Systems and methods for endoscopic tissue grasping
By using slender flexible instruments and spiral needle tissue grasping device, combined with sensor system and drive system, the problem of tissue grasping in endoscopic suture is solved, and the stability and effect of suture are improved.
Patent Information
- Application Number
- CN202380057332.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-08-16
- Filing Date
- 2023-08-15
- Publication Date
- 2025-03-14
AI Technical Summary
In the endoscopic suture procedure, it is difficult to effectively grasp and maintain the suture, resulting in poor tissue grasping and affecting the suture effect.
The elongated flexible device is used with a spiral needle tissue grasping device, combined with a sensor system and a drive system, and through real-time sensing and control, the tissue grasping device can firmly grasp tissue.
It realizes effective grasping and maintaining tissue during endoscopic suture, improves the stability and effect of suture, and reduces damage to tissue.
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Figure CN119630362A_ABST
Abstract
Description
[0001] Cross-referenced applications
[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 398,454, filed on August 16, 2022, entitled “Systems and Methods for Endoscopic Tissue Grasping,” the entire contents of which are incorporated herein by reference. Technical Field
[0003] Examples described herein relate to systems and methods for endoscopic tissue grasping. More specifically, examples may relate to tissue grasping and sensing during endoscopic suturing procedures. Background Art
[0004] Minimally invasive medical techniques can generally be aimed at reducing the amount of tissue damaged during a medical procedure, thereby reducing recovery time, discomfort, and harmful side effects for the patient. Such minimally invasive techniques can be performed through natural orifices in the patient's anatomy or through one or more surgical incisions. Through these natural orifices or incisions, an operator can insert minimally invasive medical instruments, such as therapeutic instruments, diagnostic instruments, imaging instruments, and surgical instruments. Some minimally invasive medical instruments can be used to perform endoscopic suturing. Systems and methods are needed to provide effective suture grasping and retention. Summary of the invention
[0005] The following presents a simplified summary of various examples described herein and is not intended to identify key or critical elements or to delineate the scope of the claims.
[0006] In some examples, a system may include: an elongated flexible instrument; a tissue grasping device including a helical needle extending from a distal end of the elongated flexible instrument; and a grasper drive system coupled to the tissue grasping device to drive movement of the tissue grasping device. The system may also include a control system and a sensor system coupled to the tissue grasping device, the control system being configured to receive sensor information from the sensor system and control the grasper drive system in response to the received sensor information.
[0007] In some examples, a method for operating a medical system may include inserting an elongated flexible instrument into an intraluminal passage and extending a tissue grasping device including a helical needle from the elongated flexible instrument into tissue. The method may also include receiving sensor information about penetration of the tissue grasping device into the tissue from a sensor system and controlling a drive system coupled to the tissue grasping device based on the received sensor information.
[0008] It should be understood that the above general description and the following detailed description are illustrative and explanatory in nature, and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In this regard, additional aspects, features and advantages of the present disclosure will be apparent to those skilled in the art through the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Figure 1 is a simplified diagram of a patient's anatomy based on some examples.
[0010] Figure 2 A distal portion of an endoscopic instrument system is shown according to some examples.
[0011] Figure 3 A distal portion of an endoscopic instrument system is shown according to some examples.
[0012] Figure 4A-4F Tissue grasping device configurations according to some examples are shown.
[0013] Figure 5A and Figure 5B A tissue grasping device with a pressure sensor is shown according to some examples.
[0014] Fig. 6A and Figure 6B A tissue grasping device with an optical sensor is shown according to some examples.
[0015] Fig. 7A is a cross-sectional view of a tissue grasping device with an electrical sensor according to some examples.
[0016] Figure 7B is a side view of a tissue grasping device with an electrical sensor according to some examples.
[0017] Figure 7C yes Figure 7B A layered view of an electrical sensor.
[0018] Figure 8A-8C A tissue grasping device with a fiber optic sensor is shown according to some examples.
[0019] Fig. 9 is a flowchart illustration of a method of operating a medical system according to some examples.
[0020] Figure 10A-10C Tissue is shown while the tissue grasping device is at different stages of insertion.
[0021] Fig.11 is a robot-assisted medical system according to some examples.
[0022] Examples of the present disclosure and their advantages can be best understood by referring to the detailed description below. It should be understood that similar reference numerals are used to identify similar elements shown in one or more of the accompanying drawings, wherein the illustrations therein are for illustrating examples of the present disclosure, rather than for limiting examples of the present disclosure. DETAILED DESCRIPTION
[0023] The technology described herein provides technology and treatment systems for endoscopic tissue grasping and sensing. Although the examples provided herein may relate to the suturing of gastric tissue or the technology for endoscopic sleeve gastroplasty ("ESG"), it should be understood that the technology can be used to perform procedures in an artificially created lumen or any intraluminal passage or cavity, including in a patient's trachea, colon, intestine, stomach, liver, kidney and calyces, brain, heart, circulatory system including vascular system, fistula, etc.
[0024] Figure 1 Endoscopic instrument system 100 is shown extending within anatomical passage 102 of anatomical structure 104. In some examples, anatomical structure 104 may be a stomach. Anatomical structure 104 has an anatomical reference frame (X A , Y A , Z A ). The distal portion 106 of the endoscopic instrument system 100 can be advanced into an anatomical opening (e.g., a patient's mouth) and through the anatomical passage 102 to perform a medical procedure at or near a target tissue located in a region 108 of the anatomical structure 104, such as an endoscopic sleeve gastroplasty.
[0025] Figure 2 The distal portion 106 of the endoscopic instrument system 100 is shown. The endoscopic instrument system 100 can include an elongated flexible instrument 200. The elongated flexible instrument 200 can be used as a platform to introduce working components into the anatomical structure entered 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 lumen 204 can extend through the elongated flexible instrument 200, provide access to a removable instrument system, and allow replacement of instruments during a procedure. The working lumen can also or alternatively allow fluid to pass through, or otherwise provide a passage between the proximal and distal portions of the elongated flexible instrument. In some examples, the working lumen 204 extends through the elongated flexible instrument 200 and defines an opening in the distal portion 216. In other examples, the working lumen 204 can define an opening in a sidewall of the elongated flexible instrument 200.
[0026] The instrument system 202 may be coupled to the distal portion 216 of the elongated flexible instrument 200 or delivered via the elongated flexible instrument 100. Figure 2As shown in the example of , the instrument system 202 can extend distally beyond the distal end 216 of the elongated flexible instrument 200. The instrument system 202 can include, for example, one or more of a suturing system, a biopsy system, a treatment system, or an ablation system.
[0027] The tissue grasping device 206 can be configured to extend distally from the distal end 216 of the elongated flexible instrument 200. In some examples, the tissue grasping device 206 is a spiral needle grasping device that can be rotatably driven into the tissue (e.g., spirally advanced into the tissue) by the tissue grasping drive system 212. The tissue grasping device 206 can grasp the tissue when the instrument system 202 performs a procedure such as suturing, biopsy, treatment, or ablation. In some examples, the instrument system 202 is a suturing instrument system, and the tissue grasping device 206 is a spiral needle grasping device that can be rotatably driven into the tissue by the tissue grasping drive system 212 to hold the tissue during suturing. In other examples, when the instrument system 202 includes a biopsy system, the grasping device 206 can be used to grasp tissue during a biopsy. In examples where the instrument system 202 includes a treatment system, the grasping device 206 can be used to grasp tissue while visualizing and / or treating the grasped tissue. In examples where instrument system 202 comprises an ablation system, grasping device 206 may be used to grasp tissue during ablation.
[0028] In some examples, the elongated flexible instrument 200 may include multiple instrument systems, working cavities, and / or tissue grasping devices. For example, the elongated flexible instrument 200 may include multiple instrument systems 202, and the multiple instrument systems 202 include imaging systems, lighting systems, flushing systems, and / or instrument sensor systems. Multiple instrument systems can be removably (e.g., slidably) inserted into the elongated flexible instrument through one or more working cavities. In some examples, multiple instrument systems can extend through dedicated instrument cavities in the elongated flexible instrument. In some examples, an instrument system or a portion of an instrument system can be fixed to the elongated flexible instrument.
[0029] The endoscopic instrument system 100 may also include a control system 208 in communication with the sensor system 210, the tissue grasping drive system 212, and / or the instrument drive system 214. The sensor system 210 and the tissue grasping drive system 212 may be coupled to the tissue grasping device 206. The instrument drive system 214 may be coupled to the elongated flexible instrument 200 to drive axial motion (e.g., advancement, retraction), bending, and / or rolling motion of the elongated flexible instrument. The control system 208 may be a closed-loop control system in electrical communication with the sensor system 210, the tissue grasping drive system 212, and / or the instrument drive system 214. The control system 208 may control the advancement, retraction, steering, and / or rotational motion of the endoscopic instrument system 100. In some examples, the control system 208 controls the elongated flexible instrument 200 and / or the instrument system 202 using the instrument drive system 214, which may include motors, control cables, sensors, actuators, and / or other mechanical or electrical systems that drive motion in response to control signals from the control system 208. In addition, the control system 208 can control the advancement, retraction, rotation, or other movement of the tissue grasping device 206. In some examples, the control system 208 controls the tissue grasping device 206 using a tissue grasping drive system 212. The tissue grasping drive system 212 can include motors, control cables, sensors, actuators, and / or other mechanical or electrical systems that drive the movement of the tissue grasping device 206 in response to control signals from the control system 208.
[0030] Figure 3 A distal portion 241 of an endoscopic instrument system 240 that can be used for suturing is shown. The endoscopic instrument system 240 can be an example of the endoscopic instrument system 100 and can be substantially similar to the system 100, with differences as described below. In this example, the endoscopic instrument system 240 can include an elongated flexible instrument 250 that includes a working lumen 254 extending therethrough. An imaging system 255 and an illumination system 257 can also extend within the elongated flexible instrument 250. The endoscopic instrument system 240 can also include a suturing system housing 258 coupled to the distal portion of the elongated flexible instrument 250. The suturing system housing 258 carries a spiral needle grasping device 256 (e.g., grasping device 206) and an instrument system 252 (e.g., instrument system 202) including a needle 253. The suturing system housing 258 can also include a capture port 260 into which the needle 253 can extend to secure a suture. The endoscopic instrument system 240 may include the control system 208, the sensor system 210, the grasper drive system 212, and the instrument drive system 214, as previously described.
[0031] In some examples, the endoscopic instrument system 240 can 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 down to the inside of the stomach. The stomach wall is folded from the inside to effectively reduce the size of the stomach. By reducing the size of the stomach, the number of calories that the body can absorb and the amount of food eaten are reduced. ESG is a non-surgical procedure that causes a reduction in the stomach by folding the stomach without removing portions of the stomach. ESG also uses natural body orifices to reach anatomical structures, eliminating the need for external incisions.
[0032] In an ESG procedure, gastric tissue can be grasped from the inside of the stomach and retracted to create a tissue fold. The tissue grasping device 256 can pull and retract the stomach wall. Once the tissue grasping device has fully grasped the stomach wall and retracted / folded the stomach tissue, a separate needle can be used to puncture the folded tissue and apply sutures to the folded tissue. One difficulty in the ESG procedure is how to grasp the stomach wall from the inside while grasping or biting the tissue enough to cause tissue folding. The inside of the stomach may be slippery, wherein the mucosal layer is difficult to hold, and the stomach wall may also include tough tissue that resists folding. When using the tissue grasping device to create a fold, the preferred depth or depth range of the tissue grasping device puncturing the stomach wall can cause sufficient tissue folding. The stomach wall has at least four layers, the mucosal layer (innermost layer), the submucosal layer, the muscular layer, and the serosa layer (outermost layer). In some cases, puncturing the serosa may cause the entire stomach wall to be bitten through the full thickness (full thickness). In other cases, the puncture may extend only to one of the inner layers, such as through the muscularis but not through the serosa, to avoid puncturing tissue / organs outside the stomach wall. A puncture or bite of a tissue grasping device that is too shallow may make it difficult to fold the tissue properly. A puncture or bite that is too deep may risk puncturing an organ outside the stomach.
[0033] The sensing system 210 and the control system 208 can allow the tissue grasping device 256 to achieve a firm grasp of the stomach wall without damaging extragastric tissue. The sensor system 210 coupled to the spiral needle grasping device 256 can detect when the spiral needle is driven through the tissue to reach 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 sweep through the grasped tissue to obtain a full-thickness suture bite.
[0034] The control system 208 can control the grasper drive system 212 to control the speed at which the grasping device 256 is inserted or retracted from the elongated flexible instrument 250. In addition, the control system 208 can control the grasper drive system 212 to control the depth at which the grasping device 256 penetrates the tissue. In other examples, the control system 208 provides an actuation signal to control the start and / or stop of the advancement and / or retraction of the grasping device 256. For example, the control system 208 can be configured to advance the grasping device 256 when the grasping device 256 contacts the tissue. In another example, the control system 208 is configured to stop the grasping device 256 when the distal tip of the grasping device 256 no longer contacts the tissue. When the sensor system 210 senses that the distal tip of the grasping device 256 is approaching the desired insertion depth, the control system can reduce the speed of insertion of the grasping device 256.
[0035] In some examples, the control system 208 can provide automatic control of the insertion of the grasping device 256 based on sensor data from the sensor system 210 to reach a target grasping depth. The target grasping depth can be defined as a full thickness suture bite through an organ, a depth reaching a specific measurement (e.g., in millimeters), a depth reaching a specific number of rotations of the grasping device 256, or a depth reaching a specific tissue layer (e.g., a depth specified to reach within the muscularis, or a depth that penetrates through the muscularis but not completely through the serosa, etc.). Fig. 9 A method of using the endoscopic instrument system 240 is further described.
[0036] The control system 208 can control the grasper 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., the display system 1310). The user interface can communicate with the control system 208 and provide feedback about the penetration of the grasping device 256 (e.g., notifying the user of the positioning or instructing the user to adjust or try the bite again). In some examples, the user interface can provide an identification of the layer that the grasping device 256 has entered. In other examples, the user interface can provide a side view / cross-sectional representation associated with the needle depth. For example, when activated, the user interface can include a cross-section showing a representation of the approximate needle positioning relative to the estimated tissue thickness.
[0037] Figure 4A-4F Configurations of helical needle capture devices (eg, capture devices 206, 256) are shown according to some examples. Figure 4A-4FA spiral or corkscrew shaped grasping device is shown, but other grasping devices may use other shapes to achieve puncture and tissue grasping. For example, a curved needle with one or more arcuate portions may be used and may be advantageous in situations where insertion does not normally occur perpendicular to the organ wall. Figure 4A-4F Any feature of any gripping device described in Figure 4A-4F The gripping device is combined with other features. Figure 4A-4F These are merely examples of possible configurations for the grasping device and are not meant to limit the possible configurations. In some examples, the grasping device may be manufactured as a straight member and then formed into a spiral or other shape. In some examples, the grasping device may be a disposable device that is not intended for sterilization and use with multiple patients. In other examples, the grasping device may be sterilized / reprocessed for use with multiple procedures.
[0038] Figure 4A A grasping device 300 (e.g., grasping device 206, 256) is shown, which includes a single spiral needle 302 with a sharp or angled distal tip 304. The spiral needle 302 can be rotated about an axis A to drive the needle into the tissue. In some examples, the needle 302 can be cannulated to allow a sensor device, fluid, or other material to reside within the needle for providing sensing information via the needle. The hollow needle can have an opening at the distal portion of the needle. In some examples, extending the grasping device 300 into the tissue can include rotating the spiral needle into the tissue while the needle is longitudinally advanced (along axis A) relative to the distal portion of the elongated flexible instrument 250. In some examples, extending the needle into the tissue can include rotating the spiral needle 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 toward the elongated flexible instrument 250. In some examples, extending the needle into the tissue may include rotating the helical needle into the tissue while the needle and tissue are longitudinally retracted (along axis A) relative to the distal portion of the elongated flexible instrument 250 .
[0039] Figure 4BA grasping device 310 (e.g., grasping device 206, 256) is shown, which includes a hollow spiral needle 312, through which a sensor device 314 extends or is positioned. The sensor device 314 can 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 accommodated in the hollow spiral needle 312. In some examples, the sensor device 314 can include an elongated plastic core member that can slide 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 completely accommodated in the needle 312. The slidable core 314 can provide an indication of the amount of penetration of the needle 312 into the tissue. For example, when the hollow needle 312 is inserted into the tissue, the distal movement of the slidable core 314 may be hindered by the surface of the tissue as the surrounding hollow needle 312 is driven into the tissue. When the needle 312 is inserted into the tissue for a certain distance, the distal end of the slidable core 314 can be kept at the surface of the organ wall (e.g., the innermost surface of the stomach in the intracavitary application). The difference in the advancement distance between the slidable core 314 and the needle 312 can provide a measure 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 differential measurement. The relative distance can be measured on the proximal portion or distal portion of the needle 312 or the core 314. For example, the proximal end of the needle 312 or a portion of the grasping device 310 proximal to the needle 312 can include a transparent or translucent material, a window or an opening, allowing the slidable core 314 extending through the needle 312 and any markings on the slidable core 314 to be visible. Alternatively, any part of the needle 312 can be transparent or translucent to allow observation of the markings on the slidable core 314. In another example, the movement of the slidable core 314 relative to the needle 312 can be sensed by the electromechanical sensor of the sensor system 210. The electromechanical sensor may be positioned, for example, on a proximal portion of the needle 312 or within the grasper drive system 212 .
[0040] Figure 4CA grasping device 320 (e.g., grasping device 206, 256) is shown, which includes a spiral needle 322, and a slidable sensor device 324 extends above the spiral needle 322. The sensor device 324 can be a component of the sensor system 210. In some examples, the sensor device 324 is a sheath extending above the spiral needle 322 along all or part of the length of the needle. The slidable sheath 324 can provide an indication of the distance that the needle 322 travels into the tissue. For example, when the needle 322 is inserted into the tissue, as the needle 322 is driven into the tissue, the movement of the slidable sheath 324 may be hindered by the surface of the tissue. When the needle 322 is inserted into the tissue for a certain distance, the slidable sheath 324 can remain at the surface of the organ wall (e.g., the innermost surface of the stomach in the intracavitary application). The difference in the advancement distance between the slidable sheath 324 and the needle 322 can provide a measure of the insertion distance of the needle 322 into the tissue. Markings can be placed on the slidable sheath 324 or the needle 322 to determine the difference measurement value. For example, the distal end of the slidable sheath 324 may include a transparent or translucent material, window, or opening through which the markings on the needle 322 are visible. In another example, the movement of the needle 322 relative to the slidable sheath 324 may be sensed by an electromechanical sensor of the sensor system 210. In another example, the markings on the proximal end of the needle 322 may be viewed through an endoscope of the endoscopic instrument system 240.
[0041] Figure 4D A grasping device 330 (e.g., grasping device 206, 256) is shown, which includes a spiral needle 332, and a sheath 334 extends around the spiral needle 332. In some examples, the sheath 334 can protect the needle 332 and surrounding tissue when the needle extends distally of the elongated flexible instrument. When the needle 332 is inserted into the tissue, the sheath 334 can be retracted along the axis A. Alternatively, when the needle 332 is advanced distally into the tissue, the sheath can remain at the surface of the tissue. In some examples, the sheath 334 can be a component of the sensor system 210. The sheath 324 can be slidable relative to the needle 332 to provide an indication of the distance that the needle 332 has traveled into the tissue. For example, when the needle 332 is inserted into the tissue, as the needle 332 is driven into the tissue, the movement of the slidable sheath 334 may be hindered by the surface of the tissue. When the needle 332 is inserted into the tissue a certain distance, the slidable sheath 334 can remain at the surface of the organ wall (e.g., the innermost surface of the stomach in an intracavitary application). The difference in the advancement distance between the slidable sheath 334 and the needle 332 can provide a measure 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 value. The relative distance can be measured on the proximal portion or distal portion of the needle 332 or the sheath 334.
[0042] Figure 4EA grasping device 340 (e.g., grasping device 206, 256) is shown, which includes a double spiral needle system 342, which includes a needle 344 and a needle 346. In some examples, one or both spiral needles of the double spiral needle system can be hollow. In some examples, each needle 344, 346 can work in a different sensing mode. The spiral needles 344, 346 can be wound in opposite directions around the axis A, as shown. In other examples, the spiral needles can be wound in the same direction. In some examples, the spiral needles can be nested (e.g., one needle is coiled around another needle), where one needle is advanced and rotated before the other needle is advanced and rotated. In some examples, especially if the spiral needles are wound in the same direction, the diameters of the spiral needles can be different from each other to prevent the spiral needles from interfering with each other. In some examples, the spiral needles can have different pitches.
[0043] Figure 4F A grasping device 350 (e.g., grasping devices 206, 256) is shown including a dual needle system 352. The dual needle system 352 can include a spiral needle 354 wrapped around a straight or non-spiral needle 356, which can be aligned or generally parallel to the axis A. In some examples, the straight needle and the spiral needle can each comprise a component of the sensor system 210.
[0044] Figure 5A and Figure 5B A grasping device 400 (e.g., grasping device 206, 256) is shown for use with a sensing system 210 for determining information about penetration of the grasping device into tissue 406. In some examples, the grasping device 400 is a helical hollow needle. In some examples, the sensor system 210 may include a pressure sensor 410 and a pressure source 402. The pressure source 402 may include, for example, a pump that supplies a fluid, such as air or another gas, into a lumen of the hollow grasping device 400. The pressure source 402 may include valves, regulators, and / or other control mechanisms to generate, monitor, and control fluid flow and pressure in the grasping device. The pressure source 402 and sensor 410 may be coupled directly to the needle 400, another component of the endoscopic instrument system 100, or a manual or robotic-assisted manipulator that controls the operation of the endoscopic instrument system.
[0045] The pressure source 402 may provide air or another fluid into a lumen or channel 408 in the needle 400. The channel 408 may have a distal opening 409. Figure 5AAs shown, when needle 400 is advanced into tissue 406, obstruction of distal opening 409 by tissue will prevent fluid from leaving lumen 408. As a result, back pressure in needle 400 measured by pressure sensor 410 may increase. Figure 5B As shown, the distal opening 409 may no longer be blocked by the tissue 406. As a result, the pressure in the needle 400 measured by the pressure sensor 410 may drop. Thus, the pressure sensor 410 may provide puncture information indicating whether the distal tip of the needle 400 is within the tissue or has pierced 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 through the surface of the organ can provide an indication to the user or the control system 208 to trigger the termination of advancement of the needle 400.
[0046] Additionally or alternatively, a pressure sensor coupled directly to the needle 400, another component of the endoscopic instrument system 100, or a manual or robotic assisted manipulator controlling the operation of the endoscopic instrument system can detect a pressure difference between an insufflated internal region within an organ or body cavity and a non-insufflated region outside of the organ or body cavity. When the needle 400 is within the insufflated body cavity, or when the distal 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 punctured through and exited the organ wall, the distal opening 409 may be outside of the insufflated body cavity, and the pressure sensor 410 can record a lower pressure measurement associated with the non-insufflated body cavity. The lower pressure measurement can indicate that the needle 400 has pierced through the outer 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 pierces through the surface 411 of the organ can provide an indication to the user or the control system 208 to trigger termination of advancement of the needle 410.
[0047] In some examples, the pressure sensor 410 may not need to be close to the distal tip of the needle 400 or the elongated flexible instrument 200 because the airflow in the hollow needle may be low (e.g., the pressure differential is less than 1 atm) and the signal from the pressure change is easily distinguishable. In some examples, a rotary coupler can rotate the spiral needle and release the airflow to apply pressure to the hollow spiral needle. In other examples, a microelectromechanical system (MEMS) pressure sensor can be located on a manual or robotic-assisted manipulator that controls the movement of the endoscopic instrument system 100. In this example, the pressure will rise within the spiral needle and flow all the way back to the MEMS pressure sensor. The pressure sensor can be as far away as the pump even if the pump is a considerable distance from the tissue.
[0048] Fig. 6A and Figure 6BA grasping device 500 (e.g., grasping device 206, 256) is shown that can be used with a sensing system 210 for determining information about penetration of the grasping device into tissue 504. The sensing system 210 may include an illumination device 501 and an optical sensing device 502 for detecting tissue differences. Fig. 6A As shown, the grasping device 500 may include a spiral needle 510 and an elongated device 512. In some examples, the elongated device 512 may include an illumination device 501, and the needle 510 may include an optical sensing device 502. The needle 510 may extend around the elongated device 512 in a wrapped configuration. The illumination device 501 may carry an illumination source at a distal end, or may transmit light from a remote illumination source, for example, along one or more optical fibers extending through the elongated device 512. The illumination source may be housed within the grasping device 500, attached to the exterior of the grasping device 500, or otherwise in optical communication with the grasping device 500 (e.g., via optical fibers). The optical sensing device 502 may include an optical sensor located on the distal end of the needle 510, or the optical sensing device 502 may transmit light received at the distal end of the needle 510 (generated by the illumination source) to a remote optical sensor. The optical sensing device 502 may include one or more optical fibers extending through the device 502 to transmit light. In some examples, the illumination device 501 includes a mechanical and optical coupler. In some examples, one or both of the source of illumination device 501 and the sensor of optical sensing device 502 can be remotely located on a manual or robotic assisted manipulator, with the optical signal transmitted to the grasping device 500 by optical fiber, as described herein.
[0049] The lighting device 501 and the optical sensing device 502 can be used to detect light parameters, such as differences in tissue color, light reflectivity, or other properties between tissue layers within an organ, between different tissue types (same or different organs), between different organs, and / or between an organ wall and a body cavity. Different tissue layers 504a, 504b, 504c can have different light properties. These different light properties can be measured by the optical sensing device 502 and used to determine the type of tissue in which the grasping device 500 is located. For example, four or more layers of the stomach wall (mucosa, submucosa, muscularis 1, muscularis 2, serosa) may have different light properties. The optical sensing device 502 can sense these different light properties to determine whether the grasping device 500 has reached a certain layer of the target tissue or whether the grasping device 500 has punctured through the entire organ. In one example, the optical sensing device 502 can measure the change in light reflectivity when the grasping device 500 punctures from the inside of the stomach to the abdominal cavity. The optical sensing device 502 can use illumination of known wavelengths and control algorithms to detect the departure of the needle from the target tissue. The control system 208 can use the determined needle positioning information to stop further insertion of the grasping device 500. In some examples, sensing the type of environment the needle is in can help reduce the risk of puncturing surrounding organs. For example, when performing a full-thickness suture of the stomach, it may be desirable to avoid puncturing the gallbladder. Since the gallbladder may be blue in color, and the tissue of the stomach may be pink, white, and red, the optical sensor can distinguish between these two types of tissue.
[0050] The illumination device, the optical sensing device 502, or both may include one or more fiber optic sensors that use total internal reflection to limit light loss. In small diameter optical fibers, light can be well contained within the fiber because there can be a core glass and cladding with different refractive indices, creating a graded refractive index from the core to the exterior. The interface of the inner core and the outer layer can act as a mirror, and the diameter of the optical fiber is so small that when light is transmitted along one or more optical fibers, reflections from wall to wall occur.
[0051] In some examples, such as Figure 6B As shown, the spiral needle 510 can use multiple optical fibers 506 or multiple cores of a multi-core optical fiber to host the illumination device 501 and the optical sensing device 502, and the elongated device 512 can be optionally omitted. For example, light can be transmitted along one or more optical fibers or cores to the distal end of the needle 510, and the return / reflected signal is transmitted back from the distal end of the needle 510 in one or more of the other optical fibers or cores. The multiple optical fibers or cores can be sliced at a certain angle to match the angle of the needle 510. In this example, the cut optical fibers are sharpened and polished to improve optical clarity.
[0052] Fig. 7AA cross-sectional view of a grasping device 600 (e.g., grasping device 206, 256) that can be used with a sensing system 210 for determining information about the puncture of the grasping device into tissue is shown. In this example, the sensing system 210 can include an electrical sensor 604 extending within a hollow spiral needle 601 of the grasping device 600. The electrical sensor 604 can be used to detect electrical properties, such as differences in conductivity, capacitance, impedance, or the like between target tissue walls, air in a body cavity, and between layers of unintended tissue or organs (e.g., between layers of the stomach to determine when the instrument has punctured a layer of the stomach wall). In some examples, the electrical sensor 604 can be an insulated wire. The insulating layer 602 can be coupled concentrically around the electrical sensor 604. The electrical sensor 604 can terminate at the tip of the 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. In the case of using a hypotube, the hypotube can be conductive. In the case where the hypotube is conductive, an insulating layer may be required.In some examples, it may be advantageous to deliver energy externally or internally along the line while measuring the energy returned along the return path.
[0053] Figure 7B A side view is shown, and Figure 7C A layered surface view of a grasping device 650 (e.g., grasping devices 206, 256) including a spiral needle 651 that can be used with a sensing system 210 for determining information about puncture of the grasping device into tissue is shown. In this example, a portion 652 of an electrical sensor 654 extends along a surface 653 (e.g., a stainless steel surface) of the spiral needle 651 of the grasping device 650. For example, in some embodiments, the electrical sensor 654 can include one or more conductive electrodes positioned on the outer surface of the needle 651. The electrical sensor 654 can be used to detect electrical properties, such as differences in conductivity, capacitance, impedance, or the like between target tissue walls, air in a body cavity, between layers of unintended tissue or organs (e.g., between layers of the stomach to determine when the instrument has punctured a layer of the stomach wall). The electrical sensor 654 can include an insulating layer 656 on the surface 653. A series of conductive electrodes 658 can extend along insulating layer 656, and insulating layer 660 can extend over a portion of electrodes 658 or electrical traces 659 extending from electrodes 658. In some examples, electrodes 658 can be formed of gold or another highly conductive material.
[0054] Fig. 8A , Figure 8B and Figure 8CA grasping device 700 (e.g., grasping device 206, 256) is shown that can be used with a sensing system 210 for determining information about the penetration of the grasping device 700 into tissue 701. In this example, the grasping device 700 includes a spiral needle 702. The sensor system 210 can include one or more fiber optic sensors or multiple cores of a multi-core optical fiber 704 extending within the spiral needle. As the needle 702 moves through organs and tissues, the needle 702 can compress or stretch like a spring, causing the fiber optic sensor 704 to deform similarly. This deformation of the fiber optic sensor 704 can be used to determine tissue penetration within or through a tissue wall. In some examples, the fiber optic sensor 704 can be used as a strain gauge to detect deformation or displacement of the optical fiber caused by an applied force. The fiber optic sensor 704 can include a fiber Bragg grating that reflects light of a specific wavelength. When the optical fiber becomes compressed or stretched, the fiber Bragg grating provides a strain measurement. The fiber optic sensor 704 used as a strain gauge can measure strain at many points 800 along the needle 702. In some examples, the applied force can be calculated based on the strain and / or deflection of the needle.
[0055] Fig. 8A The needle 702 is shown in a neutral position, wherein the needle 702 is not subjected to tension or compression. The needle 702 may be in this position when the needle 702 is navigating in the anatomical pathway 102, or when the needle 702 is not yet obstructed by the tissue 701. In some examples, depending on the physical properties of the needle 702 and the tissue 701, the needle 702 may remain in the neutral position even when the needle 702 is inserted into the tissue 701. The pressure measurement at point 800 obtained when the needle 702 is in the neutral position may be stored and used for comparison with the pressure measurement obtained after the needle 702 is deflected due to contact with other obstacles within the tissue or anatomical structure.
[0056] Figure 8B The distal portion 710 of the needle 702 is shown in a compressed configuration. In some examples, the pressure measurement at point 800 along the fiber optic sensor 704 can indicate that the distal portion 710 of the needle 702 is compressed. Based on a determination that the needle 702 is compressed, deflected, or otherwise deformed, the control system 208 can control the drive system 212 to stop moving, start moving, change the drive rate, continue at the same drive rate, and / or make another adjustment to the movement of the needle 702.
[0057] exist Figure 8CIn some examples, some portions of needle 702 are in a compressed state while other portions are in a neutral or stretched state. In some examples, when the distal portion 710 of needle 702 leaves organ 701 or enters a new tissue layer, the needle can return to a neutral state. The fiber optic sensor can sense these changes based on the pressure measurement point 800. In some examples where a sudden change in pressure is sensed, the control system and / or the needle drive system can be configured to automatically stop, start, or retract needle 702. Figure 8A-8C The pressure measurement points 800 shown in FIG. 8 are for illustration purposes. The fiber optic sensor may measure pressure at more or fewer locations than shown. In some examples, the fiber optic sensor may sense pressure along the entire length of the optical fiber.
[0058] In some examples, the fiber optic sensor 704 may include an optical shape sensing fiber, which may include multiple optical fibers and / or multiple cores of a multi-core fiber. The shape sensing fiber may measure a shape to determine the shape of the spiral needle 702, which may include a diameter and / or pitch of the spiral needle that changes during insertion or retraction of the spiral needle. In some examples, the shape sensing fiber may measure the torsion of the needle 702 to determine how much torque / torsional resistance there is when the needle 702 is advanced toward or into the tissue. For example, the fiber optic sensor 704 may measure the distance that the tip of the needle 702 has extended beyond the distal end of the elongated flexible instrument 200. Any number of measurements may be used to determine the depth of the needle 206 in the target tissue. In another example, the distance between the turns of the spiral needle may be compared to determine the extent to which the needle 702 is compressed or stretched.
[0059] In some examples, imaging system 255 ( Figure 3) can be a component of the sensor system 210 for determining the penetration of the grasping device 256 into the tissue. The imaging system 255, which can be an endoscopic imaging system, can capture images that can be analyzed by an operator, a sensor system, and / or a control system to determine the extent of any penetration of the grasping device 256 into the tissue. In some examples, as the spiral needle is advanced into the tissue, the tissue may move along with the embedded tissue. By analyzing the image of the spiral needle within the tissue, the tissue layer reached by the spiral needle can be determined. In some examples, the image data can capture the number of spiral turns that remain outside the tissue or have entered the tissue. The amount of spiral turns captured in the image data can be used to determine the depth of tissue penetration. In some examples, the image data can capture an image of a tissue "swirl," which may be a tissue blanching caused by the outline of the embedded spiral needle. The outline of the spiral needle can be seen as a swirling protrusion of the tissue or can be seen as a swirling tissue stretching or blanching caused by the spiral needle can allow an observer to assess the extent to which the spiral needle has penetrated the tissue. These tissue images can be used to determine the depth of tissue penetration. In some examples, artificial intelligence can be used to detect pulses, color changes and / or tissue shape changes, which can be used to determine the depth of tissue puncture. In some examples, image processing can be used to analyze 3D images to detect changes associated with tissue vortices. For example, stereoscopic image data can be used to perform structured light or 3D reconstruction. These methods can be used to generate geometric data and / or 3D models that approximate the shape of a tissue bump created by spiral engagement and tension. 3D shape data can be analyzed (e.g., using image processing techniques) to determine the characteristics of tissue deformation. For example, if the tissue bump generated is tented or less clear (e.g., more "tent-like" and less "bump-like"), the possibility of spiral capture of additional gastric organs is low.
[0060] In some examples, the sensor system 210 may include an encoder in the grasper drive system 212. The encoder may count the number of rotations of the needle 256 to determine the depth of insertion of the needle 256 into the tissue. Additionally or alternatively, the grasper drive system 212 may include one or more actuators to apply an axial push or pull movement to the needle 256 relative to the instrument 200, and the grasper drive system 212 may be used to provide axial force data to indicate whether the needle 256 has achieved full thickness suture engagement. The needle 256 may be axially dragged or pushed by the grasper drive system 212 to detect the force required to displace the grasped tissue a certain distance. The system may be programmed to iteratively check and plot the force required to displace the grasped tissue at different needle depths. The force data may indicate whether the needle 256 is too shallow, whether full thickness suture engagement has been achieved, or whether it is too deep. In some examples, the force data may be obtained from a fiber Bragg grating (FBG) sensor. Strain information from an FBG sensor within the helix, at the tip of the helix, or proximal to the helix portion may be used to determine the force data. In some examples, the force data can help indicate whether the needle 256 has been inserted into the surrounding organ. If the needle 256 is inserted into the surrounding organ, the force required to pull the tissue a certain distance will be greater than the force required to insert the needle 206 only into the target tissue. Additionally or alternatively, by moving the distal portion 216 of the instrument 200 via the instrument drive system 214, the needle 256 inserted into the tissue can be pulled or pushed axially relative to the tissue.
[0061] 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 used alone or together. The sensor system 210 can perform sensing at the distal end 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 insulated within the needle 206. In other examples, a straight needle can accommodate the sensing capability, and the spiral needle is coiled around the straight needle.
[0062] Fig. 9 is a flow chart illustrating a method 900 for grasping tissue during a medical procedure. The method 900 is shown as being capable of being performed in conjunction with Fig. 9 A set of operations or processes performed in the same or different order as shown in the example. In some examples of the method, one or more of the processes shown may be omitted. In addition, Fig. 9One or more processes not explicitly shown in the method 900 may be included before, after, between, or as part of the processes shown. In some examples, one or more of the processes of method 900 may be 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., a processor of the control system), may cause the one or more processors to perform one or more of the processes.
[0063] At optional process 902, an elongated flexible instrument may be inserted into an intraluminal passage. For example, distal portion 241 of endoscopic instrument system 240 may be advanced into an anatomical opening (e.g., a patient's oral cavity) and through anatomical passage 102 to perform a medical procedure, such as an endoscopic sleeve gastroplasty, at or near a 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 with a robotic-assisted intraluminal medical system, manually by a clinician, or both.
[0064] At process 904, a tissue grasping device may be extended from the elongated flexible instrument into the tissue. For example, a helical needle of the grasping device 206 may be extended from the distal portion 216 of the endoscopic instrument system 100 into the tissue. In some examples, the needle may be extended longitudinally at a constant or varying rate. In some examples, the needle may be extended longitudinally from the elongated flexible instrument 200. In some examples, extending the needle into the tissue may include rotating the helical needle into the tissue while the needle is longitudinally advanced relative to the distal portion of the elongated flexible instrument 200. In some examples, extending the needle into the tissue may include 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 may include rotating the helical needle into the tissue while the needle is longitudinally retracted 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 manually actuated and / or actuated by the grasper drive system 212. For example, Fig. 10A The grasping device 206 is shown extending from the elongated flexible instrument 200 prior to engagement with the tissue wall 1000. For example, Fig. 10B Grasping device 206 is shown extending into tissue wall 1000 and beginning to fold the tissue.
[0065] At process 906, sensor information regarding penetration of the tissue grasping device into the tissue may be received. For example, the sensor system 210 may detect sensor information regarding penetration of the needle 206 into the tissue. The sensor system 210 may detect the penetration depth of the needle 206, whether the needle 206 has completely penetrated through the tissue wall, whether any organs outside the target tissue have been affected, and / or which layer of tissue has been reached. The sensor system may detect the penetration using, for example, a pressure sensor system, an optical sensor system, an electrical sensor system, a fiber optic sensor system, an imaging system, an encoder in a drive system, differential measurements, or a combination of sensor information from any of the above sensor systems. In some examples, as described above, the sensor system 210 may detect the penetration depth of the needle 206, whether the needle 206 has completely penetrated through the tissue wall, whether any organs outside the target tissue have been affected, and / or which layer of tissue has been reached. Fig. 10C As shown, when the needle extends into the tissue, the spiral needle 206 pulls the tissue 1000 into a fold. When the spiral needle 206 punctures the tissue 1000, the sensor system can use any of the sensor systems described above to detect sensor information about the puncture of the needle. For example, the sensor system 210 may include a strain sensor, such as an optical fiber strain sensor extending within the needle 206. When the needle 206 pulls or pushes the tissue 1000, the optical fiber strain sensor can measure the resistance. The strain measurement value obtained by the optical fiber strain sensor can be used to determine whether full thickness puncture has been achieved.
[0066] At process 908, the puncture information can be used to control the tissue grasper drive system. For example, the control system 208 can control the grasper drive system 212 based on the received sensor information. In some examples, the control system 208 can control whether to start, terminate, or reverse the puncture. In some examples, the control system 208 can control the speed and depth of the puncture based on the received sensor information. The control system can control both the depth and puncture of the needle through the needle drive system 212. In other examples, the control system 208 can provide user feedback on the needle penetration depth, errors in tissue grasping / handling, and whether the resistance caused by the tissue allows the instrument to be safely retracted to fold the tissue.
[0067] At optional process 910, a medical procedure may be performed with the instrument system while tissue is being grasped by the tissue grasping device. Fig. 10C As shown, when needle 206 grabs tissue 1000, a portion of instrument system 202 (e.g., suture needle 253 from instrument system 252) can be swept across folded tissue 1000 to tie sutures at the fold. In other examples, the instrument system can ablate tissue, biopsy tissue, treat tissue, or otherwise perform a medical procedure while needle 206 grabs tissue.
[0068] Fig.11A robot-assisted medical system according to some examples is shown. In some examples, the systems and methods disclosed herein can be used for medical procedures performed with a robot-assisted medical system, as described in further detail below. As shown in FIG. 13 , a robot-assisted medical system 1300 may include a manipulator assembly 1302 for operating a medical instrument 1304 (e.g., an endoscopic instrument system 100 or any instrument described herein) to perform various procedures on a patient P positioned on a table T in a surgical environment 1301. The manipulator assembly 1302 may be a teleoperated assembly, a non-teleoperated assembly, or a hybrid teleoperated and non-teleoperated assembly having selected degrees of freedom of motion that may be motorized and / or teleoperated and selected degrees of freedom of motion that may be non-motorized and / or non-teleoperated. A main assembly 1306 that may be inside or outside the surgical environment 1301 typically includes one or more control devices for controlling the manipulator assembly 1302. The manipulator assembly 1302 supports the medical instrument 1304 and may optionally include a plurality of actuators or motors that drive inputs on the medical instrument 1304 in response to commands from a control system 1312. The actuator may optionally include a drive system that, when coupled to the medical device 1304, can advance the medical device 1304 into a natural or surgically created anatomical orifice. Other drive systems can move the distal end of the medical device in multiple degrees of freedom, which may include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and three degrees of rotational motion (e.g., rotation around the X, Y, Z Cartesian axes). The manipulator assembly 1302 can support various other systems for irrigation, treatment, or other purposes. Such systems may include fluid systems (e.g., including reservoirs, heating / cooling elements, pumps, and valves), generators, lasers, interrogators, and ablation components.
[0069] The robotic-assisted medical system 1300 also includes a display system 1310 for displaying images or representations of the surgical site and medical instrument 1304 generated by the sensor system 1308, which may include an endoscopic imaging system. The display system 1310 and the main assembly 1306 may be oriented so that the operator O can control the medical instrument 1304 and the main assembly 1306 with a telepresence perception. Any of the previously described graphical user interfaces may be capable of being displayed on the display system 1310 and / or the display system of the independent planning workstation.
[0070] The sensor system 1308 may include a position / location 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, posture, and / or shape of the medical device 1304. The sensor system 1308 may also include temperature, pressure, force, or contact sensors, etc.
[0071] The robot-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 implementing control between the medical device 1304, the main component 1306, the sensor system 1308, and the display system 1310. The control system 1312 also includes programming instructions (e.g., a non-transitory machine-readable medium storing instructions) to implement multiple operating modes of the robot-assisted medical system, including a navigation planning mode, a navigation mode, and / or a program mode. The control system 1312 also includes programming instructions (e.g., a non-transitory machine-readable medium storing instructions) to implement some or all of the processes described according to the aspects disclosed herein, including, for example, extending the expandable device, adjusting the temperature of the heating system, adjusting the valve to control fluid delivery, controlling the fluid flow rate, controlling the insertion and retraction of the treatment device, controlling the actuation of the distal end of the treatment device, receiving sensor information, changing the signal based on the sensor information, selecting a treatment position, and / or determining the size to which the expandable device can be expanded.
[0072] The control system 1312 may also optionally include a virtual visualization system to provide navigation assistance to the operator O when controlling the medical device 1304 during an image-guided surgical procedure. Virtual navigation using the virtual visualization system can be based on reference to a preoperative or intraoperative data set of acquired anatomical pathways. The virtual visualization system processes images of the surgical site imaged using imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermal imaging, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, etc. The control system 1312 can use the preoperative images to locate the target tissue (using visual imaging techniques and / or by receiving user input) and create a preoperative plan, including an optimal first position for performing bronchial pathway and vasculature occlusion. The preoperative plan can include, for example, a planned size of the expandable device, a treatment duration, a treatment temperature, and / or multiple deployment positions.
[0073] In the description, specific details describing some examples have been set forth. Many specific details are set forth to provide a thorough understanding of the examples. However, it will be apparent to those skilled in the art that some examples may be practiced without some or all of these specific details. The specific examples disclosed herein are intended to illustrate rather than to limit. Those skilled in the art may realize other elements within the scope and spirit of the present disclosure, although not specifically described herein.
[0074] As long as feasible, the elements described in detail with reference to an example, implementation or application may be optionally included in other examples, implementations or applications in which they are not specifically shown or described. For example, if an element is described in detail with reference to an example without being described with reference to a second example, the element may still be considered to be included in the second example. Therefore, in order to avoid unnecessary repetition in the description, one or more elements shown and described in association with an example, implementation or application may be incorporated into other examples, implementations or aspects, unless otherwise specifically described, unless the one or more elements make the example or implementation inoperative, or unless two or more elements in the element provide conflicting functions. Not all of the processes shown may be performed in all examples of the disclosed method. In addition, one or more processes not explicitly shown may be included before, after, between or as part of the process shown. In some examples, one or more of the processes may be performed by a control system, or may be implemented at least in part in the form of executable code stored on a non-transient, tangible, machine-readable medium, which may cause one or more of the one or more processors to perform the process when run by one or more processors.
[0075] Any changes and further modifications to the described devices, apparatuses, methods, and any 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 relates. In addition, the dimensions provided herein are for specific examples, and it is conceivable that different sizes, dimensions, and / or ratios may be utilized to implement the concepts of the present disclosure. In order to avoid unnecessary descriptive repetition, one or more components or actions described according to one illustrative example may be used in other illustrative examples or omitted from other illustrative examples where applicable. For the sake of brevity, multiple iterations of these combinations will not be described separately. For simplicity, in some cases, the same reference numerals are used throughout the accompanying drawings to refer to the same or similar parts.
[0076] The systems and methods described herein can be applied to imaging any of various anatomical systems via natural or surgically created connection pathways, including lungs, colon, intestines, stomach, liver, kidneys and calyces, brain, heart, circulatory system including vascular system, etc. Although some examples of medical procedures are provided herein, any reference to medical or surgical instruments and medical or surgical methods is non-restrictive. For example, the instruments, systems and methods described herein can be used for non-medical purposes, including industrial uses, general robotic uses, and sensing or manipulating non-tissue artifacts. Other example applications relate to cosmetic improvements, imaging of human or animal anatomical structures, collecting data from human or animal anatomical structures, and training medical or non-medical personnel. Additional example applications include the use of procedures for tissues removed from human or animal anatomical structures (not returned to human or animal anatomical structures), and performing procedures on human or animal corpses. In addition, these technologies can also be used for surgical and non-surgical medical treatment or diagnostic procedures.
[0077] One or more elements in the examples of the present disclosure may be implemented in software to be executed 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. A program or code segment may be stored in a processor-readable storage medium or device, which may be downloaded via a computer data signal embodied in a carrier wave over a transmission medium or a communication link. A processor-readable storage device may include any medium capable of storing information, including optical media, semiconductor media, and / or magnetic media. Examples of processor-readable storage devices include electronic circuits; semiconductor devices, semiconductor storage 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 via a computer network (such as the Internet, an intranet, etc.). Any of a variety of centralized or distributed data processing architectures may be used. Programming instructions may be implemented as multiple separate programs or subroutines, or they may be integrated into multiple other aspects of the systems described herein. In some examples, the control system can support wireless communication protocols such as Bluetooth, infrared data communication (IrDA), HomeRF, IEEE 802.11, digital enhanced cordless telecommunications (DECT), ultra-wideband (UWB), ZigBee, and wireless telemetry.
[0078] Note that the processes and displays presented may not be inherently related to any particular computer or other apparatus. Various general-purpose systems may be used with programs according to the teachings herein, or it may prove convenient to build more specialized equipment to perform the described operations. The structures required for various such systems will appear as elements in the claims. In addition, examples of the present invention are described without reference to any particular programming language. It should be understood that various programming languages may be used to implement the teachings of the present invention as described herein.
[0079] The present disclosure describes various instruments, parts of instruments and anatomical structures according to their states in three-dimensional space. As used herein, the term positioning refers to the position of an object or a part of an object 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 placement of an object or a part of an object (e.g., in one or more rotational degrees of freedom (such as roll, pitch and / or yaw)). As used herein, the term attitude refers to the positioning of an object or a part of an object on at least one translational degree of freedom, and the orientation of the object or a part of an object on at least one rotational degree of freedom (e.g., up to six total degrees of freedom). As used herein, the term shape refers to a group of attitudes, positioning or orientation measured along an object.
[0080] While certain illustrative examples of the invention have been described and shown in the drawings, it should be understood that these examples are intended to illustrate and not to limit the broad invention, and that the examples of the invention are not limited to the specific construction and arrangements shown and described, since various other modifications may occur to those skilled in the art.
Claims
1. A system comprising: Slender and flexible instruments; a tissue grasping device including a helical needle extending from a distal end of the elongated flexible instrument; a grasper drive system coupled to the tissue grasping device to drive movement of the tissue grasping device; a sensor system coupled to the tissue grasping device; and A control system is configured to receive sensor information from the sensor system and control the gripper drive system in response to the received sensor information. 2 . The system of claim 1 , wherein controlling the gripper drive system comprises providing an actuation signal to the gripper drive system. 3 . The system of claim 1 , wherein controlling the gripper drive system comprises adjusting a setting of the gripper drive system. The system of claim 1 , wherein the sensor information is displayed on a user interface.
5. The system of claim 1 further comprising an instrument system that communicates with the control system.
6. The system of claim 5, wherein the instrument system is at least one of: Suture system, Biopsy system, Treatment system, or Ablation system.
7. The system of claim 5, wherein the instrument 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 hollow and components of the sensor system extend within 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 comprises a straight needle and the helical needle is wrapped around an axis of the straight needle.
12. The system of claim 1, wherein the sensor system comprises a pressure sensor.
13. The system of claim 12, wherein the pressure sensor is configured to detect changes in fluid pressure in a lumen extending through the tissue grasping device.
14. The system of claim 1, wherein the sensor system comprises an optical sensor.
15. The system of claim 14, wherein the optical sensor is configured to detect a change in a parameter of reflected light when the tissue grasping device punctures tissue.
16. The system of claim 1, wherein the sensor system comprises an electrical sensor.
17. The system of claim 16, wherein the electrical sensor is configured to detect a change in an electrical property when the tissue grasping device penetrates tissue.
18. The system of claim 1, wherein the sensor system comprises a fiber optic sensor.
19. The system of claim 18, wherein the fiber optic sensor is configured to detect changes in strain when the tissue grasping device penetrates tissue.
20. The system of claim 18, wherein the fiber optic sensor is configured to detect a change in shape of the tissue grasping device as the tissue grasping device 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 comprises an encoder in the gripper drive system.
23. The system of claim 1, wherein the tissue grasping device comprises a slidable elongated core.
24. The system of claim 1, wherein a slidable sheath extends around the tissue grasping device.
25. A system comprising: processor; and a memory having computer readable instructions stored thereon, which when executed by the processor cause the system to: extending an elongated flexible device in the intraluminal passage; extending a tissue grasping device including a helical needle from the elongated flexible instrument into the tissue; receiving sensor information from a sensor system regarding penetration of the tissue grasping device into the tissue; and A drive system coupled to the tissue grasping device is controlled based on the received sensor information.
26. The system of claim 25, wherein controlling the drive system comprises sending at least one of the actuation signals to the drive system.
27. The system of claim 25, wherein controlling the drive system comprises adjusting a speed of the drive system.
28. The system of claim 25, wherein controlling the drive system comprises adjusting penetration depth.
29. The system of claim 25, wherein control of the drive system is automated.
30. The system of claim 25, wherein the received sensor information is displayed on a user interface.
31. The system of claim 25, wherein the computer readable instructions, when executed by the processor, further cause the system to activate an instrument system to perform an interventional procedure when the tissue grasping device has penetrated the tissue.