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WO2018001192A1 - Dispositif d'implantation anti-reflux gastro-œsophagien - Google Patents

Dispositif d'implantation anti-reflux gastro-œsophagien Download PDF

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Publication number
WO2018001192A1
WO2018001192A1 PCT/CN2017/089938 CN2017089938W WO2018001192A1 WO 2018001192 A1 WO2018001192 A1 WO 2018001192A1 CN 2017089938 W CN2017089938 W CN 2017089938W WO 2018001192 A1 WO2018001192 A1 WO 2018001192A1
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WO
WIPO (PCT)
Prior art keywords
magnetic
outer casing
locking device
housing
hole
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2017/089938
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English (en)
Chinese (zh)
Inventor
陈智敏
陈凯宾
李志刚
孙益峰
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ningbo Senscure Biotechnology Co Ltd
Original Assignee
Ningbo Senscure Biotechnology Co Ltd
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Filing date
Publication date
Application filed by Ningbo Senscure Biotechnology Co Ltd filed Critical Ningbo Senscure Biotechnology Co Ltd
Publication of WO2018001192A1 publication Critical patent/WO2018001192A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/009—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof magnetic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0001—Means for transferring electromagnetic energy to implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/216—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings

Definitions

  • the present invention relates to a medical implant device, and more particularly to an implant device that is resistant to gastroesophageal reflux.
  • the implanted device of the invention is surrounded by the laparoscopic surgery to the outside of the patient's lower esophageal sphincter to enhance the ability of the lower esophageal sphincter to close, and to resist the reflux of the stomach contents.
  • Gastroesophageal reflux disease refers to symptoms such as heartburn and duodenal excess contents that flow into the esophagus and cause heartburn, and can cause esophagitis and tissue damage other than esophagus such as pharynx, larynx, and airway. Gastroesophageal reflux disease is very common in Western countries. About 7% to 15% of the population have symptoms of gastroesophageal reflux, and the incidence increases with age. The age of 40 to 60 years is the peak age of onset. There is no difference between men and women, but there is a counter In men with esophageal esophagitis, there are more men than women (2:1 to 3:1).
  • the magnetic bead chain is laparoscopic minimally invasive surgery, with the ends of the head and tail joined together to form a closed loop that wraps around the outside of the patient's lower esophageal sphincter.
  • the disadvantages are: First, the formed ring is not round enough to fit well with the outer side of the lower esophageal sphincter. When the patient swallows food, the esophageal dilatation will rub with the device, causing discomfort to the patient, and even worse, causing the patient's esophagus.
  • Symptoms such as inflammation of the lateral sphincter; secondly, the inconvenience of the first and last ends is not conducive to the doctor's operation, increasing the operation time; third, after the magnetic bead chain is implanted in the body for a period of time, between the magnetic beads and the adjacent magnetic beads The gap will be wrapped and landfilled by human tissue. Once the patient is found to be unwell, it is difficult to remove.
  • An implantable device for gastroesophageal reflux comprising a magnetic flux and an auxiliary wire, the magnetic chain comprising a plurality of magnetic devices, a plurality of connecting units and a locking device, the magnetic device comprising Or a plurality of annular magnets and an outer casing, the outer surface of the annular magnet being provided with a coating, the annular magnet being placed inside the outer casing, the inner circumferential surface of the outer casing being a concave curved surface;
  • the connecting unit includes a connecting member and a limiting member for movably connecting the adjacent magnetic devices, the limiting member being disposed at an end of the connecting member for limiting adjacent magnetic devices
  • the locking device includes a first locking device and a second locking device, the magnetic chain further has a starting magnetic device and a terminal magnetic device, the starting magnetic device and the end magnetic device Each includes one or more annular magnets and an outer casing, the first locking device being disposed on the outer casing of the starting magnetic device, and the second locking device being disposed at the end magnetic
  • the arcuate radius of the concave curved surface is greater than or equal to the radius of the inscribed circle of the closed annular magnetic link.
  • the connecting member has a circular arc shape, and a radius of a circular arc of the connecting member is equal to a sum of a radius of an inscribed circle of the closed annular magnetic chain ring and a radius of the magnetic device.
  • the outer casing includes a sub-housing, a female outer casing, and a cover plate, the sub-housing and the female outer casing forming a butt joint, the cover plates being fixedly coupled to the sub-housing and the female, respectively
  • An end surface of the outer casing, the cover plate is provided with a through hole, and the through hole of the cover plate on the sub-housing corresponds to the through hole axial center of the cover plate on the female outer casing,
  • the two ends of the connecting member respectively pass through the through holes provided on two adjacent ones of the two adjacent magnetic devices, the limiting member restricting the connecting member from the The through hole of the cover plate slides out.
  • the outer casing includes a sub-housing, a female outer casing, and a cover plate, the sub-housing and the female outer casing form a butt joint, and the cover plate is fixedly coupled to an end surface of the sub-housing,
  • the cover plate is provided with a through hole
  • the female outer casing is provided with a through hole
  • the through hole of the cover plate corresponds to the through hole axial center of the female outer casing
  • both ends of the connecting member respectively pass through An adjacent one of the adjacent two magnetic devices and the through hole on the female housing, the limiting member restricting the connecting member from the cover of two adjacent magnetic devices
  • the through hole of the board and the through hole of the female housing slide out.
  • the magnetic flux is provided with a tubular film that is made of a degradable material.
  • the magnetic flux is provided with a tubular film made of polytetrafluoroethylene, perfluoroethylene propylene copolymer or parylene.
  • the outer shell is provided with a coating that inhibits the growth of tissue cells, the coating being a polymeric coating or a metallic coating or a drug loaded coating.
  • the drug-loaded coating can slow release of a drug that inhibits cell growth, such as rapamycin or paclitaxel.
  • the coating of the annular magnet is a medical non-degradable polymeric coating or a non-degradable bioceramic coating.
  • the medical non-degradable polymer coating is a polytetrafluoroethylene coating, or a parylene coating, or a methyl silicone oil coating.
  • the non-degradable bioceramic coating is a titanium nitride coating or a titanium oxide coating.
  • the first latching device and the second latching device are a snap-fit connection, a threaded connection, a glued connection or a slotted connection.
  • the latching connection is configured to provide a latching structure on the end faces of the first latching device and the second latching device.
  • the latching connection is configured to provide a groove on the first locking device, and an elastic card member on the second locking device, the elastic card member They are compressed into the grooves and then expanded to connect them to each other.
  • the structure of the latching connection is that the first locking device is provided with a groove with an elastic card member, and the second locking device is provided with a convex structure having a card slot. And moving the elastic card member into the card slot of the protruding structure of the second locking device to connect the first locking device and the second locking device to each other.
  • the limiting member is a convex structure, which is spherical, elliptical or flat.
  • the inner circumferential surfaces of the outer casing of the starting magnetic device and the end magnetic device are concave curved surfaces, and the circular arc radius of the concave curved surface is equal to the closed annular magnetic The radius of the inscribed circle of the link.
  • the invention has the following advantages:
  • the shape formed by the magnetic chain in series is closer to a circular shape, so that the implanted device of the present invention fits on the outer wall of the esophagus after being implanted outside the lower esophageal sphincter, thereby reducing the discomfort of the patient and reducing the esophageal sphincter of the patient.
  • the friction between the outside and the instrument fully exerts the effect of the instrument to enhance the LES.
  • the invention is provided with a starting magnetic device and a terminal magnetic device, and a first locking device and a second locking device are respectively arranged on the starting magnetic device and the end magnetic device, and the connection between the two locking devices is convenient
  • the two locking devices are attracted to each other by the ring magnets, and only need to adjust some angles, the locking device can be quickly closed, which is convenient for the doctor to operate, reducing the operation time and increasing the operation time. Surgical efficiency.
  • the connecting member of the invention has a circular arc shape, which reduces the friction of the magnetic flux during the expansion movement and increases the service life of the magnetic flux chain.
  • the surface of the ring magnet of the invention has a coating, and the coating has good acid and alkali resistance and chemical stability, so that the ring magnet is well protected and the magnet is not affected by the outside, so that the magnetic chain is long-term Resist the stomach contents in the body The role does not change.
  • the outer shell of the present invention has a coating for inhibiting the growth of tissue cells, so that the surface of the outer shell is smoother, and the fibrous structure is less likely to wrap the magnetic flux, so that the fibrous tissue does not affect the expansion range and the closing performance of the magnetic flux after implantation, and When the patient is uncomfortable with the magnetic flux, it is also convenient for the doctor to quickly take out the flux linkage.
  • the magnetic flux of the present invention is provided with a tubular film which isolates the magnetic flux from human tissue so that adjacent magnetic devices are not filled with fibrous tissue to prevent tissue from being embedded between the magnetic devices.
  • the magnetic chain expansion resistance is increased, which causes the patient to have difficulty swallowing. At the same time, when the patient has discomfort to the magnetic flux, the doctor can quickly take out the flux linkage.
  • the tubular film of the present invention is made of a degradable material, and the purpose of using the degradable material is that when the magnetic flux is implanted, the material is not completely degraded, so that the separation function can be performed, so that the gap of the magnetic chain is not Will be filled by the organization, when the patient is uncomfortable with the flux linkage, it is convenient for the doctor to quickly remove the flux linkage.
  • Figure 1 shows a schematic view of the structure of the implant device of the present invention.
  • Fig. 2 is a schematic cross-sectional view showing the magnetic chain of the implant device of the present invention.
  • Figure 3 is a cross-sectional view showing the structure of a magnetic chain of one embodiment of the implant device of the present invention.
  • FIG. 4 is a cross-sectional view showing the structure of a magnetic device of one embodiment of the implant device of the present invention.
  • Figure 5 shows a cross-sectional view of the housing of one embodiment of the implant device of the present invention.
  • Figure 6 shows a side and cross-sectional view of a sub-housing structure of one embodiment of an implant device of the present invention.
  • Figure 7 is a side elevation and cross-sectional view showing the female outer casing structure of one embodiment of the implant device of the present invention.
  • Figure 8 is a schematic view showing the structure of a cover plate of one embodiment of the implant device of the present invention.
  • Figure 9 is a schematic view showing the inner circumferential surface of the outer casing of the implant device of the present invention having a concave curved surface.
  • Figure 10 is a schematic view showing the structure of the connector of the implant device of the present invention.
  • Figure 11 is a side elevation and cross-sectional view showing the first locking device of the implant device of the present invention and the starting magnetic device in one piece.
  • Figure 12 is a side elevation and cross-sectional view showing the second locking device and the end magnetic device of the implant device of the present invention in one piece.
  • Figure 13 is a schematic view showing the structure of the initial magnetic device and the end magnetic device of the implant device of the present invention having a concave inner surface.
  • Figure 14 is a side elevational view and section of the starting magnetic device and the first locking device of the implant device of the present invention in a separate body See the schematic.
  • Figure 15 is a side elevation and cross-sectional view showing the second locking device and the end magnetic device of the implant device of the present invention in a separate body.
  • Figure 16 is a block diagram showing the structure of a locking device of one embodiment of the implant device of the present invention.
  • Figure 17 is a block diagram showing the structure of a locking device of another embodiment of the implant device of the present invention.
  • Figure 18 is a side elevation and cross-sectional view showing the first locking device of one embodiment of the implant device of the present invention.
  • Figure 19 is a block diagram showing the structure of a second locking device of one embodiment of the implant device of the present invention.
  • Figure 20 is a block diagram showing the construction of an elastic clip and a baffle of an embodiment of the implant device of the present invention.
  • Figure 21 is a side elevation and cross-sectional view showing the first locking device of still another embodiment of the implant device of the present invention.
  • Figure 22 is a block diagram showing the structure of a second locking device of still another embodiment of the implant device of the present invention.
  • Figure 23 is a schematic view showing the structure of the elastic snap of the implant device of the present invention.
  • Figure 24 is a schematic view showing the structure of a circular outer casing of the implant device of the present invention.
  • Figure 25 is a schematic view showing the structure of the retaining ring of the implant device of the present invention.
  • Figure 26 is a block diagram showing the structure of a locking device of another embodiment of the implant device of the present invention.
  • Figure 27 is a block diagram showing the structure of a locking device of another embodiment of the implant device of the present invention.
  • Figure 28 is a cross-sectional view showing the structure of a magnetic chain of another embodiment of the implant device of the present invention.
  • Figure 29 is a cross-sectional view showing the structure of the outer casing of another embodiment of the implant device of the present invention.
  • Figure 30 is a cross-sectional view showing the linear structure of a magnetic flux chain of still another embodiment of the implant device of the present invention.
  • 31A and 31B are cross-sectional views showing the structure of a magnetic chain of still another embodiment of the implant device of the present invention.
  • An anti-gastroesophageal reflux implant device 1 of the present invention includes a flux linkage 2 and an auxiliary line 3; as shown in FIGS. 2 and 3, the flux linkage 2 includes a plurality of magnetic devices 21, a plurality of connecting units 22, a locking device 23; as shown in FIG. 4, the magnetic device 21 includes one or more annular magnets 212 and a casing 211, and the outer surface of the annular magnet 212 is provided with a coating, and The inner surface of the outer casing 211 is a concave curved surface 2114; as shown in FIG.
  • the connecting unit 22 includes a connecting member 221 and a limiting member 222,
  • the connecting member 221 has a circular arc shape and is used for movably connecting the adjacent magnetic devices 21, and the limiting member 222 is disposed at an end of the connecting member 221 for restricting the adjacent magnetic device 21
  • the locking member 222 is a convex structure, and the protruding structure is spherical, elliptical or flat; as shown in FIG. 2, the locking device 23 includes a first locking device 231.
  • the flux linkage 2 further has a starting magnetic device 24 and an end magnetic device 25, the first locking device 231 is disposed on the outer casing 241 of the starting magnetic device 24, the second locking buckle The device 232 is disposed on the outer casing 251 of the end magnetic device 25, and after the implanting instrument 1 is implanted, when the first locking device 231 and the second locking device 232 are coupled to each other,
  • the flux linkage 2 forms a closed annular flux linkage; the auxiliary wires 3 are respectively disposed on the outer casing 241 of the starting magnetic device 24 and the outer casing 251 of the end magnetic device 25. As shown in FIG.
  • the outer casing 211 includes a sub-housing 2111, a female outer casing 2112, and a cover plate 2113.
  • the sub-housing 2111 and the female outer casing 2112 form a butt joint, and the cover plate 2113 is fixedly connected to the same.
  • the end surface of the outer casing 2111 and the end surface of the female outer casing 2112, as shown in FIG. 8, the cover plate 2113 is provided with a through hole 21131, and the through hole 21131 of the cover plate 2113 on the sub-housing 2111 Corresponding to the axial center of the through hole 21131 of the cover plate 2113 on the female housing 2112, two ends of the connecting member 221 respectively pass through phases disposed in two adjacent magnetic devices 25.
  • the through hole 21131 of the two adjacent cover plates 2113, the limiting member 222 restricts the connecting member 221 from sliding out of the through hole 21131 of the cover plate 2113.
  • the sub-housing 2111 is provided with a circular groove 21111.
  • the female housing 2112 is provided with a circular groove 21121, and one end of the connecting unit 22 passes through the cover plate 2113.
  • the through hole 21131, the other end of the connecting unit 22 passes through the through hole 21131 of the other cover plate 2113 adjacent thereto, and the cover plate 2113 is inserted into the circular groove 21111 and fixedly connected.
  • the other cover plate 2113 is snapped into the circular groove 21121 in the female housing 2112 of the outer casing 211 of the adjacent magnetic device 21 and fixedly connected so that the adjacent magnetic devices 21 are movably connected in this manner.
  • a plurality of the connecting units 22 connect the plurality of magnetic devices 21 together.
  • the starting magnetic device 24 includes a housing 241 and an annular magnet 212 disposed within the housing 241, the end magnetic device 25 including a housing 251 and an annular magnet disposed within the housing 251.
  • the outer casing 241 includes a sub-housing 2411, a female outer casing 2412 and a cover plate 2113, the outer casing 251 including a sub-housing 2511, a female outer casing 2512 and a cover plate 2113, the first locking device 231 and the second lock Buckle devices 232 are disposed on the female housing 2412 and the female housing 2512, respectively.
  • the first locking device 231 and the female housing 2412 have two design structures, one is a one-piece structure, as shown in FIG.
  • the second locking device 232 and the female housing 2512 also have two design structures, one is a one-piece structure, as shown in FIG. 12; the other is a split structure, as shown in FIG.
  • the sub-housing 2411 and the sub-housing 2511 are respectively provided with a circular groove 24111 and a circular groove 25111.
  • the circular groove 24111 and the circular groove 25111 are respectively provided with a cover plate 2113, one end of the connecting unit 22 Through the through hole 21131 of the cover plate 2113, the other end of the connecting unit 22 passes through the through hole 11131 of the cover plate 2113 of the magnetic device 21 adjacent thereto, and the cover plate 2113 is engaged
  • the circular groove 24111 in the starting magnetic device 24 is fixedly connected, and the other cover plate 2113 is snapped into the magnetic device 21 adjacent to the starting magnetic device 24
  • the circular groove 21121 in the female housing 2112 is fixedly connected such that the starting magnetic device 24 and the adjacent magnetic device 21 are movably connected.
  • the cover plate 2113 is snapped into the end magnetic
  • the circular groove 25111 in the device 25 is fixedly connected, and the other cover plate 2113 is snapped into the outer side of the adjacent magnetic device 21.
  • the circular groove 21121 in the casing 2112 is fixedly connected such that the end magnetic device 25 and the adjacent magnetic device 21 are movably connected, and thus connected to form a linear shape of the magnetic flux 2 shown in FIG.
  • the circumferential surface 2114 of the outer casing 211, the circumferential surface 2413 of the outer casing 241 of the starting magnetic device 24, and the circumferential surface 2513 of the outer casing 251 of the end magnetic device 25 are concave arcs.
  • the concave curved surface has an arc shape.
  • the magnetic chain 2 is formed into a closed shape as shown in FIG.
  • An annular magnetic link ring, and the flux circle formed by the flux linkage 2 has an inscribed circle radius greater than or equal to a radius of a circular arc of the concave curved surface 2114 of the outer casing 211, and a concave shape of the outer casing 241 The radius of the arc of the curved surface 2413 and the concave curved surface 2513 of the outer casing 251.
  • the design of the magnetic chain 2 is closer to a circular shape, so that the implant device 1 is more suitable for the outer wall of the esophagus after being implanted outside the lower esophageal sphincter.
  • the extrusion of the outer wall of the esophagus reduces the discomfort of the patient, and at the same time, when the flux linkage 1 is expanded and closed, the friction between the outer side of the patient's esophageal sphincter and the flux linkage 1 can be alleviated, and the symptoms of inflammation on the lateral side of the esophagus caused by friction should be avoided.
  • the role of the flux linkage 2 to enhance the LES is fully exerted.
  • the connecting member 221 has a circular arc shape, and the circular arc radius of the connecting member 221 is equal to the sum of the radius of the inscribed circle of the closed annular magnetic chain ring 2 and the radius of the magnetic device 21, such a design
  • the purpose is to reduce the circular movement of the magnetic device 21 along the circular arc shape of the connecting member 221 when the magnetic flux chain 2 is expanded and closed, and reduce the through hole in the connecting member 221 and the cover plate 2113.
  • the friction between the 21131 is reduced, so that the diameter of the through hole 21131 is reduced, so that the diameter of the through hole 21131 is not easily increased, and the limiting member 222 is not easy to be used during the long-term expansion and closure of the flux linkage 2.
  • the through hole 21131 is detached, thereby increasing the service life of the flux linkage 2.
  • the outer casing 211, the outer casing 241 of the starting magnetic device 24 and the outer surface of the outer casing 251 of the end magnetic device 25 have a coating for inhibiting the growth of tissue cells, and the coating may be a medical non-degradable polymer coating or a metal coating or a drug-loaded coating, in a preferred embodiment, the drug-loaded coating, the drug-loaded coating can slow release of a drug that inhibits cell growth, such as rapamycin or paclitaxel, such that the outer shell 211, the surface of the outer casing 241 of the starting magnetic device 24 and the outer casing 251 of the end magnetic device 25 are not easy to adhere to the tissue, so the magnetic chain 2 is not wrapped by the fibrous tissue in the human body, so that the magnetic When the chain 2 is expanded and closed, the fibrous tissue can only grow outside the range in which the flux linkage 2 is expanded, and does not affect the expansion range and the expansion and closure performance of the flux linkage 1 and, in addition, for the magnetic flux chain 2 For patients who are unwell,
  • the surface of the annular magnet 112 has a coating.
  • the coating is a medical non-degradable polymer coating, and the medical non-degradable polymer coating is a polymer. a tetrafluoroethylene coating, or a parylene coating, or a methyl silicone coating; in another preferred embodiment, the coating may also be a non-degradable bioceramic coating, the non-degradable The bioceramic coating is a titanium nitride or titanium oxide coating, which has acid and alkali resistance due to chemical stability of the coating, so that when the magnetic flux 2 is implanted in the human body, the annular magnet
  • the female housing 2412 of the starting magnetic device 24 is provided with a through hole 24121
  • the female housing 2512 of the end magnetic device 25 is provided with Through hole 25121
  • the auxiliary line 3 points Do not pass through the through hole 24121 and the through hole 25121
  • the auxiliary line 3 is respectively knotted
  • the first locking device 231 is provided with a card slot 2311 and a card plate 2312 on the circumferential surface
  • the second lock A card slot 2321 and a card plate 2322 are disposed on the circumferential surface of the buckle device 232
  • the card board 2312 is inserted into the card slot 2321 by pulling the auxiliary line 3, that is, the card board 2322 is inserted into the card slot 2322.
  • the first locking device 231 and the second locking device 232 are axially incapable of moving, and the longitudinal direction is due to the annular magnet in the starting magnetic device 24 and the end magnetic device 25. 112 mutual attraction without side slip, this design is convenient for doctors to operate, reducing the operation time and improving the efficiency of surgery.
  • the end surface of the first locking device 231 is provided with a groove 2311, and the end surface of the second locking device 232 is matched with the groove 2311.
  • the protruding structure 2321 encloses the protruding structure 2321 into the recess 2311, so that the first locking device 231 and the second locking device 232 are axially incapable of moving, and the longitudinal direction is at the beginning.
  • the magnetic device 24 and the annular magnet 112 in the end magnetic device 25 are attracted to each other without side slip, and the shape of the groove 2311 is V-shaped, or semi-circular, or rectangular, and the protrusion
  • the shape of the structure 2321 is the same as the shape of the groove 2311 corresponding thereto.
  • the first locking device 231 is provided with a circular groove 2311
  • the circular groove 2311 is provided with an internal thread 23111
  • the second locking device 232 is provided.
  • a convex cylinder 2321 having an external thread 23211, the external thread 23211 being threadedly engaged with the internal thread 23111, the second locking device 232 and the first locking device 231 Connected to each other.
  • the first locking device 231 is provided with a circular groove 2311 and a circular bevel 2312; as shown in FIGS. 19 and 20, the second locking device
  • the 232 is provided with an elastic card member 2321 and a through hole 2323 matching the elastic card member 2321, and a baffle 2322 for restricting the elastic card member 2321 to the movable through hole 2323.
  • the baffle 2322 is provided.
  • the elastic card member 2321 includes a spring 23212 and a buckle 23211.
  • One end of the buckle 23211 is provided with a spherical surface 232111, and the other end is provided with a groove 232112.
  • One end of the spring 23212 is inserted into the hole.
  • the other end of the spring 14212 is inserted into the groove 232112 of the other buckle 23211, and the elastic card 2321 is nested into the through hole 2323.
  • the baffle 2322 is inserted into the buckle 23211 through the through hole 23221, and the baffle 2322 is fixedly connected to the end surface of the through hole 2323, so that the elastic card 2321 is restricted to the In the baffle 2322, when the elastic card member 2321 is axially moved along the circular inclined surface 2312, the two buckles 2 are caused.
  • the 3211 is pressed against each other.
  • the buckle 23211 When the buckle 23211 enters the recess 2311 through the circular slope 2312, the buckle 23211 is ejected by the outward force of the spring 23212, just to make the buckle 23211.
  • Engaging in the recess 2311, and the recess 2311 is a closed circular ring in the longitudinal direction, so that the first locking device 231 and the second locking device 232 are unable to move in the axial direction and the longitudinal direction.
  • the first locking device 231 and the second locking device 232 are connected to each other.
  • the first locking device 231 includes an elastic buckle 2312, a spring 2313, a round shell 2314, and a circumferential surface of the elastic buckle 2312.
  • the surface 23121 has one end of the spring 2313 snapped into the circular groove 23122 and is fixedly connected.
  • the inner surface of the round shell 2314 is an inner circular surface 23141, and the inner circular surface 23141 is provided with a circular shape.
  • the first locking device 231 further includes a retaining ring 2316, and the retaining ring 2316 is provided with a through hole 23161.
  • the hole 23161 and the inner circular surface 23141 are concentrically aligned, and the retaining ring 2316 and the circular outer casing 2314 are fixedly connected, so that the elastic buckle 2312 and the spring 2313 are confined in the retaining ring 2316;
  • the second locking device 232 is provided with a convex structure 2321, and the convex structure 2321 is pressed.
  • the elastic buckle 2312 is contracted in the longitudinal direction.
  • the protruding structure 2321 enters the recess 2315, the elastic buckle 2312 receives the elastic buckle 2312.
  • the resilient force of the spring 2313, the elastic buckle 2312 is reset, so that the protruding structure 2321 cannot be axially pulled out from the groove 2315, and the groove 2315 is a closed circular ring in the longitudinal direction, so that the first A locking device 231 and the second locking device 232 are incapable of moving in both the axial direction and the longitudinal direction, and the first locking device 231 and the second locking device 232 are connected to each other.
  • the locking device 23 includes a first locking device 231, a second locking device 232 and a seaming line 233, and the first locking device 231 is provided with a through a hole 2311, the second locking device 232 is provided with a through hole 2321, the leading end of the sewing wire 233 passes through the through hole 2311 of the first locking device 231, and the stitching line 233 The end passes through the through hole 2321 of the second locking device 232, and the first end of the sewing line 233 is knotted, so that the first locking device 231 and the second locking device 232 shaft The first locking device 231 and the first portion are not movable due to mutual attraction of the annular magnets 112 in the starting magnetic device 24 and the end magnetic device 25 in the longitudinal direction.
  • the two locking devices 232 are connected to each other.
  • first locking device 231 and the second locking device 232 are glued and fixed by glue, at the end face 2311 of the first locking device 231.
  • the glue is coated with the auxiliary line 3, and the end surface 2321 of the second locking device 232 is attached to the end surface 2311 for fixed connection.
  • the glue used must meet the medical grade requirements.
  • the structure of the implant device in this embodiment is basically the same as that of the implant device described in the first embodiment, except that, as shown in FIG. 29, the outer casing 211 includes a sub-housing 2111 and a female housing 2112.
  • the cover plate 2113, the sub-housing 2111 and the female housing 2112 are formed in abutting connection, the cover plate 2113 is fixedly connected to the end surface of the sub-housing 2111, and the cover plate 2113 is provided with a through hole 21131.
  • the female housing 2112 is provided with a through hole 21121, and the through hole 21131 of the cover plate 2113 and the through hole 21121 of the female housing 2112 are axially opposite, and one end of the connecting unit 22 is worn.
  • the through hole 21121 of the female housing 2112, the other end of the connecting unit 22 passes through the through hole 21131 of the cover plate 2113 of the adjacent magnetic device 21, the cover plate 2113 card
  • the circular grooves 21111 of the sub-housing 2111 are inserted into and fixedly connected such that adjacent magnetic devices 21 are movably connected, and a plurality of the magnetic devices 21 are connected in a sequential manner.
  • one end of the connecting unit 22 passes through the through hole 21121 of the female housing 2112, and the other end of the connecting unit 22 passes through the through hole of the cover plate 2113 of the starting magnetic device 24.
  • the cover plate 2113 is snapped into the circular groove 24111 of the sub-housing 2411 and fixedly connected such that the starting magnetic device 24 and the adjacent magnetic device 21 are movably connected;
  • One end of the connecting unit 22 passes through the through hole 21131 of the cover plate 2113 of the magnetic device 21, and the other end of the connecting unit 22 passes through the through hole of the cover plate 2113 of the end magnetic device 25.
  • the cover plate 2113 is snapped into the circular groove 25111 of the sub-housing 2511 and fixedly connected, and the cover plate 2113 of the magnetic device 21 is snapped into the circle of the sub-housing 2111
  • the slot 21111 is internally and fixedly coupled such that the end magnetic device 25 is movably coupled to the adjacent magnetic device 21.
  • the first locking device 231 and the second locking device 232 are coupled to each other to form a magnetic flux link.
  • the structure of the implant device in this embodiment is basically the same as that of the implant device in the first embodiment, except that in the third embodiment, the tubular film 4 is disposed outside the flux chain 2.
  • the tubular film isolates the flux linkage 2 from human tissue such that adjacent magnetic devices 21 are not filled with fibrous tissue to prevent tissue from being embedded between the magnetic devices 21, resulting in an increase in the expansion resistance of the flux linkage 2, thereby Causes difficulty in swallowing.
  • FIG. 30 when the magnetic flux 2 is connected in a straight line shape, the magnetic flux 2 is inserted into the tubular film 4, and the outer wall of the magnetic chain 2 is attached to the tubular film 4.
  • the tubular film 4 is made of polytetrafluoroethylene, a perfluoroethylene propylene copolymer or parylene.
  • the tubular film 4 is of a stacked structure, such that the first locking device 231 and the second locking device 232 are joined to each other to form a magnetic link, the tubular film 4
  • the flux linkage 2 forms a circular ring, when the magnetic implant 2 is expanded and closed after the implant device 1 is implanted into a human body, the tubular film 4 is simultaneously expanded and closed with the flux linkage 2
  • the tubular film 4 is not easy to adhere to the substance and is not wrapped by the fibrous tissue in the human body.
  • the tubular film 4 has stable chemical properties and is not corroded by the tissue fluid in the human body, and will not be in the long-term implantation in the human body.
  • the expansion range and the expansion and closure performance of the flux linkage 2 are affected, and when the patient is uncomfortable with the flux linkage 2, it is convenient for the doctor to quickly take it out.
  • the tubular film 4 is made of a degradable material.
  • the degradable material is a biocompatible degradation material such as polylactic acid or the like.
  • the purpose of using the degradable material is that when the flux linkage 2 is implanted, the material is not completely degraded, so that it can function as an isolation, so that the gap of the flux linkage 2 is not filled by the tissue when the patient pairs the flux linkage 2 When there is discomfort, it is convenient for the doctor to quickly remove the flux linkage 2.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne in dispositif d'implantation anti-reflux gastro-œsophagien (1), comprenant une chaîne magnétique (2) et une ligne auxiliaire (3) ; la chaîne magnétique (2) comprend une pluralité de dispositifs magnétiques (21), une pluralité d'unités de connexion (22), et un dispositif de verrouillage (23) ; les dispositifs magnétiques (21) comprennent un ou plusieurs aimants annulaires (212) et un logement (211), et une surface circonférentielle interne du logement (211) est une surface concave orientée vers l'intérieur (2114) ; des dispositifs magnétiques adjacents (21) sont reliés de manière mobile entre eux au moyen des unités de connexion (22) ; les unités de connexion (22) comprennent un élément de connexion (221) et un élément de limitation (222) disposé sur une extrémité de celui-ci ; le dispositif de verrouillage (23) comprend un premier dispositif de verrouillage (231) et un second dispositif de verrouillage (232) ; la chaîne magnétique (2) comprend en outre un dispositif magnétique de départ (24) et un dispositif magnétique de fin (25) ; le premier dispositif de verrouillage (231) et le second dispositif de verrouillage (232) sont respectivement agencés sur des logements (241/251) du dispositif magnétique de départ (24) et du dispositif magnétique de fin (25) ; lorsque le premier dispositif de verrouillage (231) et le second dispositif de verrouillage (232) sont engagés, la chaîne magnétique (2) forme un anneau de chaîne magnétique annulaire fermé. Le dispositif d'implantation (1) est bien conçu, et a une forme faisant que la chaîne magnétique (2) connectée en série est plus proche d'une forme circulaire, de telle sorte que le dispositif d'implantation (1), lorsqu'il est implanté sur un côté externe d'un sphincter œsophagien inférieur (SOI), s'adapte mieux à la paroi externe de l'œsophage et donne un plus grand degré de liberté à une fonction de renforcement du SOI du dispositif.
PCT/CN2017/089938 2016-06-30 2017-06-26 Dispositif d'implantation anti-reflux gastro-œsophagien Ceased WO2018001192A1 (fr)

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WO2019171330A1 (fr) * 2018-03-07 2019-09-12 Ethicon Llc Dispositif d'augmentation de sphincter magnétique accordable
WO2020084598A1 (fr) * 2018-10-26 2020-04-30 Torax Medical, Inc. Dispositif magnétique d'augmentation de sphincter pour incontinence urinaire
WO2020128741A3 (fr) * 2018-12-17 2020-07-30 Ethicon Llc Ensemble de couplage pour dispositif d'assistance de sphincter implantable

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CN108294844B (zh) * 2018-01-23 2020-02-21 宁波胜杰康生物科技有限公司 一种增强括约肌功能的辅助装置
CN108309384B (zh) * 2018-02-10 2019-08-06 四川大学华西医院 一种内镜下治疗用磁铁
CN108543165B (zh) * 2018-02-27 2021-06-18 宁波胜杰康生物科技有限公司 一种基于载体的肌功能辅助装置
US20200113570A1 (en) * 2018-10-11 2020-04-16 Moises Jacobs Gastroesophageal reflux treatment system, method, and device
WO2020088428A1 (fr) * 2018-11-01 2020-05-07 史源 Appareil de soutien au sphincter d'un organisme
CN110179572A (zh) * 2019-06-20 2019-08-30 浙江省人民医院 用于物理治疗的植入设备
CN112690938A (zh) * 2021-01-15 2021-04-23 宁波胜杰康生物科技有限公司 内镜下环形组织的闭合功能增强磁珠组件
CN115919522A (zh) * 2022-12-07 2023-04-07 宁波胜杰康生物科技有限公司 一种兼容磁共振的抗胃食管反流植入器械

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