongated hollow configuration and including an inner lumen extending its length and disposed on the tissue cutter.
25. A tissue containment and removal system comprising: An organization container comprising a conductive layer containing conductive elements, internal volume, and openings; A surgical instrument configured for use within the internal volume of the tissue container and including conductive portions; as well as Contact detection system, comprising: A detection circuit, operably coupled to the conductive portion and the conductive element, and configured to generate a continuous signal between the conductive portion and the conductive element and to measure the impedance value between the conductive portion and the conductive element, and A controller is configured to actuate a warning signal whenever the impedance between the conductive portion and the conductive element is at or below a predetermined impedance threshold. The detection circuit includes an operational amplifier configured as a low-pass filter, and the low-pass filter is an inverting active low-pass filter; or The detection circuit includes resistors and capacitors configured to form a low-pass filter.
26. The tissue containment and removal system of claim 25, wherein the surgical instrument comprises a holding hook.
27. The tissue containment and removal system of claim 26, wherein the holding hook comprises a body portion made of metal, the body portion comprising the conductive portion.
28. The tissue containment and removal system of claim 25, comprising an auditory signal transmitter, wherein the controller is configured to actuate an auditory warning signal from the auditory signal transmitter whenever the impedance between the conductive portion and the conductive element is at or below the predetermined impedance threshold.
29. The tissue containment and removal system of claim 25, comprising a visual signal transmitter, wherein the controller is configured to actuate a visual warning signal from the visual signal transmitter whenever the impedance between the conductive portion and the conductive element is at or below the predetermined impedance threshold.
30. The tissue containment and removal system of claim 25, wherein the contact detection system comprises an instrument terminal operably connected to the controller and the conductive portion via a conductive conduit, and a container terminal operably connected to a conductive element of the controller and the tissue container via a conductive conduit.
31. The tissue containment and removal system of claim 30, wherein the conductive conduit operatively connecting the instrument terminal and the conductive portion comprises a snap-fit connector configured to provide a releasable electrical connection.
32. The tissue containment and removal system of claim 30, wherein the conductive conduit operatively connecting the container terminal and the conductive element of the tissue container includes a snap-fit connector configured to provide a releasable electrical connection.
33. The tissue containment and removal system of claim 25, wherein the controller comprises a console printed circuit board and a warning signal driver operatively coupled to a warning signal transmitter.
34. The tissue containment and removal system of claim 33, wherein the controller comprises a signal generator, a processor, and a memory operatively coupled to the processor.
35. The tissue containment and removal system of claim 25, wherein the contact detection system includes a power supply operatively coupled to the controller.
36. The tissue containment and removal system of claim 25, wherein the tissue container comprises a second non-conductive layer disposed on the inner surface of the conductive layer.
37. The tissue containment and removal system of claim 36, wherein the tissue container comprises a third non-conductive layer disposed on the outer surface of the conductive layer.
38. The tissue containment and removal system of claim 25, wherein the conductive layer comprises a composite braid comprising non-conductive strands interwoven with conductive strands constituting the conductive element.
39. The tissue containment and removal system of claim 25, wherein the conductive layer comprises a thin, flexible layer of non-conductive polymer material and a conductive ink pattern printed on its outer surface.
40. The tissue containment and removal system of claim 25, wherein the conductive layer and its conductive elements comprise a metal mesh.
41. The tissue containment and removal system of claim 40, wherein the wire mesh comprises stainless steel.
42. The tissue containment and removal system of claim 25, wherein the impedance threshold corresponds to a proximity value, the proximity value indicating a spacing distance of up to 1 mm between the conductive portion and the conductive element.
43. The tissue containment and removal system of claim 25, wherein the detection circuit is configured to generate a continuous signal comprising alternating current at a frequency of 10 kHz to 30 kHz.
44. The tissue containment and removal system of claim 43, wherein the detection circuit is configured to generate a continuous signal having a maximum current of up to 10 mA.
45. The tissue containment and removal system of claim 43, wherein the detection circuit is configured to generate a square wave continuity signal.
Citation Information
Patent Citations
Systems and methods for tissue capture and removal
US10695091B2
Systems and methods for tissue capture and removal
US20200253639A1
Systems and methods for tissue capture and removal
WO2019083896A1