• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    MODULAR ANASTOMOSIS MAGNETIC DEVICE The present disclosure provides modular anastomosis magnetic devices that can be inserted in digestive surgery or in any circumstance of anastomosis between adjacent organs or two hollow viscera. The device is minimally invasive and easily and quickly released using laparoscopic or endoscopic procedures.
    公开号:BR112014000655B1
    申请号:R112014000655-5
    申请日:2012-07-11
    公开日:2020-10-27
    发明作者:Juan Hernandez；Michele Diana；James Kennedy Wall
    申请人:Ircad；
    IPC主号:
    专利说明:

    Cross-reference
    This application claims the benefit of U.S. provisional application Serial No. 61 / 506,710, filed on July 12, 2011, which is incorporated herein in its entirety by reference. Foundation
    The present invention relates to a modular magnetic anastomosis device for a gastrointestinal procedure or circumstance in which an anastomosis between two hollow organs is required in a minimally invasive surgical procedure. summary
    The present invention extends this concept by inserting a modular magnetic anastomosis device that can be inserted in digestive surgery or in any circumstance of anastomosis between adjacent organs or two hollow viscera.
    In a modality, the modular magnetic set has the unpositioned configuration and can be placed in a small size channel and can be used in laparoscopy and endoscopy known to a person skilled in the art. The modular magnetic assembly takes the shape positioned at its insertion position.
    In another modality, the modular set anastomosis device is flexible and the modular aspect of the device allows it to be available in different sizes by adding magnetic elements and adapts to the anatomical shape of the structure in which it is inserted.
    In one embodiment, the anastomosis device is linear.
    In another embodiment, the anastomosis device can be U-shaped in its configuration of use.
    Alternatively, the anastomosis device can be S-shaped in its usage configuration.
    In another embodiment, the device has a circular usage configuration.
    According to one embodiment, the modular magnetic anastomosis device is a set of magnetic components, the two sets form the device used to form an anastomosis between two body walls.
    In another modality, the modular magnetic assembly is enveloped in a coating of elastic material.
    Alternatively, the modular magnetic component is enveloped in a coating made of biodegradable material.
    In an alternative embodiment, the magnets are incorporated in a biodegradable material.
    In a self-assembly modality in a connected chain of magnetic components, this modular device is based on an even number of magnetic dipoles with alternating North-South / South-North orientation.
    In another modality, alternating geometric flexible materials are connected to the magnet and allow the mechanical articulation of the magnets. Incorporation by reference
    All publications and patent applications mentioned in this specification are hereby incorporated by reference to the same extent, as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Brief description of the drawings
    The accompanying drawings incorporated and forming a part of the specification illustrate various aspects of the present invention and together with the description serve to explain the principles of the invention. In the drawings:
    Fig. 1 shows how each set is formed by a chain of magnets (3), a narrowing comprising flexible material (2), the elastic material (2) allows the chain of magnets to adopt a circular structure after positioning and a coating made of elastic material with a low coefficient of friction that allows easy movement of the device during an operation (1)
    Fig. 2 is a cross-sectional view of the magnet chain in example 1.
    Fig. 3 illustrates the positioned shape of the magnet with guidewires.
    Fig. 4 shows a variant of the set of magnets.
    Fig. 5 to Fig. 9 illustrate the transition from the unpositioned linear shape to the positioned circular structure of the device.
    Fig. 10 is the transition from the non-positioned shape of the magnet with the guide wire.
    Fig. 11 is the shaped magnet positioned with the guidewires.
    Fig. 12 is a representation of the encapsulated cover attached to a flexible band of example 2.
    Fig. 13 illustrates a detailed cross-sectional representation of the assembled cover of the device of example 2.
    Fig. 14 shows a cross-sectional view of the magnet assembly for the device of example 2.
    Fig. 15 illustrates the positioned structure of the magnet assembly.
    Fig. 16 illustrates the structure of a modular magnet assembly for a device in example 3.
    Fig. 17 is a presentation of simple magnets and external coating.
    Fig. 18 is a side view of the set of magnets in example 3.
    Fig. 19 illustrates the unpositioned shape of the magnet assembly in example 4.
    Fig. 20 describes the positioned shape of example 4.
    Fig. 21 illustrates the modular magnetic ring-shaped anastomosis device in the usage configuration of example 5.
    Fig. 22 shows a profile view of the device.
    Fig. 23 is a cross-sectional view of the magnet assemblies.
    Fig. 24 illustrates the unpositioned linear configuration.
    Fig. 25 describes different components of the magnet.
    Fig. 26 shows different geometric structures of magnet and coating of elastic material. Detailed Description
    Various methods were developed to create the anastomosis in the digestive tract with different techniques and instrumentation, such as manual and mechanical sutures using staplers, biological glue or through compression.
    The circular stapler (EEA) allows complex procedures such as colic resection or gastric bypasses to be performed using a minimally invasive (laparoscopic) approach. However, the rigid circular stapler structure does not allow anastomosis beyond the rectum. In addition, for the use of the circular stapler during a gastric bypass, an increased incision is necessary through one of the surgical trocars.
    Anastomosis through compression is a concept initially described by Denan in 1826 and was later popularized by Murphy in 1892 with the "Murphy Button". It is a surgical procedure that requires the introduction of two metal rings, screwed against each other to generate a constant compressive force in intercalated tissues. This procedure induces secondary health problems after anastomosis through the ischemia necrosis healing cycle.
    Covidien recently developed Valtrac ™, a set of biofragmentable rings (Covidien, Norwalk CT) that are composed of two rings made of absorbable material, this device eliminates manual or mechanical suture while maintaining a comparable rate of dehiscence and stenosis.
    Experiments with magnetic anastomosis in surgery have been seen since the 1980s by a Dutch group that also used magnetic rings to perform mucosal anastomosis while the serous (serous) membrane had to be sutured manually. The latency between the positioning of magnets and the performance of the anastomosis took 7 to 12 days. This prolonged time to obtain anastomosis interrupted the further development of the device.
    One device, called MAGNAMOSIS ™, is made up of 2 self-oriented magnetic rings, which produce a compressive force with a progressive internal-external gradient. This device was developed by the research group of Prof. Harrison from the "University of San Francisco" (California).
    Detailed embodiments of the present invention are disclosed herein. The present invention comprises a modular magnetic device that is minimally invasive, easily and quickly released and is precisely positioned by means of laparoscopy or endoscopy, without the use of clamps.
    According to a modality constructed with the teachings of the present invention, a magnetic anastomosis device used to form an anastomosis between two body walls includes a first set of magnets and a second set of magnets configured to be magnetically coupled to compress the two body walls to form the anastomosis. The set of magnets of the present invention is a modular magnetic structure with variable geometry. The flexible articulated modular device is composed of a network of magnetic elements placed and held in place by a flexible material made of elastic, biocompatible material and material with format memory or a material coated with a biocompatible material, known to a person skilled in the art . Suitable elastic materials include metal (for example, stainless steel), alloys (for example, titanium nickel) or polymers (for example, polyethylene, polytetrafluoroethylene (PTFE) including Teflon®, polyvinyl chloride (PVC), and compounds).
    It will be recognized by those skilled in the art that the elongated modular magnet sets of the present invention are capable of being released with the same small release configuration as that of the prior art, but also provide the advantage of reducing the likelihood of the anastomosis being closed with over time and eliminate the need for patient intervention for a second procedure for placing an anastomosis stent in order to prevent its closure. In addition, those skilled in the art will recognize the advantages of centralization and alignment of having two magnets arranged in each of the respective sets of magnets.
    Therefore, it will be recognized by those skilled in the art that the modular magnetic set with a smaller distribution configuration can be easily located on the body for precise release with the use of laparoscopic trocars through a single skin incision. The catheter made of non-ferromagnetic material can release both sets of magnets. The placement step preferably includes the introduction of the first set of modular anastomosis devices in one of the viscerals and positioning of the set of magnets with the guide wire that helps the device to acquire the configuration of use. After the first set of magnets is released to the location to be positioned by retracting the guide wire, the catheter release portion can be positioned and release the second set of magnets set to the second positioning position and the guide wire can be retracted.
    The excision step includes the introduction of a cutting instrument in one of the viscera and manipulation of the cutting instrument.
    The two sets of magnet sets can be manipulated to fit together; once fitted, the ischemic necrosis process can begin on the walls of the two viscera being treated.
    Alternatively, the set of magnets can also be implanted non-surgically using endoscopy in which one or more catheters are introduced into the stomach cavity through the patient's mouth and esophagus and colon.
    It will be recognized by those skilled in the art that modular sets of magnets can pass through the body naturally or can be removed by means such as laparoscopic removal, endoscopic removal or another procedure.
    Therefore, it will be recognized by those skilled in the art that the modular magnetic assembly in its unpositioned form can be linear. This feature allows the use of a small size channel to implement the modular magnetic device. The modular magnetic set has the advantage of being positioned in an open structure, thus allowing the adaptation of the anastomosis device to anatomical characteristics. The modular magnet set in the usage configuration can take different formats; as a circular, elongated, U-shaped and S-shaped.
    The concept of self-assembly of the magnet in a connected chain of magnetic components in this modular device is based on an even number of magnetic dipoles with alternating North-South / South-North orientation. This alternating orientation of the magnets provides stability of the magnets and overall magnetic inertia in the magnetic chain. However, despite the magnetic inertia of part of the modular anastomosis device, in the presence of each other the set of magnets self-orientates and forms the set of anastomosis.
    Although, only one set of the magnetic assembly will be described, two sets of magnets are intended for use as a magnetic anastomosis device. Example 1:
    Set of magnets enveloped in an elastic material with a hole for introducing the guidewire, which will enter the passage created in the flexible material of the narrowing and will allow the use configuration to be not positioned. Fig. 1 to Fig. 11 describe this example.
    As illustrated in Fig. 1, each set is formed of a chain of magnets (3), a narrowing comprising flexible material (2), the elastic material (1) allows the chain of the magnet to adopt a circular structure after positioning and a coating made of elastic material with a low coefficient of friction that allows easy movement of the device during an operation (1). The variant in Fig. 4 has the same structural feature with a more flexible coating that surrounds the magnets.
    Fig. 5 to Fig. 9 shows the transition from a non-positioned linear shape to a positioned circular shape.
    The illustrations in figures 10 and 11 describe the transition from the unpositioned shape to the circular shape positioned of the magnet guide wire set after release to the organ where it will be inserted. The guide wire (4) and (6) positions the magnetic chain and places the terminal parts of the magnetic chain in close proximity and helps, by mutual attraction of the magnets, in closing the ring; the positioned shape and (5) is the central crossing ring for the guide wire. Example 2:
    Fig. 12 to Fig. 15 illustrate the modular magnetic assembly as a chain formed of separate encapsulated magnets. Each magnet (2) is separately enveloped in a coating of an elastic or biocompatible material (1) and affixed to a flexible band that can adopt its positioned shape after being positioned in the organ to which it must be inserted. A passage created between the coverings (3) allows the attachment of the guide wire (4). Fig. 12 to Fig. 14 show the organization of such a modular magnetic set. Fig. 15 is a representation in which the guidewires enter the central ring (5) and close the device to its positioned shape.
    Fig. 14 and Fig. 15 illustrate the biconvex structure of the magnet assembly. The biconvex structure refines the quality of the magnetic compression anastomosis. Example 3:
    Fig. 16, 17, 18 describe the device of example 3. In one embodiment of this invention, the magnet network is embedded in layers of elastic material (3). This laminated structure is composed of a layer of silicone (1) around the magnet (2) and a layer of rubber that covers the silicone. In its release form the set of magnets is in a linear structure. In addition to this organization, the magnet chain can be enveloped in a coating of elastic and biocompatible material.
    Fig. 16 and 17 illustrate the structure of a set of magnets.
    Fig. 17 is a presentation of simple magnets and external coating.
    Fig. 18 is a profile view of the set of magnets, where (2) is the magnet, (1) the silicone layer and (3) the biocompatible polymer. Example 4:
    Fig. 19 and Fig. 20 describe the unpositioned shape and positioned shape of the magnet assembly that represents another example of this invention that comprises a magnet assembly encapsulated in an elastic or biocompatible material that can also be a material with a format memory that allows the release of magnets in a flattened configuration. A spring of elastic or biocompatible material (4) is on each side of the device in the unpositioned configuration. When it is released, the magnet assembly will automatically assume its usage configuration.
    The elastic biodegradable material (1) envelopes magnets (3) and the material with format memory (2). The circular central ring (5) holds the guidewire (6). Example 5:
    Fig. 21 to Fig. 25 describes different elements of the modular magnetic assembly of example 5.
    According to this example according to the teachings of the present invention, the modular magnet assembly is composed of a chain of ring-shaped magnetic elements (3) connected to each other by a network of articulated mechanical elements (1 and 2) . The ring-shaped magnets are enveloped with a web of sheets that allows the device to move from an unpositioned structure to the positioned structure. The alternating and specific geometry of the leaves is designed to facilitate the articulation between the magnets in the chain.
    The individual magnets and the sheets are joined by a centralized axis (4).
    Fig. 21 illustrates the modular magnetic anastomosis device in the shape of a ring in the configuration of use.
    Fig. 22 shows a profile view of the device.
    Fig. 23 is a cross-sectional view of the magnet assembly; illustrates the passage formed with the ring structure (6) for the guide wire (8). The central ring (7) is used for the wire guide (5).
    Fig. 24 illustrates the unpositioned linear configuration.
    Fig. 25 describes different components of the magnet, flexible structured sheets in the various geometries (1 and 2); the central magnet (3) and the component that forms the central axis that joins the leaves and the magnetized rings.
    权利要求:
    Claims (36)
    [0001]
    1. Modular magnet set for tissue anastomosis, the modular magnet set comprising: a) a first set of modular magnets; and b) a second set of modular magnets; wherein the first set of modular magnets and the second set of modular magnets are configured for placement on a first body wall and a second body wall respectively, at such a distance that the first set of modular magnets and the second set of modular magnets are magnetically attracted to each other through a defined tissue area and further configured to magnetically couple so that a magnetic coupling of the first set of modular magnets with the second set of modular magnets compresses the first body wall and the second body wall between the first set of modular magnets and second set of modular magnets magnetically coupled to form an anastomosis between the first body wall and the second body wall; characterized by the fact that the magnets of the first set of modular magnets are positioned so that an even number of dipoles of the magnets of the first set of modular magnets have an alternating north-south, south-north orientation.
    [0002]
    2. Modular magnet set according to claim 1, characterized in that the first set of modular magnets and the second set of modular magnets comprise at least 2 magnets.
    [0003]
    3. Modular magnet set according to claim 1, characterized in that the first set of modular magnets and the second set of modular magnets have a release configuration.
    [0004]
    4. Modular magnet set, according to claim 1, characterized in that the first set of modular magnets and the second set of modular magnets have a usage configuration.
    [0005]
    5. Modular magnet assembly, according to claim 4, characterized by the fact that the usage configuration is circular.
    [0006]
    6. Modular magnet assembly, according to claim 5, characterized by the fact that the usage configuration is elongated.
    [0007]
    7. Modular magnet assembly according to claim 5, characterized by the fact that the usage configuration is a U-shape.
    [0008]
    8. Modular magnet assembly, according to claim 5, characterized by the fact that the usage configuration is an S-shape.
    [0009]
    Modular magnet assembly according to claim 5, characterized in that it additionally comprises a guidewire configured to change a configuration of each of the first and second modular magnets from a release configuration to a usage configuration.
    [0010]
    10. Modular magnet assembly according to claim 1, characterized by the fact that each of the first set of modular magnets and second set of modular magnets comprises: a) a chain of magnets, b) a narrowing composed of flexible material with a passage of size receiving a guide wire, c) a coating composed of an elastic material with a hole used as the guide wire.
    [0011]
    11. Modular magnet assembly according to claim 10, characterized in that the release configuration of the modular magnet assembly is in an elongated shape.
    [0012]
    12. Modular magnet assembly, according to claim 11, characterized by the fact that the configuration of use of the modular magnet assembly is selected from the group consisting of: a) a circular shape; b) a U shape; c) a form of S; and d) an elongated shape.
    [0013]
    13. Modular magnet assembly according to claim 1, characterized by the fact that each magnet of the first set of modular magnets and the second set of modular magnets is separately enveloped in a coating.
    [0014]
    14. Modular magnet assembly according to claim 13, characterized by the fact that the coating is an elastic material.
    [0015]
    15. Modular magnet assembly according to claim 13, characterized by the fact that the coating is a biocompatible material.
    [0016]
    16. Modular magnet assembly, according to claim 13, characterized by the fact that the encapsulated coating is affixed to a flexible band.
    [0017]
    17. Modular magnet assembly according to claim 13, characterized by the fact that the encapsulated linings are joined with a guide wire.
    [0018]
    18. Modular magnet assembly according to claim 13, characterized in that the release configuration of the modular magnet assembly is an elongated shape.
    [0019]
    19. Modular magnet assembly, according to claim 13, characterized by the fact that the configuration of use of the modular magnet assembly is selected from the group consisting of: a) a circular shape; b) a U shape; c) a form of S; and d) an elongated shape.
    [0020]
    20. Modular magnet assembly, according to claim 13, characterized by the fact that the circular use configuration is biconvex.
    [0021]
    21. Modular magnet assembly according to claim 1, characterized in that the modular magnet assembly is embedded in a multilayer structure, said multilayer structure comprises: a) a rubber layer; b) a layer of silicone; c) magnets.
    [0022]
    22. Modular magnet assembly according to claim 21, characterized by the fact that the multilayer structure is enveloped in an elastic covering.
    [0023]
    23. Modular magnet assembly, according to claim 21, characterized by the fact that the multilayer structure is enveloped in a coating of biocompatible material.
    [0024]
    24. Modular magnet assembly according to claim 21, characterized in that the release configuration of the modular magnet assembly is an elongated shape.
    [0025]
    25. Modular magnet assembly according to claim 21, characterized in that it comprises a configuration of use of the modular magnet assembly is selected from the group consisting of: a) a circular shape; b) a U shape; c) a form of S; and d) an elongated shape.
    [0026]
    26. Modular magnet assembly, according to claim 1, characterized by the fact that the magnets are enveloped in a coating with a spring made of elastic and biocompatible material on each side of the coating.
    [0027]
    27. Modular magnet assembly according to claim 26, characterized by the fact that the coating is a material with a format memory.
    [0028]
    28. Modular magnet assembly, according to claim 26, characterized by the fact that during release, the modular magnet assembly automatically assumes a usage configuration.
    [0029]
    29. Modular magnet assembly, according to claim 26, characterized by the fact that the lining is sized to receive a guidewire.
    [0030]
    30. Modular magnet assembly according to claim 26, characterized in that the configuration of use of the modular magnet assembly is a circular shape.
    [0031]
    31. Modular magnet assembly according to claim 1, characterized in that the magnets of the first set of modular magnets and the second set of modular magnets are composed of a chain of ring-shaped magnetic elements connected to each other by a network of mechanical elements.
    [0032]
    32. Modular magnet assembly according to claim 31, characterized by the fact that the magnets are enveloped in a web of sheets.
    [0033]
    33. Modular magnet assembly according to claim 31, characterized by the fact that an alternating and specific geometry facilitates the articulation between the magnets.
    [0034]
    34. Modular magnet assembly according to claim 31, characterized by the fact that the magnets and the sheet network are connected via a centralized axis.
    [0035]
    35. Modular magnet assembly according to claim 1, characterized in that the means comprise laparoscopic exchangers.
    [0036]
    36. Modular magnet assembly, according to claim 1, characterized in that the means comprise endoscopy means.
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-10-29| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-09-08| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-10-27| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 11/07/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161506710P| true| 2011-07-12|2011-07-12|
    US61/506,710|2011-07-12|
    PCT/US2012/046272|WO2013009886A1|2011-07-12|2012-07-11|Modular magnetic anastomosis device|
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