System and method for endoluminal tissue manipulation

Abstract

The system and method for endoluminal tissue manipulation are provided. In one embodiment, said system comprises: i) A magnetic retractor reversibly attached to a delivery mechanism, said magnetic retractor comprises a clip and at least one flexible magnetic component; and ii) a magnetic control system; wherein said delivery mechanism is adapted to control said magnetic retractor to clip at a desired location before releasing said magnetic retractor; said magnetic control system is adapted to locate and control movement of said magnetic retractor released from said delivery mechanism.

Description

SYSTEM AND METHOD FOR ENDOLUMINAL TISSUE MANIPULATION FIELD OF THE INVENTION

[0001] The present invention relates to systems and methods for endoluminal tissue manipulation.BACKGROUND OF THE INVENTION

[0002] Gastrointestinal (GI) cancers account for 1 in 4 cancer cases and 1 in 3 cancer deaths globally [1]. Especially in Hong Kong, colorectum cancer is the second most common cancer, and stomach is the sixth in 2021 [2], Usually, endoscopic resection will be achieved for the early stage of tumor within GI tract, and endoscopic submucosal dissection (ESD) is often used for the submucosal resection. While dealing with the flat or large lesions, there is a need for traction of tissue to aid the resection process. The lack of reliable traction in ESD contributes to its technical demand and increased procedure time.

[0003] Without using new device for traction, double scope method was introduced by Fujii, Larissa et al. “Dual-scope endoscopic deep dissection of proximal gastric tumors (with video).” Gastrointestinal endoscopy vol. 78, 2 (2013): 365-9. doi: 10.1016 / j. gie. 2012. 12. 010.

[0004] This method requires two endoscopes during the operation. The main endoscope is responsible for the resection process. The second endoscope is inserted along the main endoscope and deploys forceps or other instrument to provide traction of the lesion site. Although this method can fully control the traction of tissue, two endoscopes have interfered with each other and requires a large working space. Also, it increases the complexity of ESD which requires two surgeons and two endoscope systems to perform the procedures.

[0005] Different new traction devices and methods have been developed to provide sufficient tension for the dissection plane and a good field of vision during the ESD procedure. The related works are listed below:A. Sakamoto, Naoto et al. “Endoscopic submucosal dissection of large colorectal tumors by using a novel spring-action S-0 clip for traction (with video).” Gastrointestinal endoscopy vol. 69,7 (2009): 1370-4. doi: 10. 1016 / j. gie. 2008. 12. 245.B. Mori, Hirohito et al. “Novel effective and repeatedly available ring -thread counter traction for safer colorectal endoscopic submucosal dissection.” Surgical endoscopy vol. 31,7 (2017): 3040-3047. doi: 10.1007 / s00464-016-5326-7.C. Sudo, Gota et al. “Multiloop method for traction during colorectal endoscopic submucosal dissection.” VideoGIE: an official video journal of the American Society for Gastrointestinal Endoscopy vol. 4,1 11-13. 23 Nov. 2018, doi: 10.1016 / j.vgie.2018.10.002ss.These methods deploy two or more clips to anchor both lesion site and the wall of organ. This requires a relatively larger workspace, mainly targeted in colorectum and some for stomach. The clips are connected and restricted by springs or strings. These methods can control traction direction by deploying new clip(s) to anchor the string of their device on new location(s). Although it does not require withdrawal of the endoscope, it put a halt of the resection process when controlling the traction direction. Besides, they need another clip anchor on the wall to provide traction force. Another disadvantage is that their traction force is weakened during resection process due to the reduce of distance between two anchoring clips. The traction force varies during the resection process.

[0006] Compared with the above traction method, magnetic traction method can manipulate the internal magnetic retractor externally and take no extra working channel during traction. Some related works on magnetic traction system are listed as follows:A. Kobayashi, Toshiaki et al. “Magnetic anchor for more effective endoscopic mucosal resection.” Japanese journal of clinical oncology vol. 34,3 (2004): 118- 23. doi: 10.1093 / jjco / hyh025B. Gotoda, Takuji et al. “Prospective clinical trial of magnetic-anchor-guided endoscopic submucosal dissection for large early gastric cancer (with videos).” Gastrointestinal endoscopy vol. 69,1 (2009): 10-5. doi: 10. 1016 / j. gie. 2008. 03. 1127C. Matsuzaki, Ippei et al. “Magnetic anchor-guided endoscopic submucosal dissection for gastric lesions (with video).” Gastrointestinal endoscopy vol. 87,6 (2018): 1576-1580. doi: 10.1016 / j.gie.2018.01.015D. Rodriguez Sanchez, Joaquin et al. “Electromagnetic assisted endoscopic submucosal dissection is more efficient than water-jet assisted and conventional ESD in experimental model.” Endoscopy international open vol. 6,4 (2018): E498-E504. doi: 10. 1055 / s-0043-125364E. Pan, Min et al. “Magnetic anchor technique assisted endoscopic submucosal dissection for early esophageal cancer.” World journal of gastrointestinal endoscopy vol. 15,10 (2023): 584-592. doi: 10.4253 / wjge.vl5.il0.584F. Wan, Xinyue et al. “The efficient of application of a fine magnetic traction system simplifies colorectal endoscopic submucosal dissection: A porcine study.” Asian journal of surgery vol. 46,1 (2023): 520-525. doi: 10. 1016 / j .asjsur.2022.06.037

[0007] Most of the current magnetic traction methods require withdrawal the endoscope to prepare the internal magnet element on the clip before the deployment of retractor. The large size of internal magnet element used in which it cannot fit inside the instrument channel. They have no localization method to detect the position of internal traction device. This heavily relies on the experience of surgeon to estimate the position of the internal traction device and try-and-error of the control of the external magnetic source to achieve a manipulation of the traction.

[0008] Hence, it shall be desirable to provide a magnetic retractor that requires no withdrawal of the endoscope, no extra instrument channel needed after deployment.The magnetic retractor could be generally used in different regions of GI tract includes but not limited to esophagus, stomach, and colorectal region. With an easily controlled magnetic retractor that providing consistent traction force, which could reduce the time needed and improve the process of ESD significantly.SUMMARY OF THE INVENTION

[0009] This invention provides a system for endoluminal tissue manipulation. In one embodiment, said system comprises: i) A magnetic retractor reversibly attached to a delivery mechanism, said magnetic retractor comprises a clip and at least one flexible magnetic component; and ii) a magnetic control system; wherein said delivery mechanism is adapted to control said magnetic retractor to clip at a desired location before releasing said magnetic retractor; said magnetic control system is adapted to locate and control movement of said magnetic retractor released from said delivery mechanism.

[0010] This invention also provides methods for using the system of this invention. IN one embodiment, said method comprises the steps of: a) Providing said magnetic retractor to a desired site using said delivery mechanism; b) Clipping said magnetic retractor to said desired site; c) Releasing said magnetic retractor from said delivery mechanism; d) Controlling movement of said magnetic retractor with said magnetic control system; and e) Removal of said magnetic retractor from said desired site.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1 is a block diagram showing the magnetic retractor system with patient’s body (1), which includes: surgical device and magnetic retractor(s) (2), magnetic control system (3), user interface device (4).

[0012] FIG. 2A-B depict said magnetic retractor system targets in endoluminal surgery, includes esophagus (1-1), stomach (1-2), duodenum (1-3), colorectal region (1-4). And illustrate the general view of its operation in several regions.

[0013] FIG. 3A-C depict the flexible magnetic clip, variations of the magnetic retractor designs allow it pass through curved channels.

[0014] FIG. 4A depicts cross-section view of illustrative variation of one-piece design of the magnetic retractor (6) and its detachable function, in which consist of shaft (2- 3), clip (2-5), embedded magnet element (2-4-1).

[0015] FIG. 4B depicts an illustrative variation of magnetic retractor with separated magnet element design (7), and its detachable function, in which consist of shaft (2-3), clip (2-5), magnet element (2-4-2-2), connection method (2-4-2-1) between said clip and said magnet element.

[0016] FIG. 5 depicts an illustrative variation of the overall system, consisting of surgical device and magnetic retractor (2), a magnetic actuation source (3-1), a magnetic localization system (3-2).

[0017] FIG. 6 depicts an illustrative variation of user interface device (4).

[0018] FIG. 7 depicts a flow chart of tissue traction procedure in endoscopic submucosal dissection (ESD) while using magnetic retraction system.

[0019] FIG. 8A-G depict a perspective view of an ESD with magnetic retractor system in the stomach in seven steps.

[0020] FIG. 9A-D depict perspective views of multiple clipping strategies of the magnetic retractor with 3D space consideration.

[0021] FIG. 10A-G depict illustrative variations of magnet element designs with flexibility and reconfigurability.

[0022] FIG. 11A-B depict illustrative variations of method in using multiple retractors to one tissue for manipulation.

[0023] FIG. 12A-B depict a side view of the ability to change numbers of magnet elements after deployment in variations of magnetic retractor designs.

[0024] FIG. 13 depicts a perspective view of tissue manipulation with magnetic localization system (3-2) and a controllable magnetic actuation source (3-1).DETAILED DESCRIPTION OF THE INVENTION

[0025] The present invention relates to systems and methods for providing dynamic traction onto endoluminal tissue through magnetic control technology, and the utilization of flexible magnetic clips for endoluminal surgical devices to conduct surgical interventions.

[0026] Described here are system for dynamic tissue manipulation in endoluminal environments; and methods of designing a surgical magnetic retractor that is utilized in endoluminal surgical devices, especially for flexible channel, and using magnetic retractor to perform tissue manipulation during surgical procedures.

[0027] In some variations, the endoluminal surgical devices can be flexible devices, for example, but not limit to, colonoscope, or non-flexible devices and the endoluminal tissues are generally in different endo-lumen environments, comprising but not except for esophagus, stomach, and colorectal regions.

[0028] The system may comprise a flexible magnetic clip for endoluminal surgical devices which contains a magnetic retractor embedding different magnetic elements’ configurations and a delivery mechanism so that it could deform for passing through flexible channel; an external magnetic actuation source generating a magnetic field which produces the relative magnetic wrench on in vivo magnetic elements of the magnetic retractor; a magnetic localization system measuring the pose of the magnetic retractor by utilizing the magnetic sensor technology and conducting magnetic localization algorithm; user interface device for the controlling of the magnetic retractor towards endoluminal tissue manipulation.

[0029] In some variations, the magnetic retractor may contain a detachable clinic clip device for the endoluminal tissue manipulation, magnetic elements for producing magnetic wrench; and a tail mechanism for inserting the detachable clinic clip and the magnetic elements through the channels of the endoluminal surgical devices. Besides, the magnetic actuation source may contain controllable magnetic field generators to actuate the motions of the magnetic retractors, and a frame holding these components. In addition, the magnetic localization system may comprise magnetic sensor arrays for positioning the pose of the magnetic retractors and a frame holding these sensors. Finally, the user interface device may comprise a controller module for receiving the controlling commands, a communication module for sending the controlling commands.

[0030] In some variations, the magnetic field can be generated by permanent magnets or electromagnets, or the combination of permanent magnets and electromagnets. Besides, the magnetic sensor arrays in the magnetic localization system can be planner sensor array and heterogeneous sensor array which may comprise sensors mounting printed circuit board and multiple-axis Hall -effect sensors.

[0031] One of the present methods is designing the magnetic retractor with magnetic elements, which may comprise two approaches to design magnetic elements: the first one is designing magnetic elements are embedded in the detachable clip, and the second is designing magnetic elements are tied with one leg of the detachable clip. Notedly, the magnetic retractor has reconfigurable performances.

[0032] In some variations, the magnetic elements may be single magnets or multiple magnets. Besides, the materials of magnetic elements may be rigid or soft materials. Moreover, multiple magnets may be a combination of magnets with different numbers and different magnetic moment directions and the multiple magnets may be constrained by means of, but not limit to, backbones, or sheath, or mechanical joints, or self-magnetic attraction. In addition, magnets may be different configurations in shape, which may include cuboid, ellipsoid, and other irregular bodies.

[0033] In some variations, the reconfigurable performance of magnetic retractor can be pre -configurable performance, for example, the length and magnetic configuration of the magnetic retractor can be reconstructed to different types before using, and adaptive configurable performance, for example, but not limit to, the shapes and curvatures of the magnetic retractor can change adaptively inside the endo-lumen channel.

[0034] Another method is proposing a surgical procedure workflow. The overall workflow may comprise the preparation procedures before magnetic retractor deployment, magnetic retractor deployment, magnetic retractor localization and control, operation during tissue manipulation.

[0035] Before performing the dynamic traction, preparing procedures are conducted, which may comprise, for example in endoscopic submucosal dissection, spot the target region for dissection with the endoscope; create coagulation marking around the endoluminal tissue boundary; perform submucosal injection around the perimeter of the endoluminal tissue; incision of the mucosa followed by a circumferential cut around the target using an electrical knife.

[0036] Performing the dynamic traction may include two steps: magnetic retractor deployment; magnetic retractor localization and control. There are two conditional judgements, which are judging enough magnetic retractor and judging satisfied retraction onto the endoluminal issue.

[0037] After performing the dynamic traction, finishing procedures are conducted, which may comprise remove the magnetic actuation source; take out the dissected endoluminal tissue.

[0038] In some variations, the dynamic traction is performed by the magnetic retractors in different clipping strategies, including both passive and active traction of theendoluminal tissue regarding to the relation between the gravity and the magnetic retractor. Precisely, the clipping strategy may include the number of the magnetic retractors, the deployment position around the endoluminal tissue of the magnetic retractors, and the controlling motions of the magnetic retractors, which depends on the different the endo-lumen environments and is determined preferentially by the surgeon.

[0039] In some variations, the dynamic traction may comprise multiple degrees of freedom motion and the endoluminal tissue manipulation can be drag and rotation.

[0040] This invention provides a system for endoluminal tissue manipulation. In one embodiment, said system comprises: a flexible magnetic clip; and a magnetic control system; and a user interface device.

[0041] In one embodiment, said flexible magnetic clip contains a magnetic retractor and a delivery mechanism for inserting said magnetic retractor through working channels of endoluminal surgical devices.

[0042] In one embodiment, said magnetic retractor contains a detachable clip for said endoluminal tissue manipulation, magnetic elements for producing magnetic wrench.

[0043] In one embodiment, said magnetic control system comprises a magnetic actuation source, generating a magnetic field.

[0044] In one embodiment, said magnetic actuation source contains controllable magnetic field generators to actuate the motions of said magnetic retractors, and a frame holding these magnetic field generators.

[0045] In one embodiment, said magnetic control system further comprises a magnetic localization system to measure the position and / or pose of said magnetic retractor.

[0046] In one embodiment, said magnetic localization system comprises magnetic sensor arrays for localizing said magnetic retractors and a frame holding said sensor arrays.

[0047] In one embodiment, said user interface device is for the control of said magnetic retractor in endoluminal tissue manipulation. It comprises a controller module for receiving controlling commands, and a communication module for sending said controlling commands.

[0048] This invention also provides methods for designing said flexible magnetic clip and using said flexible magnetic clip to perform a surgical procedure, comprising: designing said magnetic retractor with magnetic elements; and inserting said magnetic retractor into said endoluminal surgical devices through a channel; and deploying said magnetic retractor to clip said endoluminal tissue; and driving said magnetic retractor to achieve dynamic traction and / or manipulation for said endoluminal tissue.

[0049] In one embodiment, designing said magnetic retractor with magnetic elements, comprises two approaches: a) said magnetic elements are embedded in said detachable clip; b) said magnetic elements are tied with said detachable clip.

[0050] In one embodiment, said magnetic elements can be a single magnet or multiple magnets.

[0051] In one embodiment, said magnetic elements can be magnet of rigid or soft materials.

[0052] In one embodiment, said multiple magnets can be a combination of magnets with different numbers and different magnetic moment directions.

[0053] In one embodiment, said multiple magnets can be connected by means of, but not limited to, backbones, sheath, mechanical joints, or magnetic attraction.

[0054] In one embodiment, said magnets can vary in shape, including but not limited to cuboid, ellipsoid, cylinder, ball, and other irregular body.

[0055] In one embodiment, said magnetic retractor is reconfigurable in terms of length, shape, curvature and magnetic moment configuration.

[0056] In one embodiment, said endoluminal surgical devices can be flexible devices with a channel, including but not limited to colonoscope, gastroscope, bronchoscope, ureteroscope, or non-flexible devices with a channel.

[0057] In one embodiment, said channel of said endoluminal surgical devices is for passing said flexible magnetic clip.

[0058] In one embodiment, the deploying number of said magnetic retractor can be one or more.

[0059] In one embodiment, said dynamic traction comprises multiple degrees of freedom motion.

[0060] In one embodiment, said endoluminal tissue manipulation can include but not limited to pull, pan, rotate, and tilt.

[0061] In one embodiment, said endoluminal tissues are generally in different endolumen environments, comprising but not limited to esophagus, stomach, colon, bladder, lung, and abdominal regions.

[0062] In one embodiment, magnetic field can be generated by permanent magnets or electromagnets, or the combination of permanent magnets and electromagnets.

[0063] In one embodiment, said driving said magnetic retractor comprises positioning the pose of said magnetic retractor; applying a desired magnetic field by said magnetic actuation system to control said magnetic retractor to move the endoluminal tissue; adjusting said magnetic retractors by the user interface device under a magnetic control strategy by means of said magnetic localization system and said magnetic actuation system to perform dynamic traction, wherein a) said magnetic control strategy contains a magnetic localization algorithm with program instructions based on magnetic fields measured by said magnetic sensor arrays for obtaining pose of said magnetic retractor, b) a magnetic control algorithm with program instructions based on said pose of saidmagnetic retractor by said magnetic localization algorithm to obtain the magnetic control output of said magnetic actuation source.

[0064] In one embodiment, said user interface device can be attached to said endoluminal surgical device for convenient control.

[0065] In one embodiment, said magnetic sensor arrays in said magnetic localization system can be planer sensor array or heterogeneous sensor array.

[0066] In one embodiment, said dynamic traction is performed by said magnetic retractors in different clipping strategies.

[0067] In one embodiment, said different clipping strategies include both passive and active traction of said endoluminal tissue.

[0068] In one embodiment, said different clipping strategies include targeting on tissues in different position in 3D space inside the said different endo-lumen environments, traction performed against or follow gravity.

[0069] In one embodiment, said magnetic retractors conducting wrench on said endoluminal tissue. Said wrench can be from said magnetic wrench, or the gravity, or the combine action of said magnetic wrench and the gravity.

[0070] In one embodiment, said clipping strategy includes the number of said magnetic retractors, the deployment position around said endoluminal tissue of said magnetic retractors, and the controlling motions of said magnetic retractors, which depends on the said endo-lumen environments and is determined by the user.

[0071] In one embodiment, before performing said dynamic traction, for example being used for endoscopic submucosal dissection, preparation procedures are conducted, comprising: a) spot the target region for dissection with said endoscope, b) create coagulation marking around said endoluminal tissue boundary, c) perform submucosal injection around the perimeter of said endoluminal tissue, d) dissect of the mucosa followed by a circumferential cut around the endoluminal.

[0072] In one embodiment, after performing said dynamic traction, finishing procedures are conducted, comprising: a) remove said magnetic actuation source, b) take out the dissected endoluminal tissue.

[0073] In one embodiment, taking out said endoluminal tissue are performed by said endoluminal surgical device or the combination of said endoluminal surgical device and said magnetic retractor under the actuation of said magnetic actuation system.

[0074] In one embodiment, performing said dynamic traction includes two steps: a) Magnetic retractor deployment, b) Magnetic retractor motion control.

[0075] In one embodiment, said magnetic retractor motion control could be guided by users or computer controllers to achieve sufficient endoluminal tissue manipulation.

[0076] In one embodiment, said endoluminal tissue can be different size and weights based on the actual operation.

[0077] This invention provides a system for endoluminal tissue manipulation. In one embodiment, said system comprises: i) A magnetic retractor reversibly attached to a delivery mechanism, said magnetic retractor comprises a clip and at least one flexible magnetic component; and ii) a magnetic control system; wherein said delivery mechanism is adapted to control said magnetic retractor to clip at a desired location before releasing said magnetic retractor; said magnetic control system is adapted to locate and control movement of said magnetic retractor released from said delivery mechanism.

[0078] In one embodiment, said magnetic retractor is adapted to pass through working channels of an endoluminal surgical device.

[0079] In one embodiment, said endoluminal surgical device comprises one or more selected from the group consisting of colonoscope and gastroscope.

[0080] In one embodiment, said delivery mechanism is adapted to deliver said magnetic retractor through working channels of an endoluminal surgical device.

[0081] In one embodiment, said endoluminal surgical device comprises one or more selected from the group consisting of colonoscope and gastroscope.

[0082] In one embodiment, said magnetic control system comprises a magnetic actuation source for generating a magnetic field.

[0083] In one embodiment, said magnetic actuation source comprising controllable magnetic field generators to actuate the motions of said magnetic retractors, and a frame holding these magnetic field generators.

[0084] In one embodiment, said magnetic control system further comprises a magnetic localization system to measure position and / or pose of said magnetic retractor.

[0085] In one embodiment, said magnetic localization system comprises magnetic sensor arrays for localizing said magnetic retractors.

[0086] In one embodiment, said system further comprises a user interface device for controlling said magnetic retractor, said user interface device comprises a controller module for receiving controlling commands, and a communication module for sending said controlling commands.

[0087] In one embodiment, said at least one flexible magnetic component comprises magnets embedded within said magnetic retractor or magnets attached to said magnetic retractor externally via an attachment mechanism.

[0088] In one embodiment, said at least one flexible magnetic component comprises: a) a plurality of magnetic beads with through holes, wherein said plurality of magnetic beads are stringed together with a backbone which is connected to said magnetic retractor; b) a magnetic bead with through hole and a plurality of solid magnetic beads, wherein said magnetic bead with through hole is connected to said magnetic retractor via said through hole; and said plurality of solid magnetic beads are constrained by self- magnetic attraction; c) a plurality of magnetic beads connected and restrained bychainlike structures or mechanical joints; or d) a soft magnetic slug attached to a backbone.

[0089] In one embodiment, said magnetic beads with though holes in (a) or (b), said solid magnetic beads in (b) are one or more selected from the group consisting of round beads, cylindrical beads, prismatic beads.

[0090] In one embodiment, said cylindrical beads comprise fillets.

[0091] This invention also provides methods for using the system of this invention. IN one embodiment, said method comprises the steps of: a) Providing said magnetic retractor to a desired site using said delivery mechanism; b) Clipping said magnetic retractor to said desired site; c) Releasing said magnetic retractor from said delivery mechanism; d) Controlling movement of said magnetic retractor with said magnetic control system; and e) Removal of said magnetic retractor from said desired site.

[0092] In one embodiment, said desired site comprises a site within esophagus, stomach, colon, bladder, lung, or abdominal region.

[0093] In one embodiment, said movement comprises one or more selected from wrenching, pulling, pan, rotating, and tilting.

[0094] In one embodiment, said magnetic control system controls movement of said magnetic retractor by generating an appropriate magnetic field to interact with said at least one flexible magnetic component.

[0095] In one embodiment, said system comprises more than one magnetic retractor.

[0096] The present invention consists in a system for dynamic tissue manipulation in endoluminal environments, and methods of designing a surgical magnetic retractor that is utilized in endoluminal surgical devices, especially for flexible channel, and using said magnetic retractor to perform tissue manipulation during surgical procedures, comprising:

[0097] at least a flexible magnetic clip for endoluminal surgical devices which could deform for passing through flexible channel which contains a magnetic retractor with different magnetic elements’ configurations and a delivery mechanism; an external magnetic actuation source generating a magnetic field which produces the relative magnetic wrench on said in vivo magnetic elements of said magnetic retractor; a magnetic localization system measuring the pose of said magnetic retractor by utilizing the magnetic sensor technology and conducting magnetic localization algorithm; user interface device for the controlling of said magnetic retractor towards endoluminal tissue manipulation.

[0098] at least two approaches to design magnetic elements: the first one is designing magnetic elements are embedded in said detachable clip as shown in FIG. 4B, and the second is designing magnetic elements are tied with one leg of said detachable clip as shown in FIG. 4C.

[0099] at least a surgical procedure workflow: a. preparing procedures before magnetic retractor deployment; b. magnetic retractor deployment; c. magnetic retractor localization and control; d. conducting operations during tissue manipulation.

[0100] As shown, for example, in the block diagram of FIG.l, the magnetic retractor system comprises of surgical device and magnetic retractor(s) (2), magnetic control system (3) comprising a magnetic actuation source and a magnetic localization system, user interface device (4) comprising a remote-control controller which can receive the controlling commands and send said controlling commands for convenient control by surgeons.

[0101] The target working space for our invention is the shown in FIG. 2A, where is the esophagus (1-1), stomach (1-2), duodenum (1-3), colorectal region (1-4).

[0102] As shown, for example, in the situations in FIG.2B, said magnetic retractor can pass through endoscope (2-1) and reach the endoluminal tissue in different sections of gastrointestinal tract.

[0103] Notably, one of the advantages of the present invention is that said magnetic retractor can be passed through instrument channel (2-2) of endoscope (2-1) like other endoscopic instruments in FIG.3A.

[0104] FIG. 3B illustrates a flexible magnetic clip consist of two main parts: magnetic retractor (200) and delivery mechanism (201). Shaft (2-3) of said delivery mechanism is flexible.

[0105] As shown in FIG. 3C, shaft (2-3) of said magnetic retractor, and the detachable magnetic retractor in one-piece design (600), the detachable magnetic retractor with separated magnetic element (700), the detachable magnetic retractor with separated multiple magnetic elements (701) can all go through the curved instrument channel (2- 2) of endoscope (2-1) with its flexible feature.

[0106] FIG. 4A illustrates the cross-section view of one-piece design of the magnetic retractor (6) before detachment. It is detachable and can be divided into two parts: shaft (2-3), and magnetic retractor in one-piece design (600), consists of clip (2-5) with magnet element (2-4-1) embedded on the end. To allow the metal wire (6-1) which is responsible for the clip close and fire mechanism to pass through magnet element (2-4- 1), said magnet element shape with through hole.

[0107] FIG. 4B illustrates a magnetic retractor with separated magnet element design (7) before detachment. Said design is also detachable and can be divided into two parts: shaft (2-3), and magnetic retractor with separated magnet element (700), consists of magnet element (2-4-2-2) tided with one leg of clip (2-5) through any connection method (2-4-2- 1) includes but not limited to string, or wire.

[0108] As illustrated in FIG. 5, the overall system, for example, there are a magnetic localization system (3-2) using magnetic sensor array for measuring the pose of said magnetic retractor inside the patient’s body and a magnetic actuation source (3-1), which can be, for example, a permanent magnet held by a robotic arm or electromagnets array, and surgical device and magnetic retractor that perform the surgical procedure inside the patient’s body.

[0109] When performing the surgical procedure for endoluminal environments, the endoscope is generally utilized, as shown in FIG. 6, which has a manipulation handle and working channel for the further surgical intervention. Besides, the present invention comprises a user interface device (4), which can be attached on the endoscope, for example a remote-control handle (4-1) shown in FIG. 6. Said remote-control handle is used to control the motion of said magnetic retractor directly.

[0110] As shown in FIG. 7, for example, a tissue traction procedure in an endoscopic submucosal dissection (ESD) surgical intervention, comprises four prepare steps: 1. spot the target region for dissection with the endoscope; 2. create coagulation marking around the endoluminal tissue boundary; 3. perform submucosal injection around the perimeter of tissue; 4. incision of the mucosa followed by a circumferential cut around the target using an electrical knife; and two step towards magnetic retractor deployment: 1. insert magnetic retractor through the endoscope handle till it comes out from the scope's end; 2. deploy the magnetic retractor, clip and fire on the boundary of the endoluminal tissue; and a judging condition about whether there are enough magnetic retractor which decides the repeat times of two step towards magnetic retractor deployment; and two steps toward magnetic retractor localization and control: 1. localize the pose of said magnetic retractor; 2. apply desired magnetic actuation source to control the magnetic traction; and a judging condition about whether the magnetic traction is satisfied, which decides the repeat times of two steps toward magneticretractor localization and control; and steps during tissue manipulation which further comprises: dissection of the endoluminal tissue by a series of injections and cutting tools through submucosa plane to separate the endoluminal tissue from underlying muscle layer, and a judging condition about whether the whole ESD surgical intervention is completed to decide whether to return to said judging condition about whether there are enough magnetic retractor or to turn off magnetic actuation source and take out the dissected endoluminal tissue; then, ending the tissue traction procedure in an ESD surgical intervention.

[0111] FIG 8A-G illustrate a potential usage of the present invention in ESD procedure happened in stomach (1-2). Step I, after circumferential cut around the endoluminal tissue, insert said magnetic retractor through said instrument channel of endoscope till it comes out from the scope’s end. Step II, clip and fire the said magnetic retractor on boundary of the endoluminal tissue (6-2). Magnetic retractor (200) is now detached from shaft (2-3). Step III, replace said delivery mechanism from instrument channel with electric knife (2-6). Step IV, said localization system sense and provide the pose of said magnetic retractor and apply desired said magnetic actuation source for magnetic retraction. The blank arrow indicates the direction of traction force applied on the said magnetic retractor. Step V, surgeon can perform resection on endoluminal tissue once the magnetic traction exposed the desired cut zone. Step VI, beside unidirectional traction, said magnetic actuation source can control said magnetic retractor manipulate endoluminal tissue into a flipping motion to maximize the exposure of the submucosal layer. Step VII, the endoluminal tissue detached from mucosa once the resection completed. Said magnetic actuation source can be removed and proceed to the retrieval of the dissected tissue with magnetic retractor out of patient.

[0112] FIG. 9A-C illustrate the multiple clipping strategies of using said magnetic retractor with 3D space consideration. FIG. 9A illustrates the strategy of a generalagainst gravity, endoluminal tissue is located at the bottom of the working space. With the control of said magnetic actuation source, magnetic retractor (200) can achieve dynamic motion, such as a flipping of tissue. FIG. 9B illustrates the clipping strategy when the target is located at ceiling of the working space. Said magnetic retractor can provide extra weight on the endoluminal tissue’s boundary. Hence, said magnetic retractor can perform a passive traction with the help of gravity. FIG. 9C illustrates said magnetic retractor performs active traction on tissue that located on the ceiling. FIG. 9D illustrates the traction strategy of endoluminal tissue located on the side wall from two perspectives. The traction force is in a distal diagonal direction from endoscope for the ideal exposure of submucosal layer and against the weight of dissected tissue.

[0113] FIG. 10A-10G illustrate different designs and configurations of magnet element mainly used for magnetic retractor with separated magnet element design (7). FIG.10A illustrates separated magnet element (2 -4-2-2) consists of at least one magnet beads with through hole (100), connection method (2-4-2-1) considered as both the backbone of magnet element and the connection with clip (2-5). It passes through magnets and restrain the length of magnet element and provide adequate flexibility of said magnet element. FIG. 10B illustrates the said magnet element consists of at least one solid magnet beads (101) with one said magnet bead with through hole (100) just for connection with said clip’s leg. The said magnet element is constrained by the self- magnetic attraction between the said magnet beads. FIG. 10C illustrates the said magnet element consists of at least one cylindrical magnet with a through hole (102) for backbone. Said magnet design may consist of fdlet to aid the flexibility of said magnet element. FIG. 10D illustrates the design of said magnet element consisting of one magnet with side through hole (104) for connection with said clip’s leg and at least one solid cylindrical magnet (103). The length of said magnet element can be easily changed by control of the number of solid cylindrical magnets (103) which constrainits shape with self-magnetic attraction. FIG. 10E illustrates the idea of multiple magnets within said magnet element are connected and restrained by chain like structure (105). FIG. 10F illustrates the idea of multiple magnets within said magnet element are connected and restrained by mechanical joints (106). FIG. 10G illustrates the idea of said magnet element consisting of soft magnetic slug (107). For example, the magnet moment direction is along its longitudinal axis. This kind of soft magnet element can undergo self-deformation to pass through a curved channel. Overall, connection method (2-4-2-1) between said magnet element and leg of clip (2-5) includes but not limited to string, or wire.

[0114] When performing the magnetic traction, the multiple magnetic retractors could be used since the repeat of steps about deploying the magnetic retractor. As indicated in FIG. 11A, Step XII showcases the magnetic retraction using multiple magnetic retractors (200), which are controlled under the actuation of said magnetic actuation source (3-1). It is worth mentioning that the deployment number of said multiple magnetic retractors can be one or more and the deployment position of said multiple magnetic retractors can be in different position of boundary of the endoluminal tissue (6-2) as shown in FIG. 11B. For example, Step XIII showcases the magnetic traction using three said magnetic retractors.

[0115] FIG. 12A-B illustrate the number of magnet elements can be changed after the deployment of said magnetic retractor during operation. FIG. 12A show cases with one-piece design of magnetic retractor (6). FIG. 12B showcases with magnetic retractor with separated magnet element design (7). For example, additional magnet element (202) can be used when the magnetic actuation source (3-1) cannot increase the field strength anymore. The increase in numbers of magnets in said magnetic retractor can enhance the traction force. The magnetic moment direction in showcases is only an example of variations.

[0116] One of the advantages of the present invention is that the system can achieve adynamic traction by the co-development of said magnetic actuation source and said magnetic localization system. As illustrated in FIG. 13, magnetic actuation source (3- 1), for example, a permanent magnetic change to different positions with different orientations under the pose feedback of magnetic retractor (200) from said magnetic localization system (3-2), which leads to the different tractions of endoluminal tissue, like from phase XVI to phase XVII or to XVIII. Said endoluminal tissue can be drag to different position in XYZ and rotated to different orientations regarding to the requirements of surgeons. The overall process achieves a dynamic traction of said endoluminal tissue.

[0117] Reference:[1] Global burden of gastrointestinal cancers (no date) Global Cancer Observatory. Available at: https: / / gco.iarc.fr / stories / gastro-intestinal / en (Accessed: 28 November 2023).[2] Top ten cancers 2021 (no date) Hong Kong Cancer Registry, Hospital Authority. Available at: https: / / www3.ha.org.hk / cancereg / topten.html (Accessed: 28 November 2023).

Claims

What is claimed is:

1. A system, comprising: i. A magnetic retractor reversibly attached to a delivery mechanism, said magnetic retractor comprises a clip and at least one flexible magnetic component; and ii. a magnetic control system; wherein said delivery mechanism is adapted to control said magnetic retractor to clip at a desired location before releasing said magnetic retractor; said magnetic control system is adapted to locate and control movement of said magnetic retractor released from said delivery mechanism.

2. The system of claim 1, wherein said magnetic retractor is adapted to pass through working channels of an endoluminal surgical device.

3. The system of claim 2, where said endoluminal surgical device comprises one or more selected from the group consisting of colonoscope and gastroscope.

4. The system of claim 1, wherein said delivery mechanism is adapted to deliver said magnetic retractor through working channels of an endoluminal surgical device.

5. The system of claim 4, where said endoluminal surgical device comprises one or more selected from the group consisting of colonoscope and gastroscope.

6. The system of claim 1, wherein said magnetic control system comprises a magnetic actuation source for generating a magnetic field.

7. The system of claim 6, wherein said magnetic actuation source comprising controllable magnetic field generators to actuate the motions of said magnetic retractors, and a frame holding these magnetic field generators.

8. The system of claim 1, wherein said magnetic control system further comprises a magnetic localization system to measure position and / or pose of said magnetic retractor.

9. The system of claim 8, wherein said magnetic localization system comprises magnetic sensor arrays for localizing said magnetic retractors.

10. The system of claim 1, wherein said system further comprises a user interface device for controlling said magnetic retractor, said user interface device comprises a controller module for receiving controlling commands, and a communication module for sending said controlling commands.

11. The system of claim 1, wherein said at least one flexible magnetic component comprises magnets embedded within said magnetic retractor or magnets attached to said magnetic retractor externally via an attachment mechanism. e12. The system of claim 1, wherein said at least one flexible magnetic component comprises: a. a plurality of magnetic beads with through holes, wherein said plurality of magnetic beads are stringed together with a backbone which is connected to said magnetic retractor; b. a magnetic bead with through hole and a plurality of solid magnetic beads, wherein said magnetic bead with through hole is connected to said magnetic retractor via said through hole; and said plurality of solid magnetic beads are constrained by self-magnetic attraction; c. a plurality of magnetic beads connected and restrained by chainlike structures or mechanical joints; or d. a soft magnetic slug attached to a backbone.

13. The system of claim 12, wherein said magnetic beads with though holes in (a) or (b), said solid magnetic beads in (b) are one or more selected from the group consisting of round beads, cylindrical beads, prismatic beads.

14. The system of claim 13, wherein said cylindrical beads comprise fillets.

15. A method for using said system of claim 1, comprising the steps of: a. Providing said magnetic retractor to a desired site using said delivery mechanism; b. Clipping said magnetic retractor to said desired site; c. Releasing said magnetic retractor from said delivery mechanism; d. Controlling movement of said magnetic retractor with said magnetic control system; and e. Removal of said magnetic retractor from said desired site.

16. The method of claim 15, wherein said desired site comprises a site within esophagus, stomach, colon, bladder, lung, or abdominal region.

17. The method of claim 15, wherein said movement comprises one or more selected from the group consisting of wrenching, pulling, pan, rotating, and tilting.

18. The method of claim 15, wherein said magnetic control system controls movement of said magnetic retractor by generating an appropriate magnetic field to interact with said at least one flexible magnetic component.

19. The method of claim 15, wherein said system comprises more than one magnetic retractor.

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