WO2020135430A1 - 植入物的装载工具与医疗装置 - Google Patents

植入物的装载工具与医疗装置 Download PDF

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Publication number
WO2020135430A1
WO2020135430A1 PCT/CN2019/127986 CN2019127986W WO2020135430A1 WO 2020135430 A1 WO2020135430 A1 WO 2020135430A1 CN 2019127986 W CN2019127986 W CN 2019127986W WO 2020135430 A1 WO2020135430 A1 WO 2020135430A1
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WO
WIPO (PCT)
Prior art keywords
guide
seat
buckle
guide cover
implant
Prior art date
Application number
PCT/CN2019/127986
Other languages
English (en)
French (fr)
Inventor
梅杰
刘美辰
吴旭闻
桂宝珠
陈国明
李�雨
Original Assignee
上海微创心通医疗科技有限公司
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 上海微创心通医疗科技有限公司 filed Critical 上海微创心通医疗科技有限公司
Priority to ES19904549T priority Critical patent/ES2946015T3/es
Priority to EP19904549.3A priority patent/EP3903735B1/en
Priority to KR1020217023534A priority patent/KR102545918B1/ko
Publication of WO2020135430A1 publication Critical patent/WO2020135430A1/zh

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Classifications

    • 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
    • A61F2/9522—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
    • A61F2/0095—Packages or dispensers for prostheses or other implants
    • 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
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0091—Additional features; Implant or prostheses properties not otherwise provided for transparent or translucent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia

Definitions

  • the present invention relates to the field of medical devices, and in particular, to an implant loading tool and a medical device.
  • Interventional aortic valve implantation is a brand new micro-traumatic valve replacement technology developed internationally in recent years.
  • the principle is that the valve prosthesis (which includes a stent) is loaded into the delivery device and passed through the transcatheter. It can be delivered to the root of the aorta. After the stent is released, it can ensure that the valve prosthesis is fixed to the aortic annulus, replacing the degraded original valve, and improving the patient's heart function.
  • This technique can treat aortic valvular disease without opening the chest and beating the heart, eliminating the huge trauma caused by the previous surgical thoracotomy and cardiac arrest.
  • This technique requires the stent to be compressed to a very small diameter to be loaded into the conveyor catheter.
  • the stent or the valve on the stent is prone to damage or damage to the valve due to excessive compression, uneven compression, or local accidental bending, which eventually leads to defects or reduced service life of the stent or valve, and may even fail to implant and work normally.
  • the self-expanding stent's own tension makes it less likely to be fixed and compressed, and it is more prone to damage or breakage, which makes loading more difficult.
  • the technical requirements of the loading personnel are higher, and on the other hand, the implantation surgery time is prolonged invisibly, which increases the surgical risk.
  • the guide cover and the guide seat are usually used to perform preliminary compression on the stent, and then the guide cover and the guide seat are opened, and then the lumen of the guide seat is used to inflow the stent The tract is further compressed until the valve prosthesis is fully compressed.
  • the initial compression achieves the compression and partial loading of the stent, which is very important.
  • the initial compression process is prone to twisting and tilting, which can lead to deformation or damage of the stent.
  • the object of the present invention is to provide an implant loading tool and a medical device to solve the problem that the existing loading device is prone to twisting and tilting during use to deform or damage the implant.
  • an implant loading tool which includes a guide cover and a guide seat for detachably connecting with the guide cover, the guide cover has an axial direction Opposite first and second ends, the guide base has opposite third and fourth ends in the axial direction; the guide cover has a first through cavity, and the guide base is used to The third end faces the fourth end, and penetrates into the first inner cavity from the first end to the second end;
  • One of the guide cover and the guide seat is provided with a first snap portion and a second snap portion, the other of the guide cover and the guide seat is provided with a first A buckle seat and a second buckle seat; the first buckle portion is used to mate with the first buckle seat to limit the radial displacement of the guide cover relative to the guide seat Axial displacement; the second buckle portion is used for matching engagement with the second buckle seat to define the radial displacement, the axial displacement and the circumferential direction of the guide cover relative to the guide seat Turn
  • the first buckle portion and the second buckle portion are provided on the guide cover, and the first buckle seat and the second buckle seat are provided on the On the guide base;
  • the first buckle portion has a first engagement surface facing the second end and a first coupling surface toward the inside of the guide cover, the first buckle seat has a direction facing the A second engaging surface at the third end and a second coupling surface facing the outside of the guide seat;
  • the first coupling surface is used to abut the second coupling surface to define the guide cover relative to The radial displacement of the guide seat, the first engaging surface is used to abut against the second engaging surface, so as to limit the axial displacement of the guide cover relative to the guide seat, and Matching the first buckle part with the first buckle seat.
  • the second buckle portion includes a plurality of second buckles
  • the second buckle seat includes a plurality of second chutes that cooperate with the second buckles
  • the second card slot is configured as:
  • each of the second buckles has a first inclined surface; each of the second chutes has a second inclined surface that cooperates with the first inclined surface, the first inclined surface is The axial direction of the guide cover is at an angle; during the penetration of the guide seat into the first inner cavity, the second inclined surface abuts against the first inclined surface
  • an anti-skid groove is provided on the first inclined surface.
  • each of the second buckles has a third limit surface provided along the circumferential direction of the guide cover, and each of the second chutes has a third limit A fourth limiting surface matching the positioning surface; the third limiting surface and the fourth limiting surface abut against each other to limit the circumferential rotation of the guide cover relative to the guide seat
  • each of the second buckles has a third engaging surface disposed toward the second end, and each of the second chutes has a cooperation with the third engaging surface The fourth engaging surface; after the guide seat penetrates into the first inner cavity, the third engaging surface and the fourth engaging surface abut against each other to define the guide cover relative to The axial displacement of the guide seat.
  • a plurality of the second buckles are evenly distributed along the circumferential direction of the guide cover, and a plurality of the second buckles are evenly distributed along the circumferential direction of the guide seat.
  • the cross section of the first inner cavity gradually decreases from the first end to the second end.
  • the first lumen includes a first region, a second region, a third region, and a fourth region connected in sequence from the first end to the second end;
  • the inner diameter of the first zone remains constant along the axial direction of the guide cover, and the end of the first zone close to the first end is circumferentially provided with a plurality of tooth slots;
  • the inner diameter of the second zone near the first end is greater than the inner diameter of the fourth zone near the second end; [0024] the inner diameter of the third zone near the first end and close to the The inner diameter of the second end is smaller than the inner diameter of the second zone near the first end, and is larger than the inner diameter of the fourth zone near the second end.
  • the first area, the second area, the third area, and the fourth area are all circular in cross section, and the first area, the second area, the third area, and the fourth area
  • the bus bars are all straight lines; and the bus bars of the first zone, the second zone, the third zone, and the fourth zone all smoothly transition.
  • the cross sections of the first area, the second area, the third area, and the fourth area are all circular, and the generatrix of the third area and/or the fourth area is a curve,
  • the bus bars of the third zone smoothly transition with the bus bars of the fourth zone and the second zone, respectively.
  • the guide seat has a second inner cavity penetrating in the axial direction, and a cross section of the second inner cavity gradually decreases from the third end to the fourth end.
  • the second inner cavity sequentially includes a connected fifth area and a sixth area from the third end to the fourth end;
  • the inner diameter of the fifth zone near the third end is larger than the inner diameter of the fifth zone near the fourth end;
  • the inner diameter of the sixth zone near the third end is equal to the inner diameter of the fifth zone near the fourth end, and is not less than the inner diameter of the sixth zone near the fourth end.
  • the cross sections of the fifth zone and the sixth zone are both circular, and the generatrices of the fifth zone and the sixth zone are both straight lines; and Smooth transition between busbars.
  • the generatrix of the sixth area may also be a smoothly-transformed arc.
  • the outer wall of the guide seat is provided with a fixing groove with a notch along the circumferential direction, and the notch of the fixing groove faces the direction of the fourth end.
  • the fourth end extends out of the first end along the direction of the first end toward the second end Two ends.
  • the guide cover and the outer peripheral wall of the guide seat are provided with a non-slip structure to facilitate gripping.
  • the guide cover is made of a transparent material, and the guide cover is provided with an indicator ring along the circumferential direction to indicate the loading progress of the implant.
  • the present invention also provides a medical device, which includes a loading tool for an implant as described above, and further includes a delivery device, the loading tool is used to cooperate with the delivery device, An implant is loaded into the delivery device.
  • the implant is a valve stent.
  • the loading of the implant includes a guide cover and a guide seat, one of which is provided with a first buckle portion and a second buckle portion, the other is provided with a first buckle seat and a second buckle seat, and the first buckle portion is
  • the first buckle seat is matched and engaged, that is, limiting the radial displacement and the axial displacement of the guide cover and the guide seat; furthermore, the second buckle portion and the second buckle seat are matched and engaged to define the guide cover and the The radial displacement, axial displacement and circumferential rotation of the guide base.
  • the guide cover and the guide seat When the first buckle part and the first buckle seat are matched and engaged, the guide cover and the guide seat have no radial displacement, and the axial displacement is also limited to a coaxial stable state, which is convenient for the tapered head of the conveying device
  • the sleeve is inserted to facilitate the next compression of the implant; and when the second buckle portion is matched with the second buckle seat, the guide cover and the guide seat have no radial displacement, axial displacement and circumferential Rotating in the direction, the guide cover and the guide seat are relatively fixed, which can prevent the implant from twisting, tilting or wearing during the compression process.
  • the guide cover and the guide seat are connected in a matching and engaging manner with the snap portion and the snap seat, which is convenient to operate and improves the loading efficiency of the implant.
  • FIG. 1 is a front view of a guide cover of an implant loading tool provided by an embodiment of the present invention
  • FIG. 2 is an axial sectional view of the guide cover shown in FIG. 1 along the line A-A;
  • FIG. 3 is an axial cross-sectional view of a guide cover of an implant loading tool provided by a preferred embodiment of the present invention
  • FIG. 4 is a guide of an implant loading tool provided by an embodiment of the present invention Front view of the lead base;
  • FIG. 5 is an axial sectional view of the guide cover shown in FIG. 4 along the line B-B;
  • FIG. 6 is a front view of the guide cover and the guide seat of the implant loading tool provided by an embodiment of the present invention after being fitted;
  • FIG. 7 is an axial cross-sectional view of the implant loading tool shown in FIG. 6 along the line C-C;
  • FIG. 8 is a schematic diagram of a delivery device provided by an embodiment of the present invention.
  • FIG. 9 is a front view of a delivery device used in conjunction with an implant loading tool provided by an embodiment of the present invention, wherein the delivery device is used in conjunction with the fourth end of the guide base;
  • FIG. 10 is an axial sectional view of the delivery device shown in FIG. 9 cooperating with the implant loading tool;
  • FIG. 11 is a front view of a delivery device provided in accordance with an embodiment of the present invention used in conjunction with an implant loading tool Figure, where the conveying device is used in conjunction with the third end of the guide base;
  • FIG. 12 is an axial cross-sectional view of the delivery device shown in FIG. 11 cooperating with an implant loading tool
  • FIG. 13 is a schematic diagram of an implant provided by an embodiment of the present invention.
  • 1 _ guide cover 100-first lumen; 101-first end; 102-second end; 11-finger ring; 12-second snap portion; 121-first inclined surface; 122- Third engaging surface; 123-third limit surface; 124-fifth limit surface; 1 3-first area; 14-fourth area; 15-third area; 16-second area; 17-first A snap part; 171-first engaging surface; 172-first joint surface; 180-tooth groove; 181-inter-groove portion; 19-anti-slip structure;
  • 2-guide seat 200-second lumen; 201-third end; 202-fourth end; 21-top seat head end; 22-first snap seat; 221-second engagement surface 222-second joint surface; 23-fixing groove; 24-second snap seat; 241-second inclined surface; 242-fourth engaging surface; 243-fourth limiting surface; 244-groove cavity; 25- District 6; 26-District 5;
  • the present invention provides an implant loading tool and a medical device, including a guide cover and a guide seat for detachable connection with the guide cover, the guide cover has an axial opposite The first end and the second end, The guide base has opposite third and fourth ends in the axial direction; the guide cover has a first inner cavity penetrating through, and the guide base is used to direct the third end to the fourth end The direction of the end, penetrating into the first inner cavity from the first end to the second end; one of the guide cover and the guide seat is provided with a first buckle portion and a second buckle The other part of the guide cover and the guide seat is provided with a first buckle seat and a second buckle seat; the first buckle portion is used to match a card with the first buckle seat To define a radial displacement and an axial displacement of the guide cover relative to the guide seat; the second buckle portion is used to mate with the second buckle seat to define the The radial displacement, the axial displacement, and the circumferential rotation of the guide cover relative to the guide seat;
  • the matching action of the first buckle portion and the first buckle seat is prior to the matching engagement of the second buckle portion and the second buckle seat, and the second card
  • the buckle portion and the second buckle seat are matched and engaged with each other after the first buckle portion is separated from the first buckle seat.
  • the guide cover and the guide seat When the first buckle part and the first buckle seat are matched and engaged, the guide cover and the guide seat have no radial displacement, and the axial displacement is also limited to a coaxial stable state, which is convenient for the tapered head of the conveying device
  • the sleeve is inserted to facilitate the next compression of the implant; and when the second buckle portion is matched with the second buckle seat, the guide cover and the guide seat have no radial displacement, axial displacement and circumferential Rotating in the direction, the guide cover and the guide seat are relatively fixed, which can prevent the implant from twisting, tilting or wearing during the compression process.
  • the guide cover and the guide seat are connected in a matching and engaging manner with the snap portion and the snap seat, which is convenient to operate and improves the loading efficiency of the implant.
  • FIG. 1 is a front view of a guide cover of an implant loading tool provided by an embodiment of the present invention
  • FIG. 2 is a guide cover shown in FIG. 1 along AA
  • FIG. 3 is an axial sectional view of the guide cover of the implant loading tool provided by a preferred embodiment of the present invention
  • FIG. 4 is an implant loading tool provided by an embodiment of the present invention.
  • a front view of the guide base, FIG. 5 is an axial cross-sectional view of the guide cover shown in FIG. 4 along the line BB, and
  • FIG. 6 is a guide cover and guide for an implant loading tool provided by an embodiment of the present invention Front view of the seat after fitting, FIG.
  • FIG. 7 is an axial cross-sectional view of the implant loading tool shown in FIG. 6 along the CC line
  • FIG. 8 is a schematic diagram of the delivery device provided by an embodiment of the present invention
  • FIG. 9 is the present invention
  • FIG. 10 is the delivery device shown in FIG. 9 and the implant Shaft of the loading tool Sectional view
  • FIG. 11 is a front view of a delivery device provided in accordance with an embodiment of the present invention used in conjunction with an implant loading tool, wherein the delivery device is used in conjunction with the third end of the guide base
  • FIG. 12 is shown in FIG. 11
  • FIG. 13 is a schematic diagram of an implant provided by an embodiment of the present invention.
  • this embodiment provides an implant loading tool, which includes a guide cover 1 and a guide seat 2, the guide seat 2 and the guide cover 1 are Detachable connection, the guide cover 1 has a first internal cavity 100 penetrating, and the guide base 2 is used to penetrate the first internal cavity 100 to form an assembly for performing implants compression.
  • the guide cover 1 has opposite first ends 101 and second ends 102 in the axial direction, and the guide base 2 has opposite third ends 201 and fourth ends 202 in the axial direction.
  • the guide base 2 is used to penetrate the first inner cavity 100 from the first end 101 to the second end 102 in the direction of the third end 201 toward the fourth end 202, preferably To penetrate coaxially.
  • the first inner cavity 100 of the guide cover 1 includes a first region 13, a second region 16, a Three zones 15 and a fourth zone 14; the inner diameter of the first zone 13 remains constant along the axial direction of the guide cover 1 (that is, the inner diameters of the e-section and the d-section in FIG. 2 are the same), the first zone 13 A plurality of tooth slots 180 are opened in the circumferential direction near the first end 101, and a slot section 181 is formed between each two tooth slots 180; in practice, the first zone 13 is used for guiding the guide 2 Contact, abut or connect.
  • the guide cover 1 is provided with a first buckle portion 17 and a second buckle portion 12, and the guide seat 2 is correspondingly provided with a first buckle seat 22 and a second buckle seat 24
  • the first buckle portion 17 is used to match with the first buckle seat 22 to limit the radial displacement and axial displacement of the guide cover 1 relative to the guide seat 2;
  • the second buckle portion 12 is used to mate with the second buckle seat 24 to limit the radial displacement, axial displacement and circumferential rotation of the guide cover 1 relative to the guide seat 2 .
  • the distance between the first locking portion 17 and the first locking base 22 is smaller than that of the second locking The distance between the portion 12 and the second snap seat 24.
  • the distance between the buckle portion and the buckle seat here refers to the axial distance along the guide cover 1 and the guide seat 2, which has directionality, because the guide seat 2 is the third end 201 In the direction of the fourth end 202, the first end 101 and the second end 102 penetrate into the first inner cavity 100. Therefore, during the process of the guide base 2 penetrating into the first inner cavity, the second end 102 The direction toward the third end 201 is the positive direction.
  • the distance between the first locking portion 17 and the first locking seat 22 is an example, when the first The buckle portion 17 is closer to the second end 102 than the first buckle seat 22, the distance is positive, and when the first buckle portion 17 is farther from the second end 102 than the first buckle seat 22, then the The distance is a negative value, and when the distance between the first locking portion 17 and the first locking seat 22 relative to the second end 102 is the same, the first locking portion 17 and the first locking seat 22 are in the engaged state, two The distance between them is 0.
  • the distance between the second buckle portion 12 and the second buckle seat 24 also has the same directionality.
  • the distance between the first locking portion 17 and the first locking seat 22 is smaller than the distance between the second locking portion 12 and the second locking seat 24, when the guide base 2 penetrates into the first When the inner cavity 100, the first buckle portion 17 and the first buckle seat 22 will first match and engage; and when the guide base 2 continues to penetrate into the first inner cavity 100, the first buckle portion 17 and the first buckle The seat 22 is separated, and the distance between the two is a negative value until the second buckle portion 12 and the second buckle seat 24 are matched and engaged.
  • the guide cover 1 and the guide seat 2 When the first buckle portion 17 is matched with the first buckle seat 22, the guide cover 1 and the guide seat 2 have no radial displacement, and the axial displacement is also limited to a coaxial stable state, which is convenient for the conveying device
  • the conical head is inserted to facilitate the next compression of the implant; further, when the second buckle portion 12 is matched with the second buckle seat 24, the guide cover 1 and the guide seat 2 are not Radial displacement, axial displacement and circumferential rotation, the guide cover 1 and the guide seat 2 are in a relatively fixed state, which can prevent the implant from twisting, tilting or wearing during compression.
  • the guide cover 1 and the guide base 2 are connected in a matching and engaging manner with the snap portion and the snap seat, which is convenient to operate and improves the loading efficiency of the implant.
  • first buckle portion 17 and the second buckle portion 12 are not limited to be provided on the guide cover 1, nor are the first buckle seat 22 and the second buckle seat 24 Limited to the guide seat 2; the first buckle portion 17 and the second buckle portion 12 may be provided on the guide seat 2, while the first buckle seat 22 and the second buckle seat 24 are provided on the guide
  • the effect of the cover 1 is similar to this embodiment.
  • the first locking portion 17 has a first engaging surface 171 facing the second end 102 and a first coupling surface 172 facing the inside of the guide cover 1, the first The buckle base 22 has a second engaging surface 221 facing the third end 201 and a second coupling surface 222 facing the outside of the guide base 2; the first coupling surface 172 is used to communicate with the second The coupling surface 222 abuts to limit the radial displacement of the guide cover 1 relative to the guide base 2, and the first engaging surface 171 is used to abut the second engaging surface 221 to The axial displacement of the guide cover 1 relative to the guide seat 2 is limited, so that the first buckling portion 17 and the first buckle seat 22 are matched and engaged, and the guide seat 2 During the process of penetrating into the first inner cavity 100, as shown in FIG.
  • the shown guide base 2 approaches the first inner cavity 100 from the third end 201 to the fourth end 202.
  • the fourth end 202 first enters the first inner cavity 100 from the first end 101 of the guide cover 1, and then guides The guide base 2 continues to advance in the direction of the second end 102 of the guide cover 1 until the first locking portion 17 and the first locking base 22 are matched and engaged, the loading tool of the implant is in the first locked state
  • the guide cover 1 has no radial displacement with respect to the guide base 2, and the first cover 17 and the first cover 22 are matched and engaged with each other, which further defines the guide cover 1 toward the second
  • the direction of the end 102 has no axial displacement relative to the guide base 2.
  • this embodiment does not limit the axial displacement of the guide bow I cover 1 toward the first end 101 relative to the guide base 2, that is
  • the guide cover 1 is defined as a coaxial fit with respect to the guide base 2, and the axial displacement in one direction is limited.
  • the guide base 2 continues to advance in the direction of the second end 102 of the guide cover 1, the first locking portion 17 is separated from the first locking base 22.
  • the first locking portion 17 is separated from the first locking seat 22 here, which means that the first engaging surface 171 and the second engaging surface 221 are disengaged from each other without restricting the first coupling surface 172 and the second
  • the abutting relationship of the coupling surface 222 that is, the first buckling portion 17 is separated from the first buckling seat 22, refers to the direction of the guide seat 2 toward the second end 102 deeper into the first relative to the first locked state Inside the inner cavity 100, the radial displacement of both the guide cover 1 and the guide seat 2 continues to be defined by the abutment of the first coupling surface 172 and the second coupling surface 222.
  • the guide cover 1 and the guide base 2 are in a coaxial stable state, which facilitates the insertion of the tapered head of the delivery device, so as to facilitate the next compression of the implant.
  • the first locking portion 17 and the first locking seat 22 realize the guide cover 1 and the guide seat 2 by abutting the first engaging surface 171 and the second engaging surface 221
  • the axial limitation of the two, and in some other embodiments, the first buckle portion 17 and the first buckle seat 22 may also be a buckle form fixed by friction, or a buckle form of a groove and a protrusion Other forms of cooperation are used to achieve the axial definition of both the guide cover 1 and the guide base 2.
  • the first buckling portion 17 is disposed on the inter-slot portion 181 of the first region 13, as shown in FIG. 4, the first buckling seat 22 is further provided in the direction toward the fourth end 202
  • the slope surface provided in the circumferential direction of the guide base 2 is gradually expanded from the fourth end 202 toward the third end 201 to form a flare, and its maximum outer diameter is greater than the outer diameter of the second joint surface 222
  • the inner diameter of the first bonding surface 172 is preferably the same as the outer diameter of the second bonding surface 222 or slightly smaller than the outer diameter of the second bonding surface 222 to form a dimensional fit or an interference fit.
  • the first area 13 of the guide cover 1 is divided into a plurality of sub-portions by a plurality of tooth slots 180 in the circumferential direction.
  • the plurality of sub-portions are likely to undergo elastic deformation under the guidance of the slope to guide the outside of the guide cover 1 in the radial direction Expand until the first bonding surface 172 abuts the second bonding surface 222
  • both the guide cover 1 and the guide base 2 have no radial displacement.
  • the number of the tooth slots 180 can be selected according to needs, such as 2 to 12.
  • the tooth grooves 180 are preferably evenly distributed around the circumferential direction of the guide cover 1, so that a plurality of inter-groove portions 181 are symmetrically distributed in the circumferential direction of the guide cover 1, such as axis symmetry, center symmetry, or rotational symmetry.
  • the first locking portion 17 may be provided on all the inter-slot portions 181, and preferably only on some of the inter-slot portions 181, so as to realize both coaxial fixation and disassembly; more preferably, The first buckling portions 17 are symmetrically distributed around the circumferential center of the guide cover 1 to ensure that the guide cover 1 and the guide base 2 are uniformly stressed and do not tilt when combined.
  • the second buckle portion 12 includes a plurality of second buckles
  • the second buckle seat 24 includes a plurality of second buckles that cooperate with the second buckles
  • the first The two clamping slots are configured to: limit the radial displacement and circumferential rotation of the guide cover 1 relative to the guide base 2 during the penetration of the guide base 2 into the first inner cavity 100 After the guide seat 2 penetrates into the first inner cavity 100, the radial displacement, the axial displacement, and the circumferential rotation of the guide cover 1 relative to the guide seat 2 are defined.
  • the second buckle and the second buckle cooperate with each other, which is an active buckle-slot cooperation, preferably an elastic buckle-slot cooperation.
  • the second buckle may also be disposed on the inter-slot portion 181. As shown in FIGS. 1 and 2, there are two second buckles, which are symmetrically disposed between one slot on both sides of the axis of the guide cover 1 Department 181.
  • each of the second buckles has a first slope 121; each of the second slots has a second slope 241 cooperating with the first slope 121, the first
  • the inclined surface 121 forms an angle with the axial direction of the guide cover 1.
  • the first inclined surface 121 preferably gradually expands from the first end 101 to the second end 102.
  • the included angle may be greater than 0° and less than 60°. , More preferably greater than 0° and less than 30°, in order to guide the second buckle into the second slot; during the penetration of the guide seat 2 into the first internal cavity 100, the second slope 241 abuts against the first inclined surface 121 to limit the radial displacement of the guide cover 1 relative to the guide base 2.
  • Each of the second buckles has a third limiting surface 123 disposed along the circumferential direction of the guide cover 1, and each of the second chutes has a phase corresponding to the third limiting surface 123 The fourth limiting surface 243 that cooperates; the third limiting surface 123 and the fourth limiting surface 243 abut against each other to limit the circumferential rotation of the guide cover 1 relative to the guide base 2.
  • Each of the second buckles has a third engaging surface 122 disposed toward the second end 102, and each of the second chutes has a fourth engaging with the third engaging surface 122 Engagement surface 242.
  • the second clamping slot has a slot 244 that cooperates with the second buckle, and the slot 244 can be inserted into the second buckle. As shown in FIG.
  • the second inclined surface 241 and the fourth limit The positioning surface 243 is the inner wall of the groove 244, the fourth limiting surface 243 is two oppositely disposed, correspondingly, the third limiting surface 123 is the second snap along the circumferential direction of the guide cover 1 Two side walls, when the second buckle is inserted into the slot 244 of the second slot, the two side walls of each second buckle are against the two fourth limiting surfaces 243 of the corresponding slot 244 By this, the guide cover 1 is restricted from rotating circumferentially relative to the guide base 2. As shown in FIG. 7, the second inclined surface 241 is used to guide the first inclined surface 121.
  • the second inclined surface 241 and the first inclined surface An inclined surface 121 abuts, because the first inclined surface 121 and the matching second inclined surface 241 both form an angle with the axial direction of the guide cover 1, and the inner diameter of the first inclined surface 121 is from the first end 101 to the second
  • the direction of the end 102 gradually expands, that is, both the first inclined surface 121 and the second inclined surface 241 are inclined inward toward the direction in which the second buckle is inserted into the second slot, and the portion of the second buckle near the first end 101 forms a Oblique wedge.
  • the second inclined surface 241 when the second buckle is inserted into the second slot, since the second inclined surface 241 gradually shrinks toward the third end 201, the second inclined surface 241 can generate a radial direction toward the guide base 2 to the first inclined surface 121
  • the internal component force causes a certain deformation of the second buckle.
  • the rebound force of the second buckle can make the first inclined surface 121 and the second inclined surface 241 reliably abut against each other to ensure that the guide cover 1 relative to the guide seat 2 No radial displacement.
  • the second inclined surface 241 due to the elastic deformation of the second buckle, the second inclined surface 241 can also generate an axial force component toward the fourth end 202 relative to the first inclined surface 121.
  • the axial movement of the third end 201 of the lead base 2 is restricted to a certain extent.
  • the force can make the first engaging surface 171 and the second engaging surface 221 abut better together, so that when the guide cover 1 and the guide base 2 are in the first lock In the state, it is more limited that the guide cover 1 does not move axially relative to the guide base 2.
  • each of the second snaps has a third engaging surface 122 disposed toward the second end 102, and each of the second snap grooves has a third engaging surface 122 Cooperating fourth engaging surface 242; after the guide base 2 penetrates into the first inner cavity 100, the third engaging surface 122 and the fourth engaging surface 242 abut to define The guide cover 1 is axially displaced relative to the guide base 2.
  • the guide cover 1 and the guide base 2 form a fixed assembly relationship, that is, the guide cover 1 and the guide base 2 are in the second locked state, and the fourth The end 202 extends from the second end 102 along the direction of the first end 101 to the second end 102 (preferably the outer diameter of the fourth end 202 of the guide base 2 is smaller than the second end 102 of the guide cover 1 of Inner diameter so that the fourth end 202 extends beyond the second end 102).
  • the first inclined surface 121 is separated from the second inclined surface 241 at this time, and the first inclined surface 121 is closer to the third end 201 relative to the second inclined surface 241.
  • the third engaging surface 122 and the fourth engaging surface 242 abut against each other, limiting the guide cover 1 from axial displacement relative to the guide base 2.
  • the third engaging surface 122 and the fourth engaging surface 242 are not axially displaced relative to the guide seat 2 by abutting the defined guide cover 1, which also refers to defining the guide cover 1 toward the second end 102
  • the guide cover 1 and the guide base 2 Limiting other parts, for example, opposite limiting steps may be provided on the guide cover 1 and the guide seat 2, respectively, and the direction of the setting may be opposite to the third engaging surface 122 and the fourth engaging surface 24 2 respectively.
  • the two limiting steps also abut against each other, so that the axial direction of the guide cover 1 and the guide base 2 in two directions can be defined There is no axial displacement.
  • it is not limited here to limiting the guide cover 1 and the guide base 2 in the axial direction through the above solution.
  • frictional force and other methods may also be used, which is not limited in the present invention.
  • the second buckle further has a fifth limiting surface 124, the fifth limiting surface 124 is disposed toward the outside of the guide cover 1, when the third engaging surface 122 and the fourth engaging surface 242 are engaged When merging and abutting, the fifth limiting surface 124 is in contact with the second inclined surface 241 (especially the portion of the second inclined surface 241 near the third end 201), so that the second inclined surface 241 passes through the fifth limiting surface 124 It is further defined that the guide cover 1 has no radial displacement relative to the guide base 2.
  • the outer diameter of the fifth limiting surface 124 is preferably not less than the smallest inner diameter of the second inclined surface 241 (that is, the inner diameter of the second inclined surface 241 near the third end 201). In particular, the outer diameter of the fifth limiting surface 124 is slightly When it is larger than the minimum inner diameter of the second inclined surface 241, the rebound force generated by the deformation of the second buckle can better define the radial displacement of the guide cover 1 relative to the guide base 2.
  • the third engaging surface 122 of the guide cover 1 and the first engaging surface 171 have the same orientation
  • the fourth engaging surface 242 of the guide base 2 and the second engaging surface 221 have the same orientation
  • the distance between the second engaging surface 221 and the first engaging surface 171 is smaller than the fourth engaging surface 242 and the third engaging surface
  • the distance between 122 so as to ensure that the first snap portion 17 and the first snap seat 22 are matched and snapped before the second snap portion 12 and the second snap seat 24 are matched
  • the second buckle portion 12 and the second buckle seat 24 are matched and engaged with each other after the first buckle portion 17 is separated from the first buckle seat 22.
  • the second locking groove is directed toward the bottom end of the fourth end 202 and the second locking portion 12 is directed toward the first end 1
  • the distance between the tops of 01 is smaller than the distance between the first buckle portion 17 and the first buckle seat 22 (here, the distances refer to the axis along the guide cover 1 and the guide seat 2 Direction, it has directionality, because the guide base 2 penetrates the first lumen 100 from the first end 101 to the second end 102 in the direction from the third end 201 to the fourth end 202, so the guide During the process of the seat 2 penetrating into the first inner cavity 100, the direction from the second end 102 to the third end 201 may be a positive direction), so that the first locking portion 17 and the first locking seat 22 are realized During the engagement, part of the second buckle portion 12 enters the second engagement slot, and when the first engagement is achieved, the radial displacement, the axial displacement and the circumferential rotation of the guide cover 1 and the guide base 2 are limited .
  • the second buckle and the second buckle are not limited to two, both sides of the second buckle are adjacent to the inter-slot portion 181 through the tooth groove 180, at this time,
  • the two side walls adjacent to the tooth groove 180 of the second buckle may constitute the third limiting surface 123 described above.
  • a plurality of the second buckles are evenly distributed along the circumferential direction of the guide cover 1, and a plurality of the second buckles are evenly distributed along the circumferential direction of the guide base 2.
  • the evenly distributed second buckle and second buckle groove can make the guide cover 1 and the guide base 2 more uniformly stressed and less prone to tilt.
  • the number of the second buckle and the second buckle can be set differently according to needs, and the invention is not limited to this.
  • the first inner cavity 100 of the guide cover 1 is divided into a first region 13, a second region 16, and a Three zones 15 and a fourth zone 14, the inner diameter of the second zone 16 near the first end 101 (the inner diameter of section d) is greater than the inner diameter of the fourth zone 14 near the second end 102 (a section of a Inner diameter); the inner diameter of the third zone 15 near the first end 101 (the inner diameter of section c) and the inner diameter near the second end 102 (the inner diameter of section b) may be the same or different, and both are smaller than the second zone 16 is closer to the inner diameter of the first end 101 (the inner diameter of the d-section) and larger than the inner diameter of the fourth zone 14 near the second end 102 (the inner diameter of the a-section).
  • the second zone 16, the third zone 15, and the fourth zone 14 are all used to compress the implant.
  • the cross sections of the first region 13, the second region 16, the third region 15 and the fourth region 14 are all circular .
  • the generatrix of the first zone 13, the second zone 16, the third zone 15, and the fourth zone 14 (geometrical terms, the curved surface shape can be regarded as a trajectory when a moving line moves, and the moving line forming the curved surface is called a generating line ) Are straight lines, as shown in Figure 2.
  • the first zone 13 is cylindrical
  • the second zone 16 has a circular truncated cone shape with a larger bottom surface toward the first end 101
  • the third zone 15 is cylindrical or a truncated cone shape
  • the fourth zone 14 is a larger bottom surface orientation
  • the truncated cone shape of the first end 101 is more preferably, the busbars of the first zone 13, the second zone 16, the third zone 15 and the fourth zone 14 are all smoothly transitioned; the first inner cavity 100 thus configured is used For compressing implants, better results can be achieved.
  • bus bars of the first zone 13, the second zone 16, the third zone 15, and the fourth zone 14 may not be smooth transitions but may be formed by a straight line and hard junctions to form corners, or between any two of the four zones For smooth transition, the present invention does not limit this.
  • the first area 13, the second area 16, the third area 15 and the fourth area 14 are all circular in cross section, the third area 15 and the fourth area
  • the generatrix of 14 is a curve, and the generatrix of the third zone 15 smoothly transitions with the generatrix of the fourth zone 14 and the second zone 16, respectively, as shown in FIG. 3.
  • the generatrix of the third zone 15 is a concave curve toward the guide cover 1, which is beneficial to improve the fixation of the implant without external force, and it is more convenient for the operator to adjust the deviation of the posture of the implant during compression.
  • the generatrix of the fourth zone 14 may also be a curve, for example, a curve convex toward the guide cover 1, of course, the generatrix of the fourth zone 14 may also be a straight line at this time, which is not limited by the present invention .
  • the cross section of the first inner cavity 100 gradually decreases from the first end 101 to the second end 102, which means that the cross section of the first inner cavity 100 extends from the first end 101 to the second
  • the end 102 has a decreasing tendency, rather than defining that any cross-section in the first lumen 100 must be larger than the cross-section on the side of the cross-section closer to the second end 102.
  • the generatrix of the third zone 15 when the generatrix of the third zone 15 is a curve toward the concave of the guide cover 1, it may be a certain concave cross section in the concave part of the third zone 15, which may be larger than the third zone 15 near the first end 101 -The cross-section of the side, and the overall trend of the third zone 15 at this time also decreases from the first end 101 to the second end 102, so that it can also be regarded as the cross-section of the first inner cavity 100 from the first end 101 gradually decreases toward the second end 102.
  • the guide base 2 has a second inner cavity 200 penetrating in the axial direction, and a cross section of the second inner cavity 200 is from the third end 201 to the fourth end 202 slowing shrieking.
  • the cross section of the second inner cavity 200 gradually decreases from the third end 201 to the fourth end 202 here, which also means that the trend of change is gradually decreasing rather than limiting.
  • the second lumen 200 includes a fifth region 26 and a sixth region 25 connected from the third end 201 to the fourth end 202; the fifth region 26 is close to the third end 201 Inner diameter (h section inner diameter ) Greater than the inner diameter of the fifth region 26 near the fourth end 202 (inner diameter of the g-section); the inner diameter of the sixth region 25 near the third end 201 (inner diameter of the g-section) is equal to the The inner diameter of the fifth zone 26 near the fourth end 202 is not less than the inner diameter of the sixth zone 25 near the fourth end 202 (the inner diameter of the f section)
  • the fifth zone 26 is used to compress the implant.
  • the cross sections of the fifth zone 26 and the sixth zone 25 are both circular, and the generatrix of the fifth zone 26 and the sixth zone 25 are both straight lines, that is, the fifth zone 26 is larger
  • the bottom surface of is facing the circular truncated cone shape of the third end 201, and the fifth region 26 is cylindrical or circular truncated cone shape. More preferably, there is a smooth transition between the bus bars of the fifth zone 26 and the sixth zone 25.
  • the second lumen 200 configured in this way is used to compress the implant and can achieve better results.
  • busbars of the fifth zone 26 and the sixth zone 25 may not be smooth transitions but may be formed by straight lines and hard corners; or, one or both of the busbars of the fifth zone 26 and the sixth zone 25 may be curved
  • the generatrix of the sixth region 25 may also be a smoothly-transitioning arc, or a combination of a straight line and a curve. In actual use, better results can be obtained, and the present invention does not limit this.
  • the outer wall of the guide base 2 is provided with a fixing groove 23 having a notch along the circumferential direction, and the notch of the fixing groove 23 faces the direction of the fourth end 202.
  • the fixing groove 23 is used for inserting and abutting the implant to limit the axial displacement of the implant toward the third end 201.
  • non-slip structures 19 are provided on the outer peripheral walls of the guide cover 1 and the guide base 2 to facilitate gripping.
  • the anti-skid structure 19 on the guide cover 1 may be provided on the outer surface of the guide cover 1, for example, it may be an annular anti-skid edge along the circumferential direction of the guide cover 1.
  • the anti-slip structure 19 on the guide base 2 may be provided on the outer surface of the guide base 2, for example, it may be a non-slip recess.
  • the first inclined surface 121 of the second buckle may also be provided with anti-skid structures, such as anti-skid grooves or anti-skid convex teeth.
  • the present invention does not particularly limit the anti-skid structure, as long as it can facilitate gripping or increase the friction with the operator.
  • the guide cover 1 is made of a transparent material, such as polycarbonate (PC), etc.
  • the guide cover 1 is provided with an indicator ring 11 along the circumferential direction to indicate the loading progress of the implant .
  • the indicator ring 11 is used to indicate the implant located in the loading tool to achieve a predetermined degree of compression. It indicates that the next step can be performed. The operator can be prompted with the sound or light in the external handle.
  • the installation position of the indicator ring 11 can be determined according to the initial degree of compression of the implant.
  • the indicator ring 11 is not limited to a ring shape, but can also be dot-shaped , Blocky, etc.
  • the guide cover 1 is made of a transparent material, and it is not limited to that the entire guide cover 1 is made of a transparent material, but only a part of the guide cover 1 needs to be made of a transparent material, such as the second area 16 to The fourth zone 14 is made of transparent material or the like.
  • the entire guide cover 1 can be formed in one piece, or can be divided into multiple parts to be combined by welding, welding, or bonding.
  • the first area 13 and the second locking portion 12 can be made of a material with good elasticity.
  • the second area 16 to the fourth area 14 made of transparent material are fixedly assembled, etc., and the invention is not limited thereto.
  • this embodiment also provides a medical device, including the loading tool for the implant as described above, and further includes a delivery device 5, the loading tool for the implant is used to The delivery device 5 cooperates to load an implant into the delivery device 5.
  • the implant here refers to a compressible implant, such as a heart valve stent, etc.
  • the present invention does not specifically limit the geometry and material of the implant, which may be any existing implant in the art Thing.
  • valve stent 9 as an example of an implant, and with reference to the drawings, the use of the implant loading tool and the structure and principle of the medical device will be described.
  • FIG. 13 is a valve holder 9, including an outflow channel 92, an inflow channel 93, and a mounting ear 91.
  • the valve bracket 9 is compressed and loaded by the loading tool provided in this embodiment with the assistance of the delivery device 5.
  • the valve holder 9 is delivered into the patient's body by the delivery device 5 through the catheter in the contracted state to the target area and released, and expanded into the state shown in FIG. 13.
  • FIG. 8 is a delivery device 5, including a tapered head 54, a fixed head 55, a sheath tube 56, a catheter and a handle (not shown), the tapered head 54 is fixedly connected to the fixed head 55, The fixed head 55 is inserted into the sheath 56.
  • the fixing head 55 is fixed to the handle through a connecting piece, and the sheath 56 moves under the control of the handle, relatively exposing the fixing head 55 for the fixing head 55 to be connected with the hanging ear 91 of the valve support 9 as a force-applied end-to-valve support 9 Apply force.
  • the inflow channel 93 of the valve support 9 is first placed on the fixing groove 23 of the guide seat 2, and then the guide cover 1 is removed from the outflow channel 92 of the valve support 9 Press in the direction of the guide base 2 (that is, the guide base 2 penetrates into the first inner cavity 100), so that the first locking portion 17 of the guide cover 1 and the first locking base 22 of the guide base 2 are matched and engaged To relatively fix the guide cover 1 and the guide base 2 in the axial direction.
  • the second area 16 of the guide cover 1 is compressed for the first time, and the end of the outflow channel 92 slides into the third area 15.
  • the guide cover 1 and the guide base 2 form a first locked state.
  • the guide cover 1, the guide base 2 and the valve support 9 are in a coaxial stable state, which is convenient for fitting the tapered head 54 for the next compression.
  • the tapered head 54 is inserted into the second inner cavity 200 from the fourth end 202 of the guide base 2 (at this time, the guide cover 1 and the guide base 2 are in the first locked state, guide A valve support 9 is installed between the guide cover 1 and the guide base 2), and further, the mounting ears 91 and the fixing head 55 are substantially aligned, and then the guide cover 1 continues to be pushed toward the guide base 2 to make the second The buckle portion 12 is engaged with the second buckle groove 24.
  • part of the outflow channel 92 of the valve holder 9 is pushed out of the fourth area 14 from the third area 15 to form the guide cover 1, the guide seat 2 and the valve
  • the three of the brackets 9 are fixedly fitted so that the mounting ears 91 are caught in the grooves of the fixing head 55, as shown in FIGS. 9 and 10.
  • move the sheath 56 in the direction of the inflow channel 93 that is, toward the third end 201 of the guide base 2 on the right side in the figure
  • the valve holder 9 is driven to move into the sheath 56, so that the valve holder 9 starts to be loaded into the sheath 56.
  • the loading progress of the valve holder 9 can be observed through the transparent guide cap 1, and the bottom of the inflow channel 93 (ie, the lower end in FIG. 13) reaches or approaches the indicator ring 11 of the guide cap 1, which is completed
  • the valve support 9 can be effectively prevented from being twisted or tilted during the compression process Or wear, can make the compression process of the valve stent 9 smoothly.
  • the guide cover 1 and the guide base 2 can be detachably fixed twice (ie, the first locked state and the second Locked state).
  • the first buckle portion 17 and the first buckle seat 22 form a first fixation, forming a stable state in which the guide cover 1, the guide seat 2, and the valve support 9 are coaxial, which facilitates the fitting of the tapered head 54 to proceed One-step operation; the second snap portion 12 and the second card
  • the buckle seat 24 forms a second fixation.
  • This fixation realizes the radial, circumferential, and axial fixation of the guide cover 1 and the guide seat 2, which is more conducive to preventing the valve support 9 from twisting, tilting, or Wear; and this fixation method is more reliable, which can better ensure that the valve support 9, the first lumen 100 of the guide cover 1, the second lumen 200 of the guide seat 2 and the sheath 56 are coaxial during compression, The valve holder 9 is prevented from twisting or tilting during compression.
  • the guide cover 1 and the guide base 2 are connected by a buckle, which not only guarantees the fixation of the guide cover 1 and the guide base 2 during the first stage of the loading process of the valve support 9, but also facilitates opening, which is convenient
  • the next operation makes the entire operation process simple and controllable, which further improves the loading efficiency.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial 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)
  • Prostheses (AREA)
  • Electrotherapy Devices (AREA)

Abstract

一种植入物(9)的装载工具与医疗装置，植入物(9)的装载工具包括导引盖(1)以及导引座(2)，其中之一设有第一卡扣部(17)和第二卡扣部(12)，另一个设有第一卡扣座(22)和第二卡扣座(24)，第一卡扣部(17)与第一卡扣座(22)匹配卡合，即限定了导引盖(1)与导引座(2)的径向位移与轴向位移，使导引盖(1)与导引座(2)处于同轴的稳定状态，便于输送装置(5)之锥形头(54)的套入，以便于对植入物(9)进行压缩；进而第二卡扣部(12)与第二卡扣座(24)匹配卡合，可限定导引盖(1)与导引座(2)的径向位移、轴向位移和周向转动，导引盖(1)与导引座(2)为相对固定状态，能防止植入物(9)在压缩过程中发生扭转、倾斜或磨损。此外，采用卡扣部(17,22)与卡扣座(22,24)匹配卡合的方式连接导引盖(1)与导引座(2)，操作方便，提高了植入物(9)的装载效率。

Description

植入物的装载工具与医疗装置 技术领域
[0001] 本发明涉及医疗器械领域， 特别涉及一种植入物的装载工具与医疗装置。
背景技术
[0002] 介入主动脉瓣置入术是国际近年来研发的一种全新的微创伤瓣膜置换技术， 其 原理是瓣膜假体 （其包括一支架） 被装载到输送装置内， 通过经导管的方式输 送到主动脉根部， 支架释放后能够确保瓣膜假体被固定到主动脉瓣环处， 替代 功能退化的原瓣膜， 使病人心脏功能得到改善。 这项技术， 可以在不开胸、 心 脏不停跳的情况下治疗主动脉瓣瓣膜病， 免去了以前外科开胸术、 心脏停跳对 病人造成的巨大创伤。
发明概述
技术问题
[0003] 这项技术需要将支架压缩到很小的直径以载入输送器导管中。 而支架或支架上 的瓣膜容易因为过度压缩、 压缩不均匀、 或局部意外弯折造成支架损伤或瓣膜 破损， 最终导致支架或瓣膜的功能有缺陷或使用寿命降低， 甚至可能无法正常 植入、 工作。 尤其是在装载自膨胀支架的时候会因为自膨胀支架自身的张力导 致其更不易被固定和压缩， 更容易出现损伤或破损， 而使得装载变得更为困难 。 这一方面对装载人员的技术要求更高、 另一方面也无形之中延长了植入手术 时间， 增加了手术风险。
[0004] 使用装载工具装载瓣膜假体时， 通常使用导引盖与导引座配合对支架做初步压 缩， 然后打开导引盖和导引座， 再用导引座的内腔对支架的流入道做进一步压 缩， 直到瓣膜假体被完全压握。 初步压缩实现了支架压缩和部分装载， 十分重 要， 但是利用现有的装载工具， 初步压缩过程中容易发生扭转、 倾斜进而导致 支架变形或损坏， 直接影响后续操作， 甚至导致装载失败或影响植入体的使用
[0005] 因此， 需要一种操作简单、 装载效率高的装载装置。 问题的解决方案
技术解决方案
[0006] 本发明的目的在于提供一种植入物的装载工具与医疗装置， 以解决现有装载装 置在使用中容易发生扭转、 倾斜而使植入物变形或损坏的问题。
[0007] 为解决上述问题， 本发明提供一种植入物的装载工具， 其包括导引盖以及用于 与所述导引盖可拆卸连接的导引座， 所述导引盖沿轴向具有相对的第一端与第 二端， 所述导引座沿轴向具有相对的第三端与第四端； 所述导引盖具有贯通的 第一内腔， 所述导引座用于以所述第三端向所述第四端的方向， 由所述第一端 向所述第二端穿入所述第一内腔；
[0008] 所述导引盖和所述导引座中的一个设有第一卡扣部和第二卡扣部， 所述导引盖 和所述导引座中的另一个设有第一卡扣座和第二卡扣座； 所述第一卡扣部用于 与所述第一卡扣座匹配卡合， 以限定所述导引盖相对于所述导引座的径向位移 与轴向位移； 所述第二卡扣部用于与所述第二卡扣座匹配卡合， 以限定所述导 引盖相对于所述导引座的径向位移、 轴向位移和周向转动；
[0009] 其中， 在所述导引座穿入所述第一内腔的过程中， 所述第一卡扣部与所述第一 卡扣座之间的距离小于所述第二卡扣部与所述第二卡扣座之间的距离。
[0010] 可选的， 所述第一卡扣部和所述第二卡扣部设置于所述导引盖上， 所述第一卡 扣座和所述第二卡扣座设置于所述导引座上； 所述第一卡扣部具有朝向所述第 二端的第一卡合面与朝向所述导引盖之内部的第一结合面， 所述第一卡扣座具 有朝向所述第三端的第二卡合面与朝向所述导引座之外部的第二结合面； 所述 第一结合面用于与所述第二结合面相抵靠， 以限定所述导引盖相对于所述导引 座的径向位移， 所述第一卡合面用于与所述第二卡合面相抵靠， 以限定所述导 引盖相对于所述导引座的轴向位移， 进而使所述第一卡扣部与所述第一卡扣座 匹配卡合。
[0011] 可选的， 所述第二卡扣部包括多个第二卡扣， 所述第二卡扣座包括多个与所述 第二卡扣相配合的第二卡槽； 所述第二卡槽被配置为：
[0012] 在所述导引座穿入所述第一内腔的过程中， 限定所述导引盖相对于所述导引座 的径向位移与周向转动； [0013] 在所述导引座穿入所述第一内腔后， 限定所述导引盖相对于所述导引座的径向 位移、 轴向位移与周向转动。
[0014] 可选的， 每个所述第二卡扣均具有第一斜面； 每个所述第二卡槽均具有与所述 第一斜面相配合的第二斜面， 所述第一斜面与所述导引盖的轴向呈一夹角； 在 所述导引座穿入所述第一内腔的过程中， 所述第二斜面与所述第一斜面相抵靠
[0015] 可选的， 所述第一斜面上设有防滑槽。
[0016] 可选的， 每个所述第二卡扣均具有沿所述导引盖之周向设置的第三限位面， 每 个所述第二卡槽均具有与所述第三限位面相配合的第四限位面； 所述第三限位 面和所述第四限位面相抵靠， 以限定所述导引盖相对于所述导引座的周向转动
[0017] 可选的， 每个所述第二卡扣均具有朝向所述第二端设置的第三卡合面， 每个所 述第二卡槽均具有与所述第三卡合面相配合的第四卡合面； 在所述导引座穿入 所述第一内腔后， 所述第三卡合面和所述第四卡合面相抵靠， 以限定所述导引 盖相对于所述导引座的轴向位移。
[0018] 可选的， 多个所述第二卡扣沿所述导引盖之周向均匀分布， 多个所述第二卡槽 沿所述导引座之周向均匀分布。
[0019] 可选的， 当所述第一卡扣部与所述第一卡扣座匹配卡合时， 一部分所述第二卡 扣部进入所述第二卡槽， 限定所述导引盖相对于所述导引座的轴向径向位移与 周向转动。
[0020] 可选的， 所述第一内腔的横截面由所述第一端向所述第二端逐渐减小。
[0021] 可选的， 所述第一内腔由所述第一端向所述第二端包括依次连接的第一区、 第 二区、 第三区以及第四区；
[0022] 所述第一区的内径沿导引盖之轴向保持不变， 所述第一区靠近所述第一端的端 部沿周向开设有多个齿槽；
[0023] 所述第二区靠近所述第一端的内径大于所述第四区靠近所述第二端的内径； [0024] 所述第三区靠近所述第一端的内径及靠近所述第二端的内径均小于所述第二区 靠近所述第一端的内径， 且均大于所述第四区靠近所述第二端的内径。 [0025] 可选的， 所述第一区、 第二区、 第三区以及第四区的横截面均为圆形， 所述第 一区、 第二区、 第三区以及第四区的母线均为直线； 且所述第一区、 第二区、 第三区以及第四区的母线之间均光滑过渡。
[0026] 可选的， 所述第一区、 第二区、 第三区以及第四区的横截面均为圆形， 所述第 三区和 /或所述第四区的母线为曲线， 所述第三区的母线分别与所述第四区和所 述第二区的母线光滑过渡。
[0027] 可选的， 所述导引座具有沿轴向贯通的第二内腔， 所述第二内腔的横截面由所 述第三端向所述第四端逐渐减小。
[0028] 可选的， 所述第二内腔由所述第三端向所述第四端依次包括相连接的第五区与 第六区；
[0029] 所述第五区靠近所述第三端的内径大于所述第五区靠近所述第四端的内径；
[0030] 所述第六区靠近所述第三端的内径等于所述第五区靠近所述第四端的内径， 且 不小于所述第六区靠近所述第四端的内径。
[0031] 可选的， 所述第五区以及第六区的横截面均为圆形， 所述第五区以及第六区的 母线均为直线； 且所述第五区以及第六区的母线之间光滑过渡。 在一些实施例 中， 所述第六区的母线也可以是平滑过渡的圆弧。
[0032] 可选的， 所述导引座的外壁沿周向设有具有凹口的固定槽， 所述固定槽的凹口 朝向所述第四端的方向。
[0033] 可选的， 所述第二卡扣部与所述第二卡扣座匹配卡合时， 所述第四端沿所述第 一端向所述第二端的方向伸出所述第二端。
[0034] 可选的， 所述导引盖和所述导引座的外周壁上均设有防滑结构， 以便于抓握。
[0035] 可选的， 所述导引盖由透明材料制成， 所述导引盖沿周向设有指示环， 用以指 示植入物的装载进度。
[0036] 为解决上述问题， 本发明还提供一种医疗装置， 其包括如上所述的植入物的装 载工具， 还包括输送装置， 所述装载工具用于与所述输送装置相配合， 以将一 植入物装载于所述输送装置中。
[0037] 可选的， 所述植入物为瓣膜支架。
[0038] 综上所述， 在本发明提供的植入物的装载工具与医疗装置中， 所述植入物的装 载工具包括导引盖以及导引座， 其中之一设有第一卡扣部和第二卡扣部， 另一 个设有第一卡扣座和第二卡扣座， 第一卡扣部与第一卡扣座匹配卡合， 即限定 了导引盖与导引座的径向位移与轴向位移； 进而第二卡扣部与第二卡扣座匹配 卡合， 可限定导引盖与导引座的径向位移、 轴向位移和周向转动。 当第一卡扣 部与第一卡扣座匹配卡合时， 导引盖与导引座无径向位移， 轴向位移亦被限定 而处于同轴的稳定状态， 便于输送装置之锥形头的套入， 以便于对植入物进行 下一步压缩； 进而当第二卡扣部与第二卡扣座匹配卡合时， 导引盖与导引座无 径向位移、 轴向位移和周向转动， 导引盖与导引座为相对固定状态， 能防止植 入物在压缩过程中发生扭转、 倾斜或磨损。 此外， 采用卡扣部与卡扣座匹配卡 合的方式连接导引盖与导引座， 操作方便， 提高了植入物的装载效率。
发明的有益效果
对附图的简要说明
附图说明
[0039] 本领域的普通技术人员将会理解， 提供的附图用于更好地理解本发明， 而不对 本发明的范围构成任何限定。 其中：
[0040] 图 1是本发明一实施例提供的植入物的装载工具之导引盖的主视图；
[0041] 图 2是图 1所示的导引盖沿 A-A连线的轴剖面图；
[0042] 图 3是本发明一优选实施例提供的植入物的装载工具之导引盖的轴剖面图； [0043] 图 4是本发明一实施例提供的植入物的装载工具之导引座的主视图；
[0044] 图 5是图 4所示的导引盖沿 B-B连线的轴剖面图；
[0045] 图 6是本发明一实施例提供的植入物的装载工具之导引盖与导引座配合后的主 视图；
[0046] 图 7是图 6所示的植入物的装载工具沿 C-C连线的轴剖面图；
[0047] 图 8是本发明一实施例提供的输送装置的示意图；
[0048] 图 9是本发明一实施例提供的输送装置与植入物的装载工具相配合使用的主视 图， 其中输送装置与导引座之第四端相配合使用；
[0049] 图 10是图 9所示的输送装置与植入物的装载工具相配合的轴剖面图；
[0050] 图 11是本发明一实施例提供的输送装置与植入物的装载工具相配合使用的主视 图， 其中输送装置与导引座之第三端相配合使用；
[0051] 图 12是图 11所示的输送装置与植入物的装载工具相配合的轴剖面图；
[0052] 图 13是本发明一实施例提供的植入物的示意图。
[0053] 附图中：
[0054] 1_导引盖； 100 -第一内腔； 101 -第一端； 102 -第二端； 11 -指不环； 12 -第二卡 扣部； 121 -第一斜面； 122 -第三卡合面； 123 -第三限位面； 124 -第五限位面； 1 3 -第一区； 14 -第四区； 15 -第三区； 16 -第二区； 17 -第一卡扣部； 171-第一卡 合面； 172 -第一结合面； 180-齿槽； 181 -槽间部； 19 -防滑结构；
[0055] 2 -导引座； 200 -第二内腔； 201 -第三端； 202 -第四端； 21 -顶座头端； 22 -第一 卡扣座； 221-第二卡合面； 222 -第二结合面； 23 -固定槽； 24 -第二卡扣座； 241 -第二斜面； 242 -第四卡合面； 243 -第四限位面； 244 -槽腔； 25 -第六区； 26 -第 五区；
[0056] 5 -输送装置； 54 -锥形头； 55 -固定头； 56 -鞘管；
[0057] 9 -瓣膜支架； 91-挂耳； 92 -流出道； 93 -流入道。
发明实施例
本发明的实施方式
[0058] 为使本发明的目的、 优点和特征更加清楚， 以下结合附图和具体实施例对本发 明作进一步详细说明。 需说明的是， 附图均采用非常简化的形式且未按比例绘 制， 仅用以方便、 明晰地辅助说明本发明实施例的目的。 此外， 附图所展示的 结构往往是实际结构的一部分。 特别的， 各附图需要展示的侧重点不同， 有时 会采用不同的比例。
[0059] 如在本说明书和所附权利要求书中所使用的， 单数形式“一” 、 “一个” 以及 “该”包括复数对象， 除非内容另外明确指出外。 如在本说明书和所附权利要 求中所使用的， 术语“或”通常是以包括“和 /或” 的含义而进行使用的， 除非 内容另外明确指出外， 术语“近端”通常是靠近术者的一端， 术语“远端”通 常是靠近患者病变部位的一端。
[0060] 本发明提供了一种植入物的装载工具与医疗装置， 包括导引盖以及用于与所述 导引盖可拆卸连接的导引座， 所述导引盖沿轴向具有相对的第一端与第二端， 所述导引座沿轴向具有相对的第三端与第四端； 所述导引盖具有贯通的第一内 腔， 所述导引座用于以所述第三端向所述第四端的方向， 由所述第一端向所述 第二端穿入所述第一内腔； 所述导引盖和所述导引座中的一个设有第一卡扣部 和第二卡扣部， 所述导引盖和所述导引座中的另一个设有第一卡扣座和第二卡 扣座； 所述第一卡扣部用于与所述第一卡扣座匹配卡合， 以限定所述导引盖相 对于所述导引座的径向位移与轴向位移； 所述第二卡扣部用于与所述第二卡扣 座匹配卡合， 以限定所述导引盖相对于所述导引座的径向位移、 轴向位移和周 向转动； 其中， 在所述导引座穿入所述第一内腔的过程中， 所述第一卡扣部与 所述第一卡扣座之间的距离小于所述第二卡扣部与所述第二卡扣座之间的距离 。 如此配置， 所述第一卡扣部与所述第一卡扣座匹配卡合的动作先于所述第二 卡扣部与所述第二卡扣座匹配卡合， 且所述第二卡扣部与所述第二卡扣座匹配 卡合于所述第一卡扣部与所述第一卡扣座相分离后。 当第一卡扣部与第一卡扣 座匹配卡合时， 导引盖与导引座无径向位移， 轴向位移亦被限定而处于同轴的 稳定状态， 便于输送装置之锥形头的套入， 以便于对植入物进行下一步压缩； 进而当第二卡扣部与第二卡扣座匹配卡合时， 导引盖与导引座无径向位移、 轴 向位移和周向转动， 导引盖与导引座为相对固定状态， 能防止植入物在压缩过 程中发生扭转、 倾斜或磨损。 此外， 采用卡扣部与卡扣座匹配卡合的方式连接 导引盖与导引座， 操作方便， 提高了植入物的装载效率。
[0061] 以下参考附图进行描述。
[0062] 请参考图 1至图 13, 其中， 图 1是本发明一实施例提供的植入物的装载工具之导 引盖的主视图， 图 2是图 1所示的导引盖沿 A-A连线的轴剖面图， 图 3是本发明一 优选实施例提供的植入物的装载工具之导引盖的轴剖面图， 图 4是本发明一实施 例提供的植入物的装载工具之导引座的主视图， 图 5是图 4所示的导引盖沿 B-B连 线的轴剖面图， 图 6是本发明一实施例提供的植入物的装载工具之导引盖与导引 座配合后的主视图， 图 7是图 6所示的植入物的装载工具沿 C-C连线的轴剖面图， 图 8是本发明一实施例提供的输送装置的示意图， 图 9是本发明一实施例提供的 输送装置与植入物的装载工具相配合使用的主视图， 其中输送装置与导引座之 第四端相配合使用， 图 10是图 9所示的输送装置与植入物的装载工具相配合的轴 剖面图， 图 11是本发明一实施例提供的输送装置与植入物的装载工具相配合使 用的主视图， 其中输送装置与导引座之第三端相配合使用， 图 12是图 11所示的 输送装置与植入物的装载工具相配合的轴剖面图， 图 13是本发明一实施例提供 的植入物的示意图。
[0063] 如图 1至图 7所示， 本实施例提供一种植入物的装载工具， 其包括导引盖 1以及 导引座 2, 所述导引座 2与所述导引盖 1为可拆卸连接， 所述导引盖 1具有贯通的 第一内腔 100, 所述导引座 2用于穿入所述第一内腔 100， 以形成一装配体， 用以 对植入物进行压缩。 所述导引盖 1沿轴向具有相对的第一端 101与第二端 102, 所 述导引座 2沿轴向具有相对的第三端 201与第四端 202。 所述导引座 2用于以所述 第三端 201向所述第四端 202的方向， 由所述第一端 101向所述第二端 102穿入所 述第一内腔 100, 优选为同轴地穿入。
[0064] 优选的， 如图 1和图 2所示， 导引盖 1的第一内腔 100由第一端 101向第二端 102包 括依次连接的第一区 13、 第二区 16、 第三区 15以及第四区 14; 所述第一区 13的 内径沿导引盖 1之轴向保持不变 （即图 2中的 e截面与 d截面的内径相同） ， 所述 第一区 13靠近所述第一端 101的端部沿周向开设有多个齿槽 180, 每两个齿槽 180 之间形成一段槽间部 181 ; 实际中， 第一区 13用于与导引座 2相接触、 抵靠或连 接。
[0065] 所述导引盖 1设有第一卡扣部 17和第二卡扣部 12， 所述导引座 2则相对应地设有 第一卡扣座 22和第二卡扣座 24; 所述第一卡扣部 17用于与所述第一卡扣座 22匹 配卡合， 以限定所述导引盖 1相对于所述导引座 2的径向位移与轴向位移； 所述 第二卡扣部 12用于与所述第二卡扣座 24匹配卡合， 以限定所述导引盖 1相对于所 述导引座 2的径向位移、 轴向位移和周向转动。 其中， 在所述导引座 2穿入所述 第一内腔 100的过程中， 所述第一卡扣部 17与所述第一卡扣座 22之间的距离小于 所述第二卡扣部 12与所述第二卡扣座 24之间的距离。 需理解， 这里卡扣部与卡 扣座之间的距离， 指沿所述导引盖 1和导引座 2的轴向距离， 其具有方向性， 由 于导引座 2是以第三端 201向第四端 202的方向由第一端 101向第二端 102穿入第一 内腔 100, 故而在所述导引座 2穿入所述第一内腔的过程中， 可以第二端 102向第 三端 201的方向为正方向。 以第一卡扣部 17与第一卡扣座 22的距离为例， 当第一 卡扣部 17相比第一卡扣座 22更靠近第二端 102, 则其距离为正值， 当第一卡扣部 17相比第一卡扣座 22更远离第二端 102, 则其距离为负值， 而当第一卡扣部 17与 第一卡扣座 22相对第二端 102的距离相同时， 第一卡扣部 17与第一卡扣座 22即为 卡合状态， 两者的距离为 0; 同理， 第二卡扣部 12与第二卡扣座 24的距离亦具有 同样的方向性。 由于第一卡扣部 17与第一卡扣座 22之间的距离相比第二卡扣部 1 2与第二卡扣座 24之间的距离较小， 当导引座 2穿入第一内腔 100时， 第一卡扣部 17与第一卡扣座 22会首先匹配卡合； 而当导引座 2继续穿入第一内腔 100, 第一 卡扣部 17与第一卡扣座 22分离， 两者的距离即为负值， 直至第二卡扣部 12与第 二卡扣座 24匹配卡合。 如此即保证所述第一卡扣部 17与所述第一卡扣座 22匹配 卡合的动作先于所述第二卡扣部 12与所述第二卡扣座 24匹配卡合， 且所述第二 卡扣部 12与所述第二卡扣座 24匹配卡合于所述第一卡扣部 17与所述第一卡扣座 2 2相分离后。 当第一卡扣部 17与第一卡扣座 22匹配卡合时， 导引盖 1与导引座 2无 径向位移， 轴向位移亦被限定而处于同轴的稳定状态， 便于输送装置之锥形头 的套入， 以便于对植入物进行下一步压缩； 进而当第二卡扣部 12与第二卡扣座 2 4匹配卡合时， 导引盖 1与导引座 2无径向位移、 轴向位移和周向转动， 导引盖 1 与导引座 2为相对固定状态， 能防止植入物在压缩过程中发生扭转、 倾斜或磨损 。 此外， 采用卡扣部与卡扣座匹配卡合的方式连接导引盖 1与导引座 2, 操作方 便， 提高了植入物的装载效率。 需理解， 在一些其它的实施例中， 第一卡扣部 1 7和第二卡扣部 12不限于设于导引盖 1上， 第一卡扣座 22和第二卡扣座 24也不限 于设于导引座 2; 还可以是第一卡扣部 17和第二卡扣部 12设于导引座 2上， 而第 一卡扣座 22和第二卡扣座 24设于导引盖 1上， 其产生的效果与本实施例类似。
[0066] 优选的， 所述第一卡扣部 17具有朝向所述第二端 102的第一卡合面 171与朝向所 述导引盖 1之内部的第一结合面 172, 所述第一卡扣座 22具有朝向所述第三端 201 的第二卡合面 221与朝向所述导引座 2之外部的第二结合面 222; 所述第一结合面 172用于与所述第二结合面 222相抵靠， 以限定所述导引盖 1相对于所述导引座 2 的径向位移， 所述第一卡合面 171用于与所述第二卡合面 221相抵靠， 以限定所 述导引盖 1相对于所述导引座 2的轴向位移， 进而使所述第一卡扣部 17与所述第 一卡扣座 22匹配卡合， 在所述导引座 2穿入所述第一内腔 100的过程中， 如图 4所 示的导引座 2以第三端 201向第四端 202的方向朝向第一内腔 100靠近， 第四端 202 首先由导引盖 1的第一端 101进入第一内腔 100, 而后导引座 2继续向导引盖 1的第 二端 102的方向前进， 直至第一卡扣部 17与第一卡扣座 22匹配卡合时， 所述植入 物的装载工具处于第一锁定状态， 此时， 导引盖 1相对于导引座 2无径向位移， 而通过第一卡扣部 17与第一卡扣座 22的相互匹配卡合， 还限定了导引盖 1朝向第 二端 102的方向相对于导引座 2无轴向位移， 需说明的是， 本实施例并不限制导 弓 I盖 1朝向第一端 101的方向相对于导引座 2的轴向位移， 即导引盖 1相对于导引 座 2被限定为同轴配合， 轴向单方向的位移被限位。 当导引座 2继续向导引盖 1的 第二端 102的方向前进， 即令第一卡扣部 17与第一卡扣座 22相分离。 特别的， 这 里的第一卡扣部 17与第一卡扣座 22相分离， 指第一卡合面 171与第二卡合面 221 脱离抵靠， 而不限制第一结合面 172与第二结合面 222的抵靠关系， 亦即第一卡 扣部 17与第一卡扣座 22相分离， 指相对于第一锁定状态， 导引座 2朝向第二端 10 2的方向更深入第一内腔 100的内部， 而导引盖 1与导引座 2两者的径向位移继续 由第一结合面 172与第二结合面 222通过相抵靠而限定。 如此配置， 即可使导引 盖 1与导引座 2处于同轴的稳定状态， 便于输送装置之锥形头的套入， 以便于对 植入物进行下一步压缩。 需要说明的是， 本实施例中第一卡扣部 17与第一卡扣 座 22通过第一卡合面 171与第二卡合面 221相抵靠的方式实现导引盖 1与导引座 2 两者轴向的限定， 而在其它的一些实施例中， 第一卡扣部 17与第一卡扣座 22还 可以通过摩擦力固定的卡扣形式， 或者凹槽与凸起的卡扣形式等其它形式的配 合以实现导引盖 1与导引座 2两者的轴向限定。
[0067] 更优选的， 第一卡扣部 17设置于第一区 13的槽间部 181上， 如图 4所示， 第一卡 扣座 22之朝向第四端 202的方向还设有沿导引座 2之周向设置的坡面， 该坡面由 第四端 202朝向第三端 201的方向逐渐扩张， 形成一扩口， 且其最大外径大于第 二结合面 222之外径， 而第一结合面 172的内径优选与第二结合面 222之外径相同 或略小于第二结合面 222之外径， 以形成尺寸配合或过盈配合。 由于导引盖 1之 第一区 13被多个齿槽 180沿周向分为多个子部分。 在推动导引座 2进入导引盖 1的 第一内腔 100的过程中， 所述多个子部分均容易在所述坡面的引导下发生弹性形 变而沿径向向导引盖 1的外部扩张， 直至第一结合面 172与第二结合面 222相抵靠 而限定导引盖 1与导引座 2两者无径向位移。 可以理解的， 齿槽 180的数量可根据 需要而选取不同的数量， 如 2个~12个。 齿槽 180优选围绕所述导引盖 1之周向均 匀分布， 使得多个槽间部 181在导引盖 1之周向呈对称分布， 如轴对称、 中心对 称或者旋转对称等。 此外， 第一卡扣部 17可在所有的槽间部 181上均设置， 优选 地仅在部分槽间部 181上设置， 以便实现既可保证同轴固定， 也便于拆卸； 更为 优选的， 第一卡扣部 17围绕所述导引盖 1之周向中心对称分布， 以确保导引盖 1 与导引座 2结合时受力均匀， 不发生倾斜。
[0068] 进一步， 所述第二卡扣部 12包括多个第二卡扣， 所述第二卡扣座 24包括多个与 所述第二卡扣相配合的第二卡槽； 所述第二卡槽被配置为： 在所述导引座 2穿入 所述第一内腔 100的过程中， 限定所述导引盖 1相对于所述导引座 2的径向位移与 周向转动； 在所述导引座 2穿入所述第一内腔 100后， 限定所述导引盖 1相对于所 述导引座 2的径向位移、 轴向位移与周向转动。 第二卡扣与第二卡槽相互配合， 是一种主动式卡扣 -卡槽配合， 优选为弹性卡扣 -卡槽配合。 具体的， 第二卡扣 亦可设置在槽间部 181上， 如图 1和图 2所示， 第二卡扣为两个， 对称设置于导引 盖 1之轴线的两侧的一个槽间部 181上。
[0069] 优选的， 每个所述第二卡扣均具有第一斜面 121 ; 每个所述第二卡槽均具有与 所述第一斜面 121相配合的第二斜面 241， 所述第一斜面 121与所述导引盖 1的轴 向呈一夹角， 第一斜面 121优选由第一端 101向第二端 102的方向逐渐扩大， 该夹 角如可选大于 0 ° 且小于 60 ° ， 更优选为大于 0 ° 且小于 30 ° ， 以便于引导第二 卡扣插入第二卡槽； 在所述导引座 2穿入所述第一内腔 100的过程中， 所述第二 斜面 241与所述第一斜面 121相抵靠， 以限定所述导引盖 1相对于所述导引座 2的 径向位移。 每个所述第二卡扣均具有沿所述导引盖 1之周向设置的第三限位面 12 3, 每个所述第二卡槽均具有与所述第三限位面 123相配合的第四限位面 243; 所 述第三限位面 123和所述第四限位面 243相抵靠， 以限定所述导引盖 1相对于所述 导引座 2的周向转动。 每个所述第二卡扣均具有朝向所述第二端 102设置的第三 卡合面 122, 每个所述第二卡槽均具有与所述第三卡合面 122相配合的第四卡合 面 242。 在所述导引座 2穿入所述第一内腔 100后， 所述第三卡合面 122和所述第 四卡合面 242相抵靠， 以限定所述导引盖 1相对于所述导引座 2的轴向位移。 如图 4和 5所示， 第二卡槽具有一与第二卡扣相配合的槽腔 244, 该槽腔 244可供第二 卡扣插入， 如图 5所示， 第二斜面 241以及第四限位面 243即为该槽腔 244的内壁 ， 第四限位面 243为相对设置的两个， 相对应的， 第三限位面 123即为第二卡扣 沿导引盖 1之周向的两个侧壁， 当第二卡扣插入第二卡槽的槽腔 244时， 每个第 二卡扣的两个侧壁即与相对应的槽腔 244的两个第四限位面 243相抵靠， 由此导 引盖 1被限定相对于导引座 2无周向转动。 如图 7所示， 第二斜面 241则用于引导 第一斜面 121， 具体的， 当导引座 2穿入所述第一内腔 100的过程中， 所述第二斜 面 241与所述第一斜面 121相抵靠， 由于第一斜面 121以及与其相匹配的第二斜面 241均与导引盖 1的轴向呈一夹角， 且第一斜面 121的内径均由第一端 101向第二 端 102的方向逐渐扩大， 即第一斜面 121和第二斜面 241两个斜面均朝向第二卡扣 插入第二卡槽的方向向内倾斜， 第二卡扣靠近第一端 101的部位形成一斜楔形。 如此配置， 一方面， 在第二卡扣插入第二卡槽时， 由于第二斜面 241朝向第三端 201逐渐收缩， 第二斜面 241能够对第一斜面 121产生一径向朝向导引座 2内的分 力， 令第二卡扣产生一定的变形， 第二卡扣的反弹力能使第一斜面 121与第二斜 面 241可靠地抵靠在一起而保证导引盖 1相对于导引座 2无径向位移。 另一方面， 通过第二卡扣的弹性变形， 第二斜面 241相对于第一斜面 121还能产生一个朝向 第四端 202的轴向分力， 该力的存在可使第二卡扣朝向导引座 2之第三端 201的轴 向移动受到一定的限制， 配合着上述第一卡扣部 17与第一卡扣座 22的匹配卡合 的关系， 当外部的推动力小于该朝向第四端 202的轴向分力时， 该分力可使第一 卡合面 171与第二卡合面 221较好地抵靠在一起， 从而当导引盖 1与导引座 2处于 第一锁定状态时， 更能限定导引盖 1相对于导引座 2无轴向移动。
[0070] 进一步， 每个所述第二卡扣均具有朝向所述第二端 102设置的第三卡合面 122, 每个所述第二卡槽均具有与所述第三卡合面 122相配合的第四卡合面 242; 在所 述导引座 2穿入所述第一内腔 100后， 所述第三卡合面 122和所述第四卡合面 242 相抵靠， 以限定所述导引盖 1相对于所述导引座 2的轴向位移。 在导引座 2穿入第 一内腔 100后， 导引盖 1与导引座 2即形成一固定装配关系， 即导引盖 1与导引座 2 处于第二锁定状态， 此时第四端 202沿所述第一端 101向所述第二端 102的方向伸 出所述第二端 102 （优选导引座 2之第四端 202的外径小于导引盖 1之第二端 102的 内径， 以便第四端 202伸出第二端 102） 。 如图 6和图 7所示， 此时第一斜面 121与 第二斜面 241脱离， 第一斜面 121相对于位于第二斜面 241更靠近第三端 201处。 此时第三卡合面 122与第四卡合面 242相抵靠， 限定导引盖 1相对于导引座 2无轴 向位移。 需理解， 这里第三卡合面 122与第四卡合面 242通过抵靠限定的导引盖 1 相对于导引座 2无轴向位移， 亦指限定导引盖 1朝向第二端 102的轴向上相对于导 引座 2无轴向位移， 而导引盖 1朝向第一端 101的轴向上相对于导引座 2的轴向位 移可通过导引盖 1与导引座 2的其它部位进行限位， 例如可在导引盖 1与导引座 2 分别设置相对的限位台阶， 设置的方向可分别与第三卡合面 122与第四卡合面 24 2相反， 如此， 当第三卡合面 122与第四卡合面 242卡合并抵靠时， 两个限位台阶 亦相互抵靠， 如此即可限定导引盖 1与导引座 2两个方向的轴向上均无轴向位移 。 当然此处不限于通过上述方案对导引盖 1与导引座 2进行轴向限位， 如还可以 通过摩擦力等方式， 本发明对此不限。
[0071] 更进一步， 第二卡扣还具有第五限位面 124, 该第五限位面 124朝向导引盖 1之 外部设置， 当第三卡合面 122与第四卡合面 242卡合并抵靠时， 第五限位面 124与 第二斜面 241 （特别是与第二斜面 241之靠近第三端 201的部位） 相抵靠接触， 由 此第二斜面 241通过第五限位面 124进一步限定导引盖 1相对于导引座 2无径向位 移。 该第五限位面 124的外径优选不小于第二斜面 241之最小内径 （即第二斜面 2 41靠近第三端 201处的内径） ， 特别的， 第五限位面 124的外径略大于第二斜面 2 41之最小内径时， 可通过第二卡扣之变形产生的反弹力， 能更好地限定导引盖 1 相对于导引座 2的径向位移。
[0072] 再进一步， 导引盖 1之第三卡合面 122与第一卡合面 171的朝向相同， 导引座 2之 第四卡合面 242与第二卡合面 221的朝向相同， 在所述导引座 2穿入所述第一内腔 100的过程中， 第二卡合面 221与第一卡合面 171之间的距离小于第四卡合面 242 与第三卡合面 122之间的距离， 如此能保证第一卡扣部 17与所述第一卡扣座 22匹 配卡合的动作先于所述第二卡扣部 12与所述第二卡扣座 24匹配卡合， 且所述第 二卡扣部 12与所述第二卡扣座 24匹配卡合于所述第一卡扣部 17与所述第一卡扣 座 22相分离后。
[0073] 优选地， 所述第二卡槽朝向第四端 202的底端与所述第二卡扣部 12朝向第一端 1 01的顶端之间的距离小于所述第一卡扣部 17与所述第一卡扣座 22之间的距离 （ 此处距离， 均指沿所述导引盖 1和导引座 2的轴向距离， 其具有方向性， 由于导 引座 2是以第三端 201向第四端 202的方向由第一端 101向第二端 102穿入第一内腔 100, 故而在所述导引座 2穿入所述第一内腔 100的过程中， 可以第二端 102向第 三端 201的方向为正方向） ， 如此设置实现了在第一卡扣部 17与第一卡扣座 22卡 合时， 部分第二卡扣部 12进入第二卡槽， 实现了第一次卡合时， 即限定了导引 盖 1和导引座 2的径向位移、 轴向位移与周向转动。
[0074] 当导引盖 1与导引座 2处于第二锁定状态时， 通过对第二卡扣部 12施加朝向导引 盖 1之内部的压力， 可使第三卡合面 122与第四卡合面 242解除抵靠， 进而对第二 卡扣部 12施加朝向导引盖 1之第二端 102的推力， 可使导引盖 1与导引座 2解除第 二锁定状态。 进一步地对导引盖 1施加朝向第二端 102的推力， 或者， 对导引座 2 施加朝向第三端 201的拉力 （也可同时对导引盖 1和导引座 2同时施力） ， 可使导 引盖 1与导引座 2两者进一步解除第一锁定状态而相分离。
[0075] 在其它的一些实施例中， 第二卡扣和第二卡槽不限于为两个， 第二卡扣的两侧 均通过齿槽 180与槽间部 181相临接， 此时， 第二卡扣之临接齿槽 180的两个侧壁 ， 可构成上述的第三限位面 123。 多个所述第二卡扣沿所述导引盖 1之周向均匀 分布， 多个所述第二卡槽沿所述导引座 2之周向均匀分布。 均匀分布的第二卡扣 和第二卡槽可使导引盖 1与导引座 2结合时受力更均匀， 不易发生倾斜。 第二卡 扣和第二卡槽的数量可根据需要进行不同的设定， 本发明对此不限。
[0076] 如图 2和图 3所示， 所述导引盖 1之第一内腔 100由第一端 101向第二端 102划分为 依次连接的第一区 13、 第二区 16、 第三区 15以及第四区 14, 所述第二区 16靠近 所述第一端 101的内径（d截面的内径）大于所述第四区 14靠近所述第二端 102的内 径 （a截面的内径） ； 所述第三区 15靠近所述第一端 101的内径 （c截面的内径） 和靠近第二端 102的内径 （b截面的内径） 可以相同也可以不同， 并都小于第二 区 16靠近所述第一端 101的内径（d截面的内径）且大于所述第四区 14靠近所述第 二端 102的内径 （a截面的内径） 。 实际中， 第二区 16、 第三区 15以及第四区 14 均用于压缩植入物。
[0077] 优选的， 所述第一区 13、 第二区 16、 第三区 15以及第四区 14的横截面均为圆形 ， 所述第一区 13、 第二区 16、 第三区 15以及第四区 14的母线 （几何用语， 曲面 形状可看成一动线运动时的轨迹， 形成该曲面的动线即称为母线） 均为直线， 如图 2所示。 亦即， 第一区 13为圆柱形， 第二区 16为较大的底面朝向第一端 101 的圆台形， 第三区 15为圆柱形或圆台形， 第四区 14为较大的底面朝向第一端 101 的圆台形， 更优选的， 所述第一区 13、 第二区 16、 第三区 15以及第四区 14的母 线之间均光滑过渡； 如此配置的第一内腔 100用于压缩植入物， 能取得较好的效 果。 当然第一区 13、 第二区 16、 第三区 15以及第四区 14的母线之间也可以不是 光滑过渡而由直线硬交接而形成角部， 或者该四个区域中任意两者之间为光滑 过渡， 本发明对此亦不作限制。
[0078] 在其它的一些实施例中， 第一区 13、 第二区 16、 第三区 15以及第四区 14的横截 面均为圆形， 所述第三区 15和所述第四区 14的母线为曲线， 所述第三区 15的母 线分别与所述第四区 14和所述第二区 16的母线光滑过渡， 如图 3所示。 第三区 15 的母线为朝向导引盖 1内凹的曲线， 有利于在没有外力的作用下， 提高植入物的 固定程度， 更便于操作人员调整植入物在压缩过程中姿态的偏差。 与之相匹配 的， 第四区 14的母线亦可为曲线， 例如为朝向导引盖 1外凸的曲线等， 当然此时 第四区 14的母线也可以是直线， 本发明对此不作限制。
[0079] 需理解， 第一内腔 100的横截面由所述第一端 101向所述第二端 102逐渐减小， 是指第一内腔 100的横截面由第一端 101向第二端 102为一减小的趋势， 而非限定 第一内腔 100中任一横截面必须大于位于该横截面更靠近第二端 102—侧的横截 面。 例如第三区 15的母线为朝向导引盖 1内凹的曲线时， 可能在第三区 15的内凹 部分中的某一内凹横截面， 可能大于第三区 15之靠近第一端 101—侧的横截面， 而此时第三区 15的整体趋势亦是由第一端 101向第二端 102减小， 如此亦可视为 第一内腔 100的横截面由所述第一端 101向所述第二端 102逐渐减小。
[0080] 请参考图 5, 所述导引座 2具有沿轴向贯通的第二内腔 200, 所述第二内腔 200的 横截面由所述第三端 201向所述第四端 202逐渐减小。 同样的， 此处第二内腔 200 的横截面由第三端 201向第四端 202逐渐减小， 亦是指变化的趋势为逐渐减小而 非限定。 优选的， 第二内腔 200由所述第三端 201向所述第四端 202包括相连接的 第五区 26与第六区 25; 所述第五区 26靠近所述第三端 201的内径 （h截面的内径 ） 大于所述第五区 26靠近所述第四端 202的内径 （g截面的内径） ； 所述第六区 2 5靠近所述第三端 201的内径 （g截面的内径） 等于所述第五区 26靠近所述第四端 202的内径， 且不小于所述第六区 25靠近所述第四端 202的内径 （f截面的内径）
。 实际中， 第五区 26用于压缩植入物。
[0081] 优选的， 所述第五区 26以及第六区 25的横截面均为圆形， 所述第五区 26以及第 六区 25的母线均为直线， 即第五区 26为较大的底面朝向第三端 201的圆台形， 第 五区 26为圆柱形或圆台形。 更优选的， 所述第五区 26以及第六区 25的母线之间 光滑过渡。 如此配置的第二内腔 200用于压缩植入物， 能取得较好的效果。 当然 第五区 26以及第六区 25的母线之间也可以不是光滑过渡而由直线硬交接而形成 角部； 或者， 第五区 26和第六区 25的母线中的一个或两个为曲线， 如所述第六 区 25的母线也可以是平滑过渡的圆弧， 亦或者由直线与曲线组合而成。 实际使 用中亦能取得较好的效果， 本发明对此亦不作限制。
[0082] 进一步， 如图 5所示， 所述导引座 2的外壁沿周向设有具有凹口的固定槽 23, 所 述固定槽 23的凹口朝向所述第四端 202的方向。 该固定槽 23用于供植入物插入并 抵靠， 以限定植入物朝向第三端 201方向的轴向位移。
[0083] 优选的， 所述导引盖 1和所述导引座 2的外周壁上均设有防滑结构 19， 以便于抓 握。 如图 1所示， 导引盖 1上的防滑结构 19可设置在导引盖 1的外表面上， 例如可 以为沿导引盖 1之周向的环状防滑棱。 如图 4所述， 导引座 2上的防滑结构 19可设 置在导引座 2的外表面上， 例如可以为防滑凹口等。 第二卡扣之第一斜面 121上 也可以设置防滑结构， 如防滑凹槽或防滑凸齿等。 本发明对防滑结构不作特别 的限定， 其只要能便于抓握或增大与操作者之间的摩擦力即可。
[0084] 更优选的， 所述导引盖 1由透明材料制成， 如聚碳酸脂 （PC） 等， 所述导引盖 1 沿周向设有指示环 11， 用以指示植入物的装载进度。 指示环 11用于指示位于装 载工具中植入物以达到一预定的压缩程度， 提示可进行下一步操作， 其可以是 涂料标记、 凹槽、 凸棱亦或是其他醒目的标记方式， 同时也可以配合外部手柄 中的声音或者灯光等对操作者进行提示， 指示环 11的设置位置可根据植入物之 初步的压缩程度来确定， 指示环 11亦不限于为环状， 也可以是点状、 块状等。 当植入物被压缩、 装载到指示环 11的位置时， 即可打开导引盖 1和导引座 2, 再 进行下一步操作。 需理解， 这里导引盖 1由透明材料制成， 不限于导引盖 1的整 体均由透明材料制成， 而仅需要导引盖 1的一部分为透明材料制成， 如第二区 16 至第四区 14由透明材料制成等。 整个导引盖 1可一体成型， 亦可分成多个部件通 过焊接、 熔接或粘接等方式组合而成， 如第一区 13及第二卡扣部 12可采用弹性 较好的材料制成， 再与透明材料制成的第二区 16至第四区 14固定装配等， 本发 明对此亦不作限制。
[0085] 请参考图 8至图 13, 本实施例还提供一种医疗装置， 包括如上所述的植入物的 装载工具， 还包括输送装置 5, 所述植入物的装载工具用于与所述输送装置 5相 配合， 以将一植入物装载于所述输送装置 5中。 这里的植入物， 指可压缩的植入 物， 如心脏瓣膜支架等， 本发明对植入物的几何形状与材料均不作特别的限定 ， 其可以是本领域任一种现有的植入物。
[0086] 以下以一瓣膜支架 9作为植入物的范例， 结合附图， 对所述植入物的装载工具 的使用方式， 以及所述医疗装置的结构和原理进行说明。
[0087] 请参考图 13， 其为一种瓣膜支架 9， 包括流出道 92、 流入道 93和挂耳 91， 瓣膜 支架 9在输送装置 5的辅助下经过本实施例提供的装载工具压缩并装载到输送装 置 5中。 而后使用中， 瓣膜支架 9在收缩状态下由输送装置 5通过导管送入患者体 内至目标区域并释放， 展开成如图 13所示的状态。
[0088] 请参考图 8, 其为一种输送装置 5, 包括锥形头 54、 固定头 55、 鞘管 56以及导管 和手柄 （未图示） ， 锥形头 54与固定头 55固定连接， 固定头 55穿设于鞘管 56内 。 固定头 55通过连接件与手柄固定， 鞘管 56在手柄的控制下活动， 相对地暴露 出固定头 55， 供固定头 55用于与瓣膜支架 9的挂耳 91连接， 以作为施力端对瓣膜 支架 9施力。
[0089] 所述植入物的装载工具在使用中， 首先将瓣膜支架 9的流入道 93放置在导引座 2 的固定槽 23上， 而后将导引盖 1从瓣膜支架 9的流出道 92向导引座 2的方向按压 （ 即导引座 2穿入第一内腔 100） ， 使导引盖 1的第一卡扣部 17与导引座 2的第一卡 扣座 22匹配卡合， 使导引盖 1与导引座 2进行轴向的相对固定。 此时瓣膜支架 9由 于一端被固定槽 23限位， 故被导引盖 1的第二区 16进行了第一次压缩， 而流出道 92的一端则滑入第三区 15中。 此时由于第一卡扣部 17与第一卡扣座 22匹配卡合 ， 导引盖 1与导引座 2形成第一锁定状态， 导引盖 1、 导引座 2与瓣膜支架 9处于同 轴的稳定状态， 便于套入锥形头 54， 以进行下一步压缩。
[0090] 如图 4所示， 将锥形头 54由导引座 2的第四端 202穿入第二内腔 200 （此时导引盖 1与导引座 2为第一锁定状态， 导引盖 1与导引座 2之间装设有瓣膜支架 9） ， 进而 ， 将挂耳 91与固定头 55大致对齐， 而后将导引盖 1向导引座 2的方向继续推送， 使第二卡扣部 12与第二卡扣槽 24卡合， 此过程中， 部分瓣膜支架 9的流出道 92从 第三区 15被推出第四区 14, 形成导引盖 1、 导引座 2和瓣膜支架 9三者固定配合， 以便于将挂耳 91卡在固定头 55的凹槽中， 如图 9和图 10所示。 在确认挂耳 91卡入 固定头 55的凹槽后， 通过手柄操作， 将鞘管 56向流入道 93的方向 （即导引座 2之 第三端 201的方向， 图中右侧） 运动， 带动瓣膜支架 9向鞘管 56的内部移动， 使 瓣膜支架 9开始装载入鞘管 56。 此过程中， 可通过透明的导引盖 1观察瓣膜支架 9 的装载进度， 待流入道 93的底部 （即图 13中的下端部） 到达或接近导引盖 1的指 示环 11处， 即完成瓣膜支架 9第一阶段的装载。 在瓣膜支架 9第一阶段的装载过 程中， 由于导引盖 1和导引座 2可以实现径向、 周向和轴向的固定， 可有效地防 止瓣膜支架 9在压缩过程中发生扭转、 倾斜或磨损， 可使得瓣膜支架 9的压缩过 程平稳进行。
[0091] 请参考图 11和图 12 , 在完成瓣膜支架 9第一阶段的装载后， 按压第二卡扣部 12 ， 进而使导引座 2和导引盖 1分离， 导引盖 1朝向图中左侧移动 （图中未图示） ， 暴露瓣膜支架 9 , 将导引座 2倒置 （即将第三端 201与第四端 202的方向调换） ， 以第四端 202朝向第三端 201的方向， 向鞘管 56的方向 （图中左侧） 移动， 通过 导引座 2的第五区 26， 将瓣膜支架 9的流入道 93推入第六区 25， 使流入道 93的外 径压缩至与鞘管 56的内径相近。 而后， 通过继续操作手柄， 推动鞘管 56前进， 进而拉动瓣膜支架 9向图中左侧移动， 将瓣膜支架 9完全装载入鞘管 56中， 即完 成整个瓣膜支架 9的装载过程。
[0092] 综上， 瓣膜支架 9装载入本发明提供的植入物的装载工具之后， 导引盖 1和导引 座 2可以进行两次可拆卸的固定 （即第一锁定状态和第二锁定状态） 。 第一卡扣 部 17与第一卡扣座 22形成第一次固定， 形成导引盖 1、 导引座 2、 瓣膜支架 9同轴 的稳定状态， 便于套入锥形头 54， 以进行下一步操作； 第二卡扣部 12与第二卡 扣座 24形成第二次固定， 这种固定实现了导引盖 1和导引座 2的径向、 周向和轴 向固定， 更有利于防止瓣膜支架 9在压缩过程中发生扭转、 倾斜或磨损； 且该固 定方式更加牢靠， 能够更好地确保压缩过程中瓣膜支架 9、 导引盖 1之第一内腔 1 00、 导引座 2之第二内腔 200以及鞘管 56同轴， 防止瓣膜支架 9在压缩过程中发生 扭转或倾斜。 此外， 导引盖 1和导引座 2通过卡扣形式的连接， 既保证了瓣膜支 架 9在第一阶段的装载过程中， 导引盖 1与导引座 2的固定， 又方便打开， 便于下 一步操作， 使整个操作过程简单可控， 进一步提高了装载效率。
[0093] 上述描述仅是对本发明较佳实施例的描述， 并非对本发明范围的任何限定， 本 发明领域的普通技术人员根据上述揭示内容做的任何变更、 修饰， 均属于权利 要求书的保护范围。

Claims

权利要求书
[权利要求 1] 一种植入物的装载工具， 其特征在于， 包括导引盖以及用于与所述导 引盖可拆卸连接的导引座， 所述导引盖沿轴向具有相对的第一端与第 二端， 所述导引座沿轴向具有相对的第三端与第四端； 所述导引盖具 有贯通的第一内腔， 所述导引座用于以所述第三端向所述第四端的方 向， 由所述第一端向所述第二端穿入所述第一内腔； 所述导引盖和所 述导引座中的一个设有第一卡扣部和第二卡扣部， 所述导引盖和所述 导引座中的另一个设有第一卡扣座和第二卡扣座； 所述第一卡扣部用 于与所述第一卡扣座匹配卡合， 以限定所述导引盖相对于所述导引座 的径向位移与轴向位移； 所述第二卡扣部用于与所述第二卡扣座匹配 卡合， 以限定所述导引盖相对于所述导引座的径向位移、 轴向位移和 周向转动； 其中， 在所述导引座穿入所述第一内腔的过程中， 所述第 一卡扣部与所述第一卡扣座之间的距离小于所述第二卡扣部与所述第 二卡扣座之间的距离。
[权利要求 2] 根据权利要求 1所述的植入物的装载工具， 其特征在于， 所述第一卡 扣部和所述第二卡扣部设置于所述导引盖上， 所述第一卡扣座和所述 第二卡扣座设置于所述导引座上； 所述第一卡扣部具有朝向所述第二 端的第一卡合面与朝向所述导引盖之内部的第一结合面， 所述第一卡 扣座具有朝向所述第三端的第二卡合面与朝向所述导引座之外部的第 二结合面； 所述第一结合面用于与所述第二结合面相抵靠， 以限定所 述导引盖相对于所述导引座的径向位移， 所述第一卡合面用于与所述 第二卡合面相抵靠， 以限定所述导引盖相对于所述导引座的轴向位移 ， 进而使所述第一卡扣部与所述第一卡扣座匹配卡合。
[权利要求 3] 根据权利要求 2所述的植入物的装载工具， 其特征在于， 所述第二卡 扣部包括多个第二卡扣， 所述第二卡扣座包括多个与所述第二卡扣相 配合的第二卡槽； 所述第二卡槽被配置为： 在所述导引座穿入所述第 一内腔的过程中， 限定所述导引盖相对于所述导引座的径向位移与周 向转动； 在所述导引座穿入所述第一内腔后， 限定所述导引盖相对于 所述导引座的径向位移、 轴向位移与周向转动。
[权利要求 4] 根据权利要求 3所述的植入物的装载工具， 其特征在于， 每个所述第 二卡扣均具有第一斜面； 每个所述第二卡槽均具有与所述第一斜面相 配合的第二斜面， 所述第一斜面与所述导引盖的轴向呈一夹角； 在所 述导引座穿入所述第一内腔的过程中， 所述第二斜面与所述第一斜面 相抵靠。
[权利要求 5] 根据权利要求 4所述的植入物的装载工具， 其特征在于， 所述第一斜 面上设有防滑槽。
[权利要求 6] 根据权利要求 3所述的植入物的装载工具， 其特征在于， 每个所述第 二卡扣均具有沿所述导引盖之周向设置的第三限位面， 每个所述第二 卡槽均具有与所述第三限位面相配合的第四限位面； 所述第三限位面 和所述第四限位面相抵靠， 以限定所述导引盖相对于所述导引座的周 向转动。
[权利要求 7] 根据权利要求 3所述的植入物的装载工具， 其特征在于， 每个所述第 二卡扣均具有朝向所述第二端设置的第三卡合面， 每个所述第二卡槽 均具有与所述第三卡合面相配合的第四卡合面； 在所述导引座穿入所 述第一内腔后， 所述第三卡合面和所述第四卡合面相抵靠， 以限定所 述导引盖相对于所述导引座的轴向位移。
[权利要求 8] 根据权利要求 3所述的植入物的装载工具， 其特征在于， 多个所述第 二卡扣沿所述导引盖之周向均匀分布， 多个所述第二卡槽沿所述导引 座之周向均勾分布。
[权利要求 9] 根据权利要求 3所述的植入物的装载工具， 其特征在于， 当所述第一 卡扣部与所述第一卡扣座匹配卡合时， 一部分所述第二卡扣部进入所 述第二卡槽， 限定所述导引盖相对于所述导引座的轴向径向位移与周 向转动。
[权利要求 10] 根据权利要求 1所述的植入物的装载工具， 其特征在于， 所述第一内 腔的横截面由所述第一端向所述第二端逐渐减小。
[权利要求 11] 根据权利要求 10所述的植入物的装载工具， 其特征在于， 所述第一内 腔由所述第一端向所述第二端包括依次连接的第一区、 第二区、 第三 区以及第四区； 所述第一区的内径沿导引盖之轴向保持不变， 所述第 一区靠近所述第一端的端部沿周向开设有多个齿槽； 所述第二区靠近 所述第一端的内径大于所述第四区靠近所述第二端的内径； 所述第三 区靠近所述第一端的内径及靠近所述第二端的内径均小于所述第二区 靠近所述第一端的内径， 且均大于所述第四区靠近所述第二端的内径
[权利要求 12] 根据权利要求 1所述的植入物的装载工具， 其特征在于， 所述导引座 具有沿轴向贯通的第二内腔， 所述第二内腔的横截面由所述第三端向 所述第四端逐渐减小。
[权利要求 13] 根据权利要求 12所述的植入物的装载工具， 其特征在于， 所述第二内 腔由所述第三端向所述第四端依次包括相连接的第五区与第六区； 所 述第五区靠近所述第三端的内径大于所述第五区靠近所述第四端的内 径； 所述第六区靠近所述第三端的内径等于所述第五区靠近所述第四 端的内径， 且不小于所述第六区靠近所述第四端的内径。
[权利要求 14] 根据权利要求 1所述的植入物的装载工具， 其特征在于， 所述导引座 的外壁沿周向设有具有凹口的固定槽， 所述固定槽的凹口朝向所述第 四端的方向。
[权利要求 15] 根据权利要求 1所述的植入物的装载工具， 其特征在于， 所述第二卡 扣部与所述第二卡扣座匹配卡合时， 所述第四端沿所述第一端向所述 第二端的方向伸出所述第二端。
[权利要求 16] 根据权利要求 1所述的植入物的装载工具， 其特征在于， 所述导引盖 和所述导引座的外周壁上均设有防滑结构， 以便于抓握。
[权利要求 17] 根据权利要求 1~16中任一项所述的植入物的装载工具， 其特征在于， 所述导引盖由透明材料制成， 所述导引盖沿周向设有指示环， 用以指 示植入物的装载进度。
[权利要求 18] 一种医疗装置， 包括如权利要求 1~17中任一项所述的植入物的装载工 具， 还包括输送装置， 所述装载工具用于与所述输送装置相配合， 以 将一植入物装载于所述输送装置中。
［权利要求 19］ 根据权利要求 18所述的医疗装置， 其特征在于， 所述植入物为瓣膜支 架。
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EP3903735A1 (en) 2021-11-03
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ES2946015T3 (es) 2023-07-11
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