WO2019237481A1 - 一种热穿刺支架置入器 - Google Patents

一种热穿刺支架置入器 Download PDF

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Publication number
WO2019237481A1
WO2019237481A1 PCT/CN2018/099489 CN2018099489W WO2019237481A1 WO 2019237481 A1 WO2019237481 A1 WO 2019237481A1 CN 2018099489 W CN2018099489 W CN 2018099489W WO 2019237481 A1 WO2019237481 A1 WO 2019237481A1
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WO
WIPO (PCT)
Prior art keywords
conductive
tube
distal end
outer tube
proximal end
Prior art date
Application number
PCT/CN2018/099489
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English (en)
French (fr)
Inventor
孙思予
葛楠
郭瑾陶
韦建宇
沈正华
李常青
冷德嵘
孙佳铃
刘春俊
Original Assignee
南微医学科技股份有限公司
中国医科大学附属盛京医院
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Application filed by 南微医学科技股份有限公司, 中国医科大学附属盛京医院 filed Critical 南微医学科技股份有限公司
Priority to EP18922575.8A priority Critical patent/EP3808316A4/en
Publication of WO2019237481A1 publication Critical patent/WO2019237481A1/zh
Priority to US17/119,147 priority patent/US20210100668A1/en

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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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
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    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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    • 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
    • A61F2/02—Prostheses implantable into the body
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
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    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
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    • A61B17/1114—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
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    • A61B2018/00071—Electrical conductivity
    • A61B2018/00083—Electrical conductivity low, i.e. electrically insulating
    • A—HUMAN NECESSITIES
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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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2/02—Prostheses implantable into the body
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    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
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    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/001—Figure-8-shaped, e.g. hourglass-shaped

Definitions

  • the invention relates to a thermal puncture inserter in the field of medical instruments, and in particular, to a thermal puncture stent inserter with integrated cutting and injection functions.
  • the gastrointestinal gallbladder anastomosis is performed by endoscopic thermal placement through the stomach wall or duodenal wall into the target location of the gallbladder.
  • the distal end of the fully covered double mushroom head bracket is placed in the gallbladder.
  • the proximal end is placed in the stomach or duodenum to open the channel between the digestive tract and the gallbladder, that is, a new path between the digestive tract and the gallbladder is rebuilt.
  • the stones in the gallbladder are taken out using the stone extraction basket to achieve endoscopic gallbladder preservation and stone removal surgery, which provides a new treatment problem for patients with gallbladder disease that is not suitable for surgery, and can also help the gallbladder.
  • Well-functioning patients provide a treatment that preserves gallbladder function and improves patients' long-term quality of life.
  • Stomach and pancreas pseudocyst stent anastomosis surgery enter the patient's pancreas pseudocyst by endoscopic gastrocentesis, and place a large-caliber full-coated double mushroom head stent to achieve anastomosis of the stomach and pancreas pseudocyst.
  • the effusion and necrosis in the pseudocyst were fully drained.
  • Duodenal bile duct anastomosis the traditional ERCP operation, uses ERCP endoscopy to retrogradely insert guidewires and other instruments from the duodenum into the duodenal papilla to reach the common bile duct, and perform stone biopsy on the common bile duct.
  • percutaneous puncture or surgical procedures are usually performed, which may reduce the quality of life of the patient or cause greater trauma.
  • Gastrointestinal anastomosis is to enter the proximal small intestine through gastric puncture under the endoscope, and place a large-caliber full-coated double mushroom head bracket to open the channel between the stomach and the small intestine. A new path between the small intestine to solve the impact of duodenal obstruction on patients' lives.
  • the stent is usually a diameter of ⁇ 10 ⁇ ⁇ 16mm double mushroom head metal stent, and the matching thermal implanter has an outer diameter of ⁇ 3.5mm ⁇ ⁇ 3.6mm (10.5Fr ⁇ 10.8Fr). ⁇ 3.7mm, because the gap is too small, the traditional charged implanter is very uncomfortable moving back and forth in the endoscopic forceps channel, which is the main reason for the difficulty of the above operations.
  • the outer diameter of the ultrasonic endoscope is ⁇ 14mm, which is 4mm larger than that of the traditional gastroscope ⁇ 10mm. It is more inconvenient to operate and there are relatively few places to reach.
  • the present invention provides a brand-new way to solve bile duct obstruction, while saving operation time, saving surgical instruments, reducing the difficulty of surgery, and providing the possibility for more doctors to perform this operation.
  • the thermal puncture stent inserter of the present invention eliminates the traditional inner tube and conductive wire of the inserter and is replaced by conductive members, which not only serves the purpose of supporting the stent but also has the function of transmitting high-frequency electricity.
  • the outer diameter of the existing thermal puncture inserter can be reduced from 3.5mm to 3.6mm (10.5Fr to 10.8Fr) to 3.15mm (9.5Fr), so that the thermal puncture inserter can pass through the traditional gastroscope clamp ⁇ 3.2mm, providing doctors with more advanced digestive tract gallbladder anastomosis, duodenal bile duct anastomosis, gastric pancreas pseudocyst anastomosis, gastrointestinal anastomosis, and NOTES surgery.
  • one end of the conductive head is defined as the far end, and the end externally powered by the inserter is defined as the near end.
  • the thermal puncture stent inserter has a proximal end and a distal end.
  • An outer tube is provided at the distal end of the front handle. The outer tube extends from the proximal end to the distal end. The outer diameter of the distal end of the outer tube is less than or equal to 3.15 mm.
  • An insulated middle tube is provided in the tube and extends from the proximal end to the distal end. The insulated middle tube is provided with a conductive portion. The insulated middle tube and the conductive portion extend from the proximal end to the far end. The proximal end of the conductive portion can be connected to an external power source.
  • a booster tube is provided between the proximal end of the outer tube and the insulating middle tube, and the distal end of the booster tube and the proximal end of the insulating middle tube are connected to each other; an insulating portion is located on the conductive portion
  • the distal end of the conductive part is provided with an insulating part.
  • a conductive head is distributed on the insulating part. The conductive head is connected to the conductive part to realize the conductive function.
  • the bracket is compressed and located in the space between the distal end of the conductive part and the outer tube.
  • the handle is connected to the proximal end of the outer tube, and the front handle is retracted along the booster tube to drive the outer tube to retract and release the bracket.
  • the conductive part not only plays a role of conducting electricity, but also supports the stent. At the same time, it can conduct electricity, cut tissue, and release the stent after reaching the lesion.
  • the conductive part is connected to realize the conductive function, and the other end of the conductive head covers the outer surface of the insulating part.
  • the conductive portion is a hollow conductive portion.
  • the proximal end of the conductive part is in communication with the Luer connector to achieve fluid injection.
  • the conductive portion is a conductive wire.
  • the conductive part is a nickel-titanium wire
  • the conductive portion is a metal material. More preferably, the conductive portion is a stainless steel material.
  • the material of the insulating portion is ceramic.
  • the outer tube includes a proximal outer tube and a distal outer tube, and the proximal outer tube and the distal outer tube are connected by a taper.
  • the booster tube extends to the proximal end and is connected to the rear handle.
  • a positioning portion is provided between the front handle and the rear handle.
  • a resistance portion is covered on the outer surface of the conductive portion at a certain distance from the conductive head.
  • the conductive head is composed of two or four conductive wires, and the two or four conductive wires are evenly distributed in the groove on the outer surface of the insulation portion. The other end of the conductive head near the outside completely covers the outer surface of the insulating portion. When cutting with the conductive head, the cut surface of the wound is a circular surface.
  • the outer surface of the conductive portion may be covered with a riveted tube, and one end of the conductive head may extend from a distal end to a proximal end into a gap between the insulating portion and the conductive portion, and pass through the riveted tube and the conductive portion.
  • the connection implements a conductive function.
  • the outer diameter of the thermal puncture stent of the present invention is smaller than the outer diameter of the stent inserter in the prior art, and provides a new minimally invasive treatment method for many patients with gastrointestinal tract and biliary and pancreatic diseases who cannot or are unwilling to undergo surgery.
  • the thermal puncture inserter of the present invention can insert a double mushroom head nickel-titanium wire braided metal stent with a diameter of ⁇ 10mm to ⁇ 16mm, and enter the stomach, duodenum and other organs through a conventional gastroscope forceps of 3.2mm.
  • the implanter can be used to puncture the stomach wall. Or the intestinal wall, into the small intestine, gallbladder, pancreatic cyst, common bile duct and other structures, for accurate release of the stent, the above tissues can be anastomosed with the stomach or intestinal wall, respectively, to achieve drainage, gallbladder protection, stone removal, and bypass function.
  • FIG. 1A is a schematic cross-sectional view of an implanter
  • Figure 1B is a schematic diagram of the distal structure of the implanter section
  • FIG 2 is the overall schematic diagram of the implanter product
  • Fig. 3A is a schematic sectional view taken along the line B-B of Fig. 1B when the conductive portion is a hollow conductive portion
  • FIG. 3B is a schematic cross-sectional view taken along the line C-C of FIG. 1B when the conductive portion is a hollow conductive portion
  • Fig. 4A is a schematic sectional view taken along the line B-B of Fig. 1B when the conductive portion is a conductive wire
  • FIG. 4B is a schematic cross-sectional view taken along the line C-C of FIG. 1B when the conductive portion is a conductive wire
  • FIG. 5A is a cross-sectional view of the proximal tail structure of the stent inserter corresponding to FIGS. 3A and 3B
  • FIG. 5B is a partially enlarged view of 5A
  • Fig. 6 is a sectional view of the structure of the proximal tail portion of the stent inserter corresponding to Figs. 4A and 4B.
  • Figure 7A-7D are schematic diagrams of the distal end of different types of implanters
  • 8A-8B are schematic diagrams of the distal end of the integrated implanter
  • 9A-9B are schematic diagrams of the distal end of a split implanter
  • 10A-10C are schematic diagrams of the distal end of a flanged implanter
  • FIG 11 is a schematic diagram of the safety buckle
  • Figure 12 is a schematic diagram of the double mushroom head bracket fully opened
  • one end of the conductive head is defined as the far end, and the end that is externally powered by the stent inserter is defined as the proximal end.
  • the stent inserter of the present invention has a proximal end and a distal end.
  • the stent inserter includes an outer tube 21, a booster tube 22, an insulating middle tube 23, and an outer tube lock cap 25.
  • the outer tube 21 includes a proximal outer tube 211 and a distal outer tube 212.
  • the proximal outer tube 211 is disposed at the distal end of the front handle 30, and can be fixed to the front handle 30 through the outer tube lock cap 25.
  • the safety lock 26 has a thread and can be matched and installed with the proximal thread of the front handle 30.
  • the outer tube 21 is provided with an insulating middle tube 23 and a bracket. The proximal end of the bracket and the distal end of the insulating middle tube 23 are in contact with each other. The distal end of the bracket is close to the insulating portion 12 with a certain gap.
  • the outer end tube 212 is connected with a taper.
  • a booster tube 22 is provided between the proximal outer tube 211 and the insulated middle tube 23.
  • the booster tube 22 may be made of stainless steel.
  • the distal end of the booster tube 22 is close to the insulated middle tube 23. The ends are connected to each other.
  • the tapered design of the proximal outer tube 211 and the distal outer tube 212 allows the size of the distal outer tube 212 entering the lesion to be less than or equal to 3.15 mm, while between the proximal outer tube 211 and the insulating middle tube 23.
  • a booster tube 22 is provided to provide the force required to release the stent.
  • the insulating middle tube 23 can be made of a special polymer material, polyetheretherketone, and has a high-performance electrical insulation type.
  • the high-frequency power of the conductive portion 13 can be isolated from the booster tube 22, so that the operator can completely avoid the risk of electric shock.
  • the booster tube 22 extends to the proximal end and is connected to the rear handle 31.
  • a conductive seat 32 is provided at the proximal end of the rear handle 31.
  • the conductive seat 32 has a conductive plug 33 therein.
  • the conductive plug 33 can be connected to the conductive head 11 through the conductive portion 13. Power on.
  • a positioning portion 27 may also be provided between the front handle 30 and the rear handle 31.
  • the positioning portion 27 may be designed as a structure of a safety buckle 24. As shown in FIG. 11, the positioning portion 27 is a structure of a safety buckle 24.
  • First loosen the safety lock 26, retract the front handle 30 toward the proximal end, and touch the safety buckle 24.
  • the distal end of the stent is released in the distal tissue 40.
  • the stent inserter is retracted, and the stent is pulled closer to the proximal end.
  • the safety buckle 24 is removed, and the front handle 30 is continuously retracted to the proximal end, and the stent is further released in the proximal tissue 41, so that the stent is anastomosed and connected the distal tissue 40 and the proximal tissue 41.
  • the outer surface of the conductive portion 13 at a certain distance from the conductive head 11 may be covered with a resistance portion 28.
  • the resistance portion 28 can give the stent a certain resistance so that the stent does not easily fall out of the lesion.
  • the distal end of the stent inserter further includes a conductive head 11, an insulating portion 12, and a conductive portion 13.
  • the conductive plug 33 When the conductive plug 33 is connected to a high-frequency power supply, the high-frequency power is transmitted to the conductive head 11 through the conductive part 13 so that the stent inserter has a function of cutting and high-frequency cutting of human tissue.
  • the conductive part 13 can be any kind of medical metal material, such as nickel-titanium or stainless steel.
  • the conductive part 13 is provided in the insulating middle tube 23 and extends from the distal end to the proximal end.
  • the conductive part 13 is connected to the conductive plug 33 through the rear handle 31.
  • the outer diameter of the conductive part 13 can be designed according to actual needs.
  • the outer diameter of the insertion part of the existing thermal puncture stent inserter can be set from 3.5 mm to 3.6 mm (10.5 Fr to 10.8) through the design of the conductive part 13. Fr) is reduced to less than 3.2 mm (9 Fr), preferably to 3.15 mm (9.5 Fr).
  • the conductive portion 13 may be a hollow conductive portion, so as to realize a liquid injection and development function, and the conductive portion 13 may also be designed as a conductive wire.
  • the conductive part 13 is designed as a hollow conductive part, the cross-sectional view at the BB position in FIG. 1B is shown in FIG.
  • FIG. 3A which shows the positional relationship between the conductive part 13, the insulating middle tube 23 and the distal outer tube 212, and the CC position in FIG. 1B.
  • the cross-sectional view is shown in FIG. 3B, showing the positional relationship between the conductive portion 13, the insulating middle tube 23 and the proximal outer tube 212.
  • FIG. 5A is a cross-sectional view of the proximal end structure of the stent inserter corresponding to FIGS. 3A and 3B.
  • FIG. 5B is a partial enlarged view of 5A.
  • the conductive socket 32 has a conductive plug 33 therein, and the conductive plug 33 can communicate with the conductive head 11 through the conductive portion 13 so as to realize electricity; the proximal end of the conductive portion 13 is connected to the Luer connector 34.
  • the doctor can connect the Luer connector 34 through a standard injector, and can inject liquid or contrast agent into the hollow lumen.
  • the liquid contrast agent passes through the lumen of the conductive portion 13 and reaches the distal conductive head 11 of the implanter. And then inject the patient's lesion location, and the contrast agent is developed under X-rays to mark the target location of the lesion for the doctor, and the doctor can prepare for the next release of the stent.
  • FIG. 4A shows the positional relationship between the conductive portion 13, the insulating middle tube 23, and the distal outer tube 212.
  • FIG. 4B shows Positional relationship between the conductive part 13, the insulating middle tube 23 and the proximal outer tube 211;
  • FIG. 6 is a sectional view of the proximal end structure of the stent inserter corresponding to FIGS. 4A and 4B.
  • the plug 33 can be communicated with the conductive head 11 through the conductive portion 13 so as to realize electricity supply.
  • the insulating portion 12 is located at the distal end of the conductive portion 13. There is a certain gap between the insulating portion 12 and the conductive portion 13. One end of the conductive head 11 can extend from the distal end to the proximal end into the gap between the insulating portion 12 and the conductive portion 13. Therefore, the conductive portion 13 is connected to realize the conductive function, and the other end of the conductive head 11 covers the outer surface of the insulating portion 12. High-frequency electricity is transmitted to the conductive head 11 of the distal end of the stent implanter through the conductive part 13, so that the stent implanter has an electric cutting function, which can cut and puncture human tissue at high frequency.
  • the insulating part 12 can be made of ceramics or other materials. Made to prevent tissue sticking and make cutting easier.
  • the conductive part 13 of the present invention replaces the inner tube and the conductive wire of the conventional stent inserter, and has a conductive function.
  • the outer diameter of the inner tube ⁇ 1.1 mm and the outer diameter of the conductive wire ⁇ 0.3 mm are replaced with a conductive diameter of less than ⁇ 0.4 mm.
  • the total diameter is reduced by a space of ⁇ 1mm (a space of 3Fr is reduced), so that a conventional covered gastrointestinal stent (10mm ⁇ 16mm) can be inserted, and the outer diameter of the traditional thermal implanter is ⁇ 3.5mm ⁇ ⁇ 3.6mm (10.5Fr ⁇ 10.8Fr) is reduced to 3.15mm (9.5Fr), so that the electric implanter can pass through the ⁇ 3.2mm gastroscope clamp channel smoothly.
  • the structures of the conductive head 11, the insulation part 12 and the conductive part 13 at the far end of the stent inserter of the present invention may be as shown in FIGS. 7A-7D.
  • the conductive head 11 may be composed of two or four conductive wires, and one end thereof may be from The distal end extends to the proximal end into the gap between the insulating portion 12 and the conductive portion 13 so as to connect with the conductive portion 13 to realize the conductive function.
  • the other end of the conductive head 11 covers the outer surface of the insulating portion 12.
  • the conductive head 11 can also be evenly distributed in the groove on the outer surface of the insulating portion 12 with two or four conductive wires at the far end to realize the conductive cutting function.
  • the interval between adjacent conductive wires in the groove on the outer surface of the insulating portion 12 is the same, and the radial distribution on the outer surface of the insulating portion 12 is radial.
  • one end of the conductive head 11 can extend from the distal end to the proximal end into the gap between the insulating portion 12 and the conductive portion 13, so as to connect with the conductive portion 13 to realize the conductive function, and the other end of the conductive head 11 Completely covers the outer surface of the insulating portion 12.
  • the cutting surface is a round surface instead of a straight incision.
  • the outer surface of the conductive portion 13 may be covered with a riveted tube 29, and one end of the conductive head 11 may extend from the distal end to the proximal end into the gap between the insulating portion 12 and the conductive portion 13, through the riveted tube. 29 is connected with the conductive part 13 to realize the conductive function, and the riveted pipe 29 can be made of stainless steel, which can connect the conductive part 13 and the insulating part 12. As shown in FIG. 9A, the other end of the conductive head 11 can completely cover the outer surface of the insulating portion 12. At this time, when the conductive head 11 is used for cutting, the cutting surface is a round surface instead of a straight incision, which is beneficial to wound healing. .
  • the other end of the conductive head 11 may also be distributed in a groove on the surface of the insulating part 12 in the form of a conductive wire, and wound around the distal end of the stent inserter to form a beveled conductive surface. Incisions, when cutting tissue at this time, use the conductive wire wound around and the conductive wire distributed in the groove. If there is no riveted tube 29, the conductive head 11 at one end is directly connected to the conductive portion 13, and the conductive head 11 at the other end is distributed on the outer periphery of the insulating portion 12, and the conductive function can also be realized.
  • the stent implanter of the present invention When the stent implanter of the present invention is in use, after the conductive plug 33 is connected to a high-frequency power supply, the high-frequency power is transmitted to the conductive head 11 through the conductive portion 13, so that the stent implanter has a resection function and can remotely affect the lesion.
  • the end tissue 40 is cut. If the conductive part 13 is a hollow conductive part, a Luer connector is connected externally, so that the stent inserter has a liquid injection function.
  • the double mushroom head bracket 42 is released through the thermal puncture stent inserter.
  • the double mushroom head bracket 42 is opened, one end is in the distal tissue 40 and the other end is in the proximal tissue 41.

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Abstract

一种热穿刺支架置入器，支架置入器具有近端和远端，前手柄（30）远端设有外管（21），从近端向远端延伸，外管（21）远端的外径小于或等于3.15mm，外管（21）内设有绝缘中管（23），绝缘中管（23）内设有导电部（13），绝缘中管（23）和导电部（13）从近端向远端延伸，导电部（13）近端末端可与外部电源相连接，外管（21）近端和绝缘中管（23）之间设有助推管（22），助推管（22）的远端与绝缘中管（23）的近端相互连接，导电部（13）的远端设有绝缘部（12），绝缘部（12）上分布有导电头（11），导电头（11）与导电部（13）连接实现导电功能，同时导电部（13）起到支撑支架作用，支架压缩后位于导电部（13）远端与外管（21）之间的空间中。前手柄（30）与外管（21）近端相连接，沿助推管（22）后撤前手柄（30），带动外管（21）后撤释放支架。

Description

一种热穿刺支架置入器 技术领域
本发明涉及一种医疗器械领域的热穿刺置入器，特别是涉及一种切割、注射功能为一体的热穿刺支架置入器。
技术背景
消化道胆囊吻合术，就是在内镜下热置入器经胃壁或十二指肠壁穿刺进入到目标位置胆囊内，将全覆膜双蘑菇头支架的远端放置在胆囊内，蘑菇头的近端放置在胃或十二指肠内，以打通消化道和胆囊之间的通道，也就是重新造了一条消化道与胆囊之间的新路。再通过胃镜和重新建成的通道，利用取石网篮将胆囊内的结石取出，从而实现内镜下保胆取石手术，为不适宜手术的胆囊疾病病人提供了一种全新治疗问题，也能为胆囊功能良好的病人提供了一种保留胆囊功能的治疗方法，提高患者远期生活质量。胃胰腺假性囊肿支架吻合手术，在内镜下经胃穿刺进入患者胰腺假性囊肿内，放置一大口径全覆膜双蘑菇头支架，实现了胃与胰腺假性囊肿的吻合，从而对胰腺假性囊肿内积液和坏死物进行充分引流。
十二指肠胆管吻合术，传统的ERCP手术，是通过ERCP内镜从十二指肠逆行将导丝等器械插入十二指肠乳头到达胆总管，对胆总管进行取石活检治疗等。对于导丝难插入身体的病人，通常要经皮穿刺或开展外科手术，可能降低患者生活质量或带来更大的创伤。
胃肠吻合术，受肿瘤侵犯，胃中食物进入肠道的通道被堵死后，呕吐不止的患者以往要么接受开腹手术，建立胃肠新通道，要么只能靠静脉营养支持。而对于那些年纪偏大或者身体状况已经不适合进行开腹手术患者来说，生存质量极低，也给家庭带来了沉重负担。胃肠吻合术，就是在内镜下经胃穿刺进入到近端小肠内，放置一大口径全覆膜双蘑菇头支架，以打通胃和小肠之间的通道，也就是重新造了一条胃与小肠之间的新路，从而解决十二指肠梗阻给患者生活带来的影响。
以往这样的“旁路”建设需进行全麻开腹手术，创伤较大。而内镜下的微创手术创伤小，手术时间短，痛苦小，恢复快，充分体现了内镜微创的优势。近年来，随着内镜技术以及各种器械配件的不断发展和更新换代，内镜在消化系统各种疾病诊疗上发挥了愈来愈重要的作用，特别是内镜下微创治疗手术的不断创新，为很多不能或不愿手术的胃肠道和胆胰疾病的患者提供了新的微创治疗方法。目前以上四个传统手术，支架通常直径为φ10～φ16mm双蘑 菇头金属支架，配套的热置入器外径为φ3.5mm～φ3.6mm(10.5Fr～10.8Fr)，传统的超声内镜钳道φ3.7mm，因间隙过小，传统带电置入器在内镜钳道内来回运动很不自如，这是以上手术开展困难的主要原因。同时超声内镜的外径φ14mm，比传统胃镜外径φ10mm大了4mm，操作起来更不方便，能到达的地方也相对更少。
因此，为了实现通过胃镜开展胃胆吻合术，胃肠吻合术以及经人体自然腔道内镜手术(NOTES)等，需要设计更小的带电置入器，通过胃镜钳道，简化支架释放步骤，以便更安全更快捷的释放支架，本发明提供了一种全新的解决胆管梗阻的方式，同时节约了手术时间，节约手术器械，降低手术难度，为更多医生开展此项手术提供了可能。
发明内容
本发明的热穿刺支架置入器，取消了传统的置入器内管和导电丝，由导电部件代替，既起到支撑支架目的同时又具备传输高频电功能。可将现有的热穿刺置入器的外径由3.5mm～3.6mm(10.5Fr～10.8Fr)减小到3.15mm(9.5Fr)，使热穿刺置入器能过通过传统的胃镜钳道φ3.2mm，为医生做更前沿的消化道胆囊吻合术，十二指肠胆管吻合术，胃胰腺假性囊肿支架吻合手术，胃肠吻合术以及NOTES手术等提供了可能。
以下，将导电头的一端定义为远端，将置入器外接通电的一端定义为近端。
热穿刺支架置入器具有近端和远端，前手柄远端设有外管，外管从近端向远端延伸，所述外管远端的外径小于或等于3.15mm，所述外管内设有绝缘中管，从近端向远端延伸，所述绝缘中管内设有导电部，绝缘中管和导电部从近端向远端延伸，所述导电部近端末端可与外部电源相连接；所述外管近端和所述绝缘中管之间设有助推管，所述助推管的远端与所述绝缘中管的近端相互连接；绝缘部位于所述导电部的远端，导电部的远端设有绝缘部，绝缘部上分布有导电头，导电头与导电部连接实现导电功能，支架压缩后位于导电部远端与外管之间的空间中，前手柄与外管近端相连接，沿助推管后撤前手柄，带动所述外管后撤释放支架。导电部既起到导电作用，同时起到支撑支架作用，与传统支架植入器比较，减少了内管和导丝，同时可以导电，对组织进行切割，到达病灶位置后释放支架。
绝缘部和导电部之间具有一定的间隙，在置入器的远端末端具有导电头，导电头的一端可以从远端向近端延伸进入所述绝缘部和所述导电部之间的间隙，从而与导电部连接实现导电功能，导电头的另一端覆于绝缘部的外表面。
优选地，导电部为空心导电部。
更优选地，导电部的近端末端与鲁尔接头相连通实现注液。
优选地，导电部为导电丝。
优选地，导电部为镍钛丝
优选地，导电部为金属材料。更优选地，导电部为不锈钢材料。
优选地，绝缘部的材质为陶瓷。
外管包括近端外管和远端外管，所述近端外管和远端外管采用锥度连接。助推管向近端延伸与后手柄相连接，所述前手柄和后手柄之间设有定位部。在距离所述导电头一定距离的导电部的外表面上，覆有阻力部。导电头由两根或四根导电丝构成，两根或四根导电丝均匀分布在绝缘部外表面的槽内。导电头靠近外侧的另一端完全覆于绝缘部的外表面，用所述导电头进行切割时，伤口切割面是圆形面。导电部的外表面可以覆有铆接管，所述导电头的一端可以从远端向近端延伸进入所述绝缘部和所述导电部之间的间隙，通过所述铆接管与所述导电部连接实现导电功能。
有益效果：
本发明热穿刺支架的外径小于现有技术中的支架置入器的外径，为很多不能或不愿手术的胃肠道和胆胰疾病的患者提供了新的微创治疗方法。
本发明的热穿刺置入器能将直径φ10mm～φ16mm双蘑菇头镍钛丝编织金属支架装入其中，通过传统胃镜钳道3.2mm进入胃，十二指肠等器官，置入器通电穿刺胃壁或肠壁，进入小肠，胆囊，胰腺囊肿，胆总管等结构内，进行支架精确释放，可以将以上组织分别与胃壁或肠壁吻合，实现引流，保胆，取石，开通旁路等功能。
附图说明
图1A是置入器剖面示意图
图1B是置入器剖面远端结构示意图
图2是置入器产品整体示意图
图3A是当导电部为空心导电部时图1B的B-B剖面示意图
图3B是当导电部为空心导电部时图1B的C-C剖面示意图
图4A是当导电部为导电丝时图1B的B-B剖面示意图
图4B是当导电部为导电丝时图1B的C-C剖面示意图
图5A是与图3A和3B对应的支架置入器的近端尾部结构剖面图
图5B是5A的局部放大图
图6是与图4A和4B对应的支架置入器的近端尾部结构剖面图
图7A-7D是不同类型的置入器远端示意图
图8A-8B是一体式的置入器远端示意图
图9A-9B是分体式的置入器远端示意图
图10A-10C是翻边式的置入器远端示意图
图11是安全卡扣示意图
图12是双蘑菇头支架完全打开示意图
11、导电头，12、绝缘部，13、导电部，21、外管，211、近端外管，212、远端外管，22、助推管，23、绝缘中管，24、安全卡扣，25、外管紧锁帽，26、安全锁，27、定位部，28、阻力部，29、铆接管，30、前手柄，31、后手柄，32、导电座，33、导电插头，34、鲁尔接头，40、远端组织，41、近端组织，42、双蘑菇头支架
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
以下，将导电头的一端定义为远端，将支架置入器外接通电的一端定义为近端。
如图1A、1B和图2所示，本发明的支架置入器具有近端和远端，支架置入器包括外管21，助推管22，绝缘中管23，外管紧锁帽25，安全锁26，定位部27，阻力部28，前手柄30，后手柄31，导电座32，导电插头33，鲁尔接头34，导电头11，绝缘部12，导电部13。
外管21包括近端外管211和远端外管212，近端外管211设置在前手柄30远端，可通过外管紧锁帽25与前手柄30固定，前手柄30近端设有安全锁26，安全锁26具有螺纹，可与前手柄30近端螺纹匹配安装。外管21内设有绝缘中管23和支架，支架近端与绝缘中管23的远端相互抵接，支架远端与绝缘部12靠近，留有一定的间隙，近端外管211与远端外管212采用锥度连接，近端外管211和绝缘中管23之间设有助推管22，助推管22可以为不锈钢材料，助推管22的远端与绝缘中管23的近端相互连接，近端外管211和远端外管212的锥度设计，使得进入病灶部位的远端外管212的尺寸小于或等于3.15mm，而近端外管211和绝缘中管23之间设有助推管22，从而提供释放支架所需的力。绝缘中管23可以由特殊高分子材料聚醚醚酮制成，具有高性能的电绝缘型，可以将导电部13的高频电与助推管22绝 缘隔离，使操作者完全避免触电风险。助推管22向近端延伸与后手柄31相连接，在后手柄31的近端设有导电座32，导电座32内具有导电插头33，导电插头33可以通过导电部13与导电头11相连通，从而实现通电。
在前手柄30和后手柄31之间还可以设有定位部27，定位部27可以设计成安全卡扣24的结构，如图11所示，定位部27为安全卡扣24结构，释放支架时，先旋松安全锁26，将前手柄30向近端后撤，碰到安全卡扣24，支架远端在远端组织40内释放，回撤支架置入器，将支架提拉靠近近端组织内，取下安全卡扣24，继续向近端后撤前手柄30，在近端组织41内继续释放支架，从而实现支架将远端组织40和近端组织41吻合连接。
在距离导电头11一定距离的导电部13的外表面上，可覆有阻力部28，阻力部28在支架释放时，可以给支架一定的阻力，使得支架不容易滑落到病灶外部。
支架置入器的远端还包括导电头11，绝缘部12，导电部13。当导电插头33外接高频电源后，高频电源通过导电部13传送到导电头11处，使得支架置入器具有电切功能，对人体组织进行高频切割。导电部13可以为任意种类的医用金属材料，比如镍钛材料或者不锈钢材料；导电部13设于绝缘中管23内，从远端延伸到近端，通过后手柄31与导电插头33相连接，可以根据实际需求设计导电部13的外径尺寸，本发明可以通过导电部13的设计将现有的热穿刺支架置入器的置入部分的外径由3.5mm～3.6mm(10.5Fr～10.8Fr)减小到3.2mm(9Fr)以下，优选地可以减小到3.15mm(9.5Fr)。另外，导电部13可以为空心导电部，从而实现注液显影功能，导电部13也可以设计成导电丝。当导电部13设计成空心导电部时，图1B的B-B位置处的剖视图如图3A所示，显示了导电部13，绝缘中管23和远端外管212的位置关系，图1B的C-C位置处的剖视图如图3B所示，显示了导电部13，绝缘中管23和近端外管212的位置关系；图5A是与图3A和3B对应的支架置入器的近端尾部结构剖面图，图5B是对于5A的局部放大图，导电座32内具有导电插头33，导电插头33可以通过导电部13与导电头11相连通，从而实现通电；导电部13的近端与鲁尔接头34相连通，医生可以通过标准注液器连接鲁尔接头34，并可以向空心管腔内注液或造影剂，液体造影剂通过导电部13的管腔，到达置入器的远端导电头11处，进而注入病人病灶位置，造影剂在X射线下显影，为医生标明病灶目标位置，医生可为下一步支架释放做好准备。
当导电部13设计成导电丝时，导电丝可以根据需求采用不同的尺寸。图1B的B-B位置处的剖视图如图4A所示，显示了导电部13，绝缘中管23和远端外管212的位置关系，图1B的C-C位置处的剖视图如图4B所示，显示了导电部13，绝缘中管23和近端外管211的位置关系；图6是与图4A和4B对应的支架置入器的近端尾部结构剖面图，导电座32内具 有导电插头33，导电插头33可以通过导电部13与导电头11相连通，从而实现通电。
绝缘部12位于导电部13的远端，绝缘部12和导电部13之间具有一定的间隙，导电头11的一端可以从远端向近端延伸进入绝缘部12和导电部13之间的间隙，从而与导电部13连接实现导电功能，导电头11的另一端覆于绝缘部12的外表面。高频电通过导电部13传输到支架置入器的远端导电头11处，使支架置入器具有电切割功能，可以对人体组织进行高频切割及穿刺，绝缘部12可以采用陶瓷等材料制成，可以防止组织黏粘，使切割更方便的进行。
本发明导电部13取代了传统支架置入器的内管和导电丝，具有导电功能，将原来内管外径φ1.1mm和导电丝外径φ0.3mm，替换成直径小于φ0.4mm的导电部13，总直径减小了φ1mm的空间(减小了3Fr的空间)，使常规覆膜胃肠支架(10mm～16mm)可以装入，并且由原来传统的热置入器外径φ3.5mm～φ3.6mm(10.5Fr～10.8Fr)减小到3.15mm(9.5Fr)，使电置入器能够顺利通过φ3.2mm胃镜钳道。
本发明的支架置入器远端的导电头11，绝缘部12和导电部13的结构可以如图7A-7D所示，导电头11可以由两根或四根导电丝构成，其一端可以从远端向近端延伸进入绝缘部12和导电部13之间的间隙，从而与导电部13连接实现导电功能，导电头11的另一端覆于绝缘部12的外表面。导电头11还可以在远端以两根或者四根导电丝均匀分布在绝缘部12外表面的槽内，实现导电切割功能。在绝缘部12的外表面槽内相邻导电丝间隔角度相同，在绝缘部12的外表面上呈放射状的径向分布。
如图8A-8B所示，导电头11的一端可以从远端向近端延伸进入绝缘部12和导电部13之间的间隙，从而与导电部13连接实现导电功能，导电头11的另一端完全覆于绝缘部12的外表面。此时用导电头11进行切割时，切割面是圆形面，而不是一个直型切口，在利用止血夹止血时更易止血，有利于伤口愈合。
如图9A-9B所示，导电部13的外表面可以覆有铆接管29，导电头11的一端可以从远端向近端延伸进入绝缘部12和导电部13之间的间隙，通过铆接管29与导电部13连接实现导电功能，铆接管29可采用不锈钢材质，能够将导电部13和绝缘部12连接。如图9A所示，导电头11的另一端可以完全覆于绝缘部12的外表面，此时用导电头11进行切割时，切割面是圆形面，而不是直型切口，有利于伤口愈合。
如图10A-10C所示，导电头11的另一端还可以一根导电丝的形式分布在绝缘部12表面的槽内，并在支架置入器的远端末端绕圈，形成一字斜面导电切口，此时切割组织时，利用的是绕圈的导电丝和分布在槽内的导电丝。若没有铆接管29，一端的导电头11和导电部13直接相连，另一端导电头11在绝缘部12外周分布，也可实现导电功能。
本发明的支架植入器在使用时，在导电插头33外接高频电源后，高频电源通过导电部13传送到导电头11处，使得支架置入器具有电切功能，可以对病变的远端组织40进行切割，若是导电部13为空心导电部，外接鲁尔接头，使得支架置入器具有注液功能。
如图12所示，通过热穿刺支架置入器释放双蘑菇头支架42，当双蘑菇头支架42打开后，一端在远端组织40内，另一端在近端组织41内。
上所述仅是本申请的优选实施方式，使本领域技术人员能够理解或实现本申请的发明。对于这些实施例的多种修改及组合对于本领域的技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本申请的精神或范围的情况下，在其他实施例中实现。因此，本申请将不会被限制在本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。

Claims (15)

  1. 一种热穿刺支架置入器，其特征在于，所述热穿刺支架置入器具有近端和远端，前手柄远端设有外管，所述外管从近端向远端延伸，所述外管远端的外径小于或等于3.15mm，所述外管内设有绝缘中管，所述绝缘中管从近端向远端延伸，绝缘中管内设有导电部，所述导电部从近端向远端延伸，所述导电部近端末端可与外部电源相连接；所述外管近端和所述绝缘中管之间设有助推管，所述助推管的远端与绝缘中管的近端相互连接；所述绝缘部位于所述导电部的远端，所述导电部的远端设有绝缘部，绝缘部上分布有导电头，所述导电头与导电部连接实现导电功能，导电部同时起到支撑支架作用，支架压缩后位于导电部远端与外管之间的空间中，前手柄与外管近端相连接，沿助推管后撤前手柄，带动所述外管后撤释放支架。
  2. 根据权利要求1所述的热穿刺支架置入器，其特征在于，所述绝缘部和所述导电部之间具有一定的间隙，在置入器的远端末端具有导电头，所述导电头的一端可以从远端向近端延伸进入所述绝缘部和所述导电部之间的间隙，从而与导电部连接实现导电功能，所述导电头的另一端覆于绝缘部的外表面。
  3. 根据权利要求1所述的热穿刺支架置入器，其特征在于，所述导电部为空心管状导电部。
  4. 根据权利要求3所述的热穿刺支架置入器，其特征在于，所述导电部的近端末端与鲁尔接头相连通实现注液。
  5. 根据权利要求1所述的热穿刺支架置入器，其特征在于，所述导电部为导电丝。
  6. 根据权利要求1所述的热穿刺支架置入器，其特征在于，所述导电部为镍钛丝。
  7. 根据权利要求1所述的热穿刺支架置入器，其特征在于，所述导电部为金属材料。
  8. 根据权利要求7所述的热穿刺支架置入器，其特征在于，所述导电部为不锈钢材料。
  9. 根据权利要求1所述的热穿刺支架置入器，其特征在于，所述外管包括近端外管和远端外管，所述近端外管和远端外管采用锥度连接。
  10. 根据权利要求1所述的热穿刺支架置入器，其特征在于，所述助推管向近端延伸与后手柄相连接，所述前手柄和后手柄之间设有定位部。
  11. 根据权利要求1所述的热穿刺支架置入器，其特征在于，在距离所述导电头一定距离的导电部的外表面上，覆有阻力部。
  12. 根据权利要求1所述的热穿刺支架置入器，其特征在于，所述导电头由两根或四根导电丝构成，两根或四根导电丝均匀分布在绝缘部外表面的槽内。
  13. 根据权利要求1所述的热穿刺支架置入器，其特征在于，所述导电头靠近外侧的另一端完全覆于绝缘部的外表面，用所述导电头进行切割时，伤口切割面是圆形面。
  14. 根据权利要求1所述的热穿刺支架置入器，其特征在于，所述导电部的外表面可以覆有铆接管，所述导电头的一端可以从远端向近端延伸进入所述绝缘部和所述导电部之间的间隙，通过所述铆接管与所述导电部连接实现导电功能。
  15. 根据权利要求1所述的热穿刺支架置入器，其特征在于，所述绝缘部的材质为陶瓷。
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