WO2017113554A1 - 推送装置及输送系统 - Google Patents

推送装置及输送系统 Download PDF

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Publication number
WO2017113554A1
WO2017113554A1 PCT/CN2016/080685 CN2016080685W WO2017113554A1 WO 2017113554 A1 WO2017113554 A1 WO 2017113554A1 CN 2016080685 W CN2016080685 W CN 2016080685W WO 2017113554 A1 WO2017113554 A1 WO 2017113554A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal end
cable
delivery system
proximal end
lumen
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/CN2016/080685
Other languages
English (en)
French (fr)
Inventor
江巍
王刚
马仁梅
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.)
Lifetech Scientific Shenzhen Co Ltd
Original Assignee
Lifetech Scientific Shenzhen Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Priority to US15/777,317 priority Critical patent/US10751061B2/en
Priority to EP16880362.5A priority patent/EP3398566A4/en
Publication of WO2017113554A1 publication Critical patent/WO2017113554A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • A61B2017/0053—Loading magazines or sutures into applying tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00862—Material properties elastic or resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00955—Material properties thermoplastic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B2017/12004—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for haemostasis, for prevention of bleeding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices

Definitions

  • the utility model belongs to the technical field of interventional medical devices, and relates to a pushing device for pushing an interventional medical device and a manufacturing method thereof, and a conveying system for the intervention medical device.
  • interventional methods for the treatment of cardiovascular disease by catheter technology is currently a common treatment. Specifically, it refers to a treatment method in which various materials, instruments, and the like are interposed by a catheter, and is placed in a heart, an artery, a vein, or the like of a human body to treat a cardiovascular disease.
  • catheter interventional methods are used to place interventional medical devices, such as atrial septal defect (ASD) occluder, ventricular septal defect (VSD) occluder, patent ductus arteriosus (abbreviation: PDA) occluder, egg Open hole closure (referred to as: PFO) occluder, etc.
  • interventional medical devices such as atrial septal defect (ASD) occluder, ventricular septal defect (VSD) occluder, patent ductus arteriosus (abbreviation: PDA) occluder, egg Open hole closure (referred to as: PFO) occluder, etc.
  • the occlusion device is placed into the left atrial appendage by a catheter intervention method to prevent thrombosis of the left atrial appendage due to atrial fibrillation, which may cause a stroke to the brain; or prevent the thrombus from reaching the rest of the body through the human blood circulation system. , caused by systemic embolism.
  • the interventional medical device When the interventional medical device is delivered to the bronchus of the heart, the artery, the venous blood vessel, the left atrial appendage, and the lung by the delivery system, the interventional medical device is usually pushed to the predetermined site by the flexible push cable, and then disconnected. Intervention of the connection between the medical device and the push cable, release the interventional medical device, and then confirm whether the position of the interventional medical device is appropriate by the contrast or ultrasound, whether the intervention of the medical device is unsatisfactory, and whether the surgical effect is satisfactory.
  • the inner and outer diameters of the delivery sheath should be minimized.
  • the smaller the inner diameter of the sheath used the greater the pushing resistance of the interventional medical device, especially when the interventional medical device is pushed for a long path, the flexible steel cable
  • the lack of support will directly lead to the intervention of medical devices to easily deviate from the predetermined position, prolong the operation time and increase the risk of surgery for patients.
  • the present invention is directed to the above-described deficiencies of the prior art, and provides a pushing device for pushing an interventional medical device and a delivery system for the interventional medical device.
  • the steel cable of the push device of the utility model has better supportability. When the interventional medical device is transported, the interventional medical device is more difficult to deviate from the predetermined position, shortening the operation time and reducing the surgical risk of the patient.
  • the push device and the delivery system of the present invention are particularly suitable for use in an interventional device for delivering a defective anatomical defect, such as a left atrial appendage occluder.
  • the utility model provides a pushing device which comprises a steel cable.
  • the wire rope includes a long strip of wire rope body.
  • the wire rope further includes a film disposed on an outer surface of the wire rope body.
  • the cable body has opposite proximal and distal ends.
  • the proximal end of the membrane is adjacent the proximal end of the cable body.
  • the material of the film is a thermoplastic elastomer.
  • thermoplastic elastomer comprises a polyether block amide or a thermoplastic polyurethane.
  • the length of the film along the longitudinal central axis of the cable body is equal to or less than half the length of the cable body.
  • the cable body comprises an elongated inner core.
  • the inner core is made of at least three strands of steel wire.
  • the coating is provided on an outer surface of the inner core.
  • the cable body further includes a wire disposed on the inner core.
  • the coating is provided on an outer surface of the steel wire.
  • the present invention also provides a delivery system that includes the push device.
  • the present invention also provides a delivery system that also includes a hemostasis device.
  • the hemostatic device includes a hemostatic valve body having a lumen and a seal disposed in the lumen of the hemostatic valve body.
  • the seal is provided with an aperture. After the distal end of the cable body passes through the aperture from the distal end of the hemostatic valve body out of the hemostatic valve body, the coating of the cable is matched with the seal to seal the hemostatic valve body The distal end of the lumen is isolated from the outside.
  • the delivery system further comprises a delivery sheath.
  • a proximal end of the delivery sheath is coupled to a distal end of the hemostatic device, and a lumen of the delivery sheath is in communication with a lumen of the hemostatic device.
  • the delivery sheath includes a body portion and a contoured portion.
  • the body portion is coupled between the hemostatic device and the contoured portion.
  • the shaped portion includes a first shaped section.
  • An angle between the extending direction of the first shaping section and the extending direction of the main body portion ranges from 40 degrees to 50 degrees.
  • the direction in which the first shaped section extends extends the direction in which the proximal end of the first shaped section extends toward the distal end of the first shaped section.
  • the extending direction of the main body portion refers to a direction in which the proximal end of the main body portion extends toward the distal end of the main body portion.
  • the contoured portion further includes a second contoured section.
  • the first shaping section is coupled between the body portion and the second shaping section.
  • the angle between the extending direction of the second shaping section and the plane in which the first shaping section and the body portion are located ranges from 30 degrees to 40 degrees.
  • the direction in which the second shaped section extends extends the direction in which the proximal end of the second shaped section extends toward the distal end of the second shaped section.
  • the delivery system further includes a dilation tube having an outer diameter that is slightly smaller than an inner diameter of the delivery sheath, and an outer diameter of the distal end of the dilation tube from the distal end to the proximal end is gradually increased Big.
  • the dilation tube has a shaped portion that is the same shape as the shaped portion of the delivery sheath.
  • the delivery system further includes a hollow loader coupled between the delivery sheath and the hemostatic device.
  • the inner lumen of the loader is in communication with the delivery sheath and the lumen of the hemostatic device.
  • the lumen of the hemostatic valve body has a tapered section.
  • the diameter of the proximal end of the tapered section is greater than the diameter of the distal end of the tapered section.
  • the seal is adjacent the proximal end of the tapered section.
  • the delivery system is for delivering a left atrial appendage occluder.
  • the steel cable is detachably connected to the left atrial appendage occluder.
  • the utility model also provides a manufacturing method of a pushing device, comprising:
  • the coated tubular body is melted to be integrated with the cable body.
  • the temperature of the tubular body to be melted ranges from 180 degrees to 220 degrees.
  • the step of melting the tubular tubular body after the step of sheathing the tubular tubular body on the cable body is further included in the tubular tubular outer jacket
  • the step of heat shrink tubing has a melting point smaller than a melting point of the coated tubular body.
  • the manufacturing method further includes the step of removing the heat shrinkable tube.
  • the material of the film tubular body is a thermoplastic elastomer.
  • thermoplastic elastomer comprises a polyether block amide or a thermoplastic polyurethane.
  • the outer surface of the steel cable body is formed by a thermoplastic elastomer, and the steel cable after the film can ensure the flexibility of the distal end to adapt to the curved blood vessel path, and the support and pushability are more. Good, especially for complex vascular access or treatment sites, such as left atrial appendage closure.
  • Figure 1 is a schematic view of the delivery system of the first embodiment of the present invention after loading the interventional medical device;
  • Figure 2 is a schematic view of the expansion device of the delivery system of Figure 1;
  • Figure 3 is a schematic illustration of an expansion assembly of the delivery device and expansion device of the delivery system of Figure 1;
  • Figure 4 is a schematic view of the delivery device of the delivery system of Figure 1;
  • FIG. 5 is a schematic view of the loading device of the conveying system of Figure 1;
  • Figure 6a is a schematic view and partial cross-sectional view of the pushing device of the conveying system of Figure 1, the pushing device comprising a steel cable comprising an elongated wire cable body and an outer surface of the cable body Film coating
  • Figure 6b is a cross-sectional view of 42 in portion A of Figure 6a;
  • Figure 7 is a cross-sectional view of the main body of the steel cable of Figure 6a;
  • Figure 8 is a cross-sectional view of the cable body of Figure 6a and a film disposed on the outer surface of the cable body;
  • Figure 9 is a schematic view of the hemostasis device of the delivery system of Figure 1, the hemostatic device comprising a hemostatic valve body having a lumen and a seal disposed in the lumen, wherein Figure 9a is a front view and Figure 9b is a Figure 9b a cross-sectional view of portion B of Fig. 9a, and a partial cross-sectional view of portion B of Fig. 9a after elastic deformation of the sealing member;
  • Figure 10 is a schematic view of the sealing member of the hemostatic device of Figure 9 mated with the coating of the pushing device of Figure 6;
  • Figure 11 is a cross-sectional view of the main body of the steel cable covered by the multilayer tubular body according to the second embodiment of the present invention.
  • Figure 12 is a schematic view showing the assembly of the hemostatic device, the loading device, the pushing device and the interventional medical device according to the third embodiment of the present invention.
  • Figure 13 is a schematic illustration of the interventional medical device revenue loading device of Figure 12;
  • the end near the operator is referred to as the proximal end, and the end remote from the operator is referred to as the distal end.
  • the delivery system 100 of the first embodiment is used to deliver the interventional medical device 200 to the lesion and release it.
  • the interventional medical device 200 is a left atrial appendage occluder; the delivery system 100 delivers the interventional medical device 200 to the left atrial appendage and is released; the interventional medical device 200 includes two closure disks and one layer disposed in one of the closures.
  • the plugging disc is made of a material with a shape memory function and can be stretched into a line shape when used.
  • the plugging membrane consists of a good biocompatible polytetrafluoroethylene material.
  • the delivery system 100 includes a delivery device 10 , an expansion device 20 , a loading device 30 , a push device 40 , and a hemostatic device 50 .
  • the distal end of the expansion device 20 is threaded out of the distal end of the delivery device 10 to form an expansion assembly 300.
  • the distal end of the assembly of the expansion assembly 300 is tracked along a guidewire (not shown), from the femoral vein through the interatrial septum, to the left atrial appendage, and then withdrawn from the expansion device 20, retaining the delivery device 10 in the body, thus establishing an external body The passage to the body.
  • the loading device 30 is first connected between the hemostatic device 50 and the delivery device 10; then the distal end of the pushing device 40 is sequentially passed through the hemostatic device 50 and the loading device 30. After delivery device 10, it is detachably coupled to interventional medical device 200.
  • the interventional medical device 200 is threadedly coupled to the distal end of the push device 40. It can be understood that the interventional medical device 200 and the pushing device 40 can also be connected by other detachable means such as a snap connection, a magnetic connection, a pull wire connection or the like.
  • the delivery system 100 of the present invention may not include the loading device 30, and the proximal end of the delivery sheath 11 is directly connected to the distal end of the hemostatic device 50, and the inside of the sheath 11 is delivered.
  • the lumen is in communication with the lumen of the hemostatic device 50.
  • the delivery device 10 includes a hollow delivery sheath 11 and a sheath connector 12 coupled to the proximal end of the delivery sheath 11.
  • the proximal end of the delivery sheath 11 is coupled to the distal end of the loading device 30, and the lumen of the delivery sheath 11 is in communication with the lumen of the loading device 30.
  • the delivery sheath 11 includes a body portion 110 and a shaping portion 111.
  • the main body portion 110 is connected between the hemostatic device 50 and the shaping portion 111.
  • the shaping portion 111 includes a first shaped section 1111.
  • the angle between the extending direction of the first shaping section 1111 and the extending direction of the main body portion 110 ranges from 40 degrees to 50 degrees.
  • the direction in which the first shaped section 1111 extends refers to the direction in which the proximal end of the first shaped section 1111 extends toward the distal end of the first shaped section 1111.
  • the extending direction of the main body portion 110 refers to a direction in which the proximal end of the main body portion 110 extends toward the distal end of the main body portion 110.
  • the contoured portion 111 also includes a second contoured section 1112.
  • the first shaped section 1111 is coupled between the body portion 110 and the second shaped section 1112.
  • the angle between the extending direction of the second shaping section 1112 and the plane in which the first shaping section 1111 and the main body portion 110 are located ranges from 30 degrees to 40 degrees.
  • the direction in which the second shaped section 1112 extends refers to the direction in which the proximal end of the second shaped section 1112 extends toward the distal end of the second shaped section 1112.
  • the contoured portion 111 facilitates adaptation to the physiological anatomy of the left atrial appendage.
  • the second shaping section 1112 can also be omitted according to actual needs. As long as the shaping portion 111 including the first shaping section 1111 can satisfy the physiological anatomy of different individuals and different predetermined interventional treatment positions.
  • the wall of the delivery sheath 11 has a multi-layer structure including a layer of a polytetrafluoroethylene material, a stainless steel braid layer and a polyether block amide layer in this order from the inside to the outside.
  • the expansion device 20 includes a dilation tube 21, a first connection nut 22 at the proximal end of the dilation tube 21 and connected proximally to the dilation tube 21, and a dilation tube connector 23 at the proximal end of the first connection nut 22.
  • the dilation tube 21 can be threaded into the delivery sheath 11 for establishing a vascular path along the guidewire assisted delivery sheath 11, the material of which is polyethylene.
  • the outer diameter of the dilation tube 21 is slightly smaller than the inner diameter of the delivery sheath 11, so that the distal end of the dilation tube 21 can enter the delivery sheath 11 from the proximal end of the delivery sheath 11 and exit from the distal end of the delivery sheath 11.
  • the dilation tube 21 has a shaped portion having the same shape as that of the shaping portion 110 of the delivery sheath 11, and will not be described herein.
  • the distal end of the distal end of the dilation tube 21 gradually increases from the distal end to the proximal end.
  • the first connection nut 22 can be threadedly coupled to the proximal end of the delivery device 1 to connect the delivery device 10 with the expansion device 20 to form the expansion assembly 300.
  • the dilatation fitting 23 is used to limit the proximal end of the dilation tube 21 into the delivery sheath 11.
  • the loading device 30 is coupled between the delivery device 10 and the hemostasis device 50 after establishing a passage from the body to the body.
  • the loading device 30 includes a hollow loader 31.
  • the proximal end of the loader 31 can be coupled to the distal end of the hemostatic device 50.
  • the distal end of the loader 31 can be coupled to the proximal end of the delivery sheath 11 of the delivery device 10.
  • the lumen of the loader 31 can be in communication with the lumen of the hemostatic device 50.
  • the loading device 30 also includes a loader front joint 32 coupled to the distal end of the loader 31 and a loader rear joint 33 coupled to the proximal end of the loader 31.
  • the proximal end of the loader front joint 32 is provided with a second connecting nut 321 that is connectable to the sheath joint 12.
  • the loader rear joint 33 is for connection to the hemostatic device 50.
  • the material of the loader 31 is polyethylene.
  • the push device 40 is used to push the interventional medical device 200. In this embodiment, it is used to push the left atrial appendage occluder.
  • the push device 40 includes a steel cable 41.
  • the cable 41 includes an elongated cable body 411 and a coating 412 provided on the outer surface of the cable body 41.
  • the cable body 411 has opposite proximal and distal ends, and the proximal end of the membrane 412 is adjacent the proximal end of the cable body 41.
  • the material of the film 412 is a thermoplastic elastomer. In this embodiment, the material of the film 412 is a block polyether amide elastomer.
  • the length of the film 412 along the longitudinal central axis of the cable body 411 is equal to or less than half the length of the cable body 411. Specifically, the length of the cable body 411 ranges from 1000 to 1400 mm, and the length of the film 412 ranges from 400 to 750 mm. In the present embodiment, the length of the wire rope main body 411 is 1300 mm, and the length of the film 412 is 600 mm. The distance from the distal end of the film 412 to the distal end of the cable body 411 is 700 mm.
  • the film 412 may also be disposed at any desired position between the proximal end and the distal end of the cable body 411 as long as its support performance for the cable body 411 meets actual needs.
  • the film 412 is provided on the outer surface of the middle portion of the cable body 411, that is, the outer surface of the cable body 411 near the proximal end is free of a film.
  • the cable body 411 includes an elongated inner core 4111.
  • the inner core 4111 is made of at least three strands of steel wire.
  • the inner core 4111 is made of three strands of steel wire; the cable body 411 further includes a wire 4112 disposed on the inner core 4111.
  • a film 412 is disposed on the outer surface of the inner core 4111 and the wire 4112.
  • the cable 41 with the coating 412 can ensure the flexibility of the distal end to adapt to the curved blood vessel path, and the supportability and the pushability are better.
  • the interventional medical device 200 is more difficult to deviate from the predetermined position, shortening
  • the operation time reduces the risk of surgery for the patient.
  • the cable body 411 may also include only the elongated inner core 4111 which is made of three strands of steel wire, and the steel wire 4112 which is not provided on the inner core.
  • the film 412 is provided on the outer surface of the inner core 4111.
  • the push device 40 further includes a cable handle 42 coupled to the proximal end of the cable body 411, and a cable fastening screw 43 for connecting the cable body 411 and the cable handle 42 to the steel.
  • a bolt 44 at the distal end of the cable body 411 for detachable connection with the interventional medical device 200.
  • a cable receiving cavity 421 is disposed in the axial direction of the cable handle 42.
  • the cable receiving cavity 421 is for receiving the proximal end of the cable body 411.
  • the distal end of the cable handle 42 has a radially threaded side aperture 422.
  • the threaded side hole 422 is in communication with the cable receiving cavity 421.
  • the cable fastening screw 43 is screwed into the thread side hole 422, and the head end abuts the proximal end of the cable body 411, so that the fixed cable body 411 and the cable handle can be reached.
  • the purpose of 42 is the same as that the fixed cable body 411 and the cable handle can be reached.
  • the hemostatic device 50 includes a hemostatic valve body 51 having a lumen 511 and a seal 52 disposed in the lumen 511.
  • the seal 52 is provided with an aperture.
  • the distal end of the cable body 411 passes through the aperture from the distal end of the hemostatic valve body 51 through the hemostatic valve body 51, the distal end of the membrane 412 of the cable 41 can pass through the distal end of the seal 52.
  • the film 412 of the cable 41 cooperates with the seal 52 to isolate the distal end of the lumen 511 from the outside.
  • the hemostatic valve body 51 can be T-shaped or Y-shaped. In the present embodiment, the hemostatic valve body 51 is a T-valve. An external thread 510 is provided on the outer surface of the hemostatic valve body 51 near its proximal end.
  • the hemostasis device 50 further includes a compression member 53 at the proximal end of the hemostatic valve body 51 and a third connection nut 54 at the distal end of the hemostatic valve body 51.
  • the inner cavity 511 has an associated cylindrical section 513 and a tapered section 512.
  • the cylindrical section 513 is closer to the proximal end of the hemostatic valve body 51 than the tapered section 512.
  • the diameter of the cylindrical section 513 is equal to the diameter of the proximal end of the tapered section 513, and the diameter of the proximal end of the tapered section 512 is greater than the diameter of the distal end of the tapered section 512.
  • Seal 52 is adjacent the proximal end of tapered section 512.
  • the sealing member 52 is an O-shaped silicone ring.
  • the tapered section 512 can be disposed at any position of the inner cavity 511 as long as the distal end of the cable body 411 passes through the hemostatic valve body 51 from the distal end of the hemostatic valve body 51, the coating 412 of the cable 41 The distal end passes through the distal end of the sealing member 52, and the coating 412 of the cable 41 can cooperate with the sealing member 52 to isolate the distal end of the lumen 511 of the hemostatic valve body 51 from the outside.
  • the pressing member 53 includes a hollow abutting post 531 and a pressing nut 532 surrounding the abutting post 531 and connected to the abutting post 531.
  • a receiving space for receiving the hemostatic valve body 511 is formed between the outer wall of the abutting post 531 and the internal thread of the pressing nut 532, and the distal end of the abutting post 531 is closer to the hemostatic valve than the distal end of the thread of the pressing nut 532 The distal end of the body 51.
  • the outer diameter of the abutment post 531 is smaller than the diameter of the cylindrical section 513 of the hemostatic valve body 51.
  • the abutment post 531 can enter the inner cavity 511 of the hemostatic valve body 51, and the hemostatic valve body 51 and the compression nut 532 are threaded. After the connection, the abutment post 531 can abut the seal 52.
  • the seal 52 entering the distal end of the tapered section 512 is elastically deformed and contracted to hold the membrane 412, thereby isolating the distal end of the lumen 511 from the outside.
  • the sealing member 52 can also be fixed in the hemostatic valve body 51. In this case, as long as the sealing member 52 can report the coating 412, for example, the outer diameter of the circular hole of the sealing member 52 is smaller than the outer diameter of the coating 412. Or the sealing member 52 is a sealing sheet or the like having a cross-shaped slit.
  • the side of the hemostatic valve body 51 is further provided with a connecting hose 512 communicating with the inner chamber 511.
  • the end of the connecting hose 512 connected to the hemostatic valve body 51 is closer to the distal end of the hemostatic valve body 51 than the sealing member 52.
  • the other end of the hose 512 is connected to the three-way valve 513.
  • the 6% Luer cone interface 5131 of the three-way valve 513 is for connection to an external infusion set.
  • the three-way valve 513 can be connected to an external contrast instrument to perform an angiographic evaluation of the sealing effect before the interventional medical device 200 is released.
  • This embodiment is a manufacturing method of the steel cable 41 of the first embodiment, and the specific steps are as follows:
  • a polyether block amide (Arkema, France, trade name: Pebax) tubular body 4121 having a wall thickness of 0.2 mm is placed on the outer surface of the cable body 411, and the polyether is embedded.
  • the proximal end of the segment amide tubular body 4121 is adjacent to the proximal end of the cable body 411, and a fluorinated ethylene propylene copolymer (abbreviation: FEP) heat-shrinkable tube 4122 having a wall thickness of 0.3 mm is placed over the polyether block amide tubular body 4121.
  • a cable body 411 covered by a multilayer tubular body is obtained.
  • the inner diameter of the heat shrinkable tube 4122 before contraction is slightly larger than the outer diameter of the tubular body 4121; the melting point of the tubular body 4121 is lower than the melting point of the heat shrinkable tube 4122.
  • the tubular body 4121 has a melting point of 159 degrees; the heat-shrinkable tube 4122 has a heat shrinkage temperature of 210 degrees and a melting point of about 320 degrees.
  • the tubular body 4121 in a temperature range of 180 to 220 degrees to be integrated with the cable body.
  • the above-mentioned multilayer tubular body covered cable body 411 is heated to 210 degrees, at which time the polyether block amide tubular body 4121 is melted and coated with the outer surface of the cable body 411 adjacent to its proximal end. It is integrated with the cable body 411, and the outer FEP heat shrinkable tube 4122 shrinks but does not melt.
  • the structure of the steel cable 41 is as shown in FIG. 8, and includes a cable body 411 and a coating 412.
  • the polyether block amide covers the outer surface of the elongated inner core 4111 and the outer surface of the steel wire 4112 provided on the inner core 4111 to form a coating 412.
  • the material of the tubular body 4121 can also be a thermoplastic polyurethane or other thermoplastic elastomer as long as a heat-shrinkable tube having a melting point higher than the melting point of the thermoplastic elastomer is used.
  • the structure obtained by the above manufacturing method not only ensures the flexibility of the distal end of the cable body 411, but also enhances the proximal support of the cable body 411, improves the performance of the delivery system, and is more advantageous for interventional medical devices in the human environment. Push.
  • the manner of applying the coating 412 to the cable body 411 may also include thermal spraying, dispensing, plating, vacuum coating, evaporation coating, sputtering or chemical vapor deposition, and the like.
  • the material of the coating film 412 may further include a polymer material such as a thermosetting elastomer, a metal material or a polymer, as long as the supporting property of the cable body 411 having the coating film 412 satisfies actual needs.
  • This embodiment is a method for the delivery of the interventional medical device 200 in the delivery system 100 of the first embodiment, which mainly includes the following steps:
  • expansion assembly 300 (1) passing the distal end of the expansion device 20 through the distal end of the delivery device 10 and threading the proximal end of the delivery device 10 through the first connection nut 22 of the expansion device 20 to form the expansion assembly 300 shown in FIG.
  • the expansion assembly 300 is tracked along the guidewire (not shown), from the femoral vein through the interatrial septum, to the left atrial appendage, and then withdrawn from the expansion device 20, leaving the delivery device 10 in the body to establish a passage from the body to the body;
  • the loading device 30 loaded with the interventional medical device 200 shown in the step (2) is connected to the sheath joint 12, and the delivery system 100 equipped with the interventional medical device 200 shown in Fig. 1 is obtained. ;
  • the compression nut 532 is rotated counterclockwise, so that the sealing member 52 returns to the relaxed state, and the cable body 411 is retracted to drive the interventional medical treatment.
  • the instrument 200 withdraws the delivery delivery sheath 11 and then adjusts the sheath connector 12 to adjust the distal end of the delivery sheath 11 to a better position;
  • the interventional medical device is not suitable for the angiographic evaluation, the surgical effect is not satisfactory, and when the interventional medical device model needs to be replaced, firstly, the compression screw is rotated counterclockwise.
  • the cap 532 causes the seal 52 to return to a relaxed state; secondly, the cable 51 is withdrawn toward the proximal end of the delivery system 100 to drive the interventional medical device revenue delivery sheath 11; then, the second attachment nut 321 and sheath of the loading device 30 are released The connection of the fitting 12; then, the unsuitable interventional medical device is withdrawn from the sheath 11, the improperly inserted medical device is screwed to the cable 51, and the new interventional medical device is replaced; after that, the embodiment is repeated. Steps (3) to (7) of the three steps until the appropriate interventional medical device is pushed to the designated treatment site. Finally, step (8) is performed to complete the operation.
  • the delivery system of the present invention can effectively assist the doctor in the evaluation of the surgical effect during the operation, and does not need to be released after the angiographic evaluation, so that the surgical procedure is more convenient.
  • the utility model improves the supportability of the steel cable by covering the outer surface of the steel cable main body of the steel cable with the thermoplastic film, and is more advantageous for pushing the interventional medical device.
  • the sealing effect cannot be judged by contrast before the push cable and the interventional medical device are released, and the surgical equipment resources can only be increased through ultrasound judgment.
  • ultrasound observation without direct observation is straightforward, reducing the therapeutic effect of the operation.
  • the interventional medical device can be re-delivered, released, and judged.
  • the delivery system of the utility model cooperates with the coating of the steel cable in the hemostatic valve body, so that the distal end of the hemostatic valve body can be isolated from the outside during the operation, and the real-time contrast evaluation can be performed during the operation.
  • the controllable device release and the evaluation of the surgical effect can effectively prevent the harm caused to the patient after the release of the interventional medical device due to the inappropriate selection of the interventional medical device or the adjustment of the position of the interventional medical device.

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Abstract

公开了一种介入医疗器械（200）的推送装置（40）及输送系统（100）。通过在钢缆（41）的表面覆盖热塑性弹性体形成覆膜（412），在保证钢缆（41）柔顺性的同时，提高了钢缆（41）的支撑性，从而保证在输送介入医疗器械（200）时，介入医疗器械（200）较难偏离预定位置，缩短了手术时间，降低了病患的手术风险。同时，在输送系统（100）中，在止血阀体（51）内腔中设置密封件（52）与钢缆（41）的覆膜（412）相配合，使止血阀体（51）远端与外界隔离，在术中钢缆（41）没有释放器械（200）前即能通过造影评估器械（200）的释放效果，可以有效避免因为选型不合适或释放位置需要调整，对病人造成的危害。

Description

推送装置及输送系统
【技术领域】
本实用新型属于介入医疗器械技术领域，涉及一种用于推送介入医疗器械的推送装置及其制作方法，以及介入医疗器械的输送系统。
【背景技术】
通过导管技术利用介入的方法进行治疗心血管疾病是目前常用的治疗方法。具体是指将各种材料、器械等通过导管介入的治疗方法放置到人体的心脏、动脉、静脉血管等部位治疗心血管疾病。
例如通过导管介入方法放置介入医疗器械，如：房间隔缺损（简称：ASD）封堵器、室间隔缺损（简称：VSD）封堵器、动脉导管未闭（简称：PDA）封堵器、卵圆孔未闭（简称：PFO）封堵器等，到达心脏的缺损部位，封堵缺损以治疗先天性心脏病。再例如，通过导管介入方法放置封堵器到左心耳中，预防由于房颤而致左心耳形成血栓，该血栓可能上行至大脑造成的中风；或预防该血栓通过人体血液循环系统到达身体其他部位，造成的系统性栓塞。或者再例如将肺减容器械送至肺部的支气管的病变位置，以治疗肺气肿。
在通过输送系统将上述介入医疗器械输送到人体的心脏、动脉、静脉血管、左心耳、肺部的支气管中时，通常将介入医疗器械由柔性的推送钢缆推送到预定的部位，然后断开介入医疗器械和推送钢缆的连接，释放介入医疗器械，再通过造影或超声确认介入医疗器械释放位置是否合适、介入医疗器械展开是否不良、手术效果是否满意。
在实际使用过程中，为了减小病人创伤，应当尽量减小输送鞘管的内、外径。但是在选择的介入医疗器械型号不变的情况下，配合使用的鞘管内径越小，介入医疗器械的推送阻力就越大，尤其是介入医疗器械被推送的路径较长时，柔性钢缆的支撑力就会不足，直接导致介入医疗器械较易偏离预定位置，延长了手术时间，增加了病患的手术风险。
【发明内容】
本实用新型针对上述现有技术的不足，提供一种用于推送介入医疗器械的推送装置及介入医疗器械的输送系统。本实用新型推送装置的钢缆支撑性更好，输送介入医疗器械时，介入医疗器械较难偏离预定位置，缩短了手术时间，降低了病患的手术风险。
本实用新型的推送装置和输送系统尤其适用于输送解剖结构复杂的缺损部位的介入器械，如左心耳封堵器。
本实用新型提供一种推送装置，其包括钢缆。所述钢缆包括长条形的钢缆主体。所述钢缆还包括设于所述钢缆主体外表面上的覆膜。
在其中一个实施例中，所述钢缆主体具有相对的近端及远端。所述覆膜的近端邻近所述钢缆主体的近端。
在其中一个实施例中，所述覆膜的材料为热塑性弹性体。
在其中一个实施例中，所述热塑性弹性体包括聚醚嵌段酰胺或热塑性聚氨酯。
在其中一个实施例中，所述覆膜沿所述钢缆主体纵向中心轴的长度等于或小于所述钢缆主体的长度的一半。
在其中一个实施例中，所述钢缆主体包括长条形内芯。所述内芯由至少三股钢丝捻制而成。所述覆膜设于所述内芯的外表面。
在其中一个实施例中，所述钢缆主体还包括设于所述内芯上的钢丝。所述覆膜设于所述钢丝的外表面。
本实用新型还提供一种输送系统，其包括所述推送装置。
本实用新型还提供一种输送系统，其还包括止血装置。所述止血装置包括具有内腔的止血阀体及设于所述止血阀体的内腔中的密封件。所述密封件设有孔隙。当所述钢缆主体远端经所述孔隙从所述止血阀体远端穿出所述止血阀体后，所述钢缆的覆膜与所述密封件相配合以将所述止血阀体的内腔远端与外界隔离。
在其中一个实施例中，所述输送系统还包括递送鞘管。所述递送鞘管的近端与所述止血装置的远端相连，且所述递送鞘管的内腔与所述止血装置的内腔相连通。
所述递送鞘管包括主体部及塑形部。所述主体部连接于所述止血装置与塑形部之间。所述塑形部包括第一塑形段。所述第一塑形段的延伸方向与所述主体部的延伸方向之间的夹角范围为40度至50度。所述第一塑形段的延伸方向指所述第一塑形段近端向所述第一塑形段远端延伸的方向。所述主体部的延伸方向指所述主体部近端向所述主体部远端延伸的方向。
在其中一个实施例中，所述塑形部还包括第二塑形段。所述第一塑形段连接于所述主体部与第二塑形段之间。所述第二塑形段的延伸方向与所述第一塑形段及所述主体部所在的平面之间的夹角范围为30度至40度。所述第二塑形段的延伸方向指所述第二塑形段近端向所述第二塑形段远端延伸的方向。
在其中一个实施例中，所述输送系统还包括扩张管，所述扩张管的外径略小于所述递送鞘管的内径，所述扩张管远端头部从远端至近端的外径逐渐增大。
在其中一个实施例中，所述扩张管具有形状与所述递送鞘管的塑形部形状相同的塑形部。
在其中一个实施例中，所述输送系统还包括连接于所述递送鞘管与所述止血装置之间的中空的装载器。所述装载器的内腔与所述递送鞘管及所述止血装置的内腔相连通。
在其中一个实施例中，所述止血阀体的内腔具有锥形段。所述锥形段近端的直径大于所述锥形段远端的直径。所述密封件邻近所述锥形段近端。
在其中一个实施例中，所述输送系统用于输送左心耳封堵器。所述钢缆与所述左心耳封堵器可拆卸相连。
本实用新型还提供一种推送装置的制作方法，包括：
将覆膜管状体套在所述钢缆主体上；及
熔化所述覆膜管状体，使其与所述钢缆主体合为一体。
在其中一个实施例中，熔化所述覆膜管状体的温度范围为180度至220度。
在其中一个实施例中，在将所述覆膜管状体套在所述钢缆主体上步骤之后，熔化所述覆膜管状体步骤之前，所述制作方法还包括在所述覆膜管状体外套热缩管的步骤。所述热缩管的熔点小于所述覆膜管状体的熔点。在熔化所述覆膜管状体步骤之后，所述制作方法还包括去除所述热缩管的步骤。
在其中一个实施例中，所述覆膜管状体的材料为热塑性弹性体。
在其中一个实施例中，所述热塑性弹性体包括聚醚嵌段酰胺或热塑性聚氨酯。
本实用新型与现有技术相比，其钢缆主体外表面由热塑性弹性体形成覆膜，覆膜后的钢缆既能保证远端柔顺性适应弯曲的血管路径，同时支撑性和推送性更好，尤为适应复杂的血管通道或治疗部位，如左心耳堵闭术。
【附图说明】
图1为本实用新型第一实施例的输送系统装载介入医疗器械后的示意图；
图2为图1中的输送系统的扩张装置示意图；
图3为图1中的输送系统的递送装置和扩张装置组成的扩张组件的示意图；
图4为图1中的输送系统的递送装置示意图；
图5为图1中的输送系统的装载装置示意图；
图6a为图1中的输送系统的推送装置示意图和局部剖面视图，所述推送装置包括钢缆，所述钢缆包括长条形的钢缆主体和设于所述钢缆主体外表面上的覆膜；
图6b为图6a中的A部分中的42的剖视图；
图7为图6a中的钢缆主体截面图；
图8为图6a中的钢缆主体和设于钢缆主体外表面上的覆膜的截面图；
图9为图1中的输送系统的止血装置示意图，所述止血装置包括具有内腔的止血阀体和设于内腔中的密封件，其中，图9a为主视图，图9b为图9a中的B部分的剖视图，图9c为图9a中的止血阀体分解剖视图，图9d为密封件弹性形变后图9a中的B部分的局部剖视图；
图10为图9中的止血装置的密封件与图6中的推送装置的覆膜配合的示意图；
图11为本实用新型第二实施例的多层管状体覆盖的钢缆主体截面图；
图12为本实用新型第三实施例的止血装置、装载装置、推送装置与介入医疗器械组装后的示意图；
图13为图12所示的介入医疗器械收入装载装置后的示意图。
【具体实施方式】
为了使本实用新型的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本实用新型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仅用以解释本实用新型，并不用于限定本实用新型。
为了描述清晰，以下将靠近操作者的一端称作近端，将远离操作者的一端称作远端。
实施例一
实施例一的输送系统100用于将介入医疗器械200输送至病变部位并释放。本实施例中，介入医疗器械200为左心耳封堵器；输送系统100将介入医疗器械200输送至左心耳并释放；介入医疗器械200包括两个封堵盘和一层设于其中一个封堵盘内部的封堵膜。封堵盘由形状记忆功能的材料构成，使用时可以拉伸呈线条状。封堵膜由良好生物相容性的聚四氟乙烯材料构成。
请参阅图1及图2，输送系统100包括递送装置10、扩张装置20、装载装置30、推送装置40和止血装置50。
请一并参阅图3，扩张装置20的远端穿出递送装置10的远端，形成扩张组件300。
扩张组件300组件的远端沿着导丝（未示出）建立的轨道，从股静脉血管经过房间隔，到达左心耳，再撤出扩张装置20，保留递送装置10在体内，如此，建立体外到体内的通道。
请继续参阅图1，当建立体外到体内的通道后，先将装载装置30连接于止血装置50与递送装置10之间；再将推送装置40的远端依次穿出止血装置50、装载装置30和递送装置10后，与介入医疗器械200可拆卸连接。
在本实施例中，介入医疗器械200与推送装置40的远端通过螺纹连接。可以理解的是，介入医疗器械200与推送装置40还可以通过卡合连接、磁性连接、牵引丝连接等其它可拆卸方式连接。
需要说明的是，在某些情况下，本实用新型的输送系统100可以不包括装载装置30，由递送鞘管11的近端直接与止血装置50的远端相连，且递送鞘管11的内腔与止血装置50的内腔相连通。
请一并参阅图4，递送装置10包括中空的递送鞘管11及连接于递送鞘管11近端的鞘管接头12。递送鞘管11的近端与装载装置30的远端相连，且递送鞘管11的内腔与装载装置30的内腔相连通。
递送鞘管11包括主体部110及塑形部111。主体部110连接于止血装置50与塑形部111之间。塑形部111包括第一塑形段1111。第一塑形段1111的延伸方向与主体部110的延伸方向之间的夹角范围为40度至50度。第一塑形段1111的延伸方向指第一塑形段1111近端向第一塑形段1111远端延伸的方向。主体部110的延伸方向指主体部110近端向主体部110远端延伸的方向。
塑形部111还包括第二塑形段1112。第一塑形段1111连接于主体部110与第二塑形段1112之间。第二塑形段1112的延伸方向与第一塑形段1111及主体部110所在的平面之间的夹角范围为30度至40度。第二塑形段1112的延伸方向指第二塑形段1112近端向第二塑形段1112远端延伸的方向。如此，塑形部111利于适应左心耳的生理解剖结构。
可以理解的是，在临床使用过程中，第二塑形段1112还可以根据实际需要而省略。只要包括第一塑形段1111的塑形部111能满足不同个体、不同预定介入治疗位置的生理解剖结构即可。递送鞘管11的管壁为多层结构，由内而外依次包括聚四氟乙烯材质层、不锈钢编织层及聚醚嵌段酰胺层。
请再次参阅图2，扩张装置20包括扩张管21、位于扩张管21近端且与扩张管21近端相连的第一连接螺帽22及位于第一连接螺帽22近端的扩张管接头23。扩张管21可穿设在递送鞘管11内，用于沿着导丝协助递送鞘管11建立血管路径，扩张管21材料为聚乙烯。扩张管21的外径略小于递送鞘管11的内径，以便于扩张管21的远端可从递送鞘管11的近端进入递送鞘管11，并从递送鞘管11的远端穿出。扩张管21具有形状与递送鞘管11的塑形部110的形状相同的塑形部，在此不再赘述。扩张管21远端头部从远端至近端的外径逐渐增大。
第一连接螺帽22可与递送装置1的近端螺纹连接，以将递送装置10与扩张装置20连接形成扩张组件300。扩张管接头23用于限制扩张管21的近端进入递送鞘管11内。
请一并参阅图1及图5，当建立体外到体内的通道后，将装载装置30连接于递送装置10与止血装置50之间。装载装置30包括中空的装载器31。装载器31的近端可与止血装置50的远端相连。装载器31的远端可与递送装置10的递送鞘管11的近端相连。装载器31的内腔可与止血装置50的内腔相连通。
装载装置30还包括连接于装载器31远端的装载器前接头32和连接于装载器31近端的装载器后接头33。装载器前接头32的近端设有可与鞘管接头12相连的第二连接螺帽321。装载器后接头33用于与止血装置50相连。装载器31的材料为聚乙烯。
请参阅图6a，推送装置40用于推送介入医疗器械200。本实施例中，用于推送左心耳封堵器。推送装置40包括钢缆41。钢缆41包括长条形的钢缆主体411及设于钢缆主体41外表面上的覆膜412。钢缆主体411具有相对的近端及远端，覆膜412的近端邻近钢缆主体41的近端。覆膜412的材料为热塑性弹性体。在本实施例中，覆膜412的材料为嵌段聚醚酰胺弹性体。覆膜412沿钢缆主体411纵向中心轴的长度等于或小于钢缆主体411的长度的一半。具体地，钢缆主体411的长度范围为1000~1400mm，覆膜412的长度范围为400~750mm。在本实施例中，钢缆主体411的长度为1300mm，覆膜412的长度为600mm。覆膜412远端到钢缆主体411远端的距离为700mm。
应当理解的是，覆膜412也可以设于钢缆主体411近端与远端之间的任意所需要的位置，只要其对钢缆主体411的支撑性能满足实际需要即可。例如，覆膜412设于钢缆主体411中段的外表面，即钢缆主体411靠近近端的外表面上没有覆膜。
请参阅图7，钢缆主体411包括长条形内芯4111。内芯4111由至少三股钢丝捻制而成。本实施例中，内芯4111由三股钢丝捻制而成；钢缆主体411还包括设于内芯4111上的钢丝4112。
请参阅图8，覆膜412设于内芯4111和钢丝4112的外表面上。带有覆膜412的钢缆41既能保证远端柔顺性适应弯曲的血管路径，同时支撑性和推送性更好，输送介入医疗器械200时，介入医疗器械200较难偏离预定位置，缩短了手术时间，降低了病患的手术风险。
应当理解的是，钢缆主体411也可以仅包括由三股钢丝捻制而成的长条形内芯4111，没有设于内芯上的钢丝4112。覆膜412设于内芯4111的外表面。
请再次参阅图6a，推送装置40还包括与钢缆主体411近端连接的钢缆手柄42，以及用于将钢缆主体411和钢缆手柄42相连的钢缆紧固螺钉43、焊接于钢缆主体411远端的用于与介入医疗器械200可拆卸连接的螺栓44。
请参阅图6b，钢缆手柄42的轴向设有一个钢缆容置腔421。钢缆容置腔421用于收容钢缆主体411的近端。钢缆手柄42的远端有一径向的螺纹侧孔422。螺纹侧孔422与钢缆容置腔421相连通。
请同时参阅图6a及图6b，钢缆紧固螺钉43螺接于螺纹侧孔422中，且其头端抵接钢缆主体411的近端，从而可达到固定钢缆主体411和钢缆手柄42的目的。
请同时参阅图9a及图9b，止血装置50包括具有内腔511的止血阀体51及设于内腔511中的密封件52。密封件52设有孔隙。当钢缆主体411远端经孔隙从止血阀体51远端穿出止血阀体51后，钢缆41的覆膜412的远端可穿出密封件52的远端。钢缆41的覆膜412与密封件52相配合以将内腔511远端与外界隔离。
止血阀体51可以为T型或Y型。在本实施例中，止血阀体51为T型阀。止血阀体51靠近其近端的外表面上设有外螺纹510。
止血装置50还包括位于止血阀体51近端的压紧件53和位于止血阀体51远端的第三连接螺帽54。
请参阅图9c，内腔511具有相连的柱形段513及锥形段512。柱形段513较锥形段512靠近止血阀体51的近端。柱形段513的直径等于锥形段513近端的直径，且锥形段512近端的直径大于锥形段512远端的直径。密封件52邻近锥形段512近端。本实施例中，密封件52为O型硅胶圈。
可以理解的是，锥形段512可以设置于内腔511的任意位置，只要当钢缆主体411远端从止血阀体51远端穿出止血阀体51后，钢缆41的覆膜412的远端穿出密封件52的远端，钢缆41的覆膜412可以与密封件52相配合以将止血阀体51的内腔511远端与外界隔离即可。
压紧件53包括中空的抵接柱531和围绕抵接柱531且与抵接柱531相连的压紧螺帽532。抵接柱531的外壁与压紧螺帽532的内螺纹之间形成一个收容止血阀体511的收容空间，且抵接柱531的远端较压紧螺帽532的螺纹的远端靠近止血阀体51的远端。抵接柱531的外径小于止血阀体51的柱形段513的直径，如此，抵接柱531可进入止血阀体51的内腔511，且当止血阀体51与压紧螺帽532螺纹连接后，抵接柱531可抵接密封件52。
请参阅图9d，当顺时针旋转压紧螺帽532，抵接柱531向止血阀体51的远端移动，密封件52受到挤压并向锥形段512的远端移动，由于锥形段512近端的直径大于远端的直径，密封件52进入锥形段512远端的部分会发生弹性形变。
请参阅图10，进入锥形段512远端的密封件52发生弹性形变收缩后抱紧覆膜412，从而将内腔511远端与外界隔离。
请再次参阅图9b，当逆时针旋转压紧螺帽532，抵接柱531向止血阀体51的近端移动，不再抵紧密封件52，密封件52向锥形段512的近端移动并恢复松弛状态，其与覆膜412之间不再紧密接触，内腔511远端不再与外界隔离。
可以理解的是，密封件52也可以固定于止血阀体51中，此时，只要密封件52可以报紧覆膜412即可，例如密封件52的圆孔相对覆膜412的外径较小，或者密封件52为开设有十字形切口的密封片等。
请再次参阅图9a，止血阀体51的侧面还设有与内腔511相连通的连接软管512。连接软管512与止血阀体51相连的端部较密封件52靠近止血阀体51的远端。软管512的另一端连接三通阀513。三通阀513的6%鲁尔圆锥接口5131用于和外部输液器械连接。当内腔511远端与外界隔离时，三通阀513可以连接外部造影器械，在介入医疗器械200没有解脱前进行造影评估封堵效果。
实施例二
本实施例为实施例一的钢缆41的制作方法，具体步骤为：
（1）请参阅图11，将壁厚为0.2mm的聚醚嵌段酰胺（法国阿科玛公司，商品名：Pebax）管状体4121套在钢缆主体411的外表面上，并且聚醚嵌段酰胺管状体4121的近端邻近钢缆主体411的近端，将壁厚为0.3mm的氟化乙烯丙烯共聚物（简称：FEP）热缩管4122套在聚醚嵌段酰胺管状体4121上，得到多层管状体覆盖的钢缆主体411。
热缩管4122收缩前内径略大于管状体4121的外径；管状体4121的熔点低于热缩管4122的熔点。
本实施例中，管状体4121的熔点为159度；热缩管4122的热收缩温度为210度，熔点约为320度。
（2）在180度至220度的温度范围内熔化所述管状体4121，使其与所述钢缆主体合为一体。具体地，本实施例中，将上述多层管状体覆盖的钢缆主体411加热至210度，此时聚醚嵌段酰胺管状体4121熔化并包覆钢缆主体411邻近其近端的外表面，与钢缆主体411合为一体，而外层的FEP热缩管4122会发生收缩但不熔化。
（3）去除外层的热缩管4122，得到钢缆41。
钢缆41的结构如图8所示，其包括钢缆主体411及覆膜412。聚醚嵌段酰胺覆盖在长条形内芯4111的外表面以及设于内芯4111上的钢丝4112的外表面，形成覆膜412。
可以理解的是，管状体4121的材料也可以为热塑性聚氨酯或其它热塑性弹性体，只要采用熔点高于热塑性弹性体熔点的热缩管套在其上即可。
上述制作方法得到的结构既保证了钢缆主体411的远端柔顺性，也增强了钢缆主体411的近端支撑性，提高了输送系统的使用性能，更加有利于介入医疗器械在人体环境内的推送。
可以理解的是，将覆膜412施加至钢缆主体411的方式还可以包括热喷涂、滴涂、电镀、真空镀膜、蒸发镀膜、溅射或化学气相沉积法等。覆膜412的材料还可以包括热固性弹性体等高分子材料、金属材料或聚合物，只要具有覆膜412的钢缆主体411的支撑性能满足实际需要即可。
实施例三
本实施例为实施例一的输送系统100应用于临床输送介入医疗器械200的方法，主要包括以下步骤：
（1）将扩张装置20的远端穿过递送装置10的远端，并通过扩张装置20的第一连接螺帽22与递送装置10近端螺纹连接，形成图3所示的扩张组件300，将扩张组件300沿着导丝（图未示）建立的轨道，从股静脉血管经过房间隔，到达左心耳，再撤出扩张装置20，保留递送装置10在体内，建立体外到体内的通道；
（2）将止血装置50远端的第三连接螺帽54与装载装置30的装载器后接头33连接，然后将推送装置40的远端依次穿过止血装置50和装载装置30，再通过位于推送装置40远端的螺栓44螺纹连接介入医疗器械200，得到如图12所示的组装好的止血装置50、装载装置30及推送装置40；之后向近端回撤推送装置40将介入医疗器械200收入装载器31的内腔，得到如图13所示的装载有介入医疗器200的装载装置30；
（3）将步骤（2）得到的如图13所示的装载有介入医疗器200的装载装置30，与鞘管接头12连接，得到图1所示的装载有介入医疗器械200的输送系统100；
（4）逆时针旋转压紧螺帽532，使密封件52处于自然的松弛状态，，向输送系统100的近端推送推送装置40，以将介入医疗器械200输送到左心耳的预定位置并展开；
（5）顺时针旋转压紧螺帽532，此时，止血阀体51的内腔511密封件52受到抵接柱531的挤压向锥形段512远端移动，并抱紧覆膜412，使得内腔511远端与外界隔离，打开止血装置50中的三通阀513，将装有造影剂的手推注射装置（图未示）与三通阀513的6%圆锥鲁尔接头5131连接；
（6）推动手推注射装置向处于与外界隔离状态下的止血阀体51的内腔远端推送造影剂，由于此时钢缆主体411还没有和展开的介入医疗器械200解脱，可以通过影像设备观察介入医疗器械200的展开位置是否最佳，手术效果是否满意；
（7）当遇到手术效果不佳需要调整介入医疗器械200的展开位置时，首先，逆时针旋转压紧螺帽532，使得密封件52恢复松弛状态，回撤钢缆主体411以带动介入医疗器械200回撤收入递送鞘管11，然后，调整鞘管接头12以调整递送鞘管11远端至更佳位置；
（8）将介入医疗器械200推送到所述更佳的位置并展开，顺时针旋转压紧螺帽532，使得内腔511远端与外界隔离，再次进行造影评估，当评估手术效果满意后，解除钢缆主体411远端的螺栓44与介入医疗器械200的螺纹连接，释放介入医疗器械200，并撤出其他部件完成手术。
实施例四
当进行实施例三的步骤（1）~（6）后，进行造影评估时发现介入医疗器械选型不合适、手术效果不满意，需要更换介入医疗器械型号时，首先，逆时针旋转压紧螺帽532使得密封件52恢复松弛状态；其次，向输送系统100的近端后撤钢缆51以带动介入医疗器械收入递送鞘管11；接着，解除装载装置30的第二连接螺帽321与鞘管接头12的连接；然后，将不合适的介入医疗器械撤出鞘管11，解除不合适的介入医疗器械与钢缆51的螺纹连接，重新更换新的介入医疗器械；之后，再重复实施例三的步骤（3）~（7），直至将合适的介入医疗器械推送到指定的治疗位置。最后，实行步骤（8）完成手术。
因此，本实用新型的输送系统能有效地在术中帮助医生完成手术效果的评估，不需要释放后再进行造影评估，使得手术过程更加便捷。
本实用新型通过将钢缆的钢缆主体的外表面覆盖热塑性覆膜，提高了钢缆的支撑性，更加有利于推送介入医疗器械。
由于普通的推送钢缆内部的捻制结构存在缝隙，在推送钢缆与介入医疗器械解脱前不能通过造影来判断封堵效果，只能通过超声判断，增加了手术配备资源。当遇到左心耳等解剖结构复杂的治疗位点，超声观察没有造影观察直接明了，降低了手术的治疗效果。如果遇到介入医疗器械的尺寸选择不合适和展开位置不佳，只能先回收介入医疗器械后再次输送、释放、判断手术效果。而本实用新型的输送系统通过在止血阀体中设置密封件与钢缆的覆膜相配合，使得手术中能使止血阀体内腔远端与外界隔离，可以在术中进行实时造影评估，实现了器械释放与手术效果评估的可控，有效避免了因为介入医疗器械选型不合适或介入医疗器械展开位置需要调整而导致的介入医疗器械释放后再回收对病人造成的危害。
以上所述仅为本实用新型的较佳实施例而已，并不用以限制本实用新型，凡在本实用新型的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本实用新型的保护范围之内。

Claims (17)

  1. 一种推送装置，其包括钢缆，所述钢缆包括长条形的钢缆主体，其特征在于，所述钢缆还包括设于所述钢缆主体外表面上的覆膜。
  2. 根据权利要求1所述的推送装置，其特征在于，所述钢缆主体具有相对的近端及远端，所述覆膜的近端邻近所述钢缆主体的近端。
  3. 根据权利要求1所述的推送装置，其特征在于，所述覆膜的材料为热塑性弹性体。
  4. 根据权利要求3所述的推送装置，其特征在于，所述热塑性弹性体包括聚醚嵌段酰胺或热塑性聚氨酯。
  5. 根据权利要求1所述的推送装置，其特征在于，所述覆膜沿所述钢缆主体纵向中心轴的长度等于或小于所述钢缆主体的长度的一半。
  6. 根据权利要求1所述的推送装置，其特征在于，所述钢缆主体包括长条形内芯，所述内芯由至少三股钢丝捻制而成，所述覆膜设于所述内芯的外表面。
  7. 根据权利要求6所述的推送装置，其特征在于，所述钢缆主体还包括设于所述内芯上的钢丝，所述覆膜设于所述钢丝的外表面。
  8. 一种输送系统，其包括如权利要求1至7任一所述的推送装置。
  9. 如权利要求8所述的输送系统，其特征在于，所述输送系统还包括止血装置，所述止血装置包括具有内腔的止血阀体及设于所述止血阀体的内腔中的密封件，所述密封件设有孔隙，当所述钢缆主体远端经所述孔隙从所述止血阀体远端穿出所述止血阀体后，所述钢缆的覆膜与所述密封件相配合以将所述止血阀体的内腔远端与外界隔离。
  10. 根据权利要求9所述的输送系统，其特征在于，所述输送系统还包括递送鞘管，所述递送鞘管的近端与所述止血装置的远端相连，且所述递送鞘管的内腔与所述止血装置的内腔相连通。
  11. 根据权利要求10所述的输送系统，其特征在于，所述递送鞘管包括主体部及塑形部，所述主体部连接于所述止血装置与塑形部之间，所述塑形部包括第一塑形段，所述第一塑形段的延伸方向与所述主体部的延伸方向之间的夹角范围为40度至50度，所述第一塑形段的延伸方向指所述第一塑形段近端向所述第一塑形段远端延伸的方向，所述主体部的延伸方向指所述主体部近端向所述主体部远端延伸的方向。
  12. 根据权利要求11所述的输送系统，其特征在于，所述塑形部还包括第二塑形段，所述第一塑形段连接于所述主体部与第二塑形段之间，所述第二塑形段的延伸方向与所述第一塑形段及所述主体部所在的平面之间的夹角范围为30度至40度，所述第二塑形段的延伸方向指所述第二塑形段近端向所述第二塑形段远端延伸的方向。
  13. 根据权利要求11所述的输送系统，其特征在于，所述输送系统还包括扩张管，所述扩张管的外径略小于所述递送鞘管的内径，所述扩张管远端头部从远端至近端的外径逐渐增大。
  14. 根据权利要求13所述的输送系统，其特征在于，所述扩张管具有形状与所述递送鞘管的塑形部形状相同的塑形部。
  15. 根据权利要求10所述的输送系统，其特征在于，所述输送系统还包括连接于所述递送鞘管与所述止血装置之间的中空的装载器，所述装载器的内腔与所述递送鞘管及所述止血装置的内腔相连通。
  16. 根据权利要求9所述的输送系统，其特征在于，所述止血阀体的内腔具有锥形段，所述锥形段近端的直径大于所述锥形段远端的直径，所述密封件邻近所述锥形段近端。
  17. 根据权利要求9所述的输送系统，其特征在于，所述输送系统用于输送左心耳封堵器，所述钢缆与所述左心耳封堵器可拆卸相连。
PCT/CN2016/080685 2015-12-30 2016-04-29 推送装置及输送系统 Ceased WO2017113554A1 (zh)

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