Magnetic device and method for magnetically clamping portion of hollow organ of digestive tract

Abstract

A clamping device and method are provided for resecting inwardly projecting portions present in a hollow organ of a patient during, for example, weight losing surgery, appendictomy, resection or segmentation surgery, and the like. The clamping device includes a magnet assembly implantable in a lumen of a hollow organ of a patient. A magnet assembly has magnet elements arranged in the two zones and is configured to be positioned around the base of the inwardly protruding portion. Opposite magnet elements are magnetically coupled together to compress opposite walls of the base therebetween until the walls are fused together to space the inwardly protruding portion from the remainder of the organ. The inwardly protruding portion may be pulled into a lumen of a hollow organ prior to positioning the clamping device around the base. The inwardly protruding portion may be removed from the hollow organ to resect the organ.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 499,310, filed May 1, 2023, entitled “Magnetic Device and Method for Magnetically Clamping a Part of a Hollow Organ of the Digestive Tract,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0002] This technical field generally relates to devices and medical technologies for altering the structure of organs. In particular, this technical field relates to devices and medical technologies for magnetically clamping a portion of an organ to reduce its volume or remove a portion of an organ. Background Technology

[0003] Bariatric surgery can be used to treat obesity and is generally designed to restrict the size of organs such as the stomach and / or bypass parts of the stomach and / or intestine. Examples of bariatric surgery may include jejuno-ileal bypass, jejuno-colonic diversion, bile-pancreatic diversion, gastric bypass, Roux-en-Y gastric bypass, gastrectomy, gastric banding, vertical band gastrectomy, silicone ring gastrectomy, and sleeve gastrectomy.

[0004] However, these bariatric surgeries often require altering the digestive tract through incisions, sutures, punctures, and / or staples, which can traumatize the altered organs and cause bleeding. Such bariatric surgeries may also increase the risk of infection or other complications.

[0005] Similar complications can occur when an organ is removed, or when a portion of tissue or an organ is removed. For example, resection surgical procedures can be used to remove a portion of tissue or organ from the digestive, endocrine, and / or urinary systems that is diseased or damaged. Examples of resection procedures that can be performed on such organs include appendectomy and removal of tumors or lesions.

[0006] However, these resection surgeries often involve altering an organ by cutting and removing diseased or damaged tissue, which can traumatize the organ being altered and cause excessive bleeding. Such resections may also increase the risk of infection or other complications.

[0007] Therefore, many challenges remain in surgical procedures that alter the configuration of organs. Summary of the Invention

[0008] According to one aspect, a method for removing an inwardly protruding portion present in a patient's hollow organ is provided, the method comprising the steps of: inserting a magnetic assembly of a clamping device into the lumen of the hollow organ, the magnetic assembly comprising a first region and a second region, each of the first and second regions comprising at least one magnetic element having a magnetically engaged side; positioning the magnetic assembly at the base of the inwardly protruding portion such that the magnetically engaged side of the first region and the magnetically engaged side of the second region face each other; magnetically coupling the first region and the second region together to compress the opposing walls of the inwardly protruding portion therebetween; and allowing the opposing walls of the inwardly protruding portion to fuse together via ischemic pressure necrosis, while the first region and the second region remain magnetically coupled during the healing period.

[0009] In some implementations, the method also includes pulling the wall of the hollow organ into the lumen of the hollow organ to form an inwardly protruding portion.

[0010] In some implementations, inserting the magnet assembly of the clamping device into the lumen of the hollow organ includes first inserting a first section of the magnet assembly, followed by inserting a second section of the magnet assembly.

[0011] In some implementations, positioning the magnet assembly at the base of the inwardly projecting portion includes positioning a first region along a first side of the base and positioning a second region of the magnet assembly adjacent to the first region of the magnet assembly along a second side of the base opposite to the first side.

[0012] In some implementations, positioning the magnet assembly at the base of the inwardly projecting portion also includes coupling a first end and a second end of the magnet assembly via releasable fasteners to form a closed shape around the base.

[0013] In some implementations, the first and second regions of the magnet assembly are separated by a transition region, and a releasable fastener coupling the first and second ends is provided in the transition region.

[0014] In some implementations, at least one of the magnetic elements in the first region and the second region includes a plurality of magnetic elements.

[0015] In some implementations, at least one magnetic element in both the first and second regions includes multiple magnetic elements.

[0016] In some implementations, multiple magnetic elements are connected in series.

[0017] In some implementations, multiple magnetic elements are flexibly connected in series.

[0018] In some implementations, at least one magnet element in the first region has a first region magnetic pole on its magnet engagement side, and at least one magnet element in the second region has a second region magnetic pole on its magnet engagement side that is different from the first region magnetic pole.

[0019] In some implementations, magnetically coupling the first and second regions together includes magnetically coupling the first region magnetic pole on the magnet-joint side of the first region with the second region magnetic pole on the magnet-joint side of the second region.

[0020] In some implementations, the healing time ranges from approximately one week to approximately seven weeks.

[0021] In some implementations, the method also includes removing the clamping device from the lumen of the hollow organ once the healing period has ended.

[0022] In some implementations, the method also includes removing the inwardly protruding portion from the lumen of the hollow organ once the healing period has ended.

[0023] In some implementations, the hollow organ is the patient's stomach, esophagus, small intestine, large intestine, gallbladder, fallopian tube, or bladder.

[0024] In some implementations, the hollow organ is the stomach, and the method used to remove the inwardly protruding portion present in the stomach is bariatric surgery.

[0025] In some implementations, the inward protrusion includes tumors or lesions.

[0026] In some implementations, the hollow organ is the patient's large intestine, and the inwardly protruding part is the patient's appendix.

[0027] In some implementations, the insertion of the magnet assembly of the clamping device into the lumen of the hollow organ is performed via an endoscope.

[0028] According to another aspect, a method for removing an inwardly protruding portion present in a patient's hollow organ is provided, the method comprising the steps of: inserting the front end of a magnetic assembly of a clamping device into the lumen of the hollow organ; guiding the front end to position the magnetic assembly around the base of the inwardly protruding portion; and magnetically coupling the magnetic elements of the magnetic assembly together at the base of the inwardly protruding portion to compress the opposing walls of the inwardly protruding portion therebetween.

[0029] In some implementations, the method also includes pulling the wall of the hollow organ into the lumen of the hollow organ to form an inwardly protruding portion.

[0030] In some implementations, the method also includes allowing the opposing walls of the base to fuse together during the healing time period when the magnetic elements are magnetically coupled together.

[0031] In some implementations, the method also includes removing the clamping device from the lumen of the hollow organ once the healing period has ended.

[0032] In some implementations, the method also includes removing the inwardly protruding portion from the lumen of the hollow organ once the healing period has ended.

[0033] In some implementations, the clamping device also includes a releasable fastener located at the rear end of the magnet assembly, which is configured to be releasably coupled to the front end of the magnet assembly.

[0034] In some implementations, some of the magnet elements are connected in series in a first region, and some of the magnet elements are connected in series in a second region, with the first and second regions facing each other once the magnet assembly is implanted into the hollow organ.

[0035] In some implementations, the first and second zones are pivotally, flexibly, or loosely connected to each other.

[0036] According to another aspect, a method for altering the configuration of a patient's organ is provided, the method comprising the steps of: pulling at least a portion of the organ into the lumen of an adjacent hollow organ of the patient to form an inwardly projecting portion; implanting a clamping device including a magnet assembly into the lumen of the adjacent hollow organ, the magnet assembly comprising: a first region including a first magnet element; a second region including a second magnet element; and a first transition region extending between the first and second regions; positioning the magnet assembly at the base of the inwardly projecting portion such that the first and second regions face each other; magnetically coupling the first and second magnet elements together to compress opposing walls of the base; and allowing the opposing walls of the base to fuse together while the magnet elements remain magnetically coupled.

[0037] In some implementations, the magnet assembly is positioned at the base of the inwardly projecting portion, including a transition zone in which a first and a second region are releasably coupled to form a closed shape around the base.

[0038] According to another aspect, a clamping device is provided for removing an inwardly projecting portion present in the lumen of a patient's hollow organ. The clamping device includes: a magnet assembly implantable in the lumen of the patient's hollow organ, the magnet assembly including: a first region including a first magnet element; and a second region including a second magnet element; and the magnet assembly is configured to be positioned at the base of the inwardly projecting portion to magnetically couple the first region and the second region to compress the opposing walls of the inwardly projecting portion therebetween during a healing period.

[0039] In some implementations, the clamping device also includes a transition zone extending between the first and second zones, the transition zone including fasteners that couple the front end of the first zone to the rear end of the second zone.

[0040] In some implementations, fasteners include flexible fasteners.

[0041] In some implementations, the fasteners include releasable fasteners.

[0042] In some implementations, the transition zone is configured to provide a pivotal transition between the first and second zones.

[0043] In some implementations, the transition zone also includes a flexible connector.

[0044] In some implementations, at least one of the first magnet element and the second magnet element includes a plurality of magnet elements, which are connected in series with each other via a magnet element connector.

[0045] In some implementations, the magnet element connector is flexible.

[0046] In some implementations, the magnet element connector is a rigid or semi-rigid connector.

[0047] In some implementations, each of the first and second magnetic elements includes a magnetic coupling side that can be magnetically coupled to each other.

[0048] In some implementations, the magnet engagement side of the first magnet element has a first magnetic pole, and the magnet engagement side of the second magnet element has a second magnetic pole that is different from the first magnetic pole.

[0049] In some implementations, the first magnet element and the second magnet element have shapes selected from a group consisting of elliptical, stadium-shaped, circular, triangular, rectangular and octagonal shapes.

[0050] In some implementations, at least one of the first and second magnet elements includes a bevel or a rounded edge.

[0051] In some implementations, the clamping device can be configured between a pre-clamping configuration and a clamping configuration.

[0052] In some implementations, the pre-clamping configuration is either a closed pre-clamping configuration or a decoupled pre-clamping configuration.

[0053] In some implementations, at least one of the first and second magnetic elements includes a housing that includes an organ contact side and is configured to receive at least one of the first and second magnetic elements therein.

[0054] In some implementations, the organ contact side of the shell includes an elongated, flat contact surface.

[0055] In some implementations, the shell includes bevels.

[0056] In some implementations, a first magnet element and a second magnet element are received in a housing, the housing including a first end and a second end, wherein the first end and the second end of the housing are releasably coupled to each other by fasteners.

[0057] In some implementations, the first and second magnet elements are housed in corresponding housings. Attached Figure Description

[0058] Figure 1 This is a schematic side cross-sectional view of a clamping device comprising a magnet assembly having a first zone and a second zone, shown in an extended pre-clamping configuration.

[0059] Figure 2 This is a schematic side cross-sectional view of a part of a clamping device including a magnet assembly having a first zone and a second zone, shown in a pre-clamping configuration in a loop.

[0060] Figure 3 It is a schematic perspective view of a magnetic element that is in arbitrary spatial relation to the opposite wall of the base of the inwardly protruding part of the hollow organ.

[0061] Figure 4 It is a schematic side cross-sectional view of the clamping device in an extended pre-clamping configuration, with magnified views of the magnet elements in the first region and the second region of the magnet assembly.

[0062] Figure 5 It is a schematic side cross-sectional view of a clamping device in a ring-shaped pre-clamping configuration, with magnified magnetic elements in the first region and the second region of the magnet assembly.

[0063] Figure 6 This is a schematic front cross-sectional view showing a clamping device in an extended pre-clamping configuration for subsequent placement inside the stomach cavity.

[0064] Figure 7 yes Figure 6 The diagram shows a schematic front cross-sectional view of a clamping device that is folded inside the stomach cavity to be placed in a pre-clamping configuration forming a ring.

[0065] Figure 8 This is a schematic front cross-sectional view of a surgical device that pulls or draws a portion of the stomach lining into the stomach cavity.

[0066] Figure 9 yes Figure 7 A schematic front cross-sectional view of the clamping device shown in the middle, which is in a ring pre-clamping configuration and ready to be positioned at the base of the inwardly protruding portion of the stomach.

[0067] Figure 10 It is positioned at the base of the inwardly protruding portion in the gastric cavity within the ring-shaped pre-clamping configuration. Figure 9 A schematic front cross-sectional view of the clamping device shown in the figure.

[0068] Figure 11 This is a schematic perspective view of a magnetic element shown in any spatial relationship with the opposing walls of the base relative to the inwardly protruding portion, the magnetic element being received in a corresponding housing.

[0069] Figure 12 This is a schematic perspective view of three magnet elements, which are part of a magnet assembly, showing the arbitrary spatial relationship between the opposing walls of the base with respect to the inwardly projecting portion, and the magnet elements are received in a single housing.

[0070] Figure 13 This is a schematic perspective view of three magnet elements, which are part of a magnet assembly, showing an arbitrary spatial relationship between the opposing walls of the base relative to the inwardly projecting portion. The magnet elements are received in corresponding housings with rounded edges, and the continuous housings are flexibly joined together by thinner extensions of the housings.

[0071] Figure 14 This is a schematic perspective view of three magnet elements as part of a magnet assembly, shown in an arbitrary spatial relationship, with adjacent magnet elements flexibly joined together by flexible connectors.

[0072] Figure 15 This is a schematic perspective view of three magnet elements as part of a magnet assembly, shown in an arbitrary spatial relationship. Each magnet element is received in a corresponding housing, and adjacent magnet elements are flexibly joined together by a flexible connector extending between the corresponding housings.

[0073] Figure 16 This is a schematic perspective view of three magnet elements as part of a magnet assembly, shown in an arbitrary spatial relationship. The magnet elements are received in corresponding housings and are flexibly joined together within the housings by flexible connectors extending between adjacent magnet elements.

[0074] Figure 17 This is a schematic perspective view of three magnet elements as part of a magnet assembly, shown in an arbitrary spatial relationship. Each magnet element has a rounded edge, and adjacent magnet elements are flexibly joined together by a flexible connector.

[0075] Figure 18This is a schematic perspective view of six magnetic elements as part of a magnetic assembly, shown in an arbitrary spatial relationship. Each magnetic element is received in a corresponding housing with beveled edges. Adjacent magnetic elements are flexibly joined together by flexible connectors extending between the corresponding housings, and the magnetic elements are shown facing each other.

[0076] Figure 19 It is along line 19 to Figure 19 The captured location is at Figure 10 The schematic side cross-sectional view of the clamping device at the base of the inwardly protruding portion of the stomach is shown. The clamping device has six magnetic elements as part of a magnetic assembly shown in arbitrary spatial relation. Each magnetic element has a beveled edge, and adjacent magnetic elements are flexibly joined together by a flexible connector. The magnets are shown as walls with inwardly protruding bases between them.

[0077] Figure 20 It is a schematic top perspective view of a closed clamping device, which includes two magnetic elements in a first zone and two magnetic elements in a second zone, and the first and second zones are connected to each other at their ends by flexible connectors.

[0078] Figure 21 This is a schematic top perspective view of a closed clamping device, which includes multiple magnetic elements in a first zone and multiple magnetic elements in a second zone. The first and second zones are connected to each other in a first transition zone by a flexible connector and in a second transition zone by a releasable fastener.

[0079] Figure 22 It is a schematic top perspective view of a closed clamping device, which includes three magnetic elements in a first zone and three magnetic elements in a second zone, and the first and second zones are connected to each other at their ends by releasable fasteners.

[0080] Figure 23 This is a schematic side cross-sectional view of a clamping device comprising a magnetic element received in a housing having elongated flat contact sides on its organ contact side, shown in a clamping configuration in which opposing walls of the base of the inwardly projecting portion are compressed between the elongated flat contact sides.

[0081] Figure 24 It is a schematic top view of a clamping device containing magnetic elements arranged to provide a bending zone along the length of the dispensing device.

[0082] Figure 25A This is a schematic anterior cross-sectional view of the stomach, showing surgical instruments grasping and pulling into a portion of the stomach wall within the stomach cavity.

[0083] Figure 25B yes Figure 25A The schematic anterior cross-sectional view of the stomach shown in the figure illustrates the inward protrusion before the clamping line at the base of the inward protrusion of the remaining portion of the stomach, in which the clamping device is placed within the lumen of the stomach.

[0084] Figure 25C yes Figure 25A The schematic anterior cross-sectional view of the stomach shown illustrates the inward protrusion after or during the positioning of the clamping device along a clamping line positioned within the lumen of the stomach, extending inward from the base of the remaining portion of the stomach.

[0085] Figure 26A This is a schematic anterior cross-sectional view of the stomach, showing the inwardly projecting portion that is pulled or drawn into the lumen from the stomach's inner wall.

[0086] Figure 26B yes Figure 26A The schematic anterior cross-sectional view of the stomach shown in the figure illustrates the inward protrusion before the clamping device is placed at the base of the inward protrusion of the remaining portion of the stomach within the lumen of the stomach.

[0087] Figure 26C yes Figure 26A The schematic anterior cross-sectional view of the stomach shown illustrates the inward protrusion after or during the positioning of the clamping device along a clamping line positioned within the lumen of the stomach, extending inward from the base of the remaining portion of the stomach.

[0088] Figure 27A It is a schematic anterior cross-sectional view of the abdominal cavity containing the large intestine, small intestine and appendix, showing surgical instruments grasping the appendix and pulling it inward into the large intestine.

[0089] Figure 27B yes Figure 27A The schematic anterior cross-sectional view of the abdominal cavity shown in the figure illustrates the clamping line at the base of the appendix, which is an inwardly protruding portion of the large intestine lumen, after the clamping device has been placed along the clamping line.

[0090] Figure 28 This is a schematic frontal cross-sectional view of a female bladder with a tumor on the inner wall of the bladder cavity, showing the clamping line.

[0091] Figure 29A This is a schematic anterior cross-sectional view of a female bladder with a tumor on the outer wall of the bladder, showing surgical tools configured to grasp and pull into a portion of the bladder cavity wall.

[0092] Figure 29B yes Figure 29AThe schematic anterior cross-sectional view of the bladder shown in the figure illustrates the inward protrusion before the clamping device is placed along the clamping line located at the base of the inward protrusion.

[0093] Figure 29C yes Figure 29A The schematic anterior cross-sectional view of the bladder shown in the figure illustrates the inward protrusion after or during the positioning of the clamping device along the clamping line located at the base of the inward protrusion. Detailed Implementation

[0094] Surgical procedures for treating various medical conditions can involve altering the configuration of organs such as the esophagus, stomach, gallbladder, ducts of the biliary system, small intestine, colon, fallopian tubes, appendix, or bladder. Altering organ configuration can involve reducing the size of the lumen of a hollow organ or removing a portion of a solid organ via an adjacent hollow organ. Such surgeries can be performed in contexts such as bariatric surgery or other digestive surgeries, such as those that can be performed as part of cancer treatment, resection surgery, etc. Altering organ configuration by reducing the size of the lumen or by removing a portion of the organ can involve grasping and pulling in a portion of the organ to obtain an inward protrusion, and using a magnetic clamping device to clamp the opposing walls of the inward protrusion at its base to fuse the opposing walls of the base of the inward protrusion together. In some implementations, the inward protrusion can be removed in a secondary surgery, or the inward protrusion can be allowed to drain naturally from the patient. The clamping device can include various features. It should be understood that, as used herein, the term “clamping device” throughout this specification may be used interchangeably with the term “clamping implant”, since the clamping device is configured to be implanted and held in the lumen of the patient’s target hollow organ for a specific period of time that can extend from days to weeks.

[0095] The clamping device may include a flexible magnetic assembly that can be inserted into the lumen of a target hollow organ or a lumen of a patient's adjacent hollow organ. The portion to be removed or excised can then be pulled in or drawn out to form an inwardly projecting portion, and the clamping device can be positioned at the base of the inwardly projecting portion within the lumen of the organ or an adjacent hollow organ. The flexibility of the magnetic assembly can be imparted by flexibly connecting a series of magnetic elements together to form a series of magnetic elements. Each magnetic element includes a corresponding magnetic engagement side, and successive magnetic elements have their respective magnetic engagement sides on the same side. In some implementations, one or more magnetic elements may be received in a respective housing, or a series of magnetic elements may be received together in a single housing.

[0096] The clamping device can be configured in both a pre-clamping configuration and a clamping configuration. The pre-clamping configuration facilitates insertion of the clamping device into the lumen of the patient's target hollow organ and subsequent placement at the base of the inwardly projecting portion of the target hollow organ. Therefore, the pre-clamping configuration can be one that allows the clamping device to be placed at the base of the inwardly projecting portion of the hollow organ, and can take the form of a ring, circle, or band, while the clamping configuration can be one that clamps the inwardly projecting portion.

[0097] In a pre-clamping configuration, the magnetic engagement sides of multiple magnets are magnetically decoupled from each other. To achieve this type of pre-clamping configuration, the magnet assembly can extend longitudinally such that the magnetic engagement sides do not face each other, and can be inserted longitudinally into the lumen of a target hollow organ, for example, as a thin string. This type of pre-clamping configuration can be referred to as an extended pre-clamping configuration. In another example of a pre-clamping configuration, the magnet assembly can be formed in a U-shape to obtain a partial or closed loop, wherein the opposing magnetic engagement sides of the magnet elements face each other but are far enough apart that the opposing magnetic engagement sides of the magnet elements remain magnetically decoupled so as to allow the partial or closed loop to be placed at the base of an inwardly projecting portion. This pre-clamping configuration can be referred to as a loop-forming pre-clamping configuration. In other configurations, the magnet assembly can be formed in a closed shape such that the opposing magnetic engagement sides of the magnet elements face each other but are far enough apart that the opposing magnetic engagement sides remain magnetically decoupled so as to allow the closed shape to be placed at the base of an inwardly projecting portion. This pre-clamping configuration can be referred to as a closed pre-clamping configuration. In other configurations, the magnet assembly may have two regions of a magnet element that are releasably coupled to each other, such that when decoupled, the magnet assembly may include two portions that can be placed at a base of an inwardly projecting portion and then coupled at one or both ends. This pre-clamping configuration may be referred to as a decoupled pre-clamping configuration.

[0098] The selection of the pre-clamping configuration can be based on the inward protrusion of the target hollow organ or magnet assembly to be placed around it, and can take into account the available space within the lumen of the target hollow organ. If the magnet assembly is initially inserted as a string, the pre-configuration will ultimately include a U-shaped or closed shape for placement around the inward protrusion, while the magnet elements remain magnetically decoupled. In addition to facilitating insertion of the clamping device into the lumen of the target hollow organ, the pre-clamping configuration also facilitates placement of the magnet assembly within the lumen of the hollow target hollow organ around the inward protrusion along a given clamping line. In the context of this specification, the clamping line corresponds to the boundary between the inward protrusion and the remaining portion of the target hollow organ, and therefore corresponds to the trajectory where the magnet engagement side of the magnet assembly is abutted to clamp the inward protrusion from the remaining portion of the target hollow organ. The clamping line also corresponds to the base of the inward protrusion (i.e., the place where the inward protrusion demarcates from the remaining portion of the organ).

[0099] Once the clamping device is placed at the base of the inwardly projecting portion of the hollow organ, the magnetic assembly can be positioned in the clamping configuration. In the clamping configuration, opposing magnetic elements on each side of the target hollow organ are placed close enough that the opposing magnetic engagement sides of the facing magnetic elements are magnetically coupled to bring together and compress portions of the target hollow organ wall (i.e., portions of the wall at the base of the inwardly projecting portion) without puncturing the organ's tissue. Magnetic coupling holds the magnetic elements in place, and the pressure exerted by the magnetic elements on the portions of the target hollow organ wall triggers a healing mechanism that, over time, can cause portions of the organ wall to fuse along the edges of the magnetic elements. In the context of this specification, the term "fusion" can be interpreted as corresponding to the resulting healed tissue on the edges of the magnetic elements now joined to form a single structure. The organ wall portion initially compressed along the dividing line between the magnet engagement sides eventually undergoes ischemic pressure necrosis, and after a specific period of time, referred to herein as the healing period, which can extend from days to weeks, the space essentially corresponding to the width of the magnet element will eventually be confined at the base of the inwardly projecting portion, thereby separating the inwardly projecting portion from the remainder of the hollow organ.

[0100] The clamping device is configured to remain within the lumen of the patient's target hollow organ for a period of time sufficient to allow the healing process to occur and for fusion of the organ wall portion at the edge of the magnet element to take place. Monitoring the healing process helps determine the possibly appropriate timing for removing the clamping device from the lumen of the patient's target hollow organ after tissue fusion has occurred.

[0101] The clamping device may also include additional features. For example, the clamping device may include one or more features that facilitate the placement of the magnet assembly into the lumen of the target hollow organ. Such features may include a flexible elongated member, such as a flexible rope or flexible wire, configured to extend from one end of the magnet assembly, and may also be referred to as an anterior elongated member. The flexible elongated member may be configured to engage with a delivery conduit, and the delivery conduit may then be used to carry and navigate the magnet assembly into the lumen via the anterior elongated member, at the base of the inwardly projecting portion of the target hollow organ.

[0102] Optionally, the clamping device may also include a second flexible elongated member at the other end of the magnet assembly, opposite the front elongated member, and this second flexible elongated member may be referred to as the rear elongated member. During implantation of the magnet assembly, the rear elongated member can facilitate the placement of the magnet assembly.

[0103] The various implementations of the clamping device and associated methods will now be described in more detail.

[0104] Magnet assembly Magnet element refer to Figures 1 to 5 The following diagram illustrates an implementation of the clamping device 10. The clamping device 10 includes a magnet assembly 12 received within a housing 14. The magnet assembly 12 includes a plurality of magnet elements 16 flexibly joined or combined together. Each magnet element 16 includes a top side 18, a bottom side 20, a lateral side 22, and a longitudinal surface 24. In the context of this specification, the top side 18 of the magnet element 16 refers to the side facing the organ tissue 26 at the base of the inwardly projecting portion once the magnet assembly 12 is implanted into the lumen of the patient's target hollow organ and positioned at the base of the inwardly projecting portion. In the illustrated implementation, the clamping device 10 also includes flexible elongated members at each end, namely, a front elongated member 28 and a rear elongated member 30. Additionally, the housing 14 receiving the magnet elements 16 is also flexible. It should be understood that, although in Figure 1 , Figure 2 , Figures 4 to 7 , Figure 9 , Figure 10 , Figure 23 and Figure 24 The front elongated member 28 and the rear elongated member 30 are shown in the diagram, but the clamping device 10 may omit the front elongated member 28 and the rear elongated member 30. In other words, the front elongated member 28 and the rear elongated member 30 are optional features of the clamping device 10 described herein.

[0105] exist Figure 1 In this configuration, the clamping device 10 is in a pre-clamping arrangement, wherein the clamping device 10 extends longitudinally such that the ends of the magnet assembly 12 are spaced apart and opposite to each other. This type of pre-clamping arrangement can be referred to as an extended pre-clamping arrangement. Figure 2 and Figure 5 In this configuration, the clamping device 10 is also in a pre-clamping configuration, although it can be referred to as a loop-forming pre-clamping configuration. In the loop-forming pre-clamping configuration, the magnet assembly 12 folds itself into a U-shape to form a partial or closed loop, depending on the intended application. The selection of the pre-clamping configuration of the magnet assembly 12 can be based on the hollow organ targeted for treatment and the chosen insertion method. As described above, if the magnet assembly 12 is initially intended for, for example... Figure 1The thin string shown is inserted, and the pre-clamping configuration is ultimately contained within a partial or closed loop forming a U-shape for placement at the base of the inwardly projecting portion of the target hollow organ, while the magnetic element 16 remains magnetically decoupled. In other words, one characteristic of the pre-clamping configuration of the magnet assembly 12 is that the magnetic element 16 is magnetically decoupled, and the magnet assembly 12 can employ various configurations in which the magnetic element 16 is magnetically decoupled. In addition to facilitating insertion of the clamping device 10 into the lumen of the target hollow organ, the pre-clamping configuration also facilitates placement of the magnet assembly 12 at the base of the inwardly projecting portion within the lumen of the target hollow organ and along a given clamping line 42. Further details regarding these considerations are provided below.

[0106] The magnet element 16 of the magnet assembly 12 can be any type of suitable magnet. In some implementations, the magnet element 16 can be selected based on its attractive force, i.e., based on the pressure to be applied to the surface region of the tissue that will ultimately be compressed between the magnetically coupled magnet elements 16. Factors affecting the attractive force of the magnet element 16 may include the shape of the magnet element 16, the thickness of the magnet element 16, the material used to make the magnet element 16, etc. Examples of materials may include neodymium magnets (e.g., NdFeB magnets), rare earth magnets, and ferrite magnets.

[0107] Special Reference Figure 4 and Figure 5 Each of the magnet elements 16 may be a dipole magnet having a magnetic pole with a thickness spanning the magnet element 16, such that the magnet element 16 includes a first magnetic pole 34 on one side and a second magnetic pole 36 on the other side, the second magnetic pole 36 being distinct from the first magnetic pole 34. One side of the magnet element 16, also referred to above as the top side 18 of the magnet element 16, corresponds to the magnet engagement side 32, which is the side of the magnet element 16 that will ultimately face the inner surface of the organ tissue 26 of the hollow organ to be treated once the magnet assembly 12 is installed at the base of the inwardly projecting portion 50 of the target hollow organ.

[0108] The magnet element 16 can be strategically positioned along the length of the magnet assembly 12 to achieve the desired function of the magnet assembly 12. (Reference) Figures 1 to 10 This shows the first region 38 and the second region 40 of the magnet assembly 12. When the clamping device 10 is in a position such as... Figure 1 In the extended pre-clamping configuration, the elongated member 28 is guided into the lumen by the guide tip or, in some instances, the guide front elongated member 28, such as... Figure 6In this context, the first region 38 of the magnet assembly 12 corresponds to the portion of the magnet assembly 12 that can be initially inserted into the lumen of the hollow organ. Then, the first region 38 of the magnet assembly 12 will be the region that flips the base or tip of the inwardly protruding portion 50 of the target hollow organ, for example, in a posterior position, such as... Figure 7 and Figure 10 As shown in the diagram. The base of the inwardly projecting portion 50 is the region along the resection line or clamping line 42, where the organ tissue 26 is in close contact to form the inwardly projecting portion 50. In some implementations, the organ tissue 26 may be the inner wall or inner wall tissue of the lumen of the target hollow organ. For example, when the wall of the target hollow organ comprises more than one type of tissue, the organ tissue 26 compressed by the clamping device 10 may contain only the innermost (facing the lumen) tissue, or may contain a first innermost layer and a second innermost layer. In other implementations, the compressed organ tissue 26 may contain all layers of the target hollow organ wall, such as... Figure 10 As shown in the figure. In some instances, such as during an appendectomy or tumor resection, the organ tissue 26 of the magnet engagement side 32 of the magnet element 16 facing the magnet assembly 12 may respectively contain the appendix and the tumor itself, with the tumor and appendix each corresponding to an inwardly protruding portion.

[0109] exist Figures 6 to 10 In the implementation shown, when the magnet assembly 12 is inserted into the lumen of the hollow organ, the second region 40 corresponds to the portion of the magnet assembly 12 following the first region 38. For example... Figure 7 and Figure 10 As shown, the second region 40 can remain in the front position without flipping over to the rear side of the outer surface of the base of the inwardly projecting portion. It should be understood that in other implementations, such as when the base of the inwardly projecting portion is not located on the side of the hollow organ but on its front or rear side, once placed at the base of the inwardly projecting portion, the first region 38 and the second region 40 can be considered to be provided side by side, such as frontally or rearally, laterally or centrally, or lowerly and upperly.

[0110] refer to Figures 8 to 10 Alternatively, the magnet assembly 12 can be inserted into the lumen of the target hollow organ in a pre-clamped ring configuration, so that the first region 38 and the second region 40 of the magnet assembly 12 can navigate side by side in the lumen, rather than extending.

[0111] Refer again Figure 4 and Figure 5The first region 38 includes a series of magnetic elements 16, each magnetic element 16 having a magnetic engagement side 32 with the same magnetic poles (i.e., the first region magnetic poles) between them. The second region 40 also includes a series of magnetic elements 16, each magnetic element 16 also having a magnetic engagement side 32 with the same magnetic poles (i.e., the second region magnetic poles) between them, but these magnetic poles are different from the magnetic poles of the magnetic engagement side 32 of the magnetic elements 16 in the first region 38. The magnetic engagement side 32 corresponds to the top side 18 of the magnetic element 16 described above, that is, the side facing the internal wall of the hollow organ. For example, as... Figure 4 As shown, the clamping device 10 is in an extended pre-clamping configuration, with the second region 40 of the magnet assembly 12 longitudinally spaced from the first region 38. The magnet engagement side 32 of the magnet element 16 in the first region 38 has a north pole, and the magnet engagement side 32 of the magnet element 16 in the second region 40 has a south pole. Similarly, in Figure 5 In the first region 38, the clamping device 10 is in a pre-clamping configuration forming a ring, and the magnet engagement side 32 of the magnet element 16 in the second region 40 has a north pole, while the magnet engagement side 32 of the magnet element 16 in the second region 40 has a south pole.

[0112] In this configuration of the magnet assembly 12, the magnet elements 16 have different magnet engagement sides 32 depending on the regions 38, 40 where the magnet assembly 12 is located, such that once the magnet assembly 12 is in a clamping configuration, the magnet elements 16 of the first region 38 and the second region 40 of the magnet assembly 12 can attract each other and magnetically couple.

[0113] As described above, the magnetic element 16 can have various shapes and sizes. The selection of the shape and / or size of the magnetic element 16 can be based on the size of the target hollow organ and the segment to be removed (i.e., the size of the inwardly protruding portion 50) into which the clamping device 10 will be implanted. For example, when the large portion of the organ is like a stomach, a larger or elongated magnetic element 16 can be used as part of the magnetic assembly 12. On the other hand, the length of the magnetic element 16 can be kept small enough to allow the magnetic assembly 12 to navigate around the outer surface of the base of the inwardly protruding portion 50, or to facilitate the insertion of the magnetic assembly 12 into the lumen of the target hollow organ. For example, in some implementations, the magnetic element 16 designed to remove the appendix through the lumen of the large intestine can have a size ranging from about 5 mm to about 40 mm, with the total length of each of the first zone 38 and the second zone 40 totaling between about 10 mm and about 50 mm, or between about 20 mm and 40 mm; while the magnetic element 16 designed to remove the inwardly protruding portion 50 of the stomach can have a size ranging from about 5 mm to about 100 mm, with the total length of each of the first zone 38 and the second zone 40 totaling between about 30 mm and about 100 mm, or about 80 mm. It should be understood that these examples are given for illustrative purposes only and should not be interpreted restrictively.

[0114] It should also be understood that the magnet assembly 12 can have any number and / or size of magnet elements 16. For example, a magnet assembly 12 designed for appendectomy may include a first region 38 having a single magnet element 16 of approximately 30 mm and a second region 40 having a single magnet element 16 of the same size of approximately 30 mm. Alternatively, the first region 38 and the second region 40 may each include multiple magnet elements 16, such as six magnet elements 16, each having a length of approximately 5 mm, or the magnets may have different lengths from each other. In other implementations, the first region 38 may contain a single magnet of a given length, and the second region 40 may contain multiple magnets of the same or different lengths. Similar considerations apply to a magnet assembly 12 designed for gastrectomy. For example, a magnet assembly 12 designed for gastrectomy may include a first region 38 and a second region 40, each region having a single magnet element 16, which may, for example, have a length of approximately 80 mm, or may contain any number of magnet elements 16.

[0115] As a general relationship between the size of the magnetic element 16 and the lumen of the target hollow organ, the magnetic element 16 designed for removing the inwardly projecting portion 50 of a hollow organ with thicker walls and / or considered to have a larger lumen can generally be larger than the magnetic element 16 designed for a hollow organ with a smaller lumen and / or thinner walls. This general relationship takes into account the principle that larger and / or thicker hollow organs can benefit from the greater attractive force imparted by the larger magnetic element 16 to achieve the desired compression of the hollow organ wall and subsequent healing around the edge of the magnetic element 16. In some implementations, for example, different regions of the inwardly projecting portion 50 can be targeted with magnetic elements 16 of different sizes if the desired compression of one segment of the inwardly projecting portion 50 differs from that of another segment.

[0116] In addition, although in Figure 3 and Figures 11 to 16 The magnetic element 16, a portion of the illustrated magnetic assembly 12, is shown as substantially rectangular, but it should be understood that the magnetic element 16 may include tapered edges, beveled edges, bevels, rounded edges, etc. The magnetic element 16 may also have an elliptical shape, stadium shape, circular shape, triangular shape, rectangular shape, octagonal shape, or any other shape suitable for the applications described herein. In some implementations, the magnetic element 16 may have a unique shape configured to mate with the surface of the base of the opposing magnetic element and / or the inwardly projecting portion.

[0117] For example, Figure 17 An example of a series of magnetic elements 16 comprising a portion of a magnetic assembly 12 is illustrated, each magnetic element 16 having a rounded edge and a substantially elliptical shape. In some implementations, magnetic elements 16 having rounded edges or other non-sharp features can facilitate movement between adjacent magnetic elements 16 and thus provide enhanced flexibility to the magnetic assembly 12.

[0118] Figure 18 An example of a series of magnetic elements 16, a portion of a magnet assembly 12, is illustrated. Each magnetic element 16 is received in a housing with a beveled edge 17. The magnetic elements 16 are shown facing each other, as if they were placed on either side of the wall of the inwardly projecting portion 50.

[0119] Figure 19 An example of a magnet element 16, representing a portion of a magnet assembly 12, is illustrated, each magnet element 16 having a bevel 19. In some implementations, such as Figure 18 and Figure 19As shown, when the magnet element 16 or housing 14 includes bevels, the magnet engagement side 32 of the magnet element 16 or the organ contact side 44 of the housing 14 can have a smaller surface area compared to the side away from the organ tissue 26 at the base of the inwardly projecting portion, i.e., the bottom side 20. This configuration allows for a smaller compressible surface between the magnet engagement sides 32 of the opposing magnet elements 16 or between the organ contact sides 44 of the opposing housing 14, such that if ischemic necrosis occurs more rapidly than initially anticipated, the side of the magnet element 16 or housing 14 with the larger surface area can provide anchorage to prevent undesirable movement of the magnet element 16 or housing 14. In some implementations, the side of the magnet element 16 or housing 14 with the larger surface area can also help prevent the magnet element 16 or housing 14 from passing through the area of ​​already ischemic necrosis at the base of the inwardly projecting portion.

[0120] In some implementations, the first region 38 and the second region 40 of the magnet assembly 12 may each contain a single magnet element 16, which may optionally be flexibly, elastically, pivotally, and / or releasably coupled to each other at one end in a first transition region. In some instances, the single magnet element 16 of the first region 38 and the second region 40 may be a magnet element that, when magnetically coupled around the base of the inwardly projecting portion, can act as a clamp to allow the opposing walls of the inwardly projecting portion to remain close together and be magnetically compressed, such that ischemic pressure necrosis can occur over time, which in turn can cause the opposing walls to fuse together. In some implementations, the first region 38 and the second region 40 may be flexibly, elastically, pivotally, and / or releasably coupled to each other at their other ends in a second transition region.

[0121] In some implementations, the magnet engagement side 32 of the magnet element 16 contained in the first region 38 of the magnet assembly 12 may have a shape complementary to that of the magnet engagement side 32 of the magnet element 16 contained in the second region 40 of the magnet assembly 12. For example, the magnet engagement side 32 of the magnet element 16 contained in the first region 38 may include a recess, and the magnet engagement side 32 of the magnet element 16 contained in the second region 40 may include a protrusion configured to fit within the recess. In some implementations, engagement of the recess with a corresponding protrusion or other features having complementary shapes may help to stabilize the magnet element 16 of the first region 38 and the magnet element of the second region 40 together. In some implementations, the edge of the magnet element 16 contained in the first region 38 of the magnet assembly 12 may include a tenoned edge, and the edge of the magnet element 16 contained in the second region 40 of the magnet assembly 12 may include a tenoned edge complementary to one of the magnet elements 16 in the first region 38.

[0122] In some implementations, as described above, the attractive force of the magnetic element 16 can be selected based on the thickness and / or composition of the target hollow organ along the clamping line 42. For example, the attractive force of the magnetic element 16 can be proportional to the thickness of the target hollow organ wall. This principle can be applied from one target hollow organ to another, or within the same target hollow organ. For example, if the wall of the stomach is thicker than the wall of another part of the duodenum or small intestine, the attractive force of the magnetic element 16 for the magnetic assembly 12 designed for the stomach can be higher than the attractive force of the magnetic assembly 12 designed for the duodenum.

[0123] When the wall thickness varies within the same target hollow organ, the attractive force of the magnetic element 16 can vary within the first region 38, and therefore within the second region 40, such that when in a clamping configuration, the pressure applied to the organ tissue 26 of the target hollow organ at the base of the inwardly projecting portion (i.e., along the clamping line 42) along the length of the magnetic assembly 12 can also vary. For example, when the target hollow organ is the stomach, the wall thickness near the fundus is greater than that of the body or antrum. Therefore, if the inwardly projecting portion comprises organ tissue 26 from both regions of the stomach, the magnetic element 16 of the magnetic assembly 12 can be selected to have a higher attractive force in the portion of the magnetic assembly 12 that will contact the fundus wall, compared to the attractive force of the magnetic element 16 of the magnetic assembly 12 that will contact the antrum wall.

[0124] In the implementation of a target hollow organ primarily composed of muscle fibers, such as the distal colon or rectum, the attraction of the magnet element 16 can be selected to be higher than that of the magnet element 16 used for magnet components 12 designed for portions of the small intestine such as the duodenum, jejunum, or ileum.

[0125] The attractive force of the magnetic elements 16 can also be selected to facilitate the placement and implantation of the clamping device 10 into the lumen of the target hollow organ. For example, in some implementations, the attractive force between the magnetic elements 16 can be weak enough that the magnetic elements 16 can be magnetically decoupled during the placement of the clamping device 10 along the clamping line 42, so that repeated trials can be performed to reach the desired position of the magnetic assembly 12.

[0126] Furthermore, the attraction of the magnetic elements 16 can be selected based on the planned healing timeframe. For example, the attraction between the magnetic elements 16 can be weak enough to facilitate a healing timeframe ranging from a few days to several weeks. A longer healing timeframe facilitates achieving a well-fused wall and gradual application of pressure along the clamping line 42, while a magnetic element 16 with too strong an attraction may cause rapid ischemic pressure necrosis between the magnetic engagement sides 32 of the magnetic elements 16, which could weaken the healing mechanism at the edges of the magnetic elements 16 and may result in openings in the tissue of the target hollow organ. In some implementations, the attraction of the magnetic elements 16 can be selected such that the healing process occurs within a timeframe of 2 to 7 weeks after the implantation of the clamping device 10. In some implementations, the attraction of the magnetic elements 16 is selected such that the healing process occurs within a timeframe of 3 to 6 weeks after the implantation of the clamping device 10. Other durations of the healing timeframe are also possible depending on the desired outcome and the target hollow organ.

[0127] It should be noted that in some implementations, the ischemic pressure necrosis experienced by the wall of the target hollow organ along the clamping line 42 may be sufficient to cause the inwardly protruding portion 50 to be removed from the target hollow organ along the clamping line 42, wherein the fused tissue is at the edge of the magnetic element 16. In such instances, additional surgery can be performed, for example, simultaneously with the removal of the clamping device 10, to separate and remove the inwardly protruding portion of the target hollow organ. In other implementations, the ischemic pressure necrosis experienced by the wall of the target hollow organ along the clamping line 42 may be sufficient to cause the separation of the inwardly protruding portion of the target hollow organ, such that the severed inwardly protruding portion can drain naturally. Therefore, the attraction of the magnetic element 16 can also be selected based on whether it is desired that the inwardly protruding portion separates naturally from the target hollow organ.

[0128] As time progresses, monitoring of the healing process also plays a role in the results obtained on the target hollow organ after the clamping device 10 is implanted, and such monitoring can help determine at what point the clamping device 10 should be removed to obtain the desired result of separation of the inwardly protruding portion of the target hollow organ.

[0129] In some implementations, the size of the magnet element 16 can vary along the length of the magnet assembly 12. Such variation in magnet size helps increase the flexibility of the magnet assembly 12 in selected portions, particularly when the magnet assembly 12 contains multiple individually received magnet elements 16 within the housing 14, such as... Figure 11 , Figure 15 and Figure 18 As shown, or without a casing, such as Figure 14 , Figure 17 and Figure 19As shown in the diagram. For example, magnet assembly 12 may include a smaller magnet element 16 near the transition from the first region 38 to the second region 40. This is facilitated by, for example... Figure 7 The folding of the magnet assembly 12 shown in the diagram provides a smaller magnet element 16 near this transition zone, which facilitates the use of a pre-clamping configuration and a clamping configuration in a loop. Therefore, the smaller magnet element 16 near the transition from the first zone 38 to the second zone 40 can thus facilitate the placement of the clamping device 10. In some implementations, a larger magnet implant, particularly in length, located further away from this transition zone, can facilitate obtaining a continuous clamping line 42 at the base of the inwardly protruding portion 50.

[0130] Housing refer to Figures 11 to 16 and Figure 18 In some implementations, the magnet element 16 can be housed within the housing 14. Figure 11 In the middle, a single magnet element 16 is received in a corresponding housing 14, while Figure 12 In one implementation, multiple magnetic elements 16 are housed within a single housing 14. In other implementations, a certain number of magnetic elements 16 may be housed within the housing 16. For example, 2 to 10 magnetic elements 16 may be housed within a single housing 14. In such implementations, the number of magnetic elements 16 within the housing 14 is affected by their size; that is, the smaller the magnetic elements 16, the more consecutive magnetic elements 16 can be housed within a housing 14 of a given length.

[0131] As described above, the housing 14 includes an organ contact side 44 that contacts the tissue of the target hollow organ when the clamping device 10 is in the clamping configuration. In some implementations, the organ contact side 44 of the housing 14 includes an elongated, flat contact surface to facilitate uniform contact with the tissue compressed therebetween. The housing 14 can be configured to provide a non-traumatic surface, which can help avoid damage to surrounding tissues. The housing 14 may include rounded edges and / or a tapered transition between its walls. In some implementations, the housing 14 may have an elliptical or stadium-shaped shape. Figure 13 An example of a magnet element 16 received in a corresponding housing 14 having rounded edges is illustrated. The continuous housings 14 are flexibly joined together by a thinner extension 46 of the housing 14, also referred to as a connecting portion of the housing 14. More details on this are provided below.

[0132] In some implementations, the organ contact side 44 of the housing 14 of the magnet element 16 contained in the first region 38 may include a recess, and the organ contact side 44 of the housing 14 of the magnet element 16 contained in the second region 40 may include a protrusion configured to fit within the recess. Engagement of the recess with a corresponding protrusion or other features of complementary shape via the housing 14 can help stabilize the magnet element 16 in the first region 38 and the magnet element 16 in the second region 40 together. In some implementations, the edge of the organ contact side 44 of the housing 14 of the magnet element 16 contained in the first region 38 of the magnet assembly 12 may include a tenoned edge, and the edge of the organ contact side 44 of the housing 14 of the magnet element 16 contained in the second region 40 of the magnet assembly 12 may include a tenoned edge complementary to one of the tenoned edges in the housing 14 of the first region 38.

[0133] In some implementations, the housing 14 may help distribute the forces applied by the magnetic elements 16 over a larger area, depending on the application and / or the target hollow organ. The housing 14 may be made of a biocompatible material. In some implementations, the housing 14 may be made of a metal such as stainless steel, titanium, or other medical implant-grade metals. Alternatively, the housing 14 may be made of silicone or other medical implant-grade polymers. In some cases, the housing 14 is made of Silastic™ as a flexible silicone elastomer. In some implementations, the housing 14 may provide a protective coating around the magnetic elements 16, which in turn helps prevent corrosion and maintain the integrity of the magnetic elements 16. The texture of the housing 14, particularly on the organ contact side 44, may be selected to provide increased stability to the magnetic assembly 12 once in a clamping configuration. For example, the surface roughness of the implant on the organ contact side 44 of the housing 14 may be higher than that on its opposite side. Once the magnet element 16 is magnetically coupled, the surface roughness of the organ contact side 44 of the housing 14 may help prevent magnetic decoupling due to shear forces.

[0134] Connection between adjacent magnet elements As described above, the magnet assembly 12 includes magnet elements 16 connected in series with each other. In some implementations, the magnet elements 16 are flexibly connected in series with each other. The flexibly connected magnet elements 16 can be implemented in various ways. Some examples are provided below. In other implementations, some or all of the magnet elements 16 in the same region (i.e., having the same polarity) may have rigid or semi-rigid connections between adjacent magnet elements to facilitate clamping, flattening, or compressing the base of the inwardly protruding portion.

[0135] refer to Figure 13Multiple magnetic elements 16 can be received in respective individual housings 14, and the housings 14 can include portions between adjacent magnetic elements 16 adapted to provide increased flexibility for the magnetic assembly 12. Figure 13 As shown, these portions 46 can be narrower or thinner to increase their degrees of freedom of movement while remaining sufficiently robust to avoid breakage. In some implementations, the portions 46 between adjacent magnetic elements 16 of the housing 14 can be made of a different material than the remainder of the housing 14 to benefit from the specific properties of this different material, particularly in its flexibility. In some implementations, the portions 46 between adjacent magnetic elements 16 of the housing 14 can provide a certain range of motion in one plane and a limited range of motion in another plane. For example, it may be desirable to move the magnetic elements 16 relative to each other so that the magnet assembly 12 can fold around the base of the inwardly projecting portion, while it may be less desirable to move the magnetic elements 16 laterally relative to each other, as lateral movement of the magnetic elements 16 would cause the magnetic elements 16 to deviate from the clamping line 42.

[0136] refer to Figure 14 When no housing is provided around the magnet element 16, the magnet element 16 may contain hooks (not shown) on each of its lateral sides and be connected to each other via flexible connectors 48 such as cords or elastic bands. The type of flexible connector 48 can be selected to provide sufficient mobility and flexibility to the magnet assembly 12 according to a given range of motion, so that the magnet assembly 12 can be easily guided to its destination in the lumen of the hollow organ and positioned at the base of the inwardly projecting portion. For example, when it is desired to remove the appendix, for example in the case of appendicitis, the magnet assembly 12 can be positioned in the lumen of the large intestine, which is a relatively small hollow organ compared to the stomach. Therefore, it may be advantageous to make the magnet assembly 12 have increased flexibility to facilitate the guidance of the clamping device 10 in the lumen of the large intestine and to maintain it in the proper position around the base of the appendix once it returns to the inwardly projecting portion in the lumen of the large intestine.

[0137] refer to Figure 15Flexible connectors 48 can be provided between adjacent magnetic elements 16, each individually housed in a respective housing 14. In such implementations, engagement portions, such as hooks, can be provided on the lateral side of the housing 14. In some implementations, the engagement portions can be integral with the housing 14. Thus, the housing 14 can be molded as a single unit containing hooks on each of its lateral sides, the magnetic elements 16 being received within the housing 14, and adjacent magnetic elements among the plurality of magnetic elements 16 can be flexibly connected to each other via flexible connectors 48 engaging with corresponding hooks. Alternatively, hooks can be provided on the lateral side of the housing 14, and the flexible connector 48 can extend from the other side to flexibly engage with hooks adjacent to the housing 14.

[0138] In other implementations and refer to Figure 16 The magnetic elements 16 can be flexibly connected to each other by integration within the housing 14, and flexible connectors 48 can also be provided between adjacent magnetic elements 16 within the housing 14. Figure 16 In the implementation shown, with Figure 15 In contrast to the implementation shown in the figure, the flexible connector 48 is therefore shown as being integrated within the housing 14.

[0139] It should be understood that, as Figure 12 As shown, the flexibility of the magnet assembly 12 can be provided by the presence of the housing 14 surrounding the magnet element 16 itself, for example, given the flexibility of the material used to make the housing 14. In other implementations, the stiffness of the magnet assembly 12 can be provided by the housing 14, for example, given the stiffness of the material used to make the housing 14.

[0140] The distance between adjacent magnet elements 16 can be chosen to influence the final flexibility or alternative rigidity of the magnet assembly 12. In some implementations, when determining the distance between adjacent magnet elements 16, care should be taken to maintain a balance between the flexibility of the magnet assembly 12 obtained in this manner and its effect on the resulting clamping wire 42, as consecutive magnet elements 16 that are too far apart from each other may result in an uneven clamping wire 42. In some implementations, the distance between adjacent magnet elements 16 can vary along the length of the magnet assembly 12, similar to the description above regarding the size of the magnet elements 16. For example, in some implementations, magnet elements 16 located near the transition zone from the first region 38 to the second region 40 can be provided slightly spaced to provide enhanced flexibility to the magnetic assembly 12 in this transition zone. In some implementations, the interaction between the size of the magnet elements 16 and the distance between adjacent magnet elements 16 can contribute to providing enhanced flexibility to the magnet assembly 12 and the desired clamping wire 42. In some implementations, it is advantageous to provide the magnet elements 16 as close as possible to each other, as long as the flexibility of the magnet assemblies 12 is preserved. In this respect, and as mentioned above, magnet elements 16 or housings 14 with rounded edges can be advantageous in providing a way that allows the magnet elements 16 or housings 14 to be close together without compromising the flexibility of the magnet assembly 12. It should be noted that these are merely examples to illustrate the possible effects of various configurations on the flexibility of the magnet assembly 12, and various configurations of the magnet assembly 12 can be implemented to achieve the desired combination of flexibility of the magnet assembly 12 and the desired clamping wire 42, as well as corresponding healing of the tissue on the edges of the magnet elements 16.

[0141] Fastener and connector for forming a closed clamping device In other implementations, and refer to Figures 20 to 22 The clamping device can be a closed clamping device 110. The closed clamping device 110 includes a first region 38 and a second region 40 of the magnetic element 16. The first region 38 and the second region 40 can be flexibly coupled to the flexible connector 48, thereby providing a first transition region and a second transition region. In such an implementation, the closed clamping device 110 forms a closed shape when in a pre-clamping configuration, which can also be referred to as a closed pre-clamping configuration. In use, the inwardly protruding portion of the target hollow organ can be pulled through the opening of the closed clamping device 110 in the closed pre-clamping configuration, such that the closed clamping device 110 can be positioned along the clamping line around the base of the inwardly protruding portion.

[0142] When in the clamping configuration, the magnet engagement side 321 of the first region 38 couples with the corresponding magnet engagement side 322 of the second region 40, allowing the enclosed clamping device 110 to form an elongated shape around the organ tissue 26 at the base of the inwardly protruding portion, such as... Figure 21 and Figure 22As shown in the diagram. Over time, the pressure applied to the wall of the target hollow organ causes ischemic pressure necrosis at the base of the inwardly projecting portion, resulting in the fusion of the two layers to form a fold, i.e., the inwardly projecting portion is formed at its base. Over time, this fusion may also cause the inwardly projecting portion to separate from the rest of the hollow organ, or the inwardly projecting portion may be removed in a secondary surgery when the closing clamping device 110 is removed. In such a configuration, the base of the inwardly projecting portion can be considered elongated and form a substantially elliptical shape, such as... Figure 22 As shown in the image.

[0143] Special Reference Figure 20 In some implementations, the clamping device 110 can be configured such that the magnetic element 16 in the first region 38, which is closest to the first transition region or the second transition region, is magnetically coupled to the corresponding magnetic element 16 in the second region 40. In other words, the magnetic coupling side 32 of the magnetic element 16 near the first transition region in the first region 38 is magnetically coupled to the corresponding magnetic element 16 in the second region 40. 1a The magnetic coupling side 32 of the magnet element 16 near the first transition zone in the second zone 40 2a Magnetically coupled. In other implementations, the clamping device 110 can be configured such that, in a closed pre-clamping configuration, opposing magnetic elements 16 are magnetically attracted to each other toward the center of the opening. In other words, the magnetic coupling sides 32 of the magnetic elements 16 in the first region 38 near the first transition region are magnetically coupled. 1a The magnetic coupling side 32 of the magnet element 16 in the second region 40 near the second transition region can be configured to magnetically couple. 2b And vice versa (magnetic coupling side 32) 1b Magnetically attracted to the magnetic coupling side 32 2a In this type of implementation, the magnetic attraction M is directed towards the center of the base of the inwardly projecting portion, causing the base of the inwardly projecting portion to form a substantially circular, oval, or elliptical shape.

[0144] In some implementations, the first region 38 and the second region 40 can be releasably coupled at one end, such as... Figure 21 As shown, or releasably coupled at both ends, such as Figure 22 As shown in the diagram. In some implementations, the first region 38 and the second region 40 are releasably coupled by a fastener 60. The fastener 60 can be any known device for fastening the two parts together, such as hooks and loops or buckles, including magnetic buckles, bolo buckles, cylindrical buckles, box buckles, bead and ball buckles, fishhook buckles, hook buckles, etc. Thus, the flexibility of the magnetic assembly in the clamping device 110 can be partially provided by the flexible connector 48 and the releasable fastener 60.

[0145] Special Reference Figure 21The first region 38 and the second region 40 can be releasably coupled in the first transition region via a flexible connector 48 and connected in the second transition region by a fastener 60, thereby forming a closed pre-clamping configuration. Alternatively, the fastener 60 in the second transition region can be released, so that the first region 38 and the second region 40 are not coupled in the second transition region. When the fastener 60 in the second transition region is released, the clamping device 110 can be in a ring-shaped pre-clamping configuration or an extended pre-clamping configuration, depending on the method of inserting the clamping device 110 into the lumen of the target hollow organ, the nature of the surgery, the type of the target hollow organ, etc. Once the clamping device 110 is positioned around the organ tissue 26 at the base of the inwardly protruding portion, the fastener 60 can be used to couple the first region 38 and the second region 40 together in the second transition region to place the clamping device 110 in the closed pre-clamping configuration, and the magnetic coupling sides 321, 322 of the first region 38 and the second region 40 can be magnetically coupled respectively to place the clamping device 110 in the clamping configuration.

[0146] Special Reference Figure 22 The first region 38 and the second region 40 can be coupled in the first transition region and the second transition region with corresponding fasteners 60, so that the device is in a closed pre-clamping configuration. The fasteners 60 in the first transition region or the second transition region can be configured to be released, so that the first region 38 and the second region 40 are not coupled at one end, and the clamping device can be in a loop pre-clamping configuration or an extended pre-clamping configuration. In some implementations, the first region 38 and the second region 40 can be releasably decoupled in both the first transition region and the second transition region, so that the clamping device 110 can be in a decoupled pre-clamping configuration. The decoupled pre-clamping configuration can facilitate easier manipulation of the clamping device 110 around the base of the inwardly protruding portion, and then the fasteners 60 in the first transition region and the second transition region can be coupled to position the clamping device 110 in the closed pre-clamping configuration, and the magnetic coupling sides 321, 322 of the first region 38 and the second region 40 can be magnetically coupled to place the clamping device 110 in the clamping configuration.

[0147] In some implementations, the flexible connector 48 between adjacent magnet elements 16 in the same region (i.e., the first region 38 or the second region 40) can be more rigid than the flexible connector 48 that couples the first region 38 and the second region 40 to each other or to the fastener 60. In such implementations, the flexible connector 48 in the first transition region can act as a hinge, whereby the similarly rigid configuration of the first region 38 and the second region 40 can be used to flatten or elongate the base of the inward protrusion 50 until the fastener 60 at the second transition region can be fastened. In such implementations, the clamping device 110 can partially function as a clamp or jig to clamp the base when the fastener 60 is coupled and to stabilize the magnet assembly 12 at the base of the inward protrusion.

[0148] Positioning and implantation of the clamping device Now for reference Figures 23 to 29C The implementation of clamping devices at different locations in a given target hollow organ and different target hollow organs will now be described.

[0149] Figure 23 An example of a clamping device 10 in a clamping configuration is illustrated, wherein organ tissue 26 at the base of the inwardly protruding portion is compressed between the organ contact sides 44 of the housing 14, and the magnetic engagement side 32 of the magnetic element 16 from the first region 38 is magnetically coupled to the magnetic engagement side 32 of the magnetic element 16 from the second region 40. The clamping device 10 can be implanted along a desired clamping line 42 (i.e., at the base of the inwardly protruding portion).

[0150] Refer again Figures 6 to 10 An example of a clamping line 42 extending around the base of the inwardly protruding portion of the stomach is shown (in...). Figure 9 (More specifically shown in the image). The position of the clamping line 42 can vary depending on the desired stomach volume or the location of the tumor to be removed. In this type of implementation, the clamping device 10 is positioned such as... Figure 6 The extended pre-clamping configuration shown in the figure or such Figure 7 The annular pre-clamping configuration shown is inserted into the gastric lumen, and the clamping device 10 can be positioned at the base of the inwardly protruding portion. In some implementations, the clamping device 10 is placed inside the lumen in an extended pre-clamping configuration and then in an annular or closed pre-clamping configuration. In other implementations, the clamping device 10 can be placed inside the lumen in a decoupled or closed pre-clamping configuration. Insertion and guidance of the clamping device 10 can be performed endoscopically for minimally invasive procedures, such as via superior endoscopy or colonoscopy. Extended or decoupled pre-clamping configurations facilitate easier insertion of the clamping device 10 into the lumen.

[0151] In implementations of using a clamping device to reduce the volume of a target hollow organ, a selected portion of the organ to be folded to form an inwardly projecting portion is first identified, and then the selected portion of the organ is pulled into the lumen of the target hollow organ using a surgical tool 52. In some implementations, the inwardly projecting portion 50 may be pulled into or drawn into the lumen before or after the clamping device 10 is inserted into the lumen of the organ. For example, the inwardly projecting portion 50 may be pulled into the lumen and clamped with any known type of surgical clamp, and then the clamping device 10 may be inserted into the lumen. In other implementations, the clamping device 10 may be inserted into the lumen, and then the inwardly projecting portion 50 may be pulled into the lumen and immediately clamped or compressed at its base with the clamping device 10. Surgical tools 52 can be used to pull or draw the inwardly protruding portion 50 into the lumen to grasp and move the organ wall, such as endoscopic grasping forceps, flexible spring plungers, spring claws, mechanical picks or forceps, including but not limited to Adson bipolar forceps, Adson Brown forceps, Babock forceps, Carmalt forceps, etc.

[0152] When the clamping device 10 is inserted into the lumen in the extended pre-clamped configuration, the clamping device 10 can be navigated around the base of the inwardly protruding portion 50 and aligned with the desired clamping line 42. Once the clamping device 10 is correctly aligned, the magnetic element 16 of the first region 38 of the magnet assembly 12 can be made sufficiently close to the magnetic element 16 of the second region 40 of the magnet assembly 12, such that the magnetic engagement side 32 of the magnetic element 16 of the first region 38 can be magnetically coupled to the magnetic engagement side 32 of the magnetic element 16 of the second region 40. As described above, the attractive force of the magnetic element 16 can be selected to allow for repeated trials until the correct placement of the magnetic assembly 12 is achieved.

[0153] refer to Figures 25A to 25C In some implementations, the clamping line 42 may be placed at the upper part of the stomach, causing at least a portion of the gastric fundus to fold inward to form an inwardly protruding portion 50. See also Figures 26A to 26C In some implementations, the clamping line 42 can be positioned along the vertical sidewall of the stomach body, making it similar to the clamping line used in, for example, vertical sleeve gastrectomy. In both implementations, the formation of the inwardly projecting portion 50 reduces the volume of the stomach cavity. Once the stomach wall forming the inwardly projecting portion is already fused together at the base of the inwardly projecting portion, i.e., between the magnetic elements, the inwardly projecting portion 50 can be retained in the stomach cavity for a given period of time, or can be removed in a secondary surgery, for example, when the clamping device 10 is removed from the stomach cavity endoscopically.

[0154] Now for reference Figure 27A and Figure 27BA partial view of the abdominal cavity comprising the large intestine 54, small intestine 56, and appendix 58 is shown. In some implementations, the clamping device 10 can be used for an appendectomy (i.e., removal of the appendix 58). In such implementations, a surgical instrument 52 is inserted into the lumen 54a of the large intestine 54, for example via an endoscopic procedure. The appendix 58 is then pulled or retracted into the lumen 54a of the large intestine 54 using the surgical instrument 52. The clamping device 10 can be inserted into the lumen 54a of the large intestine 54 before or after the appendix 58 is pulled or retracted into the lumen 54a, and can then be positioned around the base of the appendix 58 at a clamping line 42. In such implementations, the appendix 58 can be considered to correspond to an inwardly protruding portion of the large intestine, and the clamping device 10 can be used to remove the appendix 58 via ischemic pressure necrosis. Once the organ tissue 26 around the base of the appendix 58 (i.e., the tissue at the clamping line 42) has fused together, the appendix 58 and the clamping device 10 can be removed in a secondary surgery.

[0155] In other implementations, the clamping device 10 can be used to remove or excise a portion of the inner wall of the target hollow organ. In such implementations, a portion of the organ can be removed or excised to remove, for example, tumors, lesions, necrotic tissue, etc., from the wall of the target organ. Alternatively, when the target hollow organ has two or more types of wall tissue, the inwardly projecting portion 50 can include the internal tissue of the hollow organ. In some implementations, the inwardly projecting portion 50 can completely or partially include a tumor, and the clamping device 10 can be inserted into the lumen of the target hollow organ and positioned around the base of the tumor, which would correspond to the inwardly projecting portion of the organ.

[0156] Now for reference Figure 28 The illustration shows a bladder 64 of a female patient with a tumor 66 on the inner surface of the detrusor muscle. In this implementation, a clamping device 10 can be inserted into the lumen 64a of the bladder 64 and positioned around the base of the tumor 66 at a clamping line 42, such that the inwardly projecting portion completely includes the tumor 66. In some implementations, depending on the location and depth of the tumor within the tissue lining the lumen of the bladder 64, a surgical tool 52 can be used to further pull or draw the tumor 66 into the lumen, such that the inwardly projecting portion partially includes the tumor 66, as well as healthy or non-tumor tissue of the detrusor muscle. Once ischemic pressure necrosis causes the detrusor muscle tissue between the magnetic elements of the magnet assembly to fuse together, the tumor 66 can be excised and removed from the lumen 64a of the bladder 64 in a secondary surgery, such as when the clamping device is removed. In such implementations, the clamping device 10 can serve to increase the volume of the lumen of the target hollow organ by removing extraneous portions, such as tumors, extending into the lumen of the organ.

[0157] Now for reference Figures 29A to 29CThe illustration shows a bladder 64 of a female patient with a tumor 66 on the outer wall surface of the bladder 64. In this implementation, a surgical tool 52 can be used to grasp the inner wall of the lumen 64a of the bladder 64 on the opposite side of the tumor 66. The inner wall of the lumen 64a can then be pulled inward into the lumen 64a of the bladder 64, making the tumor 66 part of the inwardly protruding portion 50. A clamping device 10 can be inserted into the lumen 64a of the bladder 64 and positioned at a clamping line 42 to surround the base of the tumor 66. Once ischemic pressure necrosis causes tissue fusion between the magnetic elements of the magnet assembly, the inwardly protruding portion 50 can be excised and removed from the lumen 64a of the bladder 64 in a secondary surgery, such as when the clamping device is removed.

[0158] Method for implanting a clamping device The method of removing a portion of a hollow organ using a clamping device as described in this article will now be described in more detail.

[0159] In some implementations, the clamping device includes a magnet assembly, which in turn includes a plurality of magnet elements flexibly connected in series. In some implementations, the magnet assembly may include fasteners, such as clips, hooks and rings, or buckles, that allow a first and a second portion of the magnet assembly to be releasably coupled so that the magnet assembly can form a closed shape.

[0160] The method involves inserting a clamping device into the lumen of a patient's target hollow organ. Since the clamping device is an implant configured to remain in the lumen of the patient's target hollow organ for a period of time, it can be sterilized prior to insertion into the lumen of the patient's hollow organ. For insertion into the lumen of the patient's target hollow organ, the magnetic assembly can be in an extended pre-clamping configuration, a ring-shaped pre-clamping configuration, a closed pre-clamping configuration, a decoupled pre-clamping configuration, or a clamping configuration (i.e., a first region of the clamping device is magnetically coupled to a second region, including magnetic decoupling of the first and second regions to position the clamping device around the base of the inwardly projecting portion). Then, in some instances, the magnetic assembly can be guided endoscopically to position it around the base of the inwardly projecting portion of the hollow organ. Various techniques can be used to insert the magnetic assembly into the lumen of the patient's target hollow organ and to position it around the base of the inwardly projecting portion of the target hollow organ. For example, these techniques can include image-guided surgery and flexible endoscopy. When the first region of the magnet assembly faces the second region of the magnet assembly, the magnet engagement side of the magnet element from the first region of the magnet assembly faces the magnet engagement side of the magnet element from the second region of the magnet assembly. Simultaneously, the magnet elements remain magnetically decoupled in either a ring-shaped pre-clamping configuration or a closed pre-clamping configuration, or in a decoupled pre-clamping configuration, to facilitate placement of the magnet assembly along a desired clamping line (i.e., around the base of the inwardly projecting portion). When the clamping device is formed in a substantially circular shape or other closed shape, whether as a closed circular shape or a ring-shaped shape, the magnet elements can remain magnetically decoupled during placement around the base of the inwardly projecting portion.

[0161] In some implementations, the method may involve using surgical instruments, such as forceps, to pull or retract a portion of the organ or an adjacent organ into the lumen of the target hollow organ before or after placing the clamping device within the lumen of the target hollow organ. For example, in appendectomy, the target hollow organ is the large intestine, and the adjacent organ to be removed is the appendix. In appendectomy, surgical instruments can be used to retract the appendix into the lumen of the large intestine, and once the appendix is ​​inside the large intestine, the clamping device can be placed at the base of the appendix.

[0162] In some implementations, such as during obesity treatment, the method may involve using a surgical tool that can be pulled or retracted into a portion of the stomach tissue to form an inward protrusion, and a clamping device that can be placed against the inner wall of the stomach at the base of the inward protrusion. By pulling or retracting a portion of the stomach tissue to form the inward protrusion, the overall volume of the stomach is reduced.

[0163] In some implementations, such as during the removal or division of a tumor or lesion or other type of unwanted tissue on the inner wall of a target hollow organ, the method may include using surgical instruments to retract or pull in the unwanted tissue, and clamping devices may be placed containing the unwanted tissue, and may also include the edges surrounding the unwanted tissue or the base of an inwardly projecting portion of healthy tissue. During the removal or division of unwanted tissue located on the outer wall of a target hollow organ (extracavitary tumor) or unwanted tissue extending through the wall of the target hollow organ, the method may include using surgical instruments to retract or pull in the unwanted tissue within the lumen of the target hollow organ to form an inwardly projecting portion, such that the unwanted tissue is closed by the inwardly projecting portion. It should be noted that when the unwanted tissue extends through the wall of the target hollow organ, a portion of the outer tissue of the inwardly projecting portion may include the unwanted tissue.

[0164] Once the magnetic elements on both sides of the magnet assembly are aligned as desired along the base of the inwardly projecting portion (i.e., at the clamping line), the magnetic elements can be brought closer together in the clamping configuration. In the clamping configuration, the magnetic elements of the first region are magnetically coupled to the magnetic elements of the second region; that is, the magnetic elements facing each other are magnetically coupled via their respective magnetic engagement sides to compress the opposing walls of the inwardly projecting portion, with the two layers forming a fold therebetween. In some implementations, when the magnetic elements are received in a housing, the housing includes an organ contact side, and the opposing walls of the inwardly projecting portion are compressed between the opposing organ contact sides of the housing. In some implementations, the organ contact side of the housing may be an elongated, flat contact surface.

[0165] In some implementations, once the clamping device is in a clamping configuration, fasteners at one or both ends of each of the first and second magnet element regions can be releasably coupled, allowing the clamping device to be in a closed clamping configuration.

[0166] Then, after the magnet assembly is implanted around the base of the inwardly projecting portion of the target hollow organ in a clamping configuration, the magnet assembly can be retained for a duration of healing time sufficient to allow the opposing walls of the inwardly projecting portion to fuse together while the magnet elements are magnetically coupled together. In some implementations, the healing period can be extended from 2 weeks to 7 weeks. In some implementations, the healing process can be monitored to determine at what point the opposing walls of the inwardly projecting portion have fused well together. In some implementations, the duration of the healing period can be determined based on the target hollow organ, the configuration of the magnet assembly (i.e., the size, magnetic field strength, and shape of the magnet elements), the patient's condition, and various other factors.

[0167] Once the opposing walls of the inwardly protruding portions have fused well together and healing is complete, the clamping device can be removed from the lumen of the target hollow organ. The method of removing the magnetic assembly can vary depending on the design of the clamping device. In some implementations, the clamping device can be removed endoscopically from the lumen of the target hollow organ and the abdominal cavity. Similarly, various techniques can be used to remove the magnetic assembly from the lumen of the patient's target hollow organ; these techniques may be the same as or different from those previously used for inserting and placing the magnetic assembly into the lumen of the target hollow organ, and may include, for example, image-guided surgery and flexible endoscopy.

[0168] In some implementations, such as in the context of surgeries for reducing the volume of hollow organs, such as bariatric surgery, the method of removing a portion of a hollow organ using a clamping device as described herein can be performed sequentially. For example, an initial or first surgery can be performed to remove a first portion of the hollow organ, thus reducing the volume of the hollow organ by a portion of the desired total volume reduction. Once the initial surgery is completed and sufficient healing time has elapsed, a subsequent or second surgery can be performed to remove the first portion of the hollow organ, thus reducing the volume of the hollow organ by another portion of the desired total volume reduction, and thus further reducing the volume of the hollow organ. In such implementations, any number of consecutive surgeries can be performed, each occurring after a sufficient corresponding healing time, until the desired total volume reduction is achieved. In some implementations, the target area (i.e., the area forming the inwardly protruding portion) in subsequent surgeries (second, third, etc. surgeries) can differ from the target area in the previous one or more surgeries. By performing successive volume reduction surgeries, the organ can have additional time to heal and adjust to the reduced volume size before further volume reduction.

[0169] This document has described and illustrated several alternative implementations and examples. The implementations of the technology described above are intended to be illustrative only. Those skilled in the art will understand the characteristics of the various implementations, as well as the possible combinations and variations of components. Those skilled in the art will further understand that any implementation can be arbitrarily combined with other implementations disclosed herein. It should be understood that the technology can be implemented in other specific forms without departing from its central characteristics. Therefore, the current implementations and examples are considered illustrative rather than restrictive in all respects, and the technology is not limited to the details given herein. Thus, although specific implementations have been illustrated and described, many modifications are conceived.

Claims

1. A method for removing an inwardly protruding portion present in a patient's hollow organ, the method comprising the steps of: The magnetic assembly of the clamping device is inserted into the lumen of the hollow organ. The magnetic assembly includes a first region and a second region, each of which includes at least one magnetic element having a magnetic engagement side. Position the magnet assembly at the base of the inwardly protruding portion such that the magnetic engagement side of the first region and the magnetic engagement side of the second region face each other. The first region and the second region are magnetically coupled together to compress the opposing walls of the inwardly protruding portion therebetween; as well as The opposing walls of the protruding portion are allowed to fuse together via ischemic pressure necrosis, while the first and second regions remain magnetically coupled during the healing period.

2. The method according to claim 1, further comprising pulling the wall of the hollow organ into the lumen of the hollow organ to form the inwardly protruding portion.

3. The method according to claim 1 or 2, wherein inserting the magnet assembly of the clamping device into the lumen of the hollow organ comprises first inserting a first region of the magnet assembly and then inserting a second region of the magnet assembly.

4. The method according to any one of claims 1 to 3, wherein positioning the magnet assembly at the base of the inwardly projecting portion comprises positioning the first region along a first side of the base, and positioning the second region of the magnet assembly adjacent to the first region of the magnet assembly along a second side of the base opposite to the first side.

5. The method of claim 4, wherein positioning the magnet assembly at the base of the inwardly projecting portion further comprises coupling a first end and a second end of the magnet assembly by a releasable fastener to form a closed shape around the base.

6. The method of claim 5, wherein the first and second regions of the magnet assembly are separated by a transition region, and the releasable fastener coupling the first and second ends is provided in the transition region.

7. The method according to any one of claims 1 to 6, wherein at least one magnetic element of at least one of the first region and the second region comprises a plurality of magnetic elements.

8. The method according to any one of claims 1 to 6, wherein at least one magnetic element of both the first region and the second region comprises a plurality of magnetic elements.

9. The method according to claim 7 or 8, wherein the plurality of magnet elements are connected in series.

10. The method of claim 9, wherein the plurality of magnet elements are flexibly connected in series.

11. The method according to any one of claims 1 to 10, wherein at least one magnet element in the first region has a first region magnetic pole on its magnet engagement side, and at least one magnet element in the second region has a second region magnetic pole on its magnet engagement side that is different from the first region magnetic pole.

12. The method of claim 11, wherein magnetically coupling the first region and the second region together comprises magnetically coupling a first region magnetic pole on the magnet engagement side of the first region to a second region magnetic pole on the magnet engagement side of the second region.

13. The method according to any one of claims 1 to 12, wherein the healing time period is in the range of about 1 week to about 7 weeks.

14. The method according to any one of claims 1 to 13, further comprising removing the clamping device from the lumen of the hollow organ once the healing period has ended.

15. The method according to any one of claims 1 to 14, further comprising removing the inwardly projecting portion from the lumen of the hollow organ once the healing period has ended.

16. The method according to any one of claims 1 to 15, wherein the hollow organ is the patient's stomach, esophagus, small intestine, large intestine, gallbladder, fallopian tube, or bladder.

17. The method of claim 16, wherein the hollow organ is the stomach, and the method for removing the inwardly protruding portion present in the stomach is bariatric surgery.

18. The method according to any one of claims 1 to 16, wherein the inwardly projecting portion comprises a tumor or lesion.

19. The method according to any one of claims 1 to 15, wherein the hollow organ is the patient's large intestine and the inwardly projecting portion is the patient's appendix.

20. The method according to any one of claims 1 to 19, wherein the insertion of the magnet assembly of the clamping device into the lumen of the hollow organ is performed by an endoscope.

21. A method for removing an inwardly protruding portion present in a patient's hollow organ, the method comprising the steps of: Insert the front end of the magnet assembly of the clamping device into the lumen of the hollow organ; Guide the front end to position the magnet assembly around the base of the inwardly projecting portion; The magnetic elements of the magnet assembly are magnetically coupled together at the base of the inwardly projecting portion to compress the opposing walls of the inwardly projecting portion therebetween.

22. The method of claim 21, further comprising pulling the wall of the hollow organ into the lumen of the hollow organ to form the inwardly projecting portion.

23. The method of claim 21 or 22, further comprising allowing the opposing walls of the base to fuse together during the healing time period when the magnetic elements are magnetically coupled together.

24. The method of claim 23, further comprising removing the clamping device from the lumen of the hollow organ once the healing period has ended.

25. The method of claim 23 or 24, further comprising removing the inwardly projecting portion from the lumen of the hollow organ once the healing period has ended.

26. The method of any one of claims 21 to 25, wherein the clamping device further comprises a releasable fastener located at the rear end of the magnet assembly, the releasable fastener being configured to be releasably coupled to the front end of the magnet assembly.

27. The method according to any one of claims 21 to 25, wherein the first portions of the magnetic elements are connected in series in a first region, and the second portions of the magnetic elements are connected in series in a second region, wherein the first region and the second region are opposite to each other once the magnetic assembly is implanted into the hollow organ.

28. The method of claim 27, wherein the first region and the second region are pivotally, elastically, or flexibly connected to each other.

29. A method for altering the structure of a patient's organ, the method comprising the steps of: At least a portion of the organ is pulled into the lumen of a patient’s adjacent hollow organ to form an inwardly protruding portion; A clamping device comprising a magnet assembly is implanted into the lumen of the adjacent hollow organ, the magnet assembly comprising: The first region includes a first magnetic element; The second region includes a second magnetic element; and A first transition zone extends between the first zone and the second zone; Position the magnet assembly at the base of the inwardly protruding portion such that the first region and the second region face each other; The first magnet element and the second magnet element are magnetically coupled together to compress the opposing walls of the base; and The opposing walls of the base are allowed to fuse together while the magnetic elements remain magnetically coupled.

30. The method of claim 29, wherein positioning the magnet assembly at the base of the inwardly projecting portion includes releasably coupling the first region and the second region in the transition region to form a closed shape around the base.

31. A clamping device for removing an inwardly protruding portion of a hollow organ present in a patient, the clamping device comprising: A magnet assembly capable of being implanted into the lumen of a patient's hollow organ, the magnet assembly comprising: The first region includes a first magnetic element; and The second region includes a second magnetic element; and The magnet assembly is configured to be positioned at the base of the inwardly projecting portion to magnetically couple the first region and the second region to compress the opposing walls of the inwardly projecting portion therebetween during the healing time period.

32. The clamping device of claim 31 further includes a transition region extending between the first region and the second region, the transition region including a fastener coupling the front end of the first region to the rear end of the second region.

33. The clamping device according to claim 32, wherein the fastener comprises a flexible fastener.

34. The clamping device according to claim 32 or 33, wherein the fastener includes a releasable fastener.

35. The clamping device according to any one of claims 32 to 34, wherein the transition zone is configured to provide a pivoting transition between the first zone and the second zone.

36. The clamping device according to any one of claims 32 to 35, wherein the transition region further comprises a flexible connector.

37. The clamping device according to any one of claims 31 to 36, wherein at least one of the first magnet element and the second magnet element comprises a plurality of magnet elements, the magnet elements of the plurality of magnet elements being connected in series with each other via a magnet element connector.

38. The clamping device according to claim 37, wherein the magnet element connector is flexible.

39. The clamping device according to claim 38, wherein the magnet element connector is a rigid or semi-rigid connector.

40. The clamping device according to any one of claims 31 to 39, wherein each of the first magnetic element and the second magnetic element includes a magnetic engagement side capable of magnetically coupling with each other.

41. The clamping device according to claim 40, wherein the magnet engagement side of the first magnet element has a first magnetic pole region, and the magnet engagement side of the second magnet element has a second magnetic pole region different from the first magnetic pole region.

42. The clamping device according to any one of claims 31 to 41, wherein the first magnet element and the second magnet element have a shape selected from the group consisting of an elliptical shape, a stadium shape, a circular shape, a triangular shape, a rectangular shape and an octagonal shape.

43. The clamping device according to any one of claims 31 to 42, wherein at least one of the first magnet element and the second magnet element comprises a bevel or a rounded edge.

44. The clamping device according to any one of claims 31 to 43, wherein the clamping device is configurable between a pre-clamping configuration and a clamping configuration.

45. The clamping device of claim 44, wherein the pre-clamping configuration is a closed pre-clamping configuration or a decoupled pre-clamping configuration.

46. ​​The clamping device of claim 31, wherein at least one of the first magnetic element and the second magnetic element comprises a housing, the housing including an organ contact side and configured to receive at least one of the first magnetic element and the second magnetic element therein.

47. The clamping device of claim 46, wherein the organ contact side of the housing comprises an elongated, flat contact side.

48. The clamping device according to claim 46 or 47, wherein the housing includes a bevel.

49. The clamping device of claim 31, wherein the first magnet element and the second magnet element are received in a housing, the housing including a first end and a second end, and wherein the first end and the second end of the housing are releasably coupled to each other by fasteners.

50. The clamping device according to claim 31, wherein the first magnet element and the second magnet element are received in corresponding housings.

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