WO2015062534A1 - 一种将植入体装载到输送系统中的装置和方法 - Google Patents

一种将植入体装载到输送系统中的装置和方法 Download PDF

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Publication number
WO2015062534A1
WO2015062534A1 PCT/CN2014/089979 CN2014089979W WO2015062534A1 WO 2015062534 A1 WO2015062534 A1 WO 2015062534A1 CN 2014089979 W CN2014089979 W CN 2014089979W WO 2015062534 A1 WO2015062534 A1 WO 2015062534A1
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WO
WIPO (PCT)
Prior art keywords
tube
open end
introducer
tapered
implant
Prior art date
Application number
PCT/CN2014/089979
Other languages
English (en)
French (fr)
Inventor
刘翔
吴明明
李�雨
贺志秀
桂宝珠
王海山
陈国明
陈韶辉
罗七一
Original Assignee
上海微创医疗器械（集团）有限公司
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Publication date
Application filed by 上海微创医疗器械（集团）有限公司 filed Critical 上海微创医疗器械（集团）有限公司
Priority to BR112016009486-7A priority Critical patent/BR112016009486B1/pt
Priority to US15/032,456 priority patent/US10098769B2/en
Priority to KR1020167014429A priority patent/KR101797575B1/ko
Priority to EP14857026.0A priority patent/EP3064174B1/en
Priority to ES14857026T priority patent/ES2713381T3/es
Priority to JP2016550926A priority patent/JP6257790B2/ja
Publication of WO2015062534A1 publication Critical patent/WO2015062534A1/zh
Priority to US16/127,895 priority patent/US11622874B2/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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
    • A61F2/9525—Means for mounting a stent or stent-graft onto or into a placement instrument using a funnel
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B5/00—Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
    • B65B5/04—Packaging single articles
    • 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
    • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
    • 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
    • A61F2002/9528—Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/53—Means to assemble or disassemble
    • Y10T29/53909—Means comprising hand manipulatable tool
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/53—Means to assemble or disassemble
    • Y10T29/53909—Means comprising hand manipulatable tool
    • Y10T29/53913—Aligner or center
    • Y10T29/53917—Tube with tube
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/53—Means to assemble or disassemble
    • Y10T29/53987—Tube, sleeve or ferrule

Definitions

  • the present invention relates to an apparatus and method for loading an implant into a delivery system.
  • Valvular heart disease is one of the most common heart diseases in China, mainly caused by rheumatic fever.
  • valve degeneration including calcification and mucus degeneration
  • metabolic disorders Damage is also increasing in our country.
  • Minimally invasive interventional therapy has the advantages of no need to open the chest, less trauma, and quick recovery of the patient.
  • the interventional treatment showed cases that can be treated by internal surgery, and the intervention can be treated; cases that cannot be treated by surgery can be treated by intervention.
  • valvular disease interventional treatment research work is significantly accelerated, percutaneous interventional valve implantation, from experimental research to small-scale clinical parallel research stage, valvular disease intervention may break through the technical "bottleneck" and rapidly achieve a wide range of clinical Application has once again become the focus of attention in the field of interventional cardiology.
  • CN101460115A describes a device for loading an interventional heart valve to a delivery system consisting of an inflow cone 42, an inflow tube 38, an outflow cone 34, an outflow tube 40 and a lid 36 through which the interventional heart valve is forced into and out.
  • Cone 34 one end of the interventional valve is compressed by the outflow cone 34, and then the inflow tube 38 passes through the hole in the middle of the cover 36, distracting the compressed and contracted portion of the interventional valve to a size comparable to that of the delivery system catheter, allowing the interventional valve support to Conveying system connection.
  • the delivery tube that operates the delivery system and the protective catheter will receive a portion of the interventional valve stent into the delivery system, then open the lid and retract the outflow cone, press the other end of the interventional valve stent into the inflow cone, and reduce the size of the remaining stent.
  • the operating delivery system delivers the entire interventional valve stent into the delivery system. The operation of such a device during surgery is complicated.
  • the present invention provides an apparatus and method for loading an implant into a delivery system that simplifies the operation of an interventional procedure using an implant.
  • an apparatus for loading an implant into a delivery system is provided.
  • the apparatus for loading an implant into a delivery system of the present invention includes a guide cover, an introducer, and a receiving tube, wherein: the guide cover has a tapered surface and communicates with a smaller open end of the tapered surface a straight tube or a tapered tube, the edge of the larger open end of the tapered surface being outwardly turned to form a cover; the guide having a circumferential surface that tapers in the axial direction, the two edges of the surface being respectively formed larger and smaller An open end having a diameter larger than a diameter of a smaller open end of the tapered surface of the guide cover; a size of the guide cover and a size of the guide such that the cover can be covered On the larger open end of the introducer, and at this time the end of the straight tube or the tapered tube can protrude from the smaller open end of the introducer; the receiving tube is in a circular tube shape, There are two open ends, the first open end of which has a diameter between the diameter of the smaller open end of the tapered surface of the guide cap and
  • the cover has a card slot; the outer edge of the larger open end of the guide has a boss, and when the guide cover is on the guide, the boss enters the Said card slot.
  • the cover body is provided with an annular groove.
  • the introducer has two tapered surfaces, the edges of the two tapered surfaces each forming a larger and smaller open end; the larger open end of the first tapered surface is the introducer a larger open end; the smaller open end of the first tapered surface has a diameter equal to or slightly smaller than the diameter of the larger open end of the second tapered surface, and the two are interconnected; the second tapered surface is smaller The open end is the smaller open end of the introducer.
  • a tapered section is formed between the tapered surface and the straight tube or the tapered tube.
  • the receiving tube is a tapered tube, or the receiving tube is composed of a straight tube and a tapered tube.
  • the larger open end of the tapered tube is the first open end of the receiving tube.
  • the implant is a heart valve stent.
  • a method of loading an implant into a delivery system comprising the steps of: Inserting the implant into the introducer, a part of the implant is exposed at each end of the introducer; the guide cover is placed on the guide, and the straight tube or the tapered tube of the guide cover is inserted through the implant And the end of the straight tube or the spinal canal of the guiding cap protrudes from the smaller open end of the introducer; the receiving tube is sleeved on the catheter of the delivery system; the delivery system seeker is inserted into the body Connecting the implant to the delivery system connecting member in the straight tube or the tapered tube of the guiding cover, moving the catheter of the delivery system and the receiving tube to partially enter the catheter into the catheter and the storage tube; The larger open end of the guiding cover is
  • the device for loading the implant into the delivery system comprises a guiding cover, an introducer, and a accommodating tube, and the valve can be loaded by only three components, and each component has a distinct shape and is not It will cause confusion; the middle of the introducer is slightly thinned, which can make the valve prosthesis into it without automatically popping out and causing inconvenience; the end of the storage tube has a long cone or all of the cone tube, which can protect the conveying system.
  • the catheter while the tapered design can make the opening of the tube larger, so it can adapt to more differently shaped valve prosthesis, protect the valve prosthesis from damage and easy to load. All of these contribute to the smooth operation of clinical procedures.
  • the guiding cap can not only connect the valve prosthesis with the delivery system connector, but also help the valve prosthesis to reduce the size to fully enter the delivery system, and the whole operation is simple and quick. Helps shorten the time of clinical surgery.
  • FIG. 1A, 1B, and 1C are schematic views of a structure of a guide cover according to an embodiment of the present invention.
  • FIGS. 2A and 2B are schematic views of a preferred structure of an introducer according to an embodiment of the present invention.
  • 3A and 3B are schematic views of a storage tube according to an embodiment of the present invention.
  • FIG. 4 is a schematic view of a valve prosthesis relating to an embodiment of the present invention.
  • FIG. 5 is a schematic illustration of loading an implant into an introducer in accordance with an embodiment of the present invention.
  • 6A and 6B are schematic views of a snap-fit operation of a guide cover and an introducer according to an embodiment of the present invention
  • FIG. 7 is a schematic illustration of a delivery system coupled to a valve prosthesis in accordance with an embodiment of the present invention.
  • FIG. 8 is a schematic view of opening a guide cover and an introducer according to an embodiment of the present invention.
  • FIG. 9 is a schematic illustration of further reducing the size of a valve prosthesis using a guide cap in accordance with an embodiment of the present invention.
  • Figure 10 is a schematic illustration of a valve prosthesis loaded into a guide cap in accordance with an embodiment of the present invention
  • FIG 11 is a schematic illustration of a valve prosthesis being harvested into a storage tube in accordance with an embodiment of the present invention.
  • FIG. 12 is a schematic illustration of a valve prosthesis fully loaded into a delivery system in accordance with an embodiment of the present invention.
  • the device for loading the implant into the delivery system in this embodiment includes a guide cover, an introducer, and a storage tube, which are respectively described below in conjunction with the drawings.
  • FIG. 1A, 1B and 1C are schematic views showing the structure of a guide cover according to an embodiment of the present invention, wherein FIG. 1A shows the outer shape of the guide cover, and FIG. 1B shows a cross section of the guide cover in the axial direction.
  • 1C is an A-direction view of a perspective view and a perspective view of the guide cover.
  • the guide cover 1 has There is a tapered surface 101 and a straight tube or tapered tube 103 communicating with the smaller open end 102 of the tapered surface, the edge of the larger open end 104 of the tapered surface being turned outwardly to form a cover opening toward the straight tube or the tapered tube 103 Body 105.
  • the introducer has a tapered surface that is a circumferential surface that tapers axially along the guide, the edges of which form a larger open end and a smaller open end of the introducer, the smaller open end having a larger diameter
  • the diameter of the free end 1031 of the straight tube or cone tube 103 is also known.
  • the size of the guide cover and the size of the introducer enable the cover 105 to be fixedly covered at the larger open end of the introducer, and at this time the free end 1031 can pass through the introducer and then from the smaller of the introducer The open end protrudes.
  • the overall shape of the introducer may be part of a cone, however the preferred manner consists of two sections of tapered surfaces that are interconnected, see Figures 2A and 2B.
  • 2A and 2B are schematic views of a preferred structure of an introducer according to an embodiment of the present invention, wherein Fig. 2B is a view taken along line A of Fig. 2A.
  • the introducer 2 has two sections of tapered surfaces 9 and 10 interconnected, each of which forms a larger open end 8 and a smaller open end 11 of the introducer.
  • the diameter of the open end of the tapered surface 9 is slightly smaller than the diameter of the open end of the tapered surface 10, that is to say the central portion of the introducer 2 is slightly tapered, which allows the implant to be It does not automatically pop up after being placed in the guide, which is convenient for the operation of the implant.
  • the cover 105 of the guide cover may be fixed to the larger open end of the introducer 2 by friction, or may be the use of the card slot 17 and the boss 12 in FIGS. 1C and 2B.
  • the card slot 17 is located in the cover body 105 and is formed by a plurality of protrusions 171 extending from the edge of the cover body 105 in the radial direction of the tapered surface 101 (see FIG. 1C).
  • the plurality of bosses 12 are located at the guide.
  • the edge of the larger open end 8 of the device forms a plane such that when the cover 105 is over the larger open end 8 of the introducer, the boss 12 can enter the card slot 17, at which point the cover 105 is properly rotated, convex
  • the table 12 can be blocked by the boss 171 to fix the cover 105 to the introducer 2.
  • FIG. 3A and 3B are schematic views of a storage tube according to an embodiment of the present invention, wherein FIG. 3A shows The outer shape of the storage tube is shown in Fig. 3B as a cross-sectional view of the storage tube.
  • the receiving tube 3 comprises a straight tube portion 5 and a cone portion 7; alternatively, there may be a transitional arc surface 6 therebetween to make the inner surface of the receiving tube 3 smoother.
  • the receiving tube 3 can also be formed by one or two tapered tubes, in which case the apex angle of the tapered tube is required to be relatively small.
  • the diameter of the open end of the cone portion 7 is between the diameter of the smaller open end 102 of the tapered surface 101 of the guide cap 1 and the diameter of the smaller open end 11 of the introducer 2.
  • the free end of the straight tube portion 5 can have an internal chamfer or fillet 4 to facilitate assembly with the catheter.
  • the implant can be loaded into the transport system, and the loading operation is sequentially shown in FIGS. 4 to 12, and the loading operation will be described below with reference to FIGS. 4 to 12.
  • the device of this embodiment can be used to load an implant such as a heart valve prosthesis into a delivery system such as a catheter.
  • 4 is a schematic illustration of a valve prosthesis associated with an embodiment of the present invention. As shown in Figure 4, the valve prosthesis 18 has a valve inflow end 19 and a valve outflow end 20 with a valve lug 27 at the end.
  • FIG. 5 is a schematic illustration of loading an implant into an introducer in accordance with an embodiment of the present invention.
  • the valve prosthesis 18 is first loaded into the introducer 2 during loading (as indicated by the arrows in the figure) such that the valve outflow end 20 of the valve prosthesis 18 is from the larger opening of the introducer 2
  • the end 8 enters the introducer 2 and is exposed from the smaller open end 11 when the valve inflow end 19 is also exposed to the outside of the larger open end 8 of the introducer 2.
  • FIG. 6A and 6B are schematic views of a snap-fit operation of a guide cover and an introducer according to an embodiment of the present invention.
  • the guide cover 1 and the guide 2 are moved toward each other in the direction of the arrow in the figure, and the straight tube or the tapered tube 103 of the guide cover 1 is guided from the larger open end 8 of the guide 2 into the guide.
  • the valve prosthesis 18 within the introducer 2 Within the valve prosthesis 18 within the introducer 2.
  • Fig. 6B the free end 1031 of the straight tube or cone 103 of the guide cap 1 is exposed from the smaller open end 11 of the introducer 2 and the valve prosthesis outflow end 20 is distracted (as indicated by the arrow in the figure) Show).
  • the valve inflow end 19 is received in the recess 13 (not shown) in the cover 105 of the guide cover 1, preventing the valve inflow end 19 from being deformed by force.
  • FIG. 7 is a schematic illustration of a delivery system coupled to a valve prosthesis in accordance with an embodiment of the present invention.
  • the receiving tube 3 is first placed over the delivery system catheter 26 and then moved together with the introducer loaded with the valve prosthesis (as indicated by the arrow in the figure), during which the delivery system seeker 24 from the guide cover 1
  • the free end 1031 of the straight tube or cone tube 103 enters the guide cap 1 and the hanger ear 23 is hung on the small hook 251 on the surface of the delivery system connector 25 (refer to Fig. 8).
  • the storage tube 3 is moved to enter the storage tube, and then the delivery system conduit 26 is used to partially cover the implant into the catheter, and then the storage tube 3 is moved to allow more parts of the implant to enter the storage tube. This step can be performed. Repeat until the implant is unable to be more coated into the catheter and the tube due to its greater radial support. As shown in Figure 8. Further, since the diameter of the open end of the cone portion 7 is between the free end 1031 of the tapered tube 103 and the smaller open end 11 of the introducer 2, the storage tube 3 can be moved in the state of Fig.
  • FIG. Figure 8 is a schematic illustration of opening a guide cover and introducer in accordance with an embodiment of the present invention. As shown in Fig. 8, the guide cover 1 and the guide 2 are opened and the two are moved in opposite directions (as indicated by the two arrows in the figure).
  • FIG. 9 is a schematic illustration of further reducing the size of a valvular prosthesis using a guide cap in accordance with an embodiment of the present invention.
  • the cover 105 of the guide cover 1 is directed toward the delivery system seeker 24 and moved toward each other (as indicated by the arrows in the figure), so that the valve inflow end 19 and its vicinity can be further reduced.
  • the delivery system seeker 24 extends from the free end 1031 of the straight tube or cone 103 of the guide cap.
  • Figure 10 is a schematic illustration of a valve prosthesis loaded into a guide cap in accordance with an embodiment of the present invention.
  • Fig. 11 is a schematic view showing the valve prosthesis being collected into the storage tube according to the embodiment of the present invention.
  • FIG 11 the delivery system catheter 26 is now pushed in the direction indicated by the arrow in the figure such that the delivery system connector 25 and its valve prosthesis between the delivery system seeker enter the delivery system catheter 26, at this time
  • the valve prosthesis 18 is fully loaded into the delivery system
  • Figure 12 is a schematic illustration of a valve prosthesis fully loaded into a delivery system in accordance with an embodiment of the present invention.
  • the guide 2 can be removed from the open end of the cone portion 7 of the housing tube 3 in the state of Fig. 11 or Fig. 12 .
  • the guide cap can both make the valve
  • the connection between the prosthesis and the delivery system connector can also help the valve prosthesis to be reduced in size to fully enter the delivery system.
  • the entire operation is relatively simple and quick, which helps to shorten the time of clinical surgery.
  • the valve can be loaded by only three components, and the shape of each component is distinct and does not cause confusion; the middle of the introducer is slightly thinned, and the valve prosthesis can be placed It does not automatically pop up and cause inconvenience; the end of the storage tube has a long cone or all of the cone tube, which can protect the delivery system catheter, and the tapered surface can make the opening of the tube larger, so it can adapt to more
  • the valve prosthesis is designed in many different shapes to protect the valve prosthesis from damage and easy to load. All of these contribute to the smooth operation of clinical procedures.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Prostheses (AREA)

Abstract

一种将植入体装载到输送系统中的装置和方法，能够简化使用植入体进行介入治疗手术时的操作。该装置包括导引盖（1）、导引器（2）和收纳管（3）。导引盖（1）具有一锥面（101）和与该锥面的较小开口端（102）连通的直管或锥管（103），该锥面的较大开口端（104）的边缘向外翻开形成开口朝向直管或锥管（103）的盖体（105）；导引器（2）具有渐缩的表面（9，10），该表面的两个边缘分别形成较大和较小的开口端（8，11），较小的开口端（11）的直径大于导引盖（1）的锥面的较小的开口端（102）的直径；导引盖（1）的尺寸和导引器（2）的尺寸使得盖体（105）能够盖在导引器（2）上并固定，并且此时直管或锥管（103）的端部能够从导引器（2）的较小的开口端（11）伸出；收纳管（3）呈圆管状，具有两个开口端，其第一开口端直径介于导引盖的锥面的较小开口端（102）直径与导引器较小开口端（11）直径之间。

Description

一种将植入体装载到输送系统中的装置和方法 技术领域
本发明涉及一种将植入体装载到输送系统中的装置和方法。
背景技术
心脏瓣膜病是我国最常见的心脏病之一，其中主要为风湿热导致的瓣膜损害；近年来随着人口老龄化的发展，瓣膜退行性变(包括钙化和粘液变性等)以及代谢障碍性瓣膜损害在我国也日益增多。
微创介入治疗方法具有无需开胸，创伤小，患者恢复快等优点。近10年内介入治疗方向显示出内外科能治疗的病例，介入都能治疗；外科手术不能治疗的病例，介入也能治疗。新世纪瓣膜病介入治疗，研究工作明显加速，经皮介入瓣膜植入术，由实验研究发展到小规模临床并行的研究阶段，瓣膜病介入可能突破技术上的“瓶颈”，迅速实现广泛的临床应用，再次成为介入性心脏病学领域的关注焦点。
CN101460115A描述了一种装载介入心脏瓣膜到输送系统的装置，它由一个流入锥体42、流入管38、流出锥体34、流出管40和盖子36组成，通过盖子36将介入心脏瓣膜压入流出锥体34，介入瓣膜的一端被流出锥体34压缩，然后流入管38从盖子36中间的孔穿过，撑开介入瓣膜被压缩缩小的部分到与输送系统导管尺寸相当，使介入瓣膜支架与输送系统连接。操作输送系统及保护导管的流出管将介入瓣膜支架一部分收到输送系统内部，然后打开盖子及退下流出锥体，将介入瓣膜支架的另外一端压入到流入锥体，缩小剩余部分的支架尺寸，操作输送系统将整个介入瓣膜支架收入到输送系统内。这种装置在手术中的操作较为复杂。
发明内容
有鉴于此，本发明提供一种将植入体装载到输送系统中的装置和方法，能够简化使用植入体进行介入治疗手术时的操作。本发明的其他优点将结合实施例加以说明。
为实现上述目的，根据本发明的一个方面，提供了一种将植入体装载到输送系统中的装置。
本发明的将植入体装载到输送系统中的装置包括导引盖、导引器、和收纳管，其中：所述导引盖具有一锥面和与该锥面的较小开口端连通的直管或锥管，该锥面的较大开口端的边缘向外翻开形成盖体；所述导引器具有沿轴向渐缩的圆周表面，该表面的两个边缘分别形成较大和较小的开口端，该较小的开口端的直径大于所述导引盖的锥面的较小的开口端的直径；所述导引盖的尺寸和所述导引器的尺寸使得所述盖体能够盖在所述导引器的较大开口端上，并且此时所述直管或锥管的端部能够从所述导引器的较小的开口端伸出；所述收纳管呈圆管状，具有两个开口端，其第一开口端直径介于所述导引盖的锥面的较小开口端的直径与导引器的较小开口端的直径之间。
可选地，所述盖体具有卡槽；所述导引器的较大开口端的外缘有凸台，当所述导引盖盖在所述导引器上时，所述凸台进入所述卡槽。
可选地，所述盖体上设置有一个环形凹槽。
可选地，所述导引器具有两段渐缩表面，该两段渐缩表面的边缘各形成较大和较小开口端；第一段渐缩表面的较大开口端为所述导引器的较大开口端；第一段渐缩表面的较小开口端的直径等于或略小于第二段渐缩表面的较大开口端的直径，并且二者互相连接；第二段渐缩表面的较小开口端为所述导引器的较小开口端。
可选地，在所述导引盖中，其锥面与所述直管或锥管之间有一过渡段。
可选地，所述收纳管为锥管，或者所述收纳管由直管和锥管连接构成，该锥管的较大开口端为所述收纳管的第一开口端。
可选地，所述收纳管的直管和锥管之间有一过渡段。
可选地，所述植入体为心脏瓣膜支架。
根据本发明的另一方面，提供了一种将植入体装载到输送系统中的方法。该输送系统具有导管，该导管一端安装有输送系统连接件，并通过位于导管延长线上的可伸缩的细杆连接有输送系统导引头，该方法使用本发明的装置实现，包括如下步骤：将植入体装入导引器，导引器的两端各露出一部分该植入体；将导引盖盖在导引器上，并使导引盖的直管或锥管穿过植入体并且所述导引盖的直管或椎管的端部从所述导引器的较小的开口端伸出；将收纳管套在输送系统的导管上；将输送系统导引头伸入导引盖的直管或锥管内，将植入体与输送系统连接件连接，移动所述输送系统的导管及所述收纳管，使所述植入体部分进入所述导管与收纳管内；将导引盖的较大开口端套在植入体上并使植入体进入导引盖的直管或锥管内，然后移动收纳管使植入体完全进入收纳管；移动导管使植入体完全进入导管内。
根据本发明的技术方案，将植入体装载到输送系统中的装置包括导引盖、导引器、和收纳管，仅用3个部件即可完成瓣膜的装载，各个部件外形特点分明，不会造成混淆；导引器的中部略为收细，能够使瓣膜假体放入其中不会自动弹出和引起操作不便；收纳管一端有一较长锥体部或全部为锥管，既可以保护输送系统导管，而锥面设计可以将管件的开口做的更大，因此能够适应更多不同形状设计的瓣膜假体，保护瓣膜假体不受到损伤，装载容易。以上这些都有助于临床手术的顺利操作。在将植入体装载到输送系统的操作中，导引盖既能使瓣膜假体与输送系统连接件连接，又能够帮助瓣膜假体减小尺寸以完全进入输送系统，整个操作较为简单、快捷，有助于缩短临床手术的时间。
附图说明
附图用于更好地理解本发明，不构成对本发明的不当限定。其中：
图1A、图1B和图1C是根据本发明实施例的导引盖的结构的示意图；
图2A和图2B是根据本发明实施例的导引器的优选结构的示意图；
图3A和图3B是根据本发明实施例的收纳管的示意图；
图4是与本发明实施例有关的一种瓣膜假体的示意图；
图5是根据本发明实施例的将植入体装载到导引器的示意图；
图6A和图6B是根据本发明实施例的将导引盖与导引器扣合操作的示意图；
图7是根据本发明实施例的输送系统与瓣膜假体连接的示意图；
图8是根据本发明实施例的打开导引盖与导引器的示意图
图9是根据本发明实施例的利用导引盖进一步缩小瓣膜假体尺寸的示意图；
图10是根据本发明实施例的瓣膜假体被装载到导引盖中的示意图；
图11是根据本发明实施例的瓣膜假体被收入到收纳管中的示意图
图12是根据本发明实施例的瓣膜假体被完全装载到输送系统中的示意图。
具体实施方式
以下结合附图对本发明的示范性实施例做出说明，其中包括本发明实施例的各种细节以助于理解，应当将它们认为仅仅是示范性的。因此，本领域普通技术人员应当认识到，可以对这里描述的实施例做出各种改变和修改，而不会背离本发明的范围和精神。同样，为了清楚和简明，以下的描述中省略了对公知功能和结构的描述。
本实施例中的将植入体装载到输送系统中的装置包括导引盖、导引器、收纳管，以下结合附图分别加以说明。
图1A、图1B和图1C是根据本发明实施例的导引盖的结构的示意图，其中图1A示出了导引盖的外形，图1B示出了导引盖轴向的一个剖面，图1C是导引盖的立体图和立体图的A向视图。如图1A和图1B所示，导引盖1具 有一锥面101和与该锥面的较小开口端102连通的直管或锥管103，该锥面的较大开口端104的边缘向外翻开形成开口朝向直管或锥管103的盖体105。盖体105内可以有一圈环形的凹槽13。导引盖1的锥面101与直管或锥管103之间可以有一段过渡弧面15，从而使导引盖1的内表面更加平顺，便于植入体在其中顺利移动。
导引器具有渐缩表面，该渐缩表面是沿导引器轴向渐缩的圆周表面，其边缘各形成导引器的较大开口端和较小开口端，其较小开口端的直径大于直管或锥管103的自由端1031的直径。并且，导引盖的尺寸与导引器的尺寸使得盖体105能够固定地盖在导引器的较大开口端，并且此时自由端1031能够通过导引器然后从导引器的较小开口端伸出。
导引器的整体形状可以是圆锥的一部分，然而优选的方式是由互相连接的两段渐缩表面构成，参考图2A和图2B。图2A和图2B是根据本发明实施例的导引器的优选结构的示意图，其中图2B为图2A的A向视图。如图2A和图2B所示，导引器2具有互相连接的两段渐缩表面9和10，它们的边缘各形成导引器的较大开口端8和较小开口端11。在渐缩表面9和10的连接处201，渐缩表面9的开口端的直径略小于渐缩表面10的开口端的直径，也就是说导引器2的中部略为收细，这使得植入体在放入导引器后不会自动弹出，便于植入手术的操作。
导引盖的盖体105可以是通过摩擦力与导引器2的较大开口端固定，也可以是利用图1C与图2B中的卡槽17以及凸台12。卡槽17位于盖体105内，是由多个凸起部171从盖体105的边缘起沿锥面101的径向延伸而形成(参见图1C)，凸台12为多个，位于导引器的较大开口端8的边缘构成的平面，这样，当盖体105盖在导引器的较大开口端8上时凸台12能够进入卡槽17，此时适当旋转盖体105，凸台12就可以被凸起部171阻挡从而使盖体105与导引器2固定。
图3A和图3B是根据本发明实施例的收纳管的示意图，其中图3A示出 了收纳管的外形，图3B是收纳管的剖面图。如图3B所示，收纳管3包括直管部5和锥体部7；可选地，二者之间还可以有一段过渡弧面6，使收纳管3的内表面更加平顺。收纳管3也可以由一个或两个锥管构成，此时需要该锥管的顶角相当小。锥体部7的开口端的直径介于导引盖1的锥面101的较小开口端102的直径与导引器2较小开口端11的直径之间。直管部5的自由端可以有一个内倒角或内圆角4，便于与导管的装配。
使用本发明实施例中的上述装置，能够将植入体装载到输送系统，装载操作依次示出图4至图12中，以下结合图4至图12对该装载操作做出说明。
本实施例中的装置可以用来将心脏瓣膜假体等植入体装载到输送系统例如导管。图4是与本发明实施例有关的一种瓣膜假体的示意图。如图4所示，瓣膜假体18具有瓣膜流入端19和瓣膜流出端20，后者的端部有瓣膜挂耳27。
图5是根据本发明实施例的将植入体装载到导引器的示意图。如图5所示，在装载时首先将瓣膜假体18装载到导引器2中(如图中箭头所示)，使瓣膜假体18的瓣膜流出端20从导引器2的较大开口端8进入导引器2并且从较小开口端11露出，此时瓣膜流入端19也露在导引器2的较大开口端8的外部。
图6A和图6B是根据本发明实施例的将导引盖与导引器扣合操作的示意图。如图6A所示，使导引盖1与导引器2沿图中箭头方向相向运动，让导引盖1的直管或锥管103从导引器2的较大开口端8伸入导引器2内的瓣膜假体18内。然后如图6B所示，导引盖1的直管或锥管103的自由端1031从导引器2的较小开口端11露出并将瓣膜假体流出端20撑开(如图中箭头所示)。此时瓣膜流入端19被容纳在导引盖1的盖体105内的凹槽13(图中未示出)中，避免了瓣膜流入端19受力变形。
图7是根据本发明实施例的输送系统与瓣膜假体连接的示意图。如图7所示，先将收纳管3套在输送系统导管26上，然后一起与装载有瓣膜假体的导引器相向运动(如图中箭头所示)，在此过程输送系统导引头24从导引盖1 的直管或锥管103的自由端1031进入导引盖1内，挂耳23挂在输送系统连接件25表面的小钩251上(参考图8)。先移动收纳管3使植入体部分进入收纳管，然后移动输送系统导管26将植入体部分包覆到导管内，再移动收纳管3使植入体更多部分进入收纳管，此步骤可重复直至植入体由于其较大的径向支撑力而无法再更多地被包覆到导管及收纳管内为止。如图8所示状态。另外，由于锥体部7的开口端的直径介于锥管103的自由端1031与导引器2的较小开口端11之间，这样，在图7的状态下移动收纳管3，可使其部分地进入导引器2的较小开口端11，使植入体部分进入收纳管，从而其外廓有所收缩，便于接下来将导引器2向图中右方移动，参考图8，图8是根据本发明实施例的打开导引盖与导引器的示意图。如图8中所示，将导引盖1和导引器2打开，并使二者反向移动(如图中两个箭头所示)。
图9是根据本发明实施例的利用导引盖进一步缩小瓣膜假体尺寸的示意图。如图9所示，将导引盖1的盖体105朝向输送系统导引头24并使二者相向运动(如图中箭头所示)，能够使瓣膜流入端19及其附近部分进一步缩小，最终如图10所示，输送系统导引头24从导引盖的直管或锥管103的自由端1031伸出。图10是根据本发明实施例的瓣膜假体被装载到导引盖中的示意图。
在图10所示的状态下，令收纳管3沿图中箭头方向运动并保持输送系统导管26不动，就可使导引盖1被收纳管顶掉，同时瓣膜假体18被收入到收纳管3中，呈图11所示状态，图11是根据本发明实施例的瓣膜假体被收入到收纳管中的示意图。
如图11所示，此时沿图中箭头所示方向推动输送系统导管26使得输送系统连接件25及其与输送系统导引头之间的瓣膜假体一起进入输送系统导管26中，此时如图12所示，瓣膜假体18被完全装载到输送系统中，图12是根据本发明实施例的瓣膜假体被完全装载到输送系统中的示意图。在图11或图12的状态下可从收纳管3的锥体部7的开口端取下导引器2。
从以上的将植入体装载到输送系统的操作可以看出，导引盖既能使瓣膜 假体与输送系统连接件连接，又能够帮助瓣膜假体减小尺寸以完全进入输送系统，整个操作较为简单、快捷，有助于缩短临床手术的时间。从本实施例的装置的结构来看，仅用3个部件即可完成瓣膜的装载，各个部件外形特点分明，不会造成混淆；导引器的中部略为收细，能够使瓣膜假体放入其中不会自动弹出和引起操作不便；收纳管一端有一较长锥体部或全部为锥管，既可以保护输送系统导管，而锥面设计可以将管件的开口做的更大，因此能够适应更多不同形状设计的瓣膜假体，保护瓣膜假体不受到损伤，装载容易。以上这些都有助于临床手术的顺利操作。
上述具体实施方式，并不构成对本发明保护范围的限制。本领域技术人员应该明白的是，取决于设计要求和其他因素，可以发生各种各样的修改、组合、子组合和替代。任何在本发明的精神和原则之内所作的修改、等同替换和改进等，均应包含在本发明保护范围之内。

Claims (9)

  1. 一种将植入体装载到输送系统中的装置，其特征在于，包括导引盖、导引器和收纳管，其中：
    所述导引盖具有一锥面和与该锥面的较小开口端连通的直管或锥管，该锥面的较大开口端的边缘向外翻开形成盖体；
    所述导引器具有沿轴向渐缩的圆周表面，该表面的两个边缘分别形成较大和较小的开口端，该较小的开口端的直径大于所述导引盖的锥面的较小的开口端的直径；
    所述导引盖的尺寸和所述导引器的尺寸使得所述盖体能够盖在所述导引器的较大开口端上，并且此时所述直管或锥管的端部能够从所述导引器的较小的开口端伸出；
    所述收纳管呈圆管状，具有两个开口端，其第一开口端直径介于所述导引盖的锥面的较小开口端的直径与导引器的较小开口端的直径之间。
  2. 根据权利要求1所述的装置，其特征在于，
    所述盖体具有卡槽；
    所述导引器的较大开口端的外缘有凸台，当所述导引盖盖在所述导引器上时，所述凸台进入所述卡槽。
  3. 根据权利要求1所述的装置，其特征在于，所述盖体上设置有一个环形凹槽。
  4. 根据权利要求1所述的装置，其特征在于，
    所述导引器具有两段渐缩表面，该两段渐缩表面的边缘各形成较大和较小开口端；
    第一段渐缩表面的较大开口端为所述导引器的较大开口端；
    第一段渐缩表面的较小开口端的直径等于或略小于第二段渐缩表面的较大开口端的直径，并且二者互相连接；
    第二段渐缩表面的较小开口端为所述导引器的较小开口端。
  5. 根据权利要求1所述的装置，其特征在于，在所述导引盖中，其锥面与所述直管或锥管之间有一过渡段。
  6. 根据权利要求1所述的装置，其特征在于，所述收纳管为锥管，或者所述收纳管由直管和锥管连接构成，该锥管的较大开口端为所述收纳管的第一开口端。
  7. 根据权利要求6所述的装置，其特征在于，所述收纳管的直管和锥管之间有一过渡段。
  8. 根据权利要求1至7中任一项所述的装置，其特征在于，所述植入体为心脏瓣膜支架。
  9. 一种将植入体装载到输送系统中的方法，该输送系统具有导管，所述导管一端安装有输送系统连接件，并通过位于导管延长线上的细杆连接有输送系统导引头，其特征在于，所述方法使用权利要求1至7中任一项所述的装置实现，包括如下步骤：
    将植入体装入导引器，导引器的两端各露出一部分该植入体；
    将导引盖盖在导引器上，并使导引盖的直管或锥管穿过植入体并且所述导引盖的直管或椎管的端部从所述导引器的较小的开口端伸出；
    将收纳管套在输送系统的导管上；
    将输送系统导引头伸入导引盖的直管或锥管内，将植入体与输送系统连接件连接，移动所述输送系统的导管及所述收纳管，使所述植入体部分进入所述导管与收纳管内；
    将导引盖的较大开口端套在植入体上并使植入体进入导引盖的直管或锥管内，然后移动收纳管使植入体完全进入收纳管；
    移动导管使植入体完全进入导管内。
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EP3064174A4 (en) 2017-03-22
US20160278955A1 (en) 2016-09-29
US11622874B2 (en) 2023-04-11
CN104586542A (zh) 2015-05-06
US10098769B2 (en) 2018-10-16
ES2713381T3 (es) 2019-05-21
BR112016009486A2 (pt) 2017-08-01
JP2016534848A (ja) 2016-11-10
KR20160096600A (ko) 2016-08-16
US20180369004A1 (en) 2018-12-27
KR101797575B1 (ko) 2017-11-15
BR112016009486B1 (pt) 2021-08-24
JP6257790B2 (ja) 2018-01-10
EP3064174B1 (en) 2018-12-05
CN106562840B (zh) 2018-06-22
CN104586542B (zh) 2017-01-04
CN106562840A (zh) 2017-04-19
EP3064174A1 (en) 2016-09-07

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