Systems and methods for endoscopic tissue grasping

Abstract

The system can include an elongated flexible instrument, a tissue grasper including a helical needle extending from a distal end of the elongated flexible instrument, and a gripping drive system coupled to the tissue grasper to drive movement of the tissue grasper. The system can further include a sensor system coupled to the tissue grasper and a control system configured to receive sensor information from the sensor system and to control the gripping drive system in response to the received sensor information.

Description

[Technical Field]

[0001] Cross-reference application This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 398,454, entitled "Systems and Methods for Endoscopic Tissue Grasping," filed August 16, 2022, the contents of which are incorporated herein by reference in their entirety.

[0002] FIELD OF THE INVENTION Examples described herein relate to systems and methods for endoscopic tissue grasping. More particularly, examples may relate to grasping and sensing tissue during an endoscopic suturing procedure. [Background technology]

[0003] Minimally invasive medical techniques generally may be intended to reduce the amount of tissue damaged during a medical procedure, thereby reducing patient recovery time, discomfort, and adverse side effects. Such minimally invasive techniques may be performed through natural orifices or one or more surgical incisions in the patient's anatomy. Through these natural orifices or incisions, surgeons can insert minimally invasive medical instruments, such as therapeutic, diagnostic, imaging, and surgical instruments. Some minimally invasive medical instruments can be used to perform endoscopic suturing. There is a need for systems and methods for providing effective suture capture and retention. Summary of the Invention

[0004] The following presents a simplified summary of various examples described herein and is not intended to identify key or critical elements or to delineate scope of the claims.

[0005] In some examples, the system can include an elongated flexible instrument, a tissue grasper including a helical needle extending from a distal end of the elongated flexible instrument, and a gripping drive system coupled to the tissue grasper to drive movement of the tissue grasper. The system can further include a sensor system coupled to the tissue grasper and a control system configured to receive sensor information from the sensor system and to control the gripping drive system in response to the received sensor information.

[0006] In some examples, a method of operating a medical system can include inserting an elongated flexible instrument into a lumen passageway and extending a tissue grasping device including a helical needle from the elongated flexible instrument into the tissue, the method can further include receiving sensor information from a sensor system regarding penetration of the tissue grasping device into the tissue, and controlling a drive system coupled to the tissue grasping device based on the received sensor information.

[0007] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope thereof. In that regard, further aspects, features, and advantages of the present disclosure will become apparent to those skilled in the art from the following detailed description. [Brief explanation of the drawings]

[0008] [Figure 1] 1 is a simplified diagram of a patient's anatomy, according to some examples. [Figure 2] 1A-1C illustrate a distal portion of an endoscopic instrument system, according to some examples. [Figure 3] 1A-1C illustrate a distal portion of an endoscopic instrument system, according to some examples. [Figure 4A] 1A-1D illustrate configurations of tissue grasping devices, according to some examples. [Figure 4B] 1A-1D illustrate configurations of tissue grasping devices, according to some examples. [Figure 4C]1A-1D illustrate configurations of tissue grasping devices, according to some examples. [Figure 4D] 1A-1D illustrate configurations of tissue grasping devices, according to some examples. [Figure 4E] 1A-1D illustrate configurations of tissue grasping devices, according to some examples. [Figure 4F] 1A-1D illustrate configurations of tissue grasping devices, according to some examples. [Figure 5A] 1A-1C illustrate tissue grasping devices including pressure sensors, according to some examples. [Figure 5B] 1A-1C illustrate tissue grasping devices including pressure sensors, according to some examples. [Figure 6A] 1A-1C illustrate tissue grasping devices including optical sensors, according to some examples. [Figure 6B] 1A-1C illustrate tissue grasping devices including optical sensors, according to some examples. [Figure 7A] 1 is a cross-sectional view of a tissue grasping device including an electrical sensor, according to some examples. [Figure 7B] FIG. 10 is a side view of a tissue grasping device including an electrical sensor, according to some examples. [Figure 7C] FIG. 7C is a hierarchical diagram of the electrical sensor of FIG. 7B. [Figure 8A] 1A-1C illustrate tissue grasping devices including fiber optic sensors, according to some examples. [Figure 8B] 1A-1C illustrate tissue grasping devices including fiber optic sensors, according to some examples. [Figure 8C] 1A-1C illustrate tissue grasping devices including fiber optic sensors, according to some examples. [Figure 9] 1 is a flowchart illustrating a method of operating a medical system, according to some examples. [Figure 10A] 1A-1C illustrate tissue with the tissue grasping device at different stages of insertion. [Figure 10B] 1A-1C illustrate tissue with the tissue grasping device at different stages of insertion. [Figure 10C] 1A-1C illustrate tissue with the tissue grasping device at different stages of insertion. [Figure 11]1 is a robotic-assisted medical system according to some examples. DETAILED DESCRIPTION OF THE INVENTION

[0009] Examples of the present disclosure and its advantages are best understood by referring to the following detailed description. It should be noted that like reference numerals are used to identify like elements shown in one or more of the figures. The elements shown in these figures are intended to illustrate examples of the present disclosure and are not intended to limit the disclosure.

[0010] The techniques described herein provide techniques and treatment systems for endoscopic tissue grasping and sensing. While the examples described herein refer to techniques for suturing gastric tissue or endoscopic sleeve gastroplasty (ESG), it is understood that the techniques described may be used to perform procedures within an artificially created lumen or any intraluminal passageway or cavity, such as a patient's trachea, colon, intestines, stomach, liver, kidneys and calyces, brain, heart, circulatory system including vasculature, and / or fistula.

[0011] FIG. 1 shows an endoscopic instrument system 100 extending into an anatomical passageway 102 of an anatomical structure 104. In some examples, the anatomical structure 104 may be a stomach. The anatomical structure 104 is referenced to an anatomical frame of reference (X A , Y A , Z A A distal portion 106 of the endoscopic instrument system 100 can be advanced into an anatomical opening (e.g., a patient's mouth) and passed through the anatomical passageway 102 to perform a medical procedure, such as an endoscopic sleeve gastroplasty, at or near a target tissue located in a region 108 of the anatomical structure 104.

[0012] FIG. 2 illustrates the distal portion 106 of the endoscopic instrument system 100. The endoscopic instrument system 100 can include an elongated flexible instrument 200. The elongated flexible instrument 200 can serve as a platform for introducing working components into the anatomical structure accessed by the endoscopic instrument system 100. In some examples, the working components include an instrument system 202 and / or a tissue grasping device 206. A working channel 204 extends through the elongated flexible instrument 200, providing passage for a removable instrument system and allowing instruments to be exchanged during a procedure. The working channel can also or alternatively allow the passage of fluids or provide access between the proximal and distal portions of the elongated flexible instrument. In some examples, the working channel 204 extends entirely through the elongated flexible instrument 200 and defines an opening at the distal portion 216. In other examples, the working channel 204 can define an opening in a sidewall of the elongated flexible instrument 200.

[0013] The instrument system 202 may be coupled to or delivered through the distal portion 216 of the elongated flexible instrument 200. As shown in the example of Figure 2, the instrument system 202 may extend distally beyond the distal portion 216 of the elongated flexible instrument 200. The instrument system 202 may include, for example, one or more of a suturing system, a biopsy system, a therapy system, or an ablation system.

[0014] The tissue grasper 206 may be distally extendable from the distal portion 216 of the elongated flexible instrument 200. In some examples, the tissue grasper 206 is a helical needle grasper that is rotationally driven by the tissue grasper drive system 212 to advance into tissue (e.g., a corkscrew-type advancement into tissue). The tissue grasper 206 can grasp tissue while the instrument system 202 performs a procedure such as suturing, biopsy, treatment, or cauterization. In some examples, the instrument system 202 is a suturing instrument system, and the tissue grasper 206 is a helical needle grasper that can be rotationally driven by the tissue grasper drive system 212 to advance into tissue to hold the tissue during suturing. In other examples, if the instrument system 202 includes a biopsy system, the grasper 206 may be used to grasp tissue during a biopsy. In examples where instrument system 202 includes a treatment system, grasper 206 may be used to grasp tissue while visualizing and / or treating the grasped tissue. In examples where instrument system 202 includes an ablation system, grasper 206 may be used to grasp tissue during ablation.

[0015] In some examples, the elongated flexible instrument 200 may include multiple instrument systems, working channels, and / or tissue grasping devices. For example, the elongated flexible instrument 200 may include multiple instrument systems 202, including an imaging system, an illumination system, an irrigation system, and / or an instrument sensor system. The multiple instrument systems may be removably (e.g., slidably) inserted into the elongated flexible instrument through one or more working channels. In some examples, the multiple instrument systems may extend through dedicated instrument channels within the elongated flexible instrument. In some examples, the instrument systems or portions of the instrument systems may be fixed to the elongated flexible instrument.

[0016] Endoscopic instrument system 100 may further include a control system 208 in communication with sensor system 210, tissue grasping drive system 212, and / or instrument drive system 214. Sensor system 210 and tissue grasping drive system 212 may be coupled to tissue grasping device 206. Instrument drive system 214 is coupled to elongated flexible instrument 200 and may drive the axial movement (e.g., advancement, retraction), bending, and / or rolling movement of the elongated flexible instrument. Control system 208 may be a closed-loop control system in electrical communication with sensor system 210, tissue grasping drive system 212, and / or instrument drive system 214. Control system 208 may control the advancement, retraction, steering, and / or rotational movement of endoscopic instrument system 100. In some examples, control system 208 may control elongated flexible instrument 200 and / or instrument system 202 via instrument drive system 214, which may include motors, control cables, sensors, actuators, and / or other mechanical or electrical systems that drive movement in response to control signals from control system 208. Additionally, control system 208 may control the advancement, retraction, rotation, or other movement of tissue graspers 206. In some examples, control system 208 may control tissue graspers 206 via tissue grasper drive system 212, which may include motors, control cables, sensors, actuators, and / or other mechanical or electrical systems that drive movement of tissue graspers 206 in response to control signals from control system 208.

[0017] FIG. 3 shows a distal portion 241 of an endoscopic instrument system 240 that can be used for suturing. Endoscopic instrument system 240 is an example of endoscopic instrument system 100 and can be substantially similar to system 100, with differences described below. In this example, endoscopic instrument system 240 includes an elongated, flexible instrument 250, which includes a working channel 254 extending therethrough. An imaging system 255 and an illumination system 257 may also extend within elongated, flexible instrument 250. Endoscopic instrument system 240 may also include a suturing system housing 258 coupled to the distal portion of elongated, flexible instrument 250. Suturing system housing 258 carries a helical needle grasping device 256 (e.g., grasping device 206) and an instrument system 252 (e.g., instrument system 202) that includes a needle 253. Suturing system housing 258 may also include a capture port 260 through which needle 253 can extend to secure a suture. The endoscopic instrument system 240 may include a control system 208, a sensor system 210, a gripper drive system 212, and an instrument drive system 214, as previously described.

[0018] In some examples, the endoscopic instrument system 240 may be used to perform an endoscopic sleeve gastroplasty (ESG) procedure. ESG is a weight loss / diabetes treatment procedure that uses an endoscopic suturing device to restrict / reduce the size of the stomach. The endoscopic instrument 240 can be inserted into the mouth and navigated to the inside of the stomach. The stomach wall folds inward, effectively reducing the size of the stomach. Reducing the size of the stomach reduces the number of calories that can be absorbed into the body and the amount of food ingested. ESG is a non-surgical procedure that reduces the stomach by folding the stomach without removing any part of it. ESG also uses natural body orifices to access the anatomy without external incisions.

[0019] In the ESG procedure, stomach tissue can be grasped from the inside of the stomach and pulled back to form a tissue fold. The tissue grasping device 256 can pull and retract the stomach wall. Once the tissue grasping device has sufficiently grasped the stomach wall and pulled / folded the stomach tissue, another needle can be used to penetrate and suture the folded tissue. One of the challenges of the ESG procedure is how to grasp the stomach wall from the inside with enough tissue hooking or biting to create a tissue fold. The inside of the stomach can be slippery with a mucosal layer that can be difficult to maintain a grip on, and the stomach wall can also contain tough tissue that resists forming a fold. When using a tissue grasping device to form a fold, the desired depth or range of depth of penetration of the stomach wall by the tissue grasping device can help form a sufficient tissue fold. The stomach wall has at least four layers: the mucosal layer (innermost), the submucosa, the muscularis, and the serosa (outermost). In some cases, penetration of the serosa may result in a full-thickness bite through the entire stomach wall. In other cases, penetration may only extend to one of the inner layers, such as through the muscularis layer without penetrating the serosa, so as not to penetrate tissue / organs outside the stomach wall. If the tissue grasping device penetrates or bites too shallowly, it may be difficult to properly fold the tissue. If the penetration or bite is too deep, there may be a risk of puncturing organs outside the stomach.

[0020] The sensing system 210 and control system 208 enable the tissue grasping device 256 to firmly grasp the stomach wall without damaging the tissue outside the stomach. The sensor system 210 coupled to the helical needle grasping device 256 can detect when the helical needle has penetrated the tissue to the target tissue depth. In some examples, when the sensor system 210 senses that the grasping device 256 is at the target tissue depth, the suture needle 253 from the instrument system 252 can be advanced through the grasped tissue to achieve a full-thickness suture bite.

[0021] The control system 208 can control the grasper drive system 212 to control the rate at which the grasper 256 is inserted into or retracted from the elongated flexible instrument 250. Additionally, the control system 208 can control the grasper drive system 212 to control the depth at which the grasper 256 penetrates tissue. In other examples, the control system 208 provides actuation signals to control the start and / or stop of the advancement and / or retraction of the grasper 256. For example, the control system 208 can be configured to advance the grasper 256 when the grasper 256 is in contact with tissue. In another example, the control system 208 is configured to stop the grasper 256 when the distal tip of the grasper 256 no longer contacts tissue. The control system can reduce the insertion rate of the grasper 256 when the sensor system 210 senses that the distal tip of the grasper 256 is approaching the desired insertion depth.

[0022] In some examples, control system 208 can automatically control insertion of gripping device 256 to reach a target gripping depth based on sensor data from sensor system 210. The target gripping depth can be defined as a full thickness engagement of the suture through the organ, a depth of a particular measurement (e.g., in mm), a depth to a particular number of rotations of gripping device 256, or a depth to a particular tissue layer (e.g., specifying a depth into the muscle layer, or a depth that penetrates the muscle layer but does not fully penetrate the serosa, etc.). Use of endoscopic instrument system 240 is further described below with reference to FIG. 9.

[0023] The control system 208 can control the gripper drive system 212 based on the sensor information received from the sensor system 210. In some examples, the sensor information received from the sensor system 210 is displayed on a user interface (e.g., a display system 1310). The user interface can communicate with the control system 208 and provide feedback regarding the penetration of the gripper 256 (e.g., notifying the user of the position or instructing the user to adjust or try to re-engage). In some examples, the user interface can provide an indication of the layer into which the gripper 256 has penetrated. In other examples, the user interface can provide a side view / cross-sectional representation that correlates with needle depth. For example, when activated, the user interface can include a cross-section showing a representation of the approximate needle position relative to an estimated tissue thickness.

[0024] 4A-4F illustrate the configuration of a helical needle grasper (e.g., grasper 206, 256) according to some examples. While FIGS. 4A-4F show helical or corkscrew-shaped graspers, other graspers may use other shapes to achieve penetration and tissue grasping. For example, curved needles having one or more arcuate sections may be used, which may be advantageous when insertion is not generally perpendicular to the organ wall. Any of the features described for any of the graspers in FIGS. 4A-4F may be combined with other features of the graspers in FIGS. 4A-4F. FIGS. 4A-4F are merely examples of possible grasper configurations and are not intended to limit the possible configurations. In some examples, the grasper may be manufactured as a straight member and then formed into a helix or other shape. In some examples, the grasper may be a single-use device that is not intended for sterilization or use on multiple patients. In other examples, the grasper may be sterilized / reprocessed for use in multiple procedures.

[0025] FIG. 4A shows a gripping device 300 (e.g., gripping devices 206, 256) including a single helical needle 302 with a sharpened or angled distal tip 304. The helical needle 302 can be rotated about axis A to drive the needle into tissue. In some examples, the needle 302 can be cannulated to allow a sensor device, fluid, or other material to be placed within the needle to provide sensing information via the needle. A cannulated needle can have an opening at the distal portion of the needle. In some examples, extending the gripping device 300 into tissue requires rotating the helical needle into the tissue while the needle is advanced longitudinally (along axis A) relative to the distal portion of the elongated flexible instrument 250. In some instances, extending the needle into the tissue requires that the helical needle be rotated into the tissue while the needle remains longitudinally stationary relative to the distal portion of the elongated flexible instrument 250 and the tissue is pulled towards the elongated flexible instrument 250. In some instances, extending the needle into the tissue requires that the helical needle be rotated into the tissue while the needle and tissue are retracted longitudinally (along axis A) relative to the distal portion of the elongated flexible instrument 250.

[0026] FIG. 4B illustrates a gripping device 310 (such as gripping devices 206, 256) that includes a cannulated helical needle 312 through which a sensor device 314 extends or is positioned. The sensor device 314 may be a component of the sensor system 210. In some examples, the sensor device 314 includes a wire sensor or a fiber optic sensor that can be housed within the cannulated helical needle 312. In some examples, the sensor device 314 can include an elongated plastic core member that is slidable relative to the needle 312. The core 314 can be positioned to extend beyond the distal end of the distal tip 304 and can be retracted to be fully housed within the needle 312. The slidable core 314 can provide an indication of how far the needle 312 has penetrated tissue. For example, as the cannulated needle 312 is inserted into tissue, the tissue surface may impede distal movement of the slidable core 314 as the surrounding cannulated needle 312 is forced into the tissue. The tip of the slidable core 314 can rest on the surface of the organ wall (e.g., the innermost surface of the stomach in an intraluminal application) while the needle 312 is inserted a distance into the tissue. The difference in advancement distance between the slidable core 314 and the needle 312 can provide a measurement of the insertion distance of the needle 312 into the tissue. Markings can be placed on the slidable core 314 or the needle 312 to determine the difference measurement. The relative distance can be measured on either the proximal or distal portion of the needle 312 or core 314. For example, the proximal end of the needle 312 or a portion of the gripping device 310 proximal to the needle 312 can include a transparent or translucent material, window, or opening through which the slidable core 314 extends, allowing the markings on the slidable core 314 to be visible. Alternatively, any portion of the needle 312 can be transparent or translucent, allowing the markings on the slidable core 314 to be visible. In another example, movement of the slidable core 314 relative to the needle 312 can be sensed by an electromechanical sensor in the sensor system 210. The electromechanical sensor can be located, for example, in the proximal portion of the needle 312 or in the grasper drive system 212.

[0027] FIG. 4C illustrates a gripping device 320 (e.g., gripping device 206, 256) that includes a helical needle 322 with a slidable sensor device 324 extending thereover. The sensor device 324 may be a component of the sensor system 210. In some examples, the sensor device 324 is a sheath that extends over the helical needle 322 along the entire length or a portion of the needle. The slidable sheath 324 can provide an indication of the distance the needle 322 has traveled within the tissue. For example, as the needle 322 is inserted into the tissue, the movement of the slidable sheath 324 may be impeded by the tissue surface as the needle 322 is pushed into the tissue. The slidable sheath 324 can rest against the surface of the organ wall (e.g., the innermost surface of the stomach in an intraluminal application) while the needle 322 is inserted the distance it is within the tissue. The difference in advancement distance between slidable sheath 324 and needle 322 can provide a measurement of the insertion distance of needle 322 into tissue. Markings can be placed on slidable sheath 324 or needle 322 to determine the difference measurement. For example, the distal end of slidable sheath 324 can include a transparent or translucent material, window, or opening through which the markings on needle 322 can be visualized. In another example, movement of needle 322 relative to slidable sheath 324 can be sensed with an electromechanical sensor of sensor system 210. In yet another example, markings on the proximal end of needle 322 can be viewed with an endoscope of endoscopic instrument system 240.

[0028] FIG. 4D illustrates a gripping device 330 (e.g., gripping device 206, 256) that includes a helical needle 332 with a sheath 334 extending therearound. In some examples, the sheath 334 can protect the needle 332 and surrounding tissue as the needle extends distally of the elongated flexible instrument. The sheath 334 can be retracted along axis A as the needle 332 is inserted into tissue. Alternatively, the sheath can remain at the surface of the tissue as the needle 332 advances distally into the tissue. In some examples, the sheath 334 can be a component of the sensor system 210. The sheath 334 can be slidable relative to the needle 332 and provide an indication of the distance the needle 332 has traveled within the tissue. For example, as the needle 332 is inserted into tissue, movement of the slidable sheath 334 can be impeded by a textured surface as the needle 332 is pushed into the tissue. The slidable sheath 334 can rest against the surface of the organ wall (e.g., the innermost surface of the stomach in an intraluminal application) while the needle 332 is inserted a distance into the tissue. The difference in advancement distance between the slidable sheath 334 and the needle 332 can provide a measurement of the insertion distance of the needle 332 into the tissue. Markings can be placed on the slidable sheath 334 or the needle 332 to determine the difference measurement. The relative distance can be measured at either the proximal or distal portion of the needle 332 or sheath 334.

[0029] FIG. 4E illustrates a gripping device 340 (e.g., gripping device 206, 256) including a dual helical needle system 342 including needle 344 and needle 346. In some examples, one or both helical needles of the dual helical needle system are cannulated. In some examples, each needle 344, 346 can function with a different sensing modality. The helical needles 344, 346 can be wound in opposite directions around axis A, as shown. In other examples, the helical needles can be wound in the same direction. In some examples, the helical needles are nested (e.g., one needle is wound around the other), with one needle advancing and rotating before the other needle advancing and rotating. In some examples, the helical needles can have different diameters to prevent interference with each other, especially when wound in the same direction. In some examples, the helical needles can have different pitches.

[0030] 4F illustrates a gripping device 350 (e.g., gripping devices 206, 256) that includes a dual needle system 352. The dual needle system 352 can include a helical needle 354 wound around a straight or non-helical needle 356, which can be aligned with axis A or generally parallel to axis A. In some examples, the straight needle and the helical needle can each include components of sensor system 210.

[0031] 5A and 5B illustrate the use of a gripping device 400 (e.g., gripping device 206, 256) in conjunction with a sensing system 210 to determine gripping device penetration information into tissue 406. In some examples, gripping device 400 is a helical cannulated needle. In some examples, sensor system 210 may include a pressure sensor 410 and a pressure source 402. Pressure source 402 may include, for example, a pump that supplies a fluid, such as air or other gas, into the lumen of cannulated gripping device 400. Pressure source 402 may include valves, regulators, and / or other control mechanisms for generating, monitoring, and controlling fluid flow and pressure within the gripping device. Pressure source 402 and sensor 410 may be directly coupled to needle 400, another component of endoscopic instrument system 100, or a manual or robotically assisted manipulator that controls operation of the endoscopic instrument system.

[0032] A pressure source 402 may supply air or other fluid to a lumen or channel 408 of the needle 400. The channel 408 may have a tip opening 409. As shown in FIG. 5A , as the needle 400 advances into tissue 406, the tissue may block the tip opening 409, preventing the fluid from exiting the channel 408. As a result, backpressure within the needle 400, as measured by a pressure sensor 410, may increase. As shown in FIG. 5B , when the needle 400 penetrates an outer surface 411 of the tissue 406 (e.g., a stomach wall), the tip opening 409 may no longer be blocked by the tissue 406. As a result, the pressure within the needle 400, as measured by the pressure sensor 410, may decrease. In this manner, the pressure sensor 410 may provide penetration information indicating whether the tip of the needle 400 is within the tissue or has broken through the outer surface 411 of the organ. Sensing a change (e.g., a drop) in pressure as the needle 400 approaches the outer surface of the organ or as the needle 400 pierces the surface of the organ can provide an indication to the user or the control system 208 to trigger the end of advancement of the needle 400.

[0033] Additionally or alternatively, a pressure sensor coupled directly to the needle 400, another component of the endoscopic instrument system 100, or a manual or robotically assisted manipulator controlling the operation of the endoscopic instrument system can detect the pressure difference between the insufflated interior region within the organ or body cavity and the uninfused region outside the organ or body cavity. When the needle 400 is within the insufflated body cavity or when the tip opening 409 is within and blocked by tissue, the pressure sensor 410 can record a pressure measurement associated with the insufflated body cavity. Once the needle 406 has penetrated and exited the organ wall, the tip opening 409 is outside the insufflated body cavity and the pressure sensor 410 may record a lower pressure measurement associated with the uninfused body cavity. The lower pressure measurement may indicate that the needle 400 has penetrated the exterior surface 411 of the body cavity. Sensing a change in pressure as the needle 410 approaches the outer surface 411 of the organ or as the needle 410 penetrates the surface 411 of the organ can provide an indication to the user or the control system 208 to trigger the end of advancement of the needle 410.

[0034] In some examples, it may not be necessary to place the pressure sensor 410 near the distal tip of the needle 400 or elongated flexible instrument 200. This is because the airflow through the cannula needle may be low (e.g., less than 1 atmosphere of pressure differential), and signals from pressure changes may be easily distinguished. In some examples, a rotary coupling may rotate the helical needle while also releasing an airflow to apply pressure to the cannula helical needle. In yet other examples, a microelectromechanical system (MEMS) pressure sensor may be located on a manual or robotically assisted manipulator that controls the movement of the endoscopic instrument system 100. In this example, pressure builds up within the helical needle and flows all the way back to the MEMS pressure sensor. The pressure sensor may be as far back as the pump, even if the pump is a considerable distance from the tissue.

[0035] 6A and 6B illustrate a gripping device 500 (e.g., gripping device 206, 256) used in conjunction with a sensing system 210 to determine penetration information of the gripping device into tissue 504. The sensing system 210 can include an illumination device 501 and a light sensing device 502 for detecting differences in tissue. As shown in FIG. 6A, the gripping device 500 can include a helical needle 510 and an elongated device 512. In some examples, the elongated device 512 can include the illumination device 501, and the needle 510 can include the light sensing device 502. The needle 510 can extend in a coiled configuration around the elongated device 512. The illumination device 501 can carry an illumination source at its tip or can transmit light from a remote illumination source, for example, along one or more optical fibers extending through the elongated device 512. The illumination source can be housed within the gripping device 500, mounted externally to the gripping device 500, or in optical communication (e.g., via an optical fiber) with the gripping device 500. The optical sensing device 502 can include an optical sensor located at the tip of the needle 510, or the optical sensing device 502 can transmit light received at the tip of the needle 510 (light generated by the illumination source) to a remote optical sensor. The optical sensing device 502 can include one or more optical fibers passing through the device 502 to transmit light. In some examples, the illumination device 501 includes mechanical and optical coupling. In some examples, one or both of the light source of the illumination device 501 and the sensor of the optical sensing device 502 are located remotely relative to a manual or robot-assisted manipulator, and the optical signal is transmitted to the gripping device 500 by an optical fiber, as described herein.

[0036] The illumination device 501 and the light sensing device 502 can be used to detect light parameters such as differences in tissue color, light reflectance, or other properties between tissue layers within an organ, between different tissue types (same or different organs), between different organs, and / or between the organ wall and the body cavity. Different tissue layers 504a, 504b, and 504c can have different light characteristics. These different light characteristics can be measured by the light sensing device 502 and used to determine the type of tissue in which the grasping device 500 is located. For example, the four or more layers of the stomach wall (mucosa, submucosa, muscularis 1, muscularis 2, and serosa) can have different light characteristics. The light sensing device 502 can sense these different light characteristics to determine whether the grasping device 500 has reached a particular layer of the target tissue or whether the grasping device 500 has penetrated the entire organ. In one example, the light sensing device 502 can measure the change in light reflectance as the grasping device 500 enters the abdominal cavity from inside the stomach. Using illumination at a known wavelength and a control algorithm, the optical sensing device 502 can detect when the needle has exited the target tissue. The control system 208 can use the determined needle position information to stop further insertion of the grasping device 500. In some instances, sensing the type of environment the needle is in can mitigate the risk of penetrating surrounding organs. For example, when performing a full-thickness suture in the stomach, it may be desirable to avoid penetrating the gallbladder. Because the gallbladder may be blue, while stomach tissue may be shades of pink, white, and red, the optical sensor can distinguish between the two types of tissue.

[0037] Either the illumination device, the light-sensing device 502, or both may include one or more optical fiber sensors that use total internal reflectance to limit light loss. In small diameter fibers, light may be well confined within the optical fiber due to the presence of a core glass and a cladding with a different refractive index that creates a graded index from the core outward. The interface between the inner core and the outer layer may act as a mirror, and because the fiber diameter is so small, wall-to-wall reflections occur as light travels through one or more fibers.

[0038] As shown in FIG. 6B, in some examples, a helical needle 510 uses multiple fibers 506 or multiple cores of a multicore fiber to host both an illumination device 501 and a light-sensing device 502, and the elongated device 512 can optionally be omitted. For example, light is transmitted along one or more fibers or cores to the tip of the needle 510, and a reflected signal is transmitted back from the tip of the needle 510 to one or more other fibers or cores. The multiple fibers or cores may be sliced ​​at an angle to match the angle of the needle 510. In this example, the cleaved fibers are sharpened and polished to enhance optical transparency.

[0039] FIG. 7A shows a cross-sectional view of a grasping device 600 (e.g., grasping device 206, 256) that can be used in conjunction with a sensing system 210 to determine the grasping device's penetration (penetration) into tissue. In this example, sensing system 210 can include an electrical sensor 604 extending into a cannulated helical needle 601 of grasping device 600. Electrical sensor 604 can be used to detect electrical properties such as differences in electrical conductivity, capacitance, or impedance between a target tissue wall, air in a body cavity, unintended tissue, or between layers of an organ (e.g., between layers of the stomach to determine whether an instrument has penetrated a particular layer of the stomach wall). In some examples, electrical sensor 604 can be an insulated wire. Insulating layer 602 can be concentrically bonded around electrical sensor 604. Electrical sensor 604 can terminate at the tip of needle 601. In other examples, the wire can extend beyond the tip of the needle 601 to ensure contact between the electrical sensor 604 and the target tissue. When a hypotube is used, the hypotube may be conductive. If the hypotube is conductive, an insulating layer may be required. In some examples, it may be advantageous to deliver energy outside or inside the wire while measuring the energy returning down the return path.

[0040] FIG. 7B shows a side view of a gripping device 650 (e.g., gripping device 206, 256), and FIG. 7C shows a layered surface view of a gripping device 650 (e.g., gripping device 206, 256) including a helical needle 651 that can be used with sensing system 210 to determine penetration (penetration) information of the gripping device into tissue. In this example, a portion 652 of electrical sensor 654 extends along a surface 653 (e.g., a stainless steel surface) of helical needle 651 of gripping device 650. For example, in some embodiments, electrical sensor 654 can include one or more conductive electrodes positioned on the outer surface of needle 651. Electrical sensor 654 can be used to detect electrical properties such as differences in electrical conductivity, capacitance, or impedance between a target tissue wall, air in a body cavity, unintended tissue, or between layers of an organ (e.g., between layers of the stomach to determine whether an instrument has penetrated a particular layer of the stomach wall). Electrical sensor 654 can include an insulating layer 656 on surface 653. A series of conductive electrodes 658 may extend along the insulating layer 656, and an insulating layer 660 may extend over portions of the electrodes 658 or electrical traces 659 extending therefrom. In some examples, the electrodes 658 may be formed from gold or other highly conductive material.

[0041] 8A, 8B, and 8C illustrate a grasping device 700 (e.g., grasping device 206, 256) that can be used in conjunction with a sensing system 210 to determine penetration information of the grasping device 700 into tissue 701. In this example, the grasping device 700 includes a helical needle 702. The sensor system 210 can include one or more fiber optic sensors extending within the helical needle, or multiple cores of a multicore fiber 704. As the needle 702 moves through the organ and tissue, it compresses or expands like a spring, causing the fiber optic sensor 704 to deform as well. This deformation of the fiber optic sensor 704 can be used to determine tissue penetration into or through a tissue wall. In some examples, the fiber optic sensor 704 can function as a strain gauge to detect deformation or displacement of the fiber due to an applied force. The fiber optic sensor 704 can include a fiber Bragg grating that reflects light of a specific wavelength. As the fiber is compressed or stretched, the fiber Bragg grating provides a measurement of the strain. Acting as a strain gauge, the fiber optic sensor 704 can measure the strain at many points 800 along the needle 702. In some examples, the applied force can be calculated from the strain and / or deflection of the needle.

[0042] 8A shows the needle 702 in a neutral position where the needle 702 is not undergoing tension or compression. The needle 702 may be in this position when navigating the needle 702 through the anatomical passageway 102 or when the needle 702 is not yet obstructed by tissue 701. In some instances, depending on the physical properties of the needle 702 and the tissue 701, the needle 702 may remain in the neutral position while the needle 702 is inserted into the tissue 701. Pressure measurements at point 800 taken while the needle 702 is in the neutral position can be saved and used to compare to pressure measurements taken after the needle 702 has deflected due to contact with tissue or other obstructions within the anatomy.

[0043] 8B shows the tip portion 710 of the needle 702 in a compressed configuration. In some examples, a pressure measurement at point 800 along the fiber optic sensor 704 may indicate that the tip portion 710 of the needle 702 is compressed. Based on a determination that the needle 702 is undergoing compression, deflection, or other deformation, the control system 208 may control the drive system 212 to stop movement, start movement, change the drive speed, continue at the same drive speed, and / or make other adjustments to the movement of the needle 702.

[0044] In FIG. 8C , portions of the needle 702 are in a compressed state, while other portions are in a neutral or extended state. In some examples, the needle may return to a neutral state once the tip portion 710 of the needle 702 exits the organ 701 or enters a new layer of tissue. The fiber optic sensor can sense these changes based on the pressure measurement points 800. In some examples where a sudden change in pressure is sensed, the control system and / or needle drive system can be configured to automatically stop, start, or retract the needle 702. The pressure measurement points 800 shown in FIGS. 8A-8C are for illustrative purposes. The fiber optic sensor can measure pressure in more or fewer locations than shown. In some examples, the fiber optic sensor can sense pressure along the entire length of the optical fiber.

[0045] In some examples, the fiber optic sensor 704 can include an optical shape-sensing fiber, which can include multiple fibers and / or multiple cores of a multi-core fiber. The shape-sensing fiber can measure shape to determine the shape of the helical needle 702 as the needle changes during insertion or retraction, which can include the diameter and / or pitch of the helical needle. In some examples, the shape-sensing optical fiber can measure the twist of the needle 702 to determine how much torque / torsional resistance is present as the needle 702 advances toward or into tissue. For example, the fiber optic sensor 704 can measure the distance the tip of the needle 702 extends beyond the distal end of the elongated flexible instrument 200. Any number of measurements can be used to determine the depth of the needle 206 within the target tissue. In another example, the distance between rotations of the helical needle can be compared to determine the degree to which the needle 702 is compressed or extended.

[0046] In some examples, the imaging system 255 ( FIG. 3 ) may be a component of the sensor system 210 used to determine the penetration of the grasping device 256 into tissue. The imaging system 255, which may be an endoscopic imaging system, captures images that may be analyzed by an operator, a sensor system, and / or a control system to determine the extent of penetration of the grasping device 256 into tissue. In some examples, as the helical needle advances into tissue, the tissue moves with the embedded tissue. By analyzing images of the helical needle within the tissue, the layer of tissue reached by the helical needle can be determined. In some examples, the image data may capture the number of helical turns remaining outside of the tissue or entering the tissue. The number of helical turns captured in the image data can be used to determine the depth of tissue penetration. In some examples, the image data may capture images of a tissue “swirl,” which may be a whitening of the tissue caused by the profile of the embedded helical needle. The spiral needle profile appears as a whorl of tissue or as a stretching or blanching of the whorl of tissue caused by the spiral, allowing the observer to assess the extent to which the spiral needle has penetrated the tissue. These images of the tissue can be used to determine the depth of tissue penetration. In some examples, artificial intelligence can be used to detect pulse, color changes, and / or changes in the shape of the tissue, which can be used to determine the depth of tissue penetration. In some examples, image processing can be used to analyze 3D images to detect changes associated with the whorl of the tissue. For example, stereoscopic image data can be used to perform structured light or 3D reconstruction. These methods can be used to create geometric data and / or 3D models that approximate the shape of the tissue bulge formed by the engagement and tension of the spiral. The 3D shape data can be analyzed (e.g., using image processing techniques) to determine characteristics of the tissue deformation. For example, if the resulting tissue bulge is tented or less defined (e.g., "tented" and not "bulged"), extra-gastric organs are less likely to be engulfed by the spiral.

[0047] In some examples, the sensor system 210 can include an encoder in the gripping drive system 212. The encoder can count the number of rotations of the needle 256 to determine the depth to which the needle 256 has been inserted into tissue. Additionally or alternatively, the gripping drive system 212 can include one or more actuators that impart an axial pushing or retracting motion to the needle 256 relative to the instrument 200, and the gripping drive system 212 can be used to provide axial force data indicating whether the needle 256 has achieved full-thickness suture penetration. The needle 256 is pulled or pushed axially by the gripping drive system 212, and the force required to displace the gripped tissue a particular distance can be detected. The system can be programmed to repeatedly check and plot the force required to displace the gripped tissue at various needle depths. The force data can indicate whether the needle 256 is too shallow, has achieved full-thickness suture penetration, or is too deep. In some examples, the force data can be obtained from a fiber Bragg gating (FBG) sensor. Strain information from FBG sensors within the helix, at the tip of the helix, or at the proximal end of the helix section can be used to determine force data. In some examples, the force data can help indicate whether the needle 256 has been inserted into a surrounding organ. If the needle 256 has been inserted into a surrounding organ, the force required to pull the tissue a certain distance will be greater than if the needle 206 had only been inserted into the target tissue. Additionally or alternatively, once inserted into tissue, the needle 256 may be pulled or pushed axially relative to the tissue by moving the distal end portion 216 of the instrument 200 via the instrument drive system 214.

[0048] The sensor system 210 is not limited to the listed sensor types and modalities. In some examples, the sensor system 210 includes multiple sensing modalities. One or more of the listed sensing types can be utilized separately or together. The sensor system 210 can sense at the tip of the needle 206, along the length of the needle 206, and / or at the proximal end of the needle 206. In some examples, the sensor is isolated within the needle 206. In yet other examples, a straight needle houses the sensing functionality, while a helical needle is wrapped around the straight needle.

[0049] FIG. 9 is a flowchart illustrating a method 900 for grasping tissue during a medical procedure. Method 900 is illustrated as a series of acts or processes that may be performed in the same order as or a different order from that shown in FIG. 9 . In some examples of the method, one or more of the illustrated processes may be omitted. Additionally, one or more processes not explicitly shown in FIG. 9 may be included before, after, between, or as part of the illustrated processes. In some examples, one or more processes of method 900 are implemented, at least in part, by a control system executing code stored on a non-transitory, tangible, machine-readable medium, which, when executed by one or more processors (e.g., processors of the control system), causes the one or more processors to perform the one or more processes.

[0050] In optional process 902, an elongated, flexible instrument may be inserted into the luminal passageway. For example, distal portion 241 of endoscopic instrument system 240 may be advanced into an anatomical opening (e.g., a patient's mouth) through anatomical passageway 102 to perform a medical procedure, such as an endoscopic sleeve gastroplasty, at or near target tissue located in region 108 of anatomical structure 104. When the medical procedure is an endoscopic sleeve gastroplasty, the target region may be one or more portions of the inner wall of the stomach. Optional process 902 may be performed by a robotically assisted endoluminal medical system, manually by a clinician, or both.

[0051] In process 904, a tissue grasping device can be extended from the elongated flexible instrument into tissue. For example, a helical needle of the grasping device 206 can be extended from the distal portion 216 of the endoscopic instrument system 100 into the tissue. In some examples, the needle can be extended longitudinally at a constant or varying rate. In some examples, the needle can be extended longitudinally from the elongated flexible instrument 200. In some examples, extending the needle into the tissue requires rotating the helical needle into the tissue while the needle advances longitudinally relative to the distal portion of the elongated flexible instrument 200. In some examples, extending the needle into the tissue requires rotating the helical needle into the tissue while the needle remains longitudinally stationary relative to the distal portion of the elongated flexible instrument 200. In some examples, extending the needle into the tissue requires rotating the helical needle into the tissue while the needle retracts longitudinally relative to the distal portion of the elongated flexible instrument 200. In some examples, the longitudinal and / or rotational movement of the helical needle may be actuated manually and / or by the gripping drive system 212. For example, Figure 10A shows the gripping device 206 extending from the elongated flexible instrument 200 and prior to engaging the tissue wall 1000. For example, Figure 10B shows the gripping device 206 extending into the tissue wall 1000 and beginning to fold the tissue.

[0052] In process 906, sensor information regarding the penetration of the tissue grasping device into the tissue may be received. For example, the sensor system 210 may detect sensor information regarding the penetration of the needle 206 into the tissue. The sensor system 210 may detect the depth of penetration of the needle 206, whether the needle 206 has completely penetrated the tissue wall, whether organs outside the target tissue have been affected, and / or which layer of tissue has been reached. The sensor system may detect penetration using, for example, a pressure sensor system, an optical sensor system, an electrical sensor system, an optical fiber sensor system, an imaging system, an encoder in the drive system, differential measurements, or a combination of sensor information from any of the above sensor systems. In some examples, as shown in FIG. 10C , the helical needle 206 pulls the tissue 1000 into a fold as the needle extends into the tissue. Once the helical needle 206 penetrates the tissue 1000, the sensor system may detect sensor information regarding needle penetration using any of the above sensor systems. For example, the sensor system 210 may include a strain sensor, such as a fiber optic strain sensor, that extends into the needle 206. The resistance may be measured by the fiber optic strain sensor as the needle 206 pulls or pushes through the tissue 1000. The strain measurements obtained by the fiber optic strain sensor may be used to determine whether full thickness penetration has been achieved.

[0053] In process 908, the penetration information can be used to control the tissue gripping drive system. For example, the control system 208 can control the gripping drive system 212 based on the received sensor information. In some examples, the control system 208 can control whether to begin, end, or reverse penetration. In some examples, the control system 208 can control the speed and depth of penetration based on the received sensor information. The control system can simultaneously control both needle depth and penetration via the needle drive system 212. In other examples, the control system 208 can provide user feedback regarding needle penetration depth, tissue gripping / handling errors, and whether the resistance posed by the tissue makes it safe to retract the instrument to fold the tissue.

[0054] In optional process 910, a medical procedure can be performed using the instrument system while the tissue is grasped by the tissue grasping device. For example, as shown in FIG. 10C , a portion of instrument system 202 (e.g., suture needle 253 of instrument system 252) can be passed through folded tissue 1000 and tie a suture around the folded portion while needle 206 grasps tissue 1000. In other examples, the instrument system can cauterize, biopsy, treat, or otherwise perform a medical procedure on the tissue while the tissue is grasped by needle 206.

[0055] FIG. 11 illustrates a robotic-assisted medical system according to some examples. In some examples, the systems and methods disclosed herein may be used in medical procedures performed by the robotic-assisted medical system, as described in more detail below. As shown in FIG. 13, the robotic-assisted medical system 1300 may include a manipulator assembly 1302 for operating a medical instrument 1304 (e.g., the endoscopic instrument system 100 or any of the instruments described herein) in performing various procedures on a patient P positioned on a table T within a surgical environment 1301. The manipulator assembly 1302 may be teleoperated, non-teleoperated, or a hybrid teleoperated and non-teleoperated assembly including selected degrees of freedom of movement that may be powered and / or teleoperated, and selected degrees of freedom of movement that may be non-powered and / or non-teleoperated. A master assembly 1306 may be internal or external to the surgical environment 1301 and generally includes one or more controllers for controlling the manipulator assembly 1302. The manipulator assembly 1302 supports the medical instrument 1304 and can optionally include multiple actuators or motors that drive inputs to the medical instrument 1304 in response to commands from the control system 1312. The actuators can optionally include drive systems that, when coupled to the medical instrument 1304, can advance the medical instrument 1304 through a natural or surgically created anatomical orifice. Other drive systems can move the tip of the medical instrument with multiple degrees of freedom, which can include three linear motions (e.g., linear motion along X, Y, and Z orthogonal axes) and three rotational motions (e.g., rotation about X, Y, and Z orthogonal axes). The manipulator assembly 1302 can support a variety of other systems for irrigation, treatment, or other purposes. Such systems can include fluid systems (e.g., including reservoirs, heating / cooling elements, pumps, and valves), generators, lasers, interrogators, and cauterization components.

[0056] The robotic-assisted medical system 1300 also includes a display system 1310 that displays images or representations of the surgical site and medical instruments 1304 generated by a sensor system 1308, which may include an endoscopic imaging system. The display system 1310 and master assembly 1306 may be oriented to allow an operator O to control the medical instruments 1304 and master assembly 1306 while being aware of their remote presence. Any of the aforementioned graphical user interfaces may be displayed on the display system 1310 and / or on a display system of a separate planning workstation.

[0057] The sensor system 1308 may include a position / localization sensor system (e.g., an actuator encoder or an electromagnetic (EM) sensor system) and / or a shape sensor system (e.g., a fiber optic shape sensor) for determining the position, orientation, speed, velocity, attitude, and / or shape of the medical tool 1304. The sensor system 1308 may include temperature, pressure, force, or contact sensors, etc.

[0058] The robotic-assisted medical system 1300 may also include a control system 1312. The control system 1312 includes at least one memory 1316 and at least one computer processor 1314 for executing control among the medical instrument 1304, the master assembly 1306, the sensor system 1308, and the display system 1310. The control system 1312 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing instructions) for implementing multiple operating modes of the robotic-assisted medical system, including a navigation planning mode, a navigation mode, and / or a treatment mode. The control system 1312 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing instructions) for performing some or all of the processes described in accordance with aspects disclosed herein, including, for example, expanding an expandable device, adjusting the temperature of a heating system, adjusting valves to control fluid delivery, controlling fluid flow rate, controlling insertion and retraction of a treatment instrument, controlling actuation of a tip of a treatment instrument, receiving sensor information, modifying a signal based on sensor information, selecting a treatment location, and / or determining an expandable size of an expandable device, etc.

[0059] The control system 1312 may optionally further include a virtual visualization system for providing navigational assistance to the operator O when controlling the medical instrument 1304 during an image-guided surgical procedure. Virtual navigation using the virtual visualization system may be based on reference to a dataset of anatomical passageways acquired preoperatively or intraoperatively. The virtual visualization system processes images of the surgical site captured using imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, and / or nanotube x-ray imaging. The control system 1312 can use the preoperative images to identify target tissues (using visual imaging techniques and / or by receiving user input) and create a preoperative plan including optimal first locations for performing bronchial passageway and vascular occlusion. The preoperative plan may include, for example, a planned size for expanding the expandable device, treatment duration, treatment temperature, and / or multiple deployment locations.

[0060] In the description, specific details are set forth to explain some examples. Numerous specific details are set forth to provide a thorough understanding of the examples. However, it will be apparent to one skilled in the art that some examples can be practiced without some or all of these specific details. The specific examples disclosed herein are intended to be illustrative and not limiting. Those skilled in the art will recognize other elements not specifically described herein that are within the scope and spirit of the present disclosure.

[0061] Elements described in detail with reference to one example, embodiment, or application may, whenever practical, be optionally included in other examples, embodiments, or applications in which they are not specifically shown or described. For example, if an element is described in detail with reference to one example but not with reference to a second example, the element may nevertheless be claimed to be included in the second example. Thus, to avoid unnecessary repetition, one or more elements shown and described in connection with one example, embodiment, or application may be incorporated into other examples, embodiments, or applications, unless specifically stated otherwise, except where one or more elements render the example or embodiment non-functional or where two or more elements provide conflicting functionality. Not all illustrated processes are performed in all examples of the disclosed methods. Furthermore, one or more processes not explicitly shown may be included before, after, between, or as part of the illustrated processes. In some examples, one or more processes may be executed by a control system or may be implemented, at least in part, in the form of executable code stored on a non-transitory, tangible, machine-readable medium that, when executed by one or more processors, causes the one or more processors to perform the one or more processes.

[0062] Any changes and further modifications to the described devices, apparatus, methods, and further applications of the principles of the present disclosure are fully contemplated, as would normally occur to one skilled in the art to which the present disclosure pertains. Furthermore, the dimensions provided herein are for specific examples, and it is contemplated that different sizes, dimensions, and / or proportions may be utilized to realize the concepts of the present disclosure. To avoid unnecessary repetition of description, one or more components or actions described according to one illustrative example may be used or omitted, if applicable, from other illustrative examples. For brevity, multiple iterations of these combinations will not be described individually. For brevity, the same reference numerals may be used throughout the drawings to refer to the same or similar parts in some instances.

[0063] The systems and methods described herein may be suitable for imaging through natural or surgically formed and connected passageways in any of a variety of anatomical systems, such as the lungs, colon, intestines, stomach, liver, kidneys and calyces, brain, heart, and / or the circulatory system, including the vasculature. While some examples are provided herein with respect to medical procedures, reference to medical or surgical instruments and methods is not limiting. For example, the instruments, systems, and methods described herein may be used for industrial applications, general robotic applications, and non-medical purposes, including sensing or manipulating non-tissue workpieces. Other exemplary applications include cosmetic enhancement, imaging of human or animal anatomies, data collection from human or animal anatomies, and training of medical or non-medical personnel. Additional exemplary applications include performing procedures on tissue removed from human or animal anatomies (without replacing it back into the human or animal anatomies) and performing procedures on human or animal cadavers. Furthermore, these techniques may be used in surgical and non-surgical medical or diagnostic procedures.

[0064] One or more elements in the examples of the present disclosure may be implemented in software for execution on a processor of a computer system, such as a control processing system. When implemented in software, the elements of the examples of the present disclosure may be code segments that perform various tasks. Programs or code segments may be stored on a processor-readable storage medium or device downloaded by a computer data signal embodied in a carrier wave via a transmission medium or a communication link. Processor-readable storage devices may include any medium capable of storing information, including optical, semiconductor, and / or magnetic media. Examples of processor-readable storage devices include electronic circuits, semiconductor devices, semiconductor memory devices, read-only memories (ROMs), flash memories, erasable programmable read-only memories (EPROMs), floppy disks, CD-ROMs, optical disks, hard disks, or other storage devices. Code segments may be downloaded over a computer network, such as the Internet or an intranet. Any of a wide variety of centralized or distributed data processing architectures may be used. Programmed instructions may be implemented as several individual programs or subroutines, or may be integrated into several other aspects of the systems described herein. In some examples, the control system may support wireless communication protocols such as Bluetooth, Infrared Data Association (IrDA), HomeRF, IEEE 802.11, Digital Enhanced Cordless Communications (DECT), Ultra Wideband (UWB), ZigBee, wireless telemetry, and the like.

[0065] It should be noted that the presented processes and displays may not be inherently related to any particular computer or other apparatus. Various general-purpose systems can be used with programs in accordance with the teachings herein, or it may prove convenient to construct more specialized apparatus to perform the described operations. The required structure for these various systems appears as an element of the claims. Moreover, examples of the present invention are not described with reference to any particular programming language. It will be understood that a variety of programming languages ​​can be used to implement the teachings of the present invention as described herein.

[0066] This disclosure describes various instruments, instrument portions, and anatomical structures in terms of their state in three-dimensional space. As used herein, the term position refers to the position of an object or object portion in three-dimensional space (e.g., three translational degrees of freedom along Cartesian x, y, and z coordinates). As used herein, the term orientation refers to the rotational configuration of an object or object portion (e.g., one or more rotational degrees of freedom, such as roll, pitch, and / or yaw). As used herein, the term pose refers to the position of an object or object portion in at least one translational degree of freedom and the orientation of that object or object portion in at least one rotational degree of freedom (e.g., up to six degrees of freedom total). As used herein, the term shape refers to a series of poses, positions, or orientations measured along an object.

[0067] While certain illustrative examples of the present invention are shown and described in the accompanying drawings, it is to be understood that such examples are merely illustrative of the broad invention and are not limiting of the invention, and the examples of the present invention are not limited to the specific constructions and arrangements shown and described, since various other modifications may occur to those skilled in the art.

Claims

1. 1. A system comprising: an elongated flexible instrument; a tissue grasping device including a helical needle extending from a distal end of the elongated flexible instrument; a gripping drive system coupled to the tissue gripping device to drive movement of the tissue gripping device; a sensor system coupled to the tissue grasping device; a control system configured to receive sensor information from the sensor system and to control the gripper drive system in response to the received sensor information; system.

2. The system of claim 1 , wherein controlling the gripper drive system includes providing an actuation signal to the gripper drive system.

3. The system of claim 1 , wherein controlling the gripper drive system includes adjusting settings of the gripper drive system.

4. The system of claim 1 , wherein the sensor information is displayed on a user interface.

5. The system of claim 1 further comprising an implement system, the implement system in communication with the control system.

6. The instrument system comprises: Suture system, Biopsy systems, Treatment system, or The system of claim 5 , wherein the system is at least one of an ablation system.

7. The system of claim 5 , wherein the tool system is configured to initiate a procedure based on the received sensor information.

8. The system of claim 1 , wherein the elongated flexible instrument comprises an endoscopic imaging system.

9. The system of claim 1 , wherein the tissue grasping device is cannulated and components of the sensor system extend into the tissue grasping device.

10. The system of claim 1 , wherein the helical needle is a first helical needle and the tissue grasping device comprises a second helical needle.

11. The system of claim 1 , wherein the tissue grasping device includes a straight needle, and the helical needle is wrapped around the axis of the straight needle.

12. The system of claim 1 , wherein the sensor system includes a pressure sensor.

13. The system of claim 12 , wherein the pressure sensor is configured to detect changes in fluid pressure within a lumen extending through the tissue grasping device.

14. The system of claim 1 , wherein the sensor system includes an optical sensor.

15. The system of claim 14 , wherein the optical sensor is configured to detect a change in a parameter of the reflected light as the tissue grasping device penetrates tissue.

16. The system of claim 1 , wherein the sensor system includes an electrical sensor.

17. The system of claim 16 , wherein the electrical sensor is configured to detect a change in an electrical characteristic as the tissue grasping device penetrates tissue.

18. The system of claim 1 , wherein the sensor system includes a fiber optic sensor.

19. 20. The system of claim 18, wherein the fiber optic sensor is configured to detect changes in strain as the tissue grasping device penetrates tissue.

20. 20. The system of claim 18, wherein the fiber optic sensor is configured to detect a change in shape of the tissue grasper as the tissue grasper penetrates tissue.

21. The system of claim 1 , wherein the sensor system comprises an imaging system.

22. The system of claim 1 , wherein the sensor system includes an encoder in the gripper drive system.

23. The system of claim 1 , wherein the tissue grasping device includes a slidable elongated core.

24. The system of claim 1 , wherein a slidable sheath extends around the tissue grasping device.

25. 1. A system comprising: a processor; and a memory storing computer-readable instructions that, when executed by the processor, cause the system to: extending an elongated flexible instrument into the lumen passage; extending a tissue grasping device including a helical needle from said elongate flexible instrument into tissue; receiving sensor information from a sensor system regarding penetration of the tissue grasping device into the tissue; and controlling a drive system coupled to the tissue grasping device based on the received sensor information. system.

26. 26. The system of claim 25, wherein controlling the drive system includes at least one of sending an actuation signal to the drive system.

27. 26. The system of claim 25, wherein controlling the drive system includes adjusting a speed of the drive system.

28. 26. The system of claim 25, wherein controlling the drive system includes adjusting depth of penetration.

29. 26. The system of claim 25, wherein controlling the drive system is automated.

30. The system of claim 25 , wherein the received sensor information is displayed on a user interface.

31. 26. The system of claim 25, wherein the computer readable instructions, when executed by a processor, further cause the system to operate an instrument system to perform an interventional procedure while the tissue grasping device is penetrating tissue.

Images