Magnetic device for digestive tract partitioning

Abstract

A partitioning device for partitioning a hollow organ of a patient's digestive tract in the context of a digestive surgery is provided. The partitioning device includes a magnet assembly implantable in the patient's abdominal cavity, the magnet assembly including a plurality of magnet elements flexibly connected in series. The magnet assembly is configured to be positioned extracorporeally around at least a portion of an outer surface of the hollow organ to magnetically couple the opposing magnet elements together to compress the opposing walls of the hollow organ therebetween until the opposing walls of the hollow organ fuse together, thereby partitioning the hollow organ. The magnet elements are receivable in a housing and have various shapes. The partitioning device can include additional features, such as a front elongated member and a back elongated member that can help position the partitioning device.

Description

Technical Field

[0001] This technical field generally relates to medical technologies for treating digestive tract disorders. In particular, this technical field relates to medical technologies for constructing hollow organs that separate the digestive tract. Background Technology

[0002] Obesity surgery can be used to treat obesity and is typically designed to limit the size of organs such as the stomach and / or bypass parts of the stomach and / or intestine. Examples of obesity surgery include jejunoileal bypass, jejunocolonic bypass, bile-pancreatic bypass, gastric bypass, Roux-en-Y gastric bypass, gastrectomy, gastric banding, vertical band gastrectomy, silicone ring gastrectomy, and sleeve gastrectomy.

[0003] However, these obesity surgeries often require altering the digestive tract through incisions, sutures, punctures, and / or staples, which can traumatize the altered organs and lead to bleeding. Such obesity surgeries also increase the risk of infection or other complications.

[0004] Therefore, many challenges remain regarding obesity surgery. Summary of the Invention

[0005] According to one aspect, a method for separating a hollow organ of a patient's digestive tract is provided, the method comprising the following steps:

[0006] The magnetic assembly of the separator is inserted into the patient's abdominal cavity. The magnetic assembly includes multiple magnetic elements flexibly connected in series.

[0007] The magnet assembly is positioned outside the cavity and along the dividing line around at least a portion of the outer surface of the hollow organ, such that the front and rear portions of the magnet assembly face each other.

[0008] The opposing magnetic elements are magnetically linked together to compress the opposing walls of the hollow organ between them; and

[0009] The opposing walls of the hollow organs are allowed to fuse together while the magnetic elements remain magnetically connected.

[0010] In some implementations, the separating device also includes a first end and a second end, wherein the magnet assembly extends between the first end and the second end.

[0011] In some implementations, the magnet assembly includes a first region and a second region, and the step of inserting the magnet assembly of the separator into the patient's abdominal cavity includes: first inserting the first region of the magnet assembly, and then inserting the second region of the magnet assembly.

[0012] In some implementations, the step of positioning the magnet assembly outside the cavity and along a dividing line around at least a portion of the outer surface of the hollow organ includes: positioning a first region of the magnet assembly as the rear portion of the magnet assembly and positioning a second region of the magnet assembly as the front portion of the magnet assembly.

[0013] In some implementations, each of the magnetic elements includes a magnetic engagement side, and the step of magnetically connecting opposing magnetic elements together includes: magnetically connecting the opposing magnetic engagement sides of the magnetic elements that face each other.

[0014] In some implementations, the magnet element of the first region of the magnet assembly has a first region magnetic pole on its magnet engagement side, and the magnet element of the second region of the magnet assembly has a second region magnetic pole that is different from the first region magnetic pole.

[0015] In some implementations, the step of magnetically connecting opposing magnetic elements together includes: magnetically connecting the first region magnetic pole of the magnetic bonding side of the first region magnetic element to the second region magnetic pole of the magnetic bonding side of the second region magnetic element.

[0016] In some implementations, the steps of allowing the opposing walls of the hollow organ to fuse together while maintaining the magnetic connection of the magnetic elements include: retaining the magnetic assembly along the separator line for a given period of time.

[0017] In some implementations, the given time period ranges from approximately one week to approximately seven weeks.

[0018] In some implementations, the method also includes removing the separator from the patient's abdominal cavity once the opposing walls of the hollow organ have fused together.

[0019] According to another aspect, a method for separating a hollow organ in a patient's digestive tract is provided, the method comprising the following steps:

[0020] The anterior elongated member of the separator and the magnet assembly are inserted into the patient's abdominal cavity. The anterior elongated member extends from the front end of the magnet assembly, and the magnet assembly includes a plurality of magnet elements flexibly connected in series.

[0021] The elongated guide member positions at least a portion of the magnet assembly outside the cavity around the outer surface of the hollow organ, such that the front and rear portions of the magnet assembly face each other.

[0022] Opposing magnetic elements are magnetically connected along the dividing line to compress the opposing walls of the hollow organ between them;

[0023] The opposing walls of the hollow organs are allowed to fuse together, while the magnetic elements are magnetically connected together.

[0024] In some implementations, guiding the anterior elongated member includes engaging the anterior elongated member with a delivery catheter and guiding the anterior elongated member via a laparoscopy around at least a portion of the outer surface of the hollow organ.

[0025] In some implementations, the anterior elongated member is configured to remain in a subcutaneous position when the opposing walls of the hollow organ fuse together.

[0026] In some implementations, the separation device also includes a rear elongated member extending from the rear end of the magnet assembly, which is configured to remain subcutaneously or externally to the patient when the opposing walls of the hollow organ fuse together.

[0027] In some implementations, the method also includes removing the separator from the patient's abdominal cavity once the opposing walls of the hollow organ have fused together.

[0028] In some implementations, the steps of removing the separator include pulling one of the anterior and posterior elongated members to remove the separator from the patient's abdominal cavity.

[0029] According to another aspect, a method for separating a hollow organ in a patient's digestive tract is provided, the method comprising the following steps:

[0030] The magnetic assembly of the separator is inserted into the patient's abdominal cavity. The magnetic assembly includes:

[0031] Multiple magnetic components are flexibly connected in series;

[0032] A housing, including an organ contact side and configured to receive the plurality of magnetic elements therein;

[0033] The magnet assembly is positioned outside the cavity around at least a portion of the outer surface of the hollow organ and along the dividing line, such that the front portion of the organ contact side and the rear portion of the organ contact side face each other.

[0034] Opposing magnetic elements are magnetically linked together to compress the opposing walls of the hollow organ between the front and rear portions of the organ-contact side of the shell; and

[0035] The opposing walls of the hollow organs are allowed to fuse together while the magnetic elements remain magnetically connected.

[0036] In some implementations, the organ contact side of the shell includes an elongated flat contact surface.

[0037] In some implementations, the housing includes beveled edges.

[0038] According to another aspect, a method for separating a hollow organ in a patient's digestive tract is provided, the method comprising the following steps:

[0039] The magnetic assembly of the separator is inserted into the patient's abdominal cavity. The magnetic assembly includes:

[0040] A plurality of magnetic elements are flexibly connected in series, each of which is received in a corresponding housing including the organ contact side;

[0041] The magnet assembly is positioned outside the cavity and along the dividing line around at least a portion of the outer surface of the hollow organ, such that the front portion of the organ contact side and the rear portion of the organ contact side face each other.

[0042] Opposing magnetic elements are magnetically linked together to compress the opposing walls of the hollow organ between the front and rear portions of the organ-contact side of the shell; and

[0043] The opposing walls of the hollow organs are allowed to fuse together while the magnetic elements remain magnetically connected.

[0044] In some implementations, the organ contact side of the shell includes an elongated flat contact surface.

[0045] In some implementations, the housing includes beveled edges.

[0046] According to another aspect, a separating device is provided for separating hollow organs of a patient's digestive tract, the separating device comprising:

[0047] A magnet assembly, which can be implanted into a patient's abdominal cavity and includes:

[0048] Multiple magnetic components are flexibly connected in series;

[0049] The magnet assembly is configured to be positioned outside the cavity around at least a portion of the outer surface of the hollow organ to magnetically connect opposing magnet elements together, thereby compressing the opposing walls of the hollow organ between them until the opposing walls of the hollow organ fuse together, thereby separating the hollow organ.

[0050] In some implementations, the separating device also includes a front elongated member and a rear elongated member, wherein the magnet assembly extends between the front elongated member and the rear elongated member.

[0051] In some implementations, the elongated anterior member is configured to engage with a delivery conduit to guide the magnet assembly to the hollow organ and around at least a portion of the outer surface of the hollow organ.

[0052] In some implementations, each of the magnet elements includes a magnet engagement side to magnetically connect the opposing magnet engagement sides of the magnet elements facing each other.

[0053] In some implementations, the magnet assembly includes a first region and a second region, wherein the magnet element of the first region of the magnet assembly has a first region magnetic pole on its magnet engagement side, and the magnet element of the second region of the magnet assembly has a second region magnetic pole different from the first region magnetic pole on its magnet engagement side.

[0054] In some implementations, the magnet element has a shape selected from a group consisting of ellipses, stadium shapes, circles, triangles, rectangles, and octagons.

[0055] In some implementations, the magnet element includes a beveled edge.

[0056] In some implementations, the magnetic element includes a circular edge.

[0057] In some implementations, the magnet engagement side of the magnet element has a smaller surface area compared to the side of the magnet element opposite to the magnet engagement side.

[0058] In some implementations, the magnetic components are flexibly connected in series via flexible connectors.

[0059] In some implementations, the flexible connector includes a flexible strip.

[0060] In some implementations, the separating device can be configured between the pre-separated structure and the separating structure.

[0061] In some implementations, the dividing device includes a curved region.

[0062] In some implementations, the attractive force of the magnetic element is determined at least in part based on the thickness and / or composition of the hollow organ.

[0063] In some implementations, the attractive force of the magnetic element is determined to facilitate the placement and implantation of the separator around a portion of the outer surface of the hollow organ.

[0064] In some implementations, the multiple flexible, series-connected magnetic elements are positioned close enough that once the opposing walls of the hollow organ fuse together, a substantially continuous dividing line can be formed.

[0065] In some implementations, the magnet element is housed within a housing.

[0066] In some implementations, each of the magnet elements is received in a corresponding housing.

[0067] In some implementations, the housing includes beveled edges.

[0068] In some implementations, the corresponding housing includes beveled edges.

[0069] According to another aspect, a separating device is provided for separating hollow organs of a patient's digestive tract, the separating device comprising:

[0070] The front slender member and the rear slender member; and

[0071] A magnet assembly extending between an anterior elongated member and a posterior elongated member, the magnet assembly being implantable into a patient's abdominal cavity and comprising:

[0072] Multiple magnetic components are flexibly connected in series;

[0073] The magnet assembly is configured to be positioned outside the cavity around at least a portion of the outer surface of the hollow organ by guiding the elongated front member of the separating device to magnetically connect opposing magnet elements together, thereby compressing the opposing walls of the hollow organ between them until the opposing walls of the hollow organ fuse together, thereby separating the hollow organ.

[0074] In some implementations, the front slender member is a flexible front slender member.

[0075] In some implementations, the flexible front elongated member includes at least one of a flexible rope and a flexible wire.

[0076] In some implementations, the elongated front member is configured to engage with the delivery conduit.

[0077] In some implementations, at least one of the anterior elongated member and the posterior elongated member is configured to anchor the separator under or outside the patient's skin while the opposing walls of the hollow organ are compressed between opposing magnetic elements.

[0078] In some implementations, the separating device can be configured between the pre-separated structure and the separating structure.

[0079] In some implementations, in the partition structure, the front elongated member and the rear elongated member are close to each other so that the partition device forms a partial loop or loop.

[0080] In some implementations, the front elongated member and the rear elongated member include a continuous elongated member configured to slidably engage with the magnet assembly.

[0081] According to another aspect, a separating device is provided for separating hollow organs of a patient's digestive tract, the separating device comprising:

[0082] Magnet assembly, including:

[0083] Multiple magnetic components are flexibly connected in series;

[0084] A housing configured to receive the plurality of magnetic elements therein and including an organ contact side;

[0085] The magnet assembly is configured to be positioned outside the cavity around at least a portion of the outer surface of the hollow organ to magnetically connect opposing magnet elements together, thereby compressing and fusing the opposing walls of the hollow organ together between opposing organ contact sides of the shell.

[0086] In some implementations, the organ contact side of the shell includes an elongated flat contact surface.

[0087] In some implementations, the shell has a shape selected from a group consisting of ellipses, stadium shapes, circles, triangles, rectangles, and octagons.

[0088] In some implementations, the housing includes beveled edges.

[0089] In some implementations, the shell includes a rounded edge.

[0090] In some implementations, the organ contact side of the housing has a smaller surface area compared to the side of the housing opposite the organ contact side.

[0091] In some implementations, the magnetic components are flexibly connected in series via flexible connectors.

[0092] In some implementations, the housing comprises multiple housings, with each of the magnetic elements received in a corresponding one of the multiple housings.

[0093] In some implementations, flexible connectors are positioned between adjacent housings in the plurality of housings.

[0094] In some implementations, the housing includes a connecting portion between adjacent housings to flexibly connect adjacent magnetic elements among the plurality of magnetic elements.

[0095] In some implementations, the housing in which the plurality of magnetic elements are received is a single housing.

[0096] In some implementations, the flexible connector is housed within a single housing.

[0097] In some implementations, the housing comprises metal.

[0098] In some implementations, the metal includes at least one of stainless steel, titanium, and medical implant-grade metals.

[0099] In some implementations, the shell comprises a polymer.

[0100] In some implementations, the polymer includes silicone resin, Silastic TM At least one of the following: and medical implant-grade polymers.

[0101] According to another aspect, a separating device is provided for separating hollow organs of the digestive tract, the separating device comprising:

[0102] A magnet assembly, which can be implanted into a patient's abdominal cavity and includes:

[0103] A plurality of magnetic elements flexibly connected in series, each of the plurality of magnetic elements having a magnetic engagement side;

[0104] A flexible housing configured to receive the plurality of magnetic elements therein, the housing including an organ contact side;

[0105] The device can be configured in a pre-segmentation structure for insertion into the abdominal cavity and in a segmentation structure for separating hollow organs;

[0106] In the pre-separated structure, the magnetic engagement sides of the magnetic elements are magnetically disengaged from each other, and in the separated structure, the magnetic assembly forms a U-shape around the hollow organ to magnetically connect the opposing magnetic engagement sides, and the opposing walls of the hollow organ are compressed and fused together between the opposing segments of the elongated flat contact surfaces of the shell.

[0107] In some implementations, the pre-split construction includes an extended pre-split construction.

[0108] In some implementations, the pre-segmentation structure includes a ring-shaped pre-segmentation structure. Attached Figure Description

[0109] Figure 1 It is a schematic side cross-sectional view of a partition device that includes a magnet assembly having a first region and a second region, shown in an extended pre-partitioned configuration.

[0110] Figure 2 It is a schematic side cross-sectional view of a partition device that includes a magnet assembly having a first region and a second region, shown in an annular pre-partitioned configuration.

[0111] Figure 3 It is a schematic perspective view of a magnetic element that is in arbitrary spatial relation to the wall of a part of a hollow organ.

[0112] Figure 4 It is a schematic side sectional view of a partition device in an extended pre-partitioned structure, and an enlarged view of a magnetic element in a first region of a magnetic assembly and a magnetic element in a second region of a magnetic assembly.

[0113] Figure 5 It is a schematic side sectional view of a partition device in a ring-shaped pre-partitioned structure, and an enlarged view of a magnetic element in a first region of a magnetic assembly and a magnetic element in a second region of a magnetic assembly.

[0114] Figure 6 This is a schematic top cross-sectional view showing a dividing device in an extended pre-divided structure for subsequent placement around the outer surface of the stomach.

[0115] Figure 7 yes Figure 6 The schematic top cross-sectional view of the dividing device shown is folded around the outer surface of the stomach to be placed in a ring-shaped pre-dividing structure.

[0116] Figure 8 This is a schematic top cross-sectional view showing a partition device in a ring-shaped pre-divided structure for subsequent placement around the outer surface of the stomach.

[0117] Figure 9 yes Figure 8 The schematic top cross-sectional view of the dividing device shown is translated to be positioned around the outer surface of the stomach.

[0118] Figure 10 yes Figure 9 The schematic top cross-sectional view of the dividing device shown is placed in an annular pre-dividing structure around the outer surface of the stomach.

[0119] Figure 11 It is a schematic perspective view of a magnetic element shown in arbitrary spatial relation to the wall of a portion of a hollow organ, the magnetic element being received in a corresponding housing.

[0120] Figure 12 It is a schematic perspective view of three magnetic elements of a portion of a magnetic assembly shown in arbitrary spatial relation to the wall of a portion of a hollow organ, the magnetic elements being received in a single housing.

[0121] Figure 13 It is a schematic perspective view of three magnetic elements of a portion of a magnetic assembly shown in arbitrary spatial relation to the wall of a portion of a hollow organ. The magnetic elements are received in corresponding housings with rounded edges, and the continuous housings are flexibly connected together by thinner extensions of the housings.

[0122] 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 connected together by flexible connectors.

[0123] 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 connected together by flexible connectors extending between the corresponding housings.

[0124] Figure 16This is a schematic perspective view of three magnetic elements as part of a magnetic assembly, shown in an arbitrary spatial relationship. The magnetic elements are received in corresponding housings and are flexibly connected together within the housings by flexible connectors extending between adjacent magnetic elements.

[0125] 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 connected together by a flexible connector.

[0126] Figure 18 This 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 connected together by flexible connectors extending between the corresponding housings, and the magnetic elements are shown facing each other.

[0127] Figure 19 This is a schematic side cross-sectional view of six magnet elements as part of a magnet assembly shown in arbitrary spatial relation. Each magnet element has a beveled edge, and adjacent magnet elements are flexibly connected together by flexible connectors. The magnet shown has walls with hollow organs between them.

[0128] Figure 20 This is a schematic side cross-sectional view of a partition device including a magnetic element received in a housing, the housing having an elongated flat contact surface on its organ contact side, the partition device shown as a partition structure in which the walls of a hollow organ are compressed between the elongated flat contact surfaces.

[0129] Figure 21 It is a schematic top view of a separating device including magnetic elements arranged to provide a curved area along the length of the separating device.

[0130] Figure 22 This is a schematic front view of the stomach, showing the entire vertical dividing line between the lesser and greater curvatures.

[0131] Figure 23 This is a schematic front view of the stomach, showing the vertical dividing line above the portion between the lesser and greater curvatures.

[0132] Figure 24 This is a schematic front view of the stomach, showing the vertical dividing line at the bottom of the portion between the lesser and greater curvatures.

[0133] Figure 25 This is a schematic front view of the stomach, showing the entire upper transverse dividing line in its upper region.

[0134] Figure 26 This is a schematic front view of the stomach, showing the entire lower transverse dividing line in its lower region.

[0135] Figure 27 This is a schematic front view of part of the stomach and duodenum, showing the dividing line that runs through the duodenum.

[0136] Figure 28 This is a transparent, schematic side sectional view of a portion of the distal colon, showing the entire dividing line.

[0137] Figure 29 This is a transparent schematic side sectional view of a portion of the proximal colon, showing the entire dividing line.

[0138] Specific implementation method

[0139] Surgical procedures for treating various medical conditions related to the digestive tract may include altering the structure of hollow organs, such as the esophagus, stomach, gallbladder, ducts of the biliary system, small intestine, colon, or rectum, or reducing the size of the lumen of such organs. Such surgeries can be performed for any procedure related to the digestive system, including bariatric surgery, and other digestive surgeries, such as those performed in the context of cancer treatment, resection, etc. Altering the structure of a hollow organ or reducing the size of its lumen may include dividing the hollow organ into segments by fusing the opposing walls of the organ together without puncturing tissue. For this purpose, a separating device may be used to implement a method for separating hollow organs of the digestive tract without puncturing tissue. Separating devices may include various features. It should be understood that, as used herein, the term "separating device" may be used interchangeably with the term "separating implant" throughout this specification, as the separating device is configured to be implanted in the patient's abdominal cavity and remain there for a period of time, ranging from several days to several weeks.

[0140] The separation device may include a flexible magnetic assembly that can be inserted into the patient's abdominal cavity and positioned outside the cavity around a portion of the outer surface of the target hollow organ. The flexibility of the magnetic assembly can be imparted by flexibly connecting a series of magnetic elements together to form a string of magnetic elements. Each of the magnetic elements 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 the series of magnetic elements may be received together in a single housing.

[0141] The separator can be configured with a pre-separation structure and a separation structure. The pre-separation structure facilitates the insertion of the separator into the patient's abdominal cavity, such as in the case of laparoscopic surgery, and its subsequent placement around the target hollow organ. On the other hand, the separation structure is a configuration that enables the separation of the hollow organ.

[0142] In a pre-segmented structure, the magnetic engagement sides of the plurality of magnets are magnetically disengaged from each other. To achieve this pre-segmented structure, the magnet assembly extends longitudinally such that the magnetic engagement sides do not face each other and can be inserted longitudinally into the abdominal cavity, for example, as a band. This type of pre-segmented structure may be referred to as an extended pre-segmented structure. In another example of a pre-segmented structure, the magnet assembly may 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 disengaged, thereby allowing the partial or closed loop to be placed around the target hollow organ. This pre-segmented structure may be referred to as a ring-shaped pre-segmented structure.

[0143] The choice of the pre-segmentation configuration may depend on the target hollow organ around which the magnet assembly will be placed, and may take into account the available space around the target hollow organ. If the magnet assembly is initially inserted as a band, the pre-segmentation will ultimately include a U-shaped configuration for placement around the target hollow organ while the magnet elements remain magnetically disengaged. In addition to facilitating insertion of the separation device into the abdominal cavity, the pre-segmentation configuration facilitates placement of the magnet assembly along a given separation line around the outer surface of the hollow target hollow organ outside the cavity. In the context of this specification, the separation line corresponds to the boundary between the two parts of the target hollow organ, and therefore corresponds to the trajectory of the separated magnet assembly with its magnetic engagement side abutting against the target hollow organ.

[0144] Once the partition device is positioned around the outer surface of the hollow organ, the magnetic assembly can be placed within the partition structure. In the partition structure, opposing magnetic elements on each side of the target hollow organ are positioned sufficiently close that the opposing magnetic engagement sides of the facing magnetic elements are magnetically coupled to bring the walls of the target hollow organ together and compress the walls between the opposing magnetic engagement sides without having to puncture the organ's tissue. The magnetic coupling holds the magnetic elements in place, and the pressure exerted by the magnetic elements on the walls of the target hollow organ triggers a healing mechanism that, over time, causes the organ walls 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 healed tissue obtained at the edges of the magnetic elements now joined to form a single structure. The two opposing walls of the organ, initially compressed between the magnetic engagement sides, eventually undergo ischemic pressure necrosis, and after a period that can extend from days to weeks, a space substantially corresponding to the width of the magnetic elements will eventually be confined between the portions of the hollow organ.

[0145] The separator is configured to remain in the patient's abdominal cavity for a period sufficient to allow the healing process to occur and for the organ walls at the edges of the magnetic element to fuse. Monitoring the healing process helps determine at what point, after tissue fusion has occurred, it is feasible to remove the separator from the patient's abdominal cavity.

[0146] The separation device may also include additional features. For example, the separation device may include one or more features that may facilitate the placement of the magnet assembly within the abdominal cavity. Such features may include a flexible elongated member, such as a flexible cord 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 catheter, which may then be used to carry and navigate the magnet assembly into the abdominal cavity via the anterior elongated member, and around the target hollow organ.

[0147] Optionally, the separation device may also include a second flexible elongated member at the other end of the magnet assembly, opposite the anterior elongated member, and this second flexible elongated member may be referred to as the posterior elongated member. The posterior elongated member is useful during implantation of the magnet assembly if it is desired to have contact with the magnet assembly from outside the patient. Either or both of the anterior and posterior elongated members may also be used to anchor the separation device subcutaneously or externally to the patient during the healing period.

[0148] The various implementations of the separation device and related methods will now be described in more detail.

[0149] Magnet assembly

[0150] Magnet components

[0151] refer to Figures 1 to 3 The diagram illustrates an implementation of the separation device 10. The separation device 10 includes a magnet assembly 12 received within a housing 14. The magnet assembly 12 includes a plurality of magnet elements 16 flexibly connected or linked together. Each magnet element 16 includes a top side 18, a bottom side 20, a lateral side 22, and a longitudinal side 24. In the context of this specification, the top side 18 of a magnet element 16 refers to the side facing the wall 26 of the target hollow organ once the magnet assembly 12 is implanted in the patient and positioned around the outer surface of the target hollow organ. In the illustrated implementation, the separation device 10 also includes flexible elongated members at each end, namely, a front elongated member 28 and a rear elongated member 30. Furthermore, the housing 14 in which the magnet elements 16 are received is also flexible.

[0152] exist Figure 1In this configuration, the separating device 10 is in a pre-separated structure, wherein the separating device 10 extends longitudinally such that the ends of the magnet assemblies 12 are spaced apart from each other and opposite to each other. This type of pre-separated structure can be referred to as an extended pre-separated structure. Figure 2 In this configuration, the separator 10 is also situated within a pre-separation structure, which may also be referred to as an annular pre-separation structure. In the annular pre-separation structure, the magnet assembly 12 folds itself in a U-shape to form a partial or closed ring, depending on the intended application. The choice of the pre-separation structure for the magnet assembly 12 may depend on the hollow organ to be treated and the chosen insertion method. As described above, if the magnet assembly 12 is initially used as, for example... Figure 1 As shown with the insertion, the pre-segmentation configuration ultimately comprises forming a partially or closed loop-like U-shape for placement around the target hollow organ, while the magnetic element 16 remains magnetically detached. In other words, a characteristic of the pre-segmentation configuration of the magnetic assembly 12 is that the magnetic element 16 is magnetically detached, and the magnetic assembly 12 can employ various configurations for the magnetic element 16 to be magnetically detached. In addition to facilitating the insertion of the separation device 10 into the abdominal cavity, the pre-segmentation configuration also facilitates the placement of the magnetic assembly 12 outside the cavity along a given separation line 42 around the outer surface of the target hollow organ.

[0153] The magnetic elements 16 of the magnet assembly 12 can be any type of suitable magnet. In some implementations, the magnetic elements 16 may be selected based on their attractive force, i.e., based on the pressure to be applied to a surface area of ​​tissue that will ultimately be compressed between the magnetically connected magnetic elements 16. Factors affecting the attractive force of the magnetic elements 16 may include the shape of the magnetic elements 16, the thickness of the magnetic elements 16, the material used to manufacture the magnetic elements 16, etc. Examples of materials may include neodymium magnets (e.g., NdFeB magnets), rare-earth magnets, and ferrite magnets.

[0154] Now for reference Figure 4 and Figure 5 Each of the magnetic elements 16 may be a dipole magnet having a magnetic pole extending through the thickness of the magnetic element 16, such that the magnetic 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 magnetic element 16 corresponds to the magnet coupling side 32, which is the side of the magnetic element 16 that will ultimately face the tissue 26 of the hollow organ to be treated once the magnet assembly 12 is mounted around the outer surface of the target hollow organ, the outer surface of which is also referred to above as the top side 18 of the magnetic element 16.

[0155] The magnet element 16 is strategically positioned along the length of the magnet assembly 12 to achieve the desired function of the magnet assembly 12. (Reference) Figures 1 to 10The diagram shows a first region 38 and a second region 40 of the magnet assembly 12. The first region 38 of the magnet assembly 12 corresponds to a portion of the magnet assembly 12 when the separating device 10 is in, for example... Figure 1 During the extended pre-segmentation construction, the anterior elongated member 28 is guided into the abdominal cavity, for example... Figure 6 In this process, the component will first be inserted into the patient's abdominal cavity. Then, the first region 38 of the magnet assembly 12 will be the region that rotates around the outer surface of the target hollow organ in the posterior position, for example... Figure 7 As shown. The second region 40 corresponds to a portion of the magnet assembly 12, which follows the first region 38 when the magnet assembly 12 is inserted into the abdominal cavity, and then remains in the anterior position without rotating around the outer surface of the target hollow organ, for example. Figure 7 As shown.

[0156] refer to Figures 8 to 10 In an implementation where the magnet assembly 12 is already in a ring-shaped pre-segmented configuration, the first region 38 and the second region 40 of the magnet assembly 12 can navigate side-by-side in the abdominal cavity rather than extending. In this implementation, the first region 38 of the magnet assembly 12 can be said to correspond to the portion of the magnet assembly 12 that will be in a posterior position once inserted into the patient's abdominal cavity, and the second region 40 can be said to correspond to the portion of the magnet assembly 12 that will be in a posterior position once inserted into the patient's abdominal cavity, or vice versa.

[0157] Return to reference Figure 4 and Figure 5 The first region 38 includes a series of magnetic elements 16, each having a magnetic connection side 32 with the same magnetic poles (i.e., the first region magnetic poles) relative to each other. The second region 40 also includes a series of magnetic elements 16, each also having a magnetic connection side 32 with the same magnetic poles (i.e., the second region magnetic poles) relative to each other, but with different magnetic poles than those of the magnetic connection side 32 of the magnetic elements 16 in the first region 38. The magnetic connection side 32 corresponds to the top side 18 of the aforementioned magnetic elements 16, i.e., the side facing the wall of the hollow organ. For example, as... Figure 4 As shown, the separating device 10 is in an extended pre-separated configuration, and the second region 40 of the magnet assembly 12 is longitudinally spaced from the first region 38. The magnet connection side 32 of the magnet element 16 in the first region 38 has a north pole, and the magnet connection side 32 of the magnet element 16 in the second region 40 has a south pole. Similarly, in Figure 5 In the middle, the separating device 10 is in an annular pre-separated structure, and the magnet connecting side 32 of the magnet element 16 in the first region 38 has a north pole, while the magnet connecting side 32 of the magnet element 16 in the second region 40 has a south pole.

[0158] This configuration of the magnet assembly 12 enables the magnet elements 16 of the first region 38 and the second region 40 of the magnet assembly 12 to attract each other and to be magnetically connected once the magnet assembly 12 is in a separated configuration, wherein the magnet elements 16 have different magnetic connection sides 32 depending on their location along the regions 38, 40 of the magnet assembly 12.

[0159] As described above, the magnetic element 16 can have various shapes and sizes. The choice of shape and / or size of the magnetic element 16 may depend on the target hollow organ around which the separating device 10 will be implanted. For example, for organs such as the stomach that are substantially larger and flatter than parts of the small intestine (e.g., the duodenum, jejunum, or colon), an elongated magnetic element 16 may be used as part of the magnetic assembly 12. On the other hand, the length of the magnetic element 16 may be kept small enough to allow the magnetic assembly 12 to navigate around the outer surface of the stomach or another target hollow organ. For example, in some implementations, a magnetic element 16 designed to separate bile ducts may have a size ranging from about 2 mm to about 10 mm, while a magnetic element 16 designed to separate the stomach may have a size ranging from about 2 cm to about 10 cm. As a general relationship between the size of the magnetic element 16 and the target hollow organ, a magnetic element 16 designed to separate thicker and / or larger hollow organs may generally be larger than a magnetic element 16 designed for smaller and / or thinner hollow organs. This general relationship takes into account the principle that larger and / or thicker hollow organs can withstand a greater attractive force imparted by the larger magnetic element 16, in order to achieve the desired compression of the hollow organ walls and subsequent healing around the edges of the magnetic element 16. In some implementations, for a magnetic assembly 12 configured with an annular pre-segmentation, the magnetic element 16 can be longer than for a magnetic assembly 12 configured with an extended pre-segmentation, because in the annular pre-segmentation, the magnetic assembly 12 has already folded itself.

[0160] In addition, although Figure 3 and Figures 11 to 16 In the example given, a portion of the magnet assembly 12 is shown as a substantially rectangular magnet element 16; however, it should be understood that the magnet element 16 may include tapered edges, beveled edges, rounded edges, etc. The magnet element 16 may also have elliptical, stadium-shaped, circular, triangular, rectangular, octagonal, or any other shape suitable for the applications described herein.

[0161] For example, Figure 17 An example of a series of magnetic elements 16, representing a portion of a magnet assembly 12, is shown, each magnetic element 16 having a rounded edge and a generally 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 magnet assembly 12.

[0162] Figure 18 An example of a series of magnetic elements 16, a portion of a magnetic assembly 12, is shown. Each magnetic element 16 is received in a housing having 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 a target hollow organ.

[0163] Figure 19 An example of a magnet element 16, representing a portion of a magnet assembly 12, is shown, each magnet element 16 having a beveled edge 19. In some implementations, such as Figure 18 or Figure 19 As shown, when the magnet element 16 or housing 14 includes beveled edges, the magnet-connecting 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 positioned away from the wall of the hollow organ (i.e., the bottom side 20). This configuration allows for a smaller compressible surface between the magnet-connecting 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 faster than initially anticipated, the side of the magnet element 16 or housing 14 with a larger surface area can provide an anchor to prevent undesired movement of the magnet element 16 or housing 14. In some implementations, the side of the magnet element 16 or housing 14 with a larger surface area may also help prevent the magnet element 16 or housing 14 from penetrating the area of ​​the hollow organ wall where ischemic necrosis occurs.

[0164] In some implementations, the magnet engagement side 32 of the magnet element 16 included 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 included in the second region 40 of the magnet assembly 12. For example, the magnet engagement side 32 of the magnet element 16 included in the first region 38 may include a recess, and the magnet engagement side 32 of the magnet element 16 included in the second region 40 may include a protrusion configured to engage within the recess. In some implementations, engagement of the recess with a corresponding protrusion or other features having complementary shapes may help stabilize the magnet element 16 in the first region 38 and the magnet element in the second region 40. In some implementations, the edge of the magnet element 16 included in the first region 38 of the magnet assembly 12 may include a slotted edge, and the edge of the magnet element 16 included in the second region 40 of the magnet assembly 12 may include a slotted edge complementary to the slotted edge of the magnet element 16 in the first region 38.

[0165] 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 dividing 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 of the magnetic assembly 12 designed for the stomach can be higher than that of the magnetic assembly 12 designed for the duodenum.

[0166] 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 the pressure applied to the tissue of the target hollow organ along the length of the magnetic assembly 12 can also vary once in the partitioned configuration. For example, when the target hollow organ is the stomach, the wall thickness of the stomach is greater near the fundus than in the body or antrum of the stomach. Therefore, the magnetic element 16 of the magnetic assembly 12 can be selected to have a higher attractive force in the upper part of the magnetic assembly 12 (i.e., closer to the transition from the first region 38 to the second region 40) compared to the attractive force in the lower part of the magnetic assembly 12 (i.e., away from the transition from the first region 38 to the second region 40). In the context of instances relating to the stomach, the terms “upper” and “lower” are used to refer to the portion of the magnet assembly 12 once it is implanted around the outer surface of the stomach and when the patient stands up, wherein the “upper” portion corresponds to the portion of the stomach in the fundus region and the “lower” portion corresponds to the portion of the stomach in the body or antrum region.

[0167] 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 the attraction of the magnet assembly 12, which is designed for portions of the small intestine, such as the duodenum, jejunum, or ileum.

[0168] The attractive force of the magnetic element 16 can also be selected to facilitate the placement and implantation of the separator 10 around the target hollow organ. For example, in some implementations, the attractive force between the magnetic elements 16 can be weak enough that the separator 10 can be magnetically disengaged during placement along the separator line 42, allowing trial and error to reach the desired position of the magnetic assembly 12.

[0169] Furthermore, the attraction force of the magnetic elements 16 can be selected based on the planned healing period. For example, the attraction force between the magnetic elements 16 can be weak enough to facilitate a healing period ranging from a few days to a few weeks. A longer healing period facilitates obtaining a well-fused wall and gradually applying pressure along the septum, while a magnetic element 16 with too strong an attraction force can cause rapid ischemic pressure necrosis between the magnetic connection sides 32 of the magnetic elements 16. This can impair the healing mechanism at the edges of the magnetic elements 16 and can lead to openings in the tissue of the target hollow organ. In some implementations, the attraction force 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 septum device 10. In some implementations, the attraction force of the magnetic elements 16 can be selected such that the healing process occurs within a timeframe of 3 to 6 weeks after the implantation of the septum device 10. Other durations of healing period are also possible depending on the desired outcome and the target hollow organ.

[0170] It should be noted that in some implementations, ischemic pressure necrosis of the target hollow organ wall along the partition line 42 may be sufficient to cause separation of the target hollow organ from the fused tissue at the edge of the magnetic element 16 along the partition line 42. In other implementations, ischemic pressure necrosis of the target hollow organ wall along the partition line 42 may be sufficient to cause separation of the partitioned segment of the target hollow organ. Therefore, the attractive force of the magnetic element 16 can also be selected depending on whether separation of the target hollow organ or separation of a portion of the target hollow organ is required.

[0171] Monitoring the healing process over time also plays a role in the results obtained on the target hollow organ after the implantation of the separator 10, and this monitoring can help determine at what point the separator 10 should be removed to obtain the desired result of separation of the target hollow organ or a portion thereof.

[0172] In some implementations, the dimensions of the magnet element 16 may vary along the length of the magnet assembly 12. This variation in magnet dimensions can help increase the flexibility of the magnet assembly 12 in selected portions, particularly when the magnet assembly 12 includes multiple magnet elements 16, received individually in or without a housing 14, such as... Figures 12 to 15 and Figure 18 As shown. 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. The smaller magnet element 16 disposed near this transition region can be configured as follows: Figure 7The folding of the magnet assembly 12 facilitates the use of annular pre-segmentation and segmentation structures. The smaller magnet element 16 near the transition from the first region 38 to the second region 40 thus facilitates the placement of the segmentation device 10. In some implementations, a larger magnet implant located away from this transition region, particularly in terms of length, facilitates the creation of continuous segmentation lines 42.

[0173] case

[0174] refer to Figures 11 to 16 and Figure 18 In some implementations, the magnet element 16 may be received within the housing 14. Figure 11 In the middle, a single magnetic element 16 is received in a corresponding housing 14, while Figure 12 In one implementation, multiple magnetic elements 16 are received within a single housing 14. In other implementations, a certain number of magnetic elements 16 may be received within the housing 16. For example, 2 to 10 magnetic elements 16 may be received within a single housing 14. In this implementation, the number of magnetic elements 16 within the housing 14 may be influenced by its size; that is, the smaller the magnetic elements 16, the more continuous the magnetic elements 16 can be received within a housing 14 of a given length.

[0175] As described above, the housing 14 includes an organ contact side 44 that contacts the tissue of the target hollow organ when the separating device 10 is in the separating 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 may be configured to provide a damage-preventing surface that may help avoid damage to surrounding tissues. The housing 14 may include rounded edges and / or tapered transitions between its walls. In some implementations, the housing 14 may have an elliptical or stadium shape. Figure 13 An example is shown of a magnet element 16 received in a corresponding housing 14 having rounded edges, the continuous housings 14 being flexibly connected together by a thinner extension 46 of the housing 14 (also referred to as a connecting portion of the housing 14). Additional details regarding this are provided below.

[0176] In some implementations, the organ contact side 44 of the housing 14 of the magnet element 16 included in the first region 38 may include a recess, and the organ contact side 44 of the housing 14 of the magnet element 16 included in the second region 40 may include a protrusion configured to engage within the recess. The engagement of the recess with a corresponding protrusion or other features of complementary shape via the housing 14 may help stabilize the magnet element 16 in the first region 38 and the magnet element in the second region 40. In some implementations, the edge of the organ contact side 44 of the housing 14 of the magnet element 16 included in the first region 38 of the magnet assembly 12 may include a slotted edge, and the edge of the organ contact side 44 of the housing 14 of the magnet element 16 included in the second region 40 of the magnet assembly 12 may include a slotted edge complementary to one of the slotted edges in the housing 14 of the first region 38.

[0177] In some implementations, the housing 14 may help diffuse the force applied by the magnetic element 16 over a larger area, which may be advantageous depending on the application and / or on a 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... TM It is made of a flexible silicone elastomer. In some implementations, the housing 14 may provide a protective coating around the magnet element 16, which in turn helps prevent corrosion and maintain the integrity of the magnet element 16. The texture of the housing 14, particularly the texture on the organ contact side 44, may be selected to provide increased stability to the magnet assembly 12 once in the separation configuration. For example, the surface roughness of the implant on the organ contact side 44 of the housing 14 may be higher than the surface roughness on its opposite side. The surface roughness of the organ contact side 44 of the housing 14 can be beneficial: once the magnet element 16 is magnetically engaged, it prevents magnetic delamination due to shear forces.

[0178] Flexible connection between adjacent magnet components

[0179] As described above, the magnet assembly 12 includes magnet elements 16 that are flexibly connected in series with each other. The flexibly connected magnet elements 16 can be achieved in various ways. Examples are provided below.

[0180] refer to Figure 13 Multiple magnetic elements 16 may be received in respective individual housings 14, and the housings 14 may include portions between adjacent magnetic elements 16, adapted to provide increased flexibility for the magnetic assembly 12. Figure 13As 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 portion 46 of the housing 14 between adjacent magnetic elements 16 can be made of a different material than the rest of the housing 14 to benefit from the specific properties of this different material, particularly in terms of its flexibility. In some implementations, the portion 46 of the housing 14 between adjacent magnetic elements 16 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 magnetic assembly 12 can fold around the target hollow organ, while it may be less desirable to move the magnetic elements 16 laterally relative to each other, since lateral movement of the magnetic elements 16 can help to turn the magnetic elements 16 away from the dividing line 42.

[0181] refer to Figure 14 When no housing is provided around the magnet element 16, the magnet element 16 may include hooks (not shown) on each of its lateral sides and be connected to each other via flexible connectors 48 (e.g., straps). The type of flexible connector 48 may be selected to provide sufficient mobility and flexibility to the magnet assembly 12 according to a given range of motion, such that the magnet assembly 12 can be easily guided to its destination in the abdominal cavity and positioned around the target hollow organ. For example, when the target hollow organ is substantially cylindrical, such as the duodenum or colon, the circumference of such organ may be relatively small compared to the size of the stomach, and it may be advantageous to have a magnet assembly 12 with increased flexibility to facilitate guiding the separator 10 around the organ and holding it in place.

[0182] refer to Figure 15 Flexible connectors 48 may be disposed between adjacent magnetic elements 16 individually housed in respective housings 14. In this implementation, engagement portions, such as hooks, may be disposed on the lateral sides of housing 14. In some implementations, the engagement portions may be integral with housing 14. Housing 14 may thus be molded as a single unit including hooks on each of its lateral sides, wherein magnetic elements 16 are received in housing 14, and adjacent magnetic elements among the plurality of magnetic elements 16 may be flexibly connected to each other via flexible connectors 48 engaging with corresponding hooks. Alternatively, hooks may be disposed on the lateral sides of housing 14, and flexible connectors 48 may extend from the other side to flexibly connect with hooks of adjacent housings 14.

[0183] For other implementation methods, 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 disposed between adjacent magnetic elements 16 within the housing 14. Figure 16 In the implementation shown, with Figure 15In contrast to the implementation shown, the flexible connector 48 is therefore shown as being integrated within the housing 14.

[0184] It should be understood that, such 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, the flexibility of the material used to manufacture the housing 14.

[0185] The distance between adjacent magnet elements 16 can be chosen to influence the final flexibility 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 way and the impact on the final separation line 42, as consecutive magnet elements 16 that may be too far apart from each other may result in a less uniform separation line 42. In some implementations, the distance between adjacent magnet elements 16 can vary along the length of the magnet assembly 12, similar to what has been described above regarding the dimensions of the magnet elements 16. For example, in some implementations, magnet elements 16 located near the transition from the first region 38 to the second region 40 can be positioned slightly further apart to provide enhanced flexibility to the magnet assembly 12 in this transition region. In some implementations, the interaction between the dimensions 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 separation line 42. In some implementations, it can be advantageous to position the magnet elements 16 as close to each other as possible, as long as the flexibility of the magnet assembly 12 is maintained. In this respect, as described above, the magnet element 16 or housing 14 with rounded edges can facilitate bringing the magnet element 16 or housing 14 close together without compromising the flexibility of the magnet assembly 12. It should be noted that these are merely examples illustrating the 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 and desired separation line 42, as well as corresponding healing of tissue on the edges of the magnet element 16.

[0186] Positioning and implantation of the separation device

[0187] Now for reference Figures 20 to 29 The implementation methods related to implanting septal components at different locations in a given target hollow organ and different target hollow organs will now be described.

[0188] Figure 20An example of a partition device 10 in a partition configuration is shown, wherein the opposing walls of the target hollow organ are 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 partition device 10 can be implanted along a desired partition line 42, and an example of the location of the partition line 42 is provided below.

[0189] Figure 21 An example of a partition device 10 in a partition configuration is shown, and a top view of the partition device 10 is shown. Figure 21 The illustrated separating device 10 includes a curved region 21. The curved region 21 can be provided, for example, by the shape of the housing 14 or by means of connection via magnetic elements 16. In some implementations, a curved magnetic element 16 may also be provided. The shape and position of the curved region 21 can vary, and Figure 21 This is an example shown for illustrative purposes only. This type of construction of the dividing device 10, namely the dividing device 12 including the curved region 21, can be advantageous for placing the dividing device 12, for example, around a tumor or around a portion of the transverse colon.

[0190] Figure 22 An example of a vertical dividing line 42 extending from the fundus of the stomach to the antrum and between the lesser and greater curvatures is shown to obtain a vertical cannulation of the stomach after tissue healing at the edge of the magnetic element 16. The position of the dividing line 42 can vary depending on the volume of the desired area of ​​the stomach. In this implementation, the magnetic assembly 12 is placed at the desired location around the outer surface of the stomach by inserting the dividing device 10, which is in the extended pre-divided structure, into the abdominal cavity and positioning it around the outer surface of the stomach. Figure 7 As shown. The insertion and guidance of the magnet assembly 12 can be performed laparoscopically for minimally invasive surgery, which also advantageously allows for minimal interference with the connective tissue, arteries, veins, and other organs surrounding the stomach. When the magnet assembly 12 is inserted into the abdominal cavity with an extended pre-segmented configuration, the magnet assembly 12 can be navigated around the outer surface of the stomach and aligned with the desired septum 42. Once the correct alignment of the magnet assembly 12 is achieved, the magnet element 16 of the first region 38 of the magnet assembly 12 can be brought sufficiently close to the magnet element 16 of the second region 40 of the magnet assembly 12, such that the magnet engagement side of the magnet element 16 of the first region 38 can be magnetically coupled to the magnet engagement side of the magnet element 16 of the second region 40. As described above, the attractive force of the magnet element 16 can be selected to allow for trial and error until the correct placement of the magnet assembly 12 is achieved.

[0191] Alternatively, the placement of the magnet assembly 12 can be performed during open surgery. In this case, the magnet assembly 12 can be positioned around the stomach with an extended pre-segmentation or with a ring-shaped pre-segmentation. A variety of other techniques can also be used to locate and implant the magnet assembly 12. For example, image-guided surgery (e.g., ultrasound, magnetic resonance imaging, computed tomography, etc.) and flexible endoscopy are techniques that can be used to adequately insert and / or position the magnet assembly 12 around the target hollow organ. It should be noted that any other suitable technique that allows the magnet assembly 12 to be inserted and / or placed around the outer surface of the target hollow organ can also be used.

[0192] refer to Figure 23 and Figure 24 In some implementations, the separator 42 may extend substantially vertically along a given portion of the stomach, i.e., without crossing the entire height of the stomach. Figure 23 In the implementation shown, the separator line 42 can be referred to as the upper vertical separator line, while... Figure 24 In the implementation shown, the separator line 42 can be referred to as the lower vertical separator line. This can be implemented in conjunction with the above-described method for... Figure 18 The technique shown is similar to that of the full-height dividing line 42, so as to place the magnet assembly 12 around the outer surface of the stomach.

[0193] refer to Figure 25 and Figure 26 In some implementations, the separator 42 may run along the upper part of the stomach ( Figure 25 ) or along the lower part of the stomach ( Figure 26 The septum extends substantially laterally, thus providing a complete lateral partition of the stomach. This complete lateral partition can lead to the formation of a gastric pouch that can connect to another part of the digestive tract. This type of partition can be used in conjunction with anastomoses formed using different devices to maintain gastrointestinal continuity, where another part of the digestive tract connects to the partitioned portion of the stomach. For example, the entire upper septum 42 can be used to form Roux-en-Y gastric bypasses, such as a transverse colonic Roux-en-Y gastric bypass, a transverse colonic Roux-en-Y gastric bypass, and long-limb Roux-en-Y gastric bypasses, mini-gastric bypasses, single-anastomotic gastric bypasses, duodenal switches, single-anastomotic switches, and other bypasses. In, for example... Figure 25 and Figure 26 In the implementation shown, due to the continuous nature of the digestive tract, the magnet assembly 12 in the extended pre-segment can be directed so that the magnet assembly 12 is placed completely laterally around the outer surface of the stomach.

[0194] Figure 27This illustration shows an implementation of a dividing line 42 located near the pyloric sphincter, surrounding the outer surface of a portion of the digestive tract in a region located in the proximal duodenum. In other implementations, the dividing line 42 may be located around the outer surface of a portion of the digestive tract located in a region of the distal duodenum. In still other implementations, the dividing line 42 may be located on any intestinal ring along the duodenum. In still other implementations, the dividing line 42 may be located on any other part of the small intestine, such as the jejunum or ileum. (This is related to the above regarding...) Figure 25 and Figure 26 Similar to the description, due to the continuous nature of the digestive tract, the extended pre-segmented magnetic assembly 12 is instructed to be placed around the outer surface of the duodenum.

[0195] Figure 28 The implementation of the diaphragm 42, which extends laterally across a portion of the distal colon, is shown, wherein the wall thickness is greater than... Figure 29 The wall thickness shown Figure 29 The implementation of the dividing line 42, which extends laterally across a portion of the proximal colon, is shown.

[0196] Method for implanting a separation device

[0197] The method of separating the hollow organs of a patient's digestive tract using the separating device as described herein will now be described in more detail.

[0198] The separation device includes an anterior elongated member and a posterior elongated member, with a magnetic assembly extending therebetween. The magnetic assembly includes a plurality of magnetic elements flexibly connected in series. The anterior elongated member may include any type of flexible member. In some implementations, the anterior elongated member may be configured to engage with a delivery catheter to allow the elongated member to be navigated laparoscopically. In some implementations, the posterior elongated member may also include any type of flexible member, which may optionally be configured to engage with the delivery catheter or remain in an external or subcutaneous position outside the patient. Alternatively, at least one of the anterior and posterior elongated members may be omitted.

[0199] When an elongated anterior member is present, the method may include inserting the elongated anterior member of the septum and a magnetic assembly into the patient's abdominal cavity. Since the septum is an implant configured to remain in the patient's abdominal cavity for a period of time, it can be sterilized prior to insertion. For insertion into the patient's abdominal cavity, the magnetic assembly may be in an extended pre-septum configuration or an annular pre-septum configuration. The magnetic assembly is then guided via the elongated anterior member of the septum (when present) to a target hollow organ to position the magnetic assembly outside the cavity around at least a portion of the outer surface of the hollow organ, such that the anterior and posterior portions of the magnetic assembly face each other. Various techniques can be used to insert the magnetic assembly into the patient's abdominal cavity and to position the magnetic assembly around the outer surface of the target hollow organ. These techniques may include, for example, laparoscopic surgery, open surgery, image-guided surgery, and flexible endoscopy. When the front of the magnet assembly faces the rear 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, while the magnet elements remain magnetically disengaged in the annular pre-separated structure so that the magnet assembly can be placed along the desired separation line.

[0200] Once the magnetic elements on both sides of the magnet assembly are aligned along the dividing line as needed, the magnetic elements can be brought closer together in a separated configuration. In this separated configuration, the magnetic elements of the first region are magnetically connected to the magnetic elements of the second region; that is, the magnetic elements facing each other are magnetically connected via their respective magnetic engagement sides to compress the opposing walls of the hollow organ between them. 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 target hollow organ 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.

[0201] In some implementations, the anterior elongated member can be brought near the posterior elongated member, and one or both of the anterior and posterior elongated members can be placed outside the patient or held in a percutaneous position. In other implementations, the anterior and posterior elongated members can be continuous elongated members slidably engaged with the magnet assembly, and after the magnet assembly is implanted in a separated configuration, the anterior and posterior elongated members can be removed from the patient's abdominal cavity by pulling one of the anterior and posterior elongated members.

[0202] Then, after the magnet assembly is implanted in a separated configuration around the target hollow organ, the magnet assembly is held in place for a healing period sufficient to allow the opposing walls of the hollow organ to fuse together, while the magnet elements are magnetically connected together. In some implementations, the healing period can be extended from 2 weeks to 7 weeks. In some implementations, monitoring of the healing process can be performed to determine at what point the walls of the target hollow organ are well fused together, i.e., there is no leakage between the two separated portions. The duration of the healing period can depend on, for example, the target hollow organ, the construction of the magnet assembly, the patient's condition, and various other factors.

[0203] Once the walls of the target hollow organ have fused well together and healed, the magnetic assembly can be removed from the patient's peritoneum. The method used to remove the magnetic assembly can vary depending on the design of the separation device. The magnetic assembly can be removed laparoscopically from the target hollow organ and peritoneum by optionally pulling one of the anterior and posterior elongated members out of the patient using a delivery catheter. Alternatively, the magnetic assembly can be removed laparoscopically from the target hollow organ and peritoneum by directly pulling it out of the patient, also optionally using a delivery catheter. In some implementations, the magnetic assembly can be removed during open surgery. Furthermore, various techniques can be used to remove the magnetic assembly from the patient's peritoneum; these techniques may be the same as or different from those previously used for inserting and placing the magnetic assembly around the target hollow organ, and may include, for example, laparoscopic surgery, open surgery, image-guided surgery, and flexible endoscopy.

[0204] Several alternative implementations and examples have been described and illustrated herein. The implementations of the technology described above are intended to be exemplary only. Those skilled in the art will understand the characteristics of each implementation, as well as the possible combinations and variations of components. Those skilled in the art will also understand that any implementation can be provided through any combination with other implementations disclosed herein. It should be understood that this technology can be implemented in other specific forms without departing from the central characteristics of this technology. Therefore, these implementations and examples are to be considered illustrative rather than restrictive in all respects, and the technology is not limited to the details given herein. Thus, while specific implementations have been shown and described, many modifications are conceivable.

Claims

1. A separating device for separating hollow organs of a patient's digestive tract, the separating device comprising: A magnet assembly, implantable into the patient's abdominal cavity, includes: Multiple magnetic components are flexibly connected in series; The magnet assembly is configured to be positioned outside the cavity around at least a portion of the outer surface of the hollow organ to magnetically connect opposing magnet elements together, thereby compressing the opposing walls of the hollow organ therebetween and subjecting the opposing walls of the hollow organ to ischemic pressure necrosis to fuse the opposing walls of the hollow organ together, thereby separating the hollow organ.

2. The separating device according to claim 1, further comprising: A front elongated member and a rear elongated member, wherein the magnet assembly extends between the front elongated member and the rear elongated member.

3. The separating device according to claim 2, wherein, The elongated anterior member is configured to engage with a delivery conduit to guide the magnet assembly to the hollow organ and around at least a portion of the outer surface of the hollow organ.

4. The separating device according to any one of claims 1 to 3, wherein, Each of the magnetic elements includes a magnetic engagement side to magnetically connect opposing magnetic engagement sides of the magnetic element facing each other.

5. The separating device according to claim 4, wherein, The magnet assembly includes a first region and a second region. The magnet element of the first region of the magnet assembly has a first region magnetic pole on its magnet engagement side, and the magnet element of the second region of the magnet assembly has a second region magnetic pole that is different from the first region magnetic pole on its magnet engagement side.

6. The separating device according to any one of claims 4 and 5, wherein, The magnet engagement side of the magnet element has a smaller surface area compared to the side of the magnet element opposite to the magnet engagement side.

7. The separating device according to any one of claims 1 to 6, wherein, The magnet element has a shape selected from the group consisting of ellipse, stadium shape, circle, triangle, rectangle and octagon.

8. The separating device according to any one of claims 1 to 7, wherein, The magnetic element includes a beveled edge.

9. The separating device according to any one of claims 1 to 7, wherein, The magnetic element includes a circular edge.

10. The separating device according to any one of claims 1 to 9, wherein, The magnetic components are flexibly connected in series via flexible connectors.

11. The separating device according to claim 10, wherein, The flexible connector includes a flexible strip.

12. The separating device according to any one of claims 1 to 11, wherein, The separating device can be configured between the pre-separated structure and the separating structure.

13. The separating device according to any one of claims 1 to 12, wherein, The separating device includes a curved region.

14. The separating device according to any one of claims 1 to 13, wherein, The attractive force of the magnetic element is determined at least in part based on the thickness and / or composition of the hollow organ.

15. The separating device according to any one of claims 1 to 13, wherein, The attractive force of the magnetic element was determined to facilitate the placement and implantation of the separator around a portion of the outer surface of the hollow organ.

16. The separating device according to any one of claims 1 to 15, wherein, The multiple flexibly connected magnetic elements are arranged close enough to form a substantially continuous dividing line once the opposing walls of the hollow organ fuse together.

17. The separating device according to any one of claims 1 to 16, wherein, The magnet element is received in the housing.

18. The separating device according to any one of claims 1 to 16, wherein, Each of the magnetic elements is received in a corresponding housing.

19. The separating device according to claim 17, wherein, The housing includes beveled edges.

20. The separating device according to claim 18, wherein, The corresponding housing includes a beveled edge.

21. A separating device for separating hollow organs of a patient's digestive tract, the separating device comprising: A front slender member and a rear slender member; as well as A magnet assembly extending between the anterior elongated member and the posterior elongated member, the magnet assembly being implantable into a patient's abdominal cavity and comprising: Multiple magnetic components are flexibly connected in series; The magnet assembly is configured to be positioned outside the cavity around at least a portion of the outer surface of the hollow organ by guiding the elongated anterior member of the separating device to magnetically connect opposing magnet elements together, thereby compressing the opposing walls of the hollow organ therebetween and subjecting the opposing walls of the hollow organ to ischemic pressure necrosis to fuse the opposing walls of the hollow organ together, thereby separating the hollow organ.

22. The separating device according to claim 21, wherein, The aforementioned front slender member is a flexible front slender member.

23. The separating device according to claim 22, wherein, The flexible front elongated member includes at least one of a flexible rope and a flexible line.

24. The separating device according to any one of claims 22 or 23, wherein, The elongated front member is configured to engage with the delivery conduit.

25. The separating device according to any one of claims 21 to 24, wherein, At least one of the anterior elongated member and the posterior elongated member is configured to anchor the separating device subcutaneously or externally to the patient while the opposing walls of the hollow organ are compressed between opposing magnetic elements.

26. The separating device according to any one of claims 21 to 25, wherein, The separating device can be configured between the pre-separated structure and the separating structure.

27. The separating device according to claim 26, wherein, In the separation configuration, the front elongated member and the rear elongated member are close to each other so that the separation device forms a partial loop or loop.

28. The separating device according to any one of claims 21 to 27, wherein, The front elongated member and the rear elongated member include a continuous elongated member configured to slidably engage with the magnet assembly.

29. A separating device for separating hollow organs of a patient's digestive tract, the separating device comprising: Magnet assembly, including: Multiple magnetic components are flexibly connected in series; A housing configured to receive the plurality of magnetic elements therein and including an organ contact side; The magnet assembly is configured to be positioned outside the cavity around at least a portion of the outer surface of the hollow organ to magnetically connect opposing magnet elements together, thereby compressing the opposing walls of the hollow organ between opposing organ contact sides of the housing and subjecting the opposing walls of the hollow organ to ischemic pressure necrosis to fuse the opposing walls of the hollow organ together.

30. The separating device according to claim 29, wherein, The organ contact side of the housing includes an elongated flat contact surface.

31. The separating device according to claim 29 or 30, wherein, The shell has a shape selected from the group consisting of ellipse, stadium shape, circle, triangle, rectangle and octagon.

32. The separating device according to any one of claims 29 to 31, wherein, The housing includes beveled edges.

33. The separating device according to any one of claims 29 to 31, wherein, The shell includes a circular edge.

34. The separating device according to any one of claims 29 to 33, wherein, The organ-contacting side of the housing has a smaller surface area compared to the side of the housing opposite to the organ-contacting side.

35. The separating device according to any one of claims 29 to 34, wherein, The magnetic components are flexibly connected in series via flexible connectors.

36. The separating device according to claim 35, wherein, The housing includes a plurality of housings, each of the magnetic elements being received in a corresponding one of the plurality of housings.

37. The separating device according to claim 36, wherein, The flexible connector is disposed between adjacent housings in the plurality of housings.

38. The separating device according to claim 36, wherein, The housing includes a connection portion between adjacent housings in the plurality of housings to flexibly connect adjacent magnetic elements in the plurality of magnetic elements together.

39. The separating device according to claim 35, wherein, The housing in which the plurality of magnetic elements are received is a single housing.

40. The separating device according to claim 39, wherein, The flexible connector is disposed within the single housing.

41. The separating device according to any one of claims 29 to 40, wherein, The housing comprises metal.

42. The separating device according to claim 41, wherein, The metal includes at least one of stainless steel, titanium, and medical implant-grade metals.

43. The separating device according to any one of claims 29 to 42, wherein, The shell comprises a polymer.

44. The separating device according to claim 43, wherein, The polymer includes silicone resin, Silastic TM At least one of the following: and medical implant-grade polymers.

45. A separating device for separating hollow organs of the digestive tract, the separating device comprising: A magnet assembly, implantable into the patient's abdominal cavity, includes: A plurality of magnetic elements flexibly connected in series, each of the plurality of magnetic elements having a magnetic engagement side; A flexible housing configured to receive the plurality of magnetic elements therein, the housing including an organ contact side; The device can be configured in a pre-segmentation for insertion into the abdominal cavity and in a separation structure for separating the hollow organ; In the pre-separated structure, the magnet engagement sides of the magnet elements are magnetically disengaged from each other, and in the separated structure, the magnet assembly forms a U-shape around the hollow organ to magnetically connect the opposing magnet engagement sides, and the opposing walls of the hollow organ are compressed between the opposing organ contact sides of the housing, and the opposing walls of the hollow organ are subjected to ischemic pressure necrosis to fuse the opposing walls of the hollow organ together.

46. ​​The separating device according to claim 45, wherein, The pre-segmentation structure includes an extended pre-segmentation structure.

47. The separating device according to claim 45, wherein, The pre-segmentation structure includes a ring-shaped pre-segmentation structure.

Images