WO2020151538A1 - 植入物的装载工具、压缩装置及装载系统 - Google Patents

植入物的装载工具、压缩装置及装载系统 Download PDF

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Publication number
WO2020151538A1
WO2020151538A1 PCT/CN2020/072134 CN2020072134W WO2020151538A1 WO 2020151538 A1 WO2020151538 A1 WO 2020151538A1 CN 2020072134 W CN2020072134 W CN 2020072134W WO 2020151538 A1 WO2020151538 A1 WO 2020151538A1
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WO
WIPO (PCT)
Prior art keywords
implant
protective tube
connecting portion
protective
guide cover
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2020/072134
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English (en)
French (fr)
Inventor
梅杰
刘美辰
吴旭闻
桂宝珠
陈国明
李�雨
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Microport Cardioflow Medtech Co Ltd
Original Assignee
Shanghai Microport Cardioflow Medtech Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=71735430&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2020151538(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Shanghai Microport Cardioflow Medtech Co Ltd filed Critical Shanghai Microport Cardioflow Medtech Co Ltd
Priority to EP20745653.4A priority Critical patent/EP3915520B1/en
Priority to ES20745653T priority patent/ES2976644T3/es
Priority to KR1020217026401A priority patent/KR102640498B1/ko
Publication of WO2020151538A1 publication Critical patent/WO2020151538A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—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
    • 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
    • A61F2/02—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
    • 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
    • A61F2/2442—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
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/844—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents folded prior to deployment

Definitions

  • the invention relates to the field of medical equipment, and in particular to a loading tool, a compression device and a loading system for implants.
  • Interventional aortic valve placement is a brand-new minimally invasive valve replacement technology developed internationally in recent years. Its principle is that the valve prosthesis (which includes a stent) is loaded into the delivery device and delivered to it through a catheter. At the aortic root, after the stent is released, it can ensure that the valve prosthesis is fixed to the aortic valve annulus, replacing the degraded original valve, and improving the patient's heart function.
  • This technology can treat aortic valvular disease without opening the chest and the heart is beating, avoiding the huge trauma caused by previous surgical thoracotomy and cardiac arrest.
  • This technique requires compressing the stent to a small diameter to load into the delivery catheter.
  • the stent or the valve on the stent is prone to stent damage or valve damage due to excessive compression, uneven compression, or local accidental bending, which will eventually lead to defects in the function of the stent or valve or reduced service life, and may even fail to implant and work normally .
  • the self-expanding stent is loaded, the self-expanding stent is less likely to be fixed and compressed due to its own tension, and it is more likely to be damaged or broken, making it more difficult to load.
  • the technical requirements for the loading personnel are higher.
  • it also invisibly prolongs the implantation operation time and increases the operation risk.
  • the purpose of the present invention is to provide a loading tool, a compression device and a loading system for an implant, so as to solve the problem that the existing loading device requires multiple operations during use.
  • the present invention provides an implant loading tool, which is used to cooperate with an implant compression device to load an implant into a delivery device, the implant loading tool includes :
  • a protective tube for the delivery device to pass through the protective tube has a relatively proximal end and a distal end, the proximal end is used for the implant to penetrate;
  • the protective tube is configured to be connected to the compression device of the implant through the first connecting portion, while remaining coaxial with the compression device of the implant.
  • the delivery device includes a sheath tube, and the protective tube is provided with an anti-drop structure, and the anti-drop structure is used to limit the sheath tube not to extend beyond the proximal end of the protective tube.
  • the inner wall of the protection tube has a protrusion extending toward the inside of the protection tube, and the protrusion constitutes the anti-drop structure.
  • the proximal end of the protective tube is sleeved with an anti-dropping buckle, and the anti-dropping buckle has a limiting portion extending toward the inside of the protective tube, and the limiting portion constitutes the anti-falling structure .
  • the proximal end of the protective tube is a flared structure, and the inner diameter of the flared structure gradually increases from the distal end to the proximal direction of the protective tube.
  • a second connecting portion is provided on the protective tube, and the second connecting portion is used to connect with the protective sleeve to limit the distance of the protective tube toward the protective tube relative to the protective sleeve. The axial displacement of the end.
  • the second connecting portion has a first limiting surface, and the first limiting surface protrudes from the outer peripheral surface of the protective tube;
  • the protective sleeve has a second limiting surface, and the first limiting surface The limiting surface is used for abutting against the second limiting surface to limit the axial displacement of the protective tube relative to the protective sleeve toward the distal end of the protective tube.
  • the first connecting portion includes a plurality of engaging teeth, and the plurality of engaging teeth are arranged on the inner wall of the protective cover along the circumferential direction of the protective cover, and are used for connecting with the implant
  • the locking groove on the compression device matches.
  • the first connecting portion has an internal thread provided on the inner wall of the protective sleeve for matching with the external thread on the compression device of the implant.
  • a non-slip structure is provided on the outer wall of the protective cover.
  • the present invention also provides an implant compression device, which is used to cooperate with the above-mentioned implant loading tool, and the implant compression device includes:
  • the guide cover has a third connecting portion, and the third connecting portion is used for mating connection with the first connecting portion, so that the protection tube and the guide cover remain coaxial;
  • the guide seat is detachably connected with the guide cover to compress the implant.
  • the third connecting portion includes a plurality of engaging grooves, and the plurality of engaging grooves are provided on the outer wall of the guide cover along the circumferential direction of the guide cover, and are used to interact with the loading tool Match the engaging teeth on the
  • the third connecting portion has an external thread provided on the outer wall of the guide cover.
  • the guide cover has opposite first and second ends; the guide cover also has a first inner cavity through which the cross section of the first inner cavity extends from the first end to The second end gradually decreases; the guide seat has a third end and a fourth end opposite to each other; the guide seat is used to move from the third end to the fourth end along the direction from the third end to the fourth end. One end penetrates into the first inner cavity.
  • an implant loading system which includes:
  • a delivery device, the loading tool of the implant and the compression device of the implant are used to cooperate with the delivery device to load an implant in the delivery device; wherein, the protective tube
  • the proximal end of the guide cover is arranged face to face with the second end of the guide cover; the first connecting part of the protective sleeve is connected to the third connecting part of the guide cover, so that the protection tube and the guide cover Stay coaxial.
  • the implant is a valve stent; the delivery device includes a sheath, and the valve stent is used to be loaded into the sheath.
  • the implant loading tool is used to cooperate with an implant compression device to combine an implant Loaded into a delivery device
  • the loading tool of the implant includes a protective tube and a protective sleeve
  • the protective tube is used for the delivery device to pass through
  • the protective sleeve is connected to the compression device through the first connecting part
  • the detachable connection can keep the protection tube and the compression device coaxial.
  • FIG. 1 is a front view of a protective tube provided by Embodiment 1 of the present invention.
  • Figure 2 is an axial sectional view of the protective tube shown in Figure 1;
  • Figure 3 is a partial enlarged view of the protective tube shown in Figure 2;
  • FIG. 4 is a partial axial cross-sectional view of the protective tube provided by the second embodiment of the present invention.
  • Figure 5 is a front view of the protective cover provided by the first embodiment of the present invention.
  • Figure 6 is an axial sectional view of the protective sleeve shown in Figure 5;
  • FIG. 7 is a front view of a protective cover provided by Embodiment 2 of the present invention.
  • Figure 8 is an axial cross-sectional view of the protective sleeve shown in Figure 7;
  • Figure 9 is a front view of the guide cover provided in the first embodiment of the present invention.
  • Figure 10 is an axial sectional view of the guide cover shown in Figure 9;
  • Fig. 11 is a front view of a guide seat provided in the first embodiment of the present invention.
  • Figure 12 is an axial sectional view of the guide seat shown in Figure 11;
  • FIG. 13 is a schematic diagram of the guide cover and the guide base provided by the first embodiment of the present invention, wherein the fourth connecting portion of the guide cover is connected to the fifth connecting portion of the guide base;
  • Figure 14 is an axial sectional view of the guide cover and the guide seat shown in Figure 13;
  • FIG. 15 is a schematic diagram of a conveying device provided by Embodiment 1 of the present invention.
  • Figure 16 is a front view (partial cross-sectional view) of the loading system provided in the first embodiment of the present invention, in which the implant is about to be loaded into the sheath;
  • Figure 17 is an axial sectional view of the loading system shown in Figure 16;
  • Figure 18 is a partial enlarged view of the loading system shown in Figure 17;
  • 19 is an axial cross-sectional view of the loading system provided by the first embodiment of the present invention, in which the implant part has been loaded into the sheath;
  • Figure 20 is a partial enlarged view of the loading system shown in Figure 19;
  • 21 is an axial cross-sectional view of the loading system provided by the first embodiment of the present invention, in which the protective sleeve and the guide cover have moved to the distal end of the protective tube to expose the proximal end of the protective tube;
  • Fig. 22 is a schematic diagram of an implant provided in Embodiment 1 of the present invention.
  • 100-protection tube 101-proximal end; 102-distal; 110-anti-drop structure; 120-flaring structure; 130-first limit surface; 140-anti-drop buckle;
  • 300-guide cover 301-first end; 302-second end; 310-first inner cavity; 320-locking groove; 330-fourth connecting part; 331-tooth groove;
  • 400-guide seat 401-third end; 402-fourth end; 410-second inner cavity; 420-fixing groove; 430-fifth connecting part; 440-sixth connecting part;
  • 5-transport device 54-cone head; 55-fixed head; 56-sheath;
  • the invention provides a loading tool, a compression device and a loading system for an implant.
  • the loading tool of the implant is used to cooperate with a compression device of an implant to load an implant into a delivery device
  • the loading tool of the implant includes a protective tube and a protective sleeve; the protective tube is used for the delivery device to pass through, the protective tube has opposite proximal and distal ends, and the proximal end is used for For the implant to penetrate, the distal end is used for the delivery device to penetrate; the protective sleeve can be movably sleeved on the protective tube, and the protective sleeve is connected to the implant
  • the device remains coaxial. With such a configuration, no special person is required to fix the connecting part of the sheath and the implant, the loading tool
  • Figure 1 is a front view of the protective tube provided by Embodiment 1 of the present invention
  • Figure 2 is an axial sectional view of the protective tube shown in Figure 1
  • Figure 3 is the protective tube shown in Figure 2
  • Figure 4 is a partial axial cross-sectional view of the protective tube provided in the second embodiment of the present invention
  • Figure 5 is a front view of the protective sleeve provided in the first embodiment of the present invention
  • Figure 6 is the protective sleeve shown in Figure 5
  • Fig. 7 is a front view of the protective cover provided in the second embodiment of the present invention
  • Fig. 8 is an axial cross-sectional view of the protective cover shown in Fig. 7, and Fig.
  • FIG. 9 is the guide cover provided in the first embodiment of the present invention Front view
  • FIG. 10 is an axial cross-sectional view of the guide cover shown in FIG. 9
  • FIG. 11 is a front view of the guide seat provided by Embodiment 1 of the present invention
  • FIG. 12 is an axial cross-sectional view of the guide seat shown in FIG.
  • Figure 13 is a schematic diagram of the guide cover and the guide base provided by the first embodiment of the present invention, in which the fourth connecting portion of the guide cover is connected to the fifth connecting portion of the guide seat
  • Figure 14 is shown in Figure 13
  • Fig. 15 is a schematic diagram of the conveying device provided in the first embodiment of the present invention
  • Fig. 15 is a schematic diagram of the conveying device provided in the first embodiment of the present invention
  • FIG. 16 is a front view (partial cross-sectional view) of the loading system provided in the first embodiment of the present invention , Wherein the implant is about to be loaded into the sheath,
  • Figure 17 is an axial cross-sectional view of the loading system shown in Figure 16
  • Figure 18 is a partial enlarged view of the loading system shown in Figure 17
  • Figure 19 is the first embodiment of the present invention
  • FIG. 20 is a partial enlarged view of the loading system shown in FIG. 19, and FIG.
  • FIG 21 is an axial cross-sectional view of the loading system provided by Embodiment 1 of the present invention In the figure, the protective sleeve and the guide cover have moved to the distal end of the protective tube until the proximal end of the protective tube is exposed.
  • Figure 22 is a schematic diagram of the implant provided in the first embodiment of the present invention.
  • This embodiment provides an implant loading tool for cooperating with an implant compression device to load an implant into a delivery device
  • the loading tool for the implant includes a protective tube 100 and a protective sleeve 200.
  • the protective tube 100 has a proximal end 101 and a distal end 102 opposite to each other. The proximal end 101 and the distal end 102 are opposite to the protective tube 100.
  • the protective tube 100 is used for a delivery device to pass through (the delivery device preferably includes a sheath that passes through the protective tube 100), wherein the proximal end 101 is used for For an implant to penetrate, the distal end 102 is used for the delivery device to penetrate; the protective sleeve 200 is movably sleeved on the protective tube 100. And the protective cover 200 has a first connecting portion, the first connecting portion is used to detachably connect with the compression device of the implant, when the first connecting portion is connected with the compression device of the implant The protective sleeve 200 can be used to keep the protective tube 100 coaxial with respect to the compression device.
  • this embodiment provides an implant compression device, which is used to cooperate with a loading tool of the implant.
  • the compression device of the implant includes a guide cover 300 and a guide seat 400; the guide cover 300 has a third connecting portion, and the third connecting portion is used for mating connection with the first connecting portion, In order to keep the protective tube 100 and the guide cover 300 coaxial; the guide seat 400 and the guide cover 300 are detachably connected to compress the implant.
  • This embodiment also provides an implant loading system, which includes the above-mentioned implant loading tool and implant compression device, and also includes a delivery device 5, so
  • the delivery device 5 preferably includes a sheath 56.
  • the implant loading tool and the implant compression device are used to cooperate with the delivery device 5 to load the implant on the delivery device. 5 in the sheath 56; wherein, the proximal end 101 of the protective tube 100 and the second end 302 of the guide cover 300 are arranged face to face; the first connecting portion of the protective sleeve 200 and the guide cover 300
  • the third connecting part is connected to keep the protection tube 100 and the guide cover 300 coaxial.
  • a valve stent 9 is taken as an example of an implant to describe in detail the loading tool, compression device, and loading system of the implant provided in this embodiment.
  • the valve stent 9 includes an outflow channel 92, an inflow channel 93 and a hanging ear 91.
  • the valve stent 9 is compressed by the loading system provided in this embodiment with the assistance of the delivery device 5 and loaded into the sheath 56 .
  • the valve stent 9 is delivered to the target area by the delivery device 5 through the catheter by the delivery device 5 in the contracted state and released, and expanded to the state shown in FIG. 22.
  • the implant here refers to a compressible implant, such as a heart valve stent, but is not limited to the valve stent 9.
  • the present invention does not specifically limit the geometry and material of the implant, which can be Any existing implant in the art.
  • the protective tube 100 has a hollow inner cavity whose inner diameter matches the outer diameter of the sheath 56 (for example, the inner diameter of the protective tube 100 is slightly larger than that of the sheath 56 Outer diameter) for the sheath 56 to be movably inserted.
  • the protective sleeve 200 has a protective sleeve inner cavity 210, and the inner diameter of the protective sleeve inner cavity 210 matches the outer diameter of the protective tube 100 (for example, the inner diameter of the protective sleeve inner cavity 210 is slightly larger than the outer diameter of the protective tube 100).
  • the protective sleeve 200 can be movably sleeved on the protective tube 100.
  • the two can move relatively axially and remain coaxial.
  • the radial displacement of the protective sleeve 200 relative to the protective tube 100 can be limited to ensure that when the protective sleeve 200 is connected to the third connecting portion of the guide cover 300 through the first connecting portion, the protective tube 100 has no radial displacement relative to the guide cover 300 .
  • the first connecting portion of the protective cover 200 includes a plurality of engaging teeth 220, and the plurality of engaging teeth 220 are circumferentially arranged at The inner wall of the protective sleeve 200;
  • the third connecting portion of the guide cover 300 includes a plurality of engaging grooves 320 which are circumferentially arranged on the outer wall of the guide cover 300; engaging teeth 220 and the engaging groove 320 have the same number, the size and position are matched, and the two can be engaged with each other to limit the protective cover 200 without axial displacement and radial displacement relative to the guide cover 300, and the protective cover 200 can pass the protection
  • the sleeve cavity 210 defines at least no radial displacement of the protective tube 100 relative to the guide cover 300, and preferably also defines no axial displacement of the protective tube 100 relative to the guide cover 300. More preferably, when the engaging teeth 220 are engaged with the engaging groove 320, the protective tube 100, the protective sleeve 200 and the guide cover
  • the proximal end 101 of the protective tube 100 is provided with a flaring structure 120; the inner diameter of the flaring structure 120 gradually increases from the distal end 102 of the protective tube 100 to the proximal end 101.
  • the maximum inner diameter b of the flared structure 120 is close to the proximal end 101; the minimum inner diameter of the flared structure 120 is equal to the inner diameter c of the protective tube 100.
  • the valve stent 9 will be compressed from the expanded state and loaded into the sheath 56. The end (the head end) of the sheath 56 facing the valve stent 9 is received by the valve stent.
  • the head end With the effect of radial supporting force, the head end will undergo a slight morphological change (expansion). At this time, the presence of the flaring structure 120 provides support for the head end of the sheath 56. The mouth structure 120 fits together to prevent the head end of the sheath tube 56 from being over-expanded and damaged.
  • the flaring structure 120 can provide the valve stent 9 with compressive strain during the compression process of the valve stent 9 to reduce the Wear of the valve stent 9.
  • the bus bar of the flaring structure 120 is not limited to the straight line in FIG. 3, but may also be a curve, such as a convex curve facing the inside of the protective tube 100, or a combination of straight lines and curves, etc. The present invention does not limit this.
  • the length of the flaring structure 120 in the axial direction is 10%-30% of the sheath length.
  • the proximal end 101 of the protective tube 100 is provided with an anti-dropping structure 110, and the anti-dropping structure 110 is used to limit the sheath tube 56 not to exceed the protective tube 100 during the process of loading the valve stent 9 Near-end 101.
  • the inner wall of the protective tube 100 has a protrusion extending toward the inside of the protective tube 100, and the protrusion constitutes the anti-drop structure 110.
  • the protruding portion has a ring shape and is arranged on the proximal end 101 of the protective tube 100 or an inner wall close to the proximal end 101.
  • the inner diameter a of the protrusion is slightly smaller than the inner diameter c of the protective tube 100, is greater than or equal to the outer diameter x of the sheath tube 56 in the normal state, and less than or equal to the outer diameter x'of the end of the sheath tube 56 in the expanded state.
  • the inner diameter a is greater than or equal to the outer diameter x of the sheath tube 56 in the normal state, which can ensure that the sheath tube 56 can pass through the protective tube 100 when the valve stent 9 is not loaded, so that the tapered head (the maximum outer diameter of the tapered head)
  • the outer diameter of the sheath tube 56 is substantially the same) can pass through the protective tube 100.
  • the purpose of setting the inner diameter a to be less than or equal to the outer diameter x'of the end of the sheath tube 56 in the expanded state is: during the loading process, due to the radial support force of the valve stent 9, the head end of the sheath tube 56 A slight morphological change, that is, expansion.
  • the outer diameter x'of the end of the sheath 56 in the expanded state is greater than the outer diameter x of the sheath 56 in the normal state, and only the end with the inner diameter a less than or equal to the sheath 56 is set
  • the outer diameter x'of the portion in the expanded state can limit the sheath 56 to the distal side of the protrusion.
  • the purpose of the anti-fall structure 110 is to make the sheath 56 penetrate through the distal end 102 and be confined to the inside of the protective tube 100 and not exceed the proximal end 101 when the valve stent 9 is loaded, so as to prevent the sheath 56 from exceeding the protective tube 100
  • the proximal end 101 of the valve is damaged when the valve stent 9 is loaded. Specifically, during the loading process of the valve stent 9, the valve stent 9 and the sheath 56 move towards each other.
  • the sheath tube 56 When the valve stent 9 is loaded into the sheath 56 During the process, the sheath tube 56 will have a movement tendency opposite to the movement direction of the valve stent 9, and under the blocking of the anti-fall structure 110, it can be ensured that the sheath tube 56 is confined to the inside of the protective tube 100 in the axial direction.
  • the inner diameter a of the raised portion is smaller than the inner diameter c of the protective tube 100, which means that the inner diameter of the raised portion is smaller than the inner diameter of the protective tube 100 and the adjacent part of the raised portion, and an expansion is provided at the proximal end 101 of the protective tube 100
  • the inner diameter a of the protrusion is smaller than the inner diameter b of the flared structure 120 near the proximal end 101.
  • the flaring structure 120 ensures that the inner diameter of the protrusion is not less than the inner diameter of the protective tube 100, the sheath 56 can be closer to the protective tube 100, and the radial position of the sheath 56 in the protective tube 100 is fixed, which is beneficial to realize protection.
  • the tube 100, the protective sleeve 200 and the compression device are coaxial; preferably, the protrusion of the anti-dropping structure 110, the flaring structure 120 and the protective tube 100 are integrally formed, which has a relatively high structural strength.
  • the protrusion may not be a ring shape but a plurality of protruding teeth distributed around the axis of the protection tube 100, which can also achieve similar effects.
  • the protective tube 100 is provided with a second connecting portion, the second connecting portion is used to connect with the protective sleeve 200 to limit the protective tube 100 opposite In the axial displacement of the protective sleeve 200 toward the distal end 102; preferably, the second connecting portion has a first limiting surface 130, and the first limiting surface 130 protrudes from the protective tube 100
  • the outer peripheral surface of the protective sleeve 200 has a second limiting surface 230, and the first limiting surface 130 is used to abut against the second limiting surface 230.
  • the two opposing first limiting surface 130 and the second limiting surface 230 are abutted to limit the protective tube 100 to the distance relative to the protective sleeve 200.
  • Axial displacement of end 102 As shown in FIGS. 3, 6 and 16, the protective tube 100 relative to the protective sleeve 200 is limited by the axial displacement from the proximal end 101 to the distal end 102 of the protective tube.
  • the protective tube 100 is defined in an axial direction (toward the distal end 102) relative to the protective sleeve 200.
  • Direction and radial degrees of freedom.
  • the part of the first connecting part in the protective sleeve 200 has a groove cavity with a larger inner diameter than the inner diameter of the inner cavity 210 of the protective sleeve, and the groove cavity is used to accommodate the outer peripheral surface of the protective tube 100.
  • the axial cross-sectional shape of the cavity includes, but is not limited to, rectangular or trapezoidal. It should be understood that the second connecting portion is not limited to using the first limit surface 130 to connect with the protective sleeve 200, and the protective tube 100 and the protective sleeve 200 can also be connected by means such as interference fit, threaded fit, or snap fit.
  • the protective tube 100 has no axial (direction toward the distal end 102) and radial degrees of freedom relative to the protective sleeve 200.
  • the outside of the protective cover 200 may be stepped to facilitate the operator to grasp and apply force, but the outer shape of the protective cover 200 is not limited to a stepped shape, and may also be a cylindrical shape, a cone shape or even an irregular shape. Etc., the present invention does not limit this.
  • the guide cover 300 has a first end 301 and a second end 302 opposite to each other, the guide cover 300 also has a first inner cavity 310 that penetrates, and the guide seat 400 has a third end 401 opposite to each other. And the fourth end 402; the guide seat 400 is used to penetrate the first inner cavity 310 from the first end 301 along the direction from the third end 401 to the fourth end 402 to form An assembly for compressing the valve stent 9.
  • the cross section of the first inner cavity 310 gradually decreases from the first end 301 to the second end 302.
  • the cross section of the first inner cavity 310 gradually decreases from the first end 301 to the second end 302, which means that the cross section of the first inner cavity 310 is from the first end 301 to the second end 302. A decreasing trend, but does not limit any cross-section of the first inner cavity 310 to be larger than the cross-section on the side closer to the second end 302 of the cross-section.
  • the first cavity 310 of the guide cover 300 includes a first area and a second area connected in sequence from the first end 301 to the second end 302; the horizontal direction of the first area and the second area
  • the cross-sections are all circular, and the inner diameter of the first zone remains unchanged along the axial direction of the guide cover 300 (ie, the e-section to the right in FIG. 10).
  • the inner diameter of the second zone decreases from the side close to the first end 301 to the side close to the second end 302 (that is, the inner diameter of the e section in FIG. 10 is larger than the inner diameter of the d section).
  • the generatrix of the second area (in geometric terms, the shape of the curved surface can be regarded as the trajectory of a moving line, and the moving line forming the curved surface is called the generatrix) can be a straight line or a curve, such as a convex toward the inside of the guide cover 300
  • the curve or the concave curve may also be a combination of a straight line and a curve.
  • the bus bar in the first zone and the bus bar in the second zone transition smoothly.
  • the first area is used to contact, abut or connect with the guide base 400, and the second area is used to compress the valve stent 9.
  • the end of the first zone close to the first end 301 is provided with a plurality of tooth grooves 331 in the circumferential direction, and an inter-groove portion is formed between every two tooth grooves 331, so that the first zone can It is conveniently connected to the guide base 400 by expansion.
  • the guiding cover 300 has a fourth connecting portion 330; the guiding seat 400 has a fifth connecting portion 430 and a sixth connecting portion 440, and the fifth connecting portion 430 is opposite to the sixth connecting portion 440. It is closer to the fourth end 402; wherein, the fourth connecting portion 330 is used to detachably connect with the fifth connecting portion 430 and the sixth connecting portion 440 to define the guide cover 300 The radial displacement and axial displacement relative to the guide seat 400.
  • connection action of the fourth connection portion 330 and the fifth connection portion 430 precedes the connection of the fourth connection portion 330 and the sixth connection portion 440, and the fourth connection The portion 330 and the sixth connecting portion 440 are connected after the fourth connecting portion 330 and the fifth connecting portion 430 are separated.
  • the guide cover 300 and the guide seat 400 have no radial displacement, and the axial displacement is also limited and in a coaxial and stable state, which facilitates the tapering of the conveying device 5
  • the insertion of the head 54 facilitates the next compression of the valve stent 9 and also prevents the valve stent 9 from tilting or abrasion during the compression process.
  • the fourth connecting portion 330 is connected to the sixth connecting portion 440, that is, when the fourth connecting portion 330 is connected to the fifth connecting portion 430, the guiding seat 400 is deeper into the first inner cavity 310 of the guiding cover 300. The assembled body formed at this time completes the preliminary compression of the valve support 9.
  • the fourth connecting portion 330 includes a plurality of buckles arranged near the first end 301 in the inter-slot portion, and the fifth connecting portion 430 and the sixth connecting portion 440 are both connected to the buckles of the fourth connecting portion 330.
  • a matching buckle seat (such as a ring-shaped groove provided along the circumference of the guide seat 400).
  • the guide cover 300 and the guide seat 400 are connected by the way of matching and snapping of the buckle and the buckle seat, which is convenient for assembly and operation, and easy for disassembly, which improves the compression efficiency of the valve support 9. Because the first area of the guide cover 300 is divided into a plurality of sub-parts in the circumferential direction by a plurality of tooth grooves 331.
  • the multiple sub-parts are easy to be elastically deformed under the guidance of the guide seat 400 to guide the outside of the cover 300 in the radial direction. Expand until the buckle of the fourth connecting portion 330 matches with the buckle seat of the fifth connecting portion 430 or the sixth connecting portion 440, and the guide seat 400 is restricted to have no radial displacement relative to the guide cover 300. It can be understood that the number of the tooth grooves 331 can be selected according to needs, such as 2-12.
  • the tooth grooves 331 are preferably evenly distributed around the circumference of the guide cover 300, so that the plurality of grooves are symmetrically distributed in the circumference of the guide cover 300, such as axial symmetry, center symmetry, or rotational symmetry.
  • the buckle of the fourth connecting portion 330 can be provided on all the slots, preferably only on part of the slots, so as to ensure coaxial fixation and easy disassembly; more preferably Yes, the buckles are symmetrically distributed around the circumferential center of the guide cover 300 to ensure that the guide cover 300 and the guide seat 400 receive a uniform force when combined with the guide seat 400 without tilting.
  • the fourth connecting portion 330 and the fifth connecting portion 430 and the sixth connecting portion 440 may also be connected by friction fixing or interference fit, which is not limited in the present invention.
  • the guide seat 400 has a second inner cavity 410 penetrating in the axial direction, and the cross section of the second inner cavity 410 gradually decreases from the third end 401 to the fourth end 402 .
  • the cross-section of the second inner cavity 410 gradually decreases from the third end 401 to the fourth end 402, which also means that the changing trend is gradually reduced and not limited.
  • the second inner cavity 410 includes a third area and a fourth area connected from the third end 401 to the fourth end 402; the inner diameter of the third area near the third end 401 is larger than that of the third end 401.
  • the third area is close to the inner diameter of the fourth end 402; the inner diameter of the fourth area close to the third end 401 is equal to the inner diameter of the third area close to the fourth end 402, and is not less than the inner diameter of the fourth end 402.
  • the four regions are close to the inner diameter of the fourth end 402.
  • the third zone is used to compress the implant.
  • the cross-sections of the third zone and the fourth zone are both circular, and the bus bars of the third zone and the fourth zone are both straight lines, that is, the third zone has a larger bottom surface facing the third end 401 Round cone shape, the fourth area is cylindrical or round cone shape. More preferably, there is a smooth transition between the bus bars of the third zone and the fourth zone.
  • the second inner cavity 410 configured in this way is used to compress the valve stent 9 and can achieve better results.
  • busbars of the third zone and the fourth zone may not be smoothly transitioned, but a straight line is hardly connected to form a corner; or, one or two of the busbars of the third zone and the fourth zone are curved, which is actually used It can also achieve better results, and the present invention does not limit this.
  • the outer wall of the guide seat 400 is provided with a fixing groove 420 with an opening along the circumferential direction, and the opening of the fixing groove 420 faces the direction of the fourth end 402.
  • the fixing groove 420 is used for inserting and abutting the valve stent 9 (mainly the inflow channel 93 of the valve stent 9) to limit the axial displacement of the valve stent 9 toward the third end 401.
  • FIG. 15 is a delivery device 5, including a tapered head 54, a fixed head 55, a sheath 56, a catheter and a handle (not shown), the tapered head 54 is fixedly connected to the fixed head 55, and the fixed head 55
  • the sheath 56 is movably sleeved on the fixed head 55 under the control of the handle by connecting the connecting piece with the handle.
  • the fixing head 55 is used to connect with the hanging ear 91 of the valve support 9 as a force application end to apply force to the valve support 9.
  • the fixed head 55 is extended out of the sheath 56 through a handle operation.
  • the tapered head 54 is inserted into the second inner cavity 410 from the fourth end 402 of the guide seat 400 (at this time, the guide cover 300 and the guide seat 400 are in the first locked state, and the guide cover 300 and the guide seat 400 A valve holder 9) is installed between, and further, the hanging ear 91 is roughly aligned with the fixed head 55, and then the guide cover 300 is pushed in the direction of the guide seat 400, so that the fourth connecting part 330 and the sixth connecting part 440 is engaged to complete the further compression of the valve support 9.
  • part of the outflow channel 92 of the valve stent 9 and the hanging ears 91 are pushed out of the second end 302 of the guide cover 300 to form a fixed fit of the guide cover 300, the guide seat 400 and the valve stent 9 to facilitate Clip the hanging ear 91 in the groove of the fixed head 55.
  • the first connecting portion of the protective sleeve 200 and the third connecting portion of the guide cover 300 are connected to form a protective tube 100, a protective sleeve 200, and a guide
  • the cover 300 and the valve holder 9 are coaxial, which makes the hanging ear 91 and the groove of the fixed head 55 tightly combined, stable and reliable, and the operator can free his hands to operate the handle at the other end, realizing single operation.
  • the fixed head 55 drives the valve stent 9 toward the sheath 56
  • the internal movement of the valve stent 9 starts to be loaded into the sheath 56.
  • the valve stent 9 first touches the proximal end 101 of the protective tube 100, which prevents the valve stent 9 from directly squeezing and rubbing against the end of the sheath 56. Therefore, the protective tube 100 disperses the contact between the valve stent 9 and the sheath 56. The force exerted a protective effect on the sheath 56.
  • the tip end of the sheath tube 56 near the guide cap 300 (that is, the end where the valve stent 9 enters) will undergo a slight morphological change (expansion) due to the radial support force of the valve stent 9, and then fit the protective tube 100
  • the flaring structure 120 at the proximal end of the tube makes the protective tube 100 better protect the head end of the sheath tube 56.
  • the guide seat 400 and the guide cover 300 are separated, and the protective sleeve 200 and the guide cover 300 are both moved toward the distal end 102 of the protective tube 100 until the The proximal end 101 of the protective tube 100 (that is, the valve stent 9 is exposed) is used to load another part of the valve stent 9.
  • the protective cover 200 and the guide cover 300 can be separated from each other, or can be moved together as a whole.
  • the guiding base 400 is turned upside down (that is, the third end 401 And the direction of the fourth end 402), move the fourth end 402 to the third end 401 in the direction of the sheath 56 (left side in the figure), pass the third zone of the guide base 400, and move the valve stent
  • the inflow channel 93 of 9 is pushed into the fourth zone, so that the outer diameter of the inflow channel 93 is compressed to be close to the inner diameter of the sheath 56.
  • valve stent 9 is completely loaded into the sheath 56 and the entire valve stent 9 loading process is completed.
  • the first connecting portion of the protective sleeve 200 is connected with the third connecting portion of the guide cover 300 to make the protective tube 100 and the protective sleeve 200 ,
  • the guide cover 300 remains coaxial, which is beneficial to realize the fixing of the hanging ear 91 of the valve stent 9 to the fixed head 55, the loading tool and the compression device are fixed stably and firmly, and the operator can free his hands to operate the handle at the other end , A single person operation is realized.
  • the loading efficiency and the loading effect are further improved, and the valve stent 9 is prevented from tilting or breaking during the compression process.
  • the proximal end 101 of the protective tube 100 is provided with an anti-dropping buckle 140.
  • the material hardness of the anti-dropping buckle 140 is lower than that of the protective tube 100.
  • silica gel or rubber can be used.
  • the axial section of the anti-dropping buckle 140 is an L shape, one end is sleeved on the outer circumference of the proximal end 101 of the protection tube 100, and the other end of the L shape extends in the protection tube 100 along the radial direction of the protection tube 100 to form a limit position
  • the limiting portion forms the anti-dropping structure 110.
  • the limiting portion is preferably ring-shaped, and its inner diameter a is smaller than the inner diameter b of the proximal end 101 of the protective tube 100 adjacent to it.
  • the first connecting portion of the protective sleeve 200 has an internal thread 250 arranged on the inner wall of the protective sleeve 200, and to match it, in the compression device,
  • the third connecting portion has an external thread provided on the outer wall of the guide cover 300.
  • the protective sleeve 200 can be defined relative to the axis of the compression device. The radial displacement and the radial displacement can keep the protection tube 100 and the compression device fixed in the radial and axial directions.
  • a non-slip structure 240 is provided on the outer wall of the protective cover 200 to increase friction and facilitate the operator to grasp.
  • the anti-slip structure 240 can be, for example, an anti-slip groove or an anti-slip protruding tooth.
  • the present invention does not specifically limit the specific structure of the anti-slip structure 240, as long as it can facilitate grasping or increase the friction with the operator.

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Abstract

一种植入物的装载工具、压缩装置及装载系统。植入物的装载工具用于与植入物的压缩装置相配合，将植入物装载入输送装置（5）。植入物的装载工具包括保护管（100）和保护套（200）。保护管（100）用于供输送装置（5）穿设于其中，而保护套（200）通过第一连接部与压缩装置可拆卸地连接，可使保护管（100）与压缩装置保持同轴。如此配置，使得装载工具与压缩装置的固定较为稳定，可实现单人操作，对植入物的装载效率较高，操作也较为简单。

Description

植入物的装载工具、压缩装置及装载系统 技术领域
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、压缩装置及装载系统。
背景技术
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。
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。
一般的，利用传统的装载工具装载支架时，将支架载入到输送器导管前，需要先将支架固定到输送器导管中的固定部件上，例如固定耳，然后再逐步完成装载。如果支架固定不当可能会导致支架变形、装载失败、甚至损坏支架。由于输送器的导管较长，整个输送器尺寸很大，为了保证支架能够顺利装载到输送器导管中，需要一人双手负责操作固定支架,还需要至少一人来操作手柄，所以需要至少两人，甚至更多人完成整个支架的装载过程。
因此，需要一种操作简单、装载效率高以及可实现单人操作的装载装置。
发明内容
本发明的目的在于提供一种植入物的装载工具、压缩装置及装载系统，以解决现有装载装置在使用中需多人操作的问题。
为解决上述问题，本发明提供一种植入物的装载工具，用于与一植入物的压缩装置相配合，将一植入物装载入一输送装置，所述植入物的装载工具包括：
保护管，用于供所述输送装置穿设于其中，所述保护管具有相对的近端和远端，所述近端用于供所述植入物穿入；以及
保护套，可活动地套设于所述保护管上，且所述保护套具有与所述植入物的压缩装置可拆卸地连接的第一连接部；
其中，所述保护管被配置为通过所述第一连接部与所述植入物的压缩装置的连接，而与所述植入物的压缩装置保持同轴。
可选的，所述输送装置包括鞘管，所述保护管设置有防脱结构，所述防脱结构用以限定所述鞘管不超出所述保护管的近端。
可选的，所述保护管的内壁上具有向所述保护管的内部延伸的凸起部，所述凸起部构成所述防脱结构。
可选的，所述保护管的近端套设有防脱卡扣，所述防脱卡扣具有向所述保护管的内部延伸的限位部，所述限位部构成所述防脱结构。
可选的，所述保护管的近端为扩口结构，所述扩口结构的内径由所述保护管的远端向近端方向逐渐增大。
可选的，所述保护管上设置有第二连接部，所述第二连接部用于与所述保护套连接，以限定所述保护管相对于所述保护套朝向所述保护管的远端的轴向位移。
可选的，所述第二连接部具有第一限位面，所述第一限位面凸出于所述保护管的外周面；所述保护套具有第二限位面，所述第一限位面用于与所述第二限位面相抵靠，以限定所述保护管相对于所述保护套朝向所述保护管的远端的轴向位移。
可选的，所述第一连接部包括多个卡合齿，所述多个卡合齿沿所述保护套的周向设置于所述保护套的内壁，用于与所述植入物的压缩装置上的卡合 槽相匹配。
可选的，所述第一连接部具有设置于所述保护套的内壁上的内螺纹，用于与所述植入物的压缩装置上的外螺纹相匹配。
可选的，所述保护套的外壁上设有防滑结构。
为解决上述问题，本发明还提供一种植入物的压缩装置，用于与如上所述的植入物的装载工具相配合，所述植入物的压缩装置包括：
导引盖，具有第三连接部，所述第三连接部用于与所述第一连接部相配合连接，以使所述保护管与所述导引盖保持同轴；以及
导引座，与所述导引盖可拆卸地连接，以压缩所述植入物。
可选的，所述第三连接部包括多个卡合槽，所述多个卡合槽沿所述导引盖的周向设置于所述导引盖的外壁，用于与所述装载工具上的卡合齿相匹配。
可选的，所述第三连接部具有设置于所述导引盖的外壁上的外螺纹。
可选的，所述导引盖具有相对的第一端和第二端；所述导引盖还具有贯通的第一内腔，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；所述导引座具有相对的第三端与第四端；所述导引座用于沿所述第三端向所述第四端的方向，由所述第一端穿入所述第一内腔。
为解决上述问题，本发明还提供一种植入物的装载系统，其包括：
如上所述的植入物的装载工具；
如上所述的植入物的压缩装置；以及
输送装置，所述植入物的装载工具和所述植入物的压缩装置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；其中，所述保护管的近端与所述导引盖的第二端面对面设置；所述保护套的第一连接部与所述导引盖的第三连接部连接，以使所述保护管与所述导引盖保持同轴。
可选的，所述植入物为瓣膜支架；所述输送装置包括一鞘管，所述瓣膜支架用于装载入所述鞘管中。
综上所述，在本发明提供的植入物的装载工具、压缩装置及装载系统中，所述植入物的装载工具用于与一植入物的压缩装置相配合，将一植入物装载入一输送装置，所述植入物的装载工具包括保护管和保护套，所述保护管用 以供所述输送装置穿设于其中，而所述保护套通过第一连接部与压缩装置可拆卸地连接，可使所述保护管与所述压缩装置保持同轴。如此配置，不需要专人负责对输送装置和植入物的连接部位进行固定，装载工具与压缩装置的固定稳定、牢靠，可实现单人操作对植入物进行装载，装载效率高，操作简单。
附图说明
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：
图1是本发明实施例一提供的保护管的主视图；
图2是图1所示的保护管的轴剖面图；
图3是图2所示的保护管的局部放大图；
图4是本发明实施例二提供的保护管的局部轴剖面图；
图5是本发明实施例一提供的保护套的主视图；
图6是图5所示的保护套的轴剖面图；
图7是本发明实施例二提供的保护套的主视图；
图8是图7所示的保护套的轴剖面图；
图9是本发明实施例一提供的导引盖的主视图；
图10是图9所示的导引盖的轴剖面图；
图11是本发明实施例一提供的导引座的主视图；
图12是图11所示的导引座的轴剖面图；
图13是本发明实施例一提供的导引盖与导引座相配合的示意图，其中导引盖的第四连接部与导引座的第五连接部连接；
图14是图13所示的导引盖与导引座的轴剖面图；
图15是本发明实施例一提供的输送装置的示意图；
图16是本发明实施例一提供的装载系统的主视(局部剖视)图，其中植入物即将开始装载进入鞘管；
图17是图16所示的装载系统的轴剖面图；
图18是图17所示的装载系统的局部放大图；
图19是本发明实施例一提供的装载系统的轴剖面图，其中植入物部分已装载进入鞘管；
图20是图19所示的装载系统的局部放大图；
图21是本发明实施例一提供的装载系统的轴剖面图，其中保护套与导引盖已向保护管的远端移动，至暴露出保护管的近端；
图22是本发明实施例一提供的植入物的示意图。
附图中：
100-保护管；101-近端；102-远端；110-防脱结构；120-扩口结构；130-第一限位面；140-防脱卡扣；
200-保护套；210-保护套内腔；220-卡合齿；230-第二限位面；240-防滑结构；250-内螺纹；
300-导引盖；301-第一端；302-第二端；310-第一内腔；320-卡合槽；330-第四连接部；331-齿槽；
400-导引座；401-第三端；402-第四端；410-第二内腔；420-固定槽；430-第五连接部；440-第六连接部；
5-输送装置；54-锥形头；55-固定头；56-鞘管；
9-瓣膜支架；91-挂耳；92-流出道；93-流入道。
具体实施方式
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。
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。
本发明提供了一种植入物的装载工具、压缩装置及装载系统，所述植入物的装载工具用于与一植入物的压缩装置相配合，将一植入物装载入一输送装置，所述植入物的装载工具包括保护管和保护套；所述保护管用于供所述输送装置穿设于其中，所述保护管具有相对的近端和远端，所述近端用于供所述植入物穿入，所述远端用于供所述输送装置穿入；所述保护套可活动地套设于所述保护管上，且所述保护套具有与所述植入物的压缩装置可拆卸地连接的第一连接部，其中，所述保护管被配置为通过所述第一连接部与所述植入物的压缩装置连接，并与所述植入物的压缩装置保持同轴。如此配置，不需要专人负责对鞘管和植入物的连接部位进行固定，装载工具与压缩装置的固定稳定、牢靠，可实现单人操作对植入物进行装载，装载效率高，操作简单。
请参考图1至图22，其中，图1是本发明实施例一提供的保护管的主视图，图2是图1所示的保护管的轴剖面图，图3是图2所示的保护管的局部放大图，图4是本发明实施例二提供的保护管的局部轴剖面图，图5是本发明实施例一提供的保护套的主视图，图6是图5所示的保护套的轴剖面图，图7是本发明实施例二提供的保护套的主视图，图8是图7所示的保护套的轴剖面图，图9是本发明实施例一提供的导引盖的主视图，图10是图9所示的导引盖的轴剖面图，图11是本发明实施例一提供的导引座的主视图，图12是图11所示的导引座的轴剖面图，图13是本发明实施例一提供的导引盖与导引座相配合的示意图，其中导引盖的第四连接部与导引座的第五连接部连接，图14是图13所示的导引盖与导引座的轴剖面图，图15是本发明实施例一提供的输送装置的示意图，图16是本发明实施例一提供的装载系统的主视(局部剖视)图，其中植入物即将开始装载进入鞘管，图17是图16所示的装载系统的轴剖面图，图18是图17所示的装载系统的局部放大图，图19是本发明实施例一提供的装载系统的轴剖面图，其中植入物部分已装载进入鞘管，图20是图19所示的装载系统的局部放大图，图21是本发明实施例一提 供的装载系统的轴剖面图，其中保护套与导引盖已向保护管的远端移动，至暴露出保护管的近端，图22是本发明实施例一提供的植入物的示意图。
以下参考附图进行描述。
实施例一
请参考图1至图3、图5以及图6，本实施例提供一种植入物的装载工具，用于与一植入物的压缩装置相配合，将一植入物装载入一输送装置，所述植入物的装载工具包括保护管100和保护套200，所述保护管100具有相对的近端101和远端102，此处的近端101与远端102为保护管100之相对的两端，所述保护管100用于供一输送装置穿设于其中(所述输送装置优选包括一鞘管，该鞘管穿设于保护管100中)，其中所述近端101用以供一植入物穿入，所述远端102用以供所述输送装置穿入；所述保护套200可活动地套设于所述保护管100上。且所述保护套200具有第一连接部，所述第一连接部用于与植入物的压缩装置可拆卸地连接，当所述第一连接部与所述植入物的压缩装置连接时，可通过保护套200使所述保护管100相对于所述压缩装置保持同轴。
进一步，请参考图9至图14，本实施例提供一种植入物的压缩装置，其用于与所述植入物的装载工具相配合。所述植入物的压缩装置包括导引盖300与导引座400；所述导引盖300具有第三连接部，所述第三连接部用于与所述第一连接部相配合连接，以使所述保护管100与所述导引盖300保持同轴；所述导引座400与所述导引盖300可拆卸地连接，以压缩植入物。
更进一步，请参考图15至图21，本实施例还提供一种植入物的装载系统，其包括上述的植入物的装载工具以及植入物的压缩装置，还包括一输送装置5，所述输送装置5优选包括一鞘管56，所述植入物的装载工具和所述植入物的压缩装置用于与所述输送装置5相配合，以将植入物装载于所述输送装置5的鞘管56中；其中，所述保护管100的近端101与所述导引盖300的第二端302面对面设置；所述保护套200的第一连接部与所述导引盖300的第三连接部连接，以使所述保护管100与所述导引盖300保持同轴。如此配置，不需 要专人负责对鞘管56和植入物的连接部位进行固定，通过保护套200与导引盖300的连接即可保证压缩装置与保护管100保持同轴，可实现单人操作对植入物进行装载，装载效率高，操作简单。
下面以一瓣膜支架9作为植入物的范例，对本实施例提供的植入物的装载工具、压缩装置及装载系统进行详细地说明。如图22所示，所述瓣膜支架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系统压缩并装载到鞘管56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22所示的状态。需理解，这里的植入物指可压缩的植入物，如心脏瓣膜支架等，但不限于为瓣膜支架9，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。
请参考图1和图2，并结合图15，保护管100具有一中空的内腔，该内腔的内径与鞘管56的外径相匹配(如保护管100的内径略大于鞘管56的外径)，以供鞘管56可活动地穿设。如图6所示，保护套200具有保护套内腔210，该保护套内腔210的内径与保护管100的外径相匹配(如保护套内腔210的内径略大于保护管100的外径)，以使保护套200可活动地套设于保护管100上。具体的，当保护套200套设于保护管100上时，两者可发生相对地轴向运动而保持同轴。如此可限定保护套200相对保护管100的径向位移，保证当保护套200通过第一连接部与导引盖300的第三连接部连接后，保护管100相对导引盖300无径向位移。
优选的，如图6、图9和图16所示，在本实施例中，保护套200的第一连接部包括多个卡合齿220，所述多个卡合齿220沿周向设置于所述保护套200的内壁；导引盖300的第三连接部包括多个卡合槽320，所述多个卡合槽320沿周向设置于所述导引盖300的外壁；卡合齿220与卡合槽320数量相同，尺寸和位置相匹配，两者可以互相卡合，以限定所述保护套200相对于导引盖300无轴向位移和径向位移，进而保护套200通过保护套内腔210，限定保护管100相对于导引盖300至少无径向位移，优选还限定保护管100相对于导引盖300无轴向位移。更优选的，当卡合齿220与卡合槽320相卡合时， 保护管100、保护套200以及导引盖300三者同轴。
进一步，如图3所示，所述保护管100之近端101设置了扩口结构120；所述扩口结构120的内径由所述保护管100的远端102向近端101方向逐渐增大(扩口结构120的最大内径b为靠近近端101处)；所述扩口结构120的最小内径与所述保护管100的内径c相等。请参考图20，由于在瓣膜支架9的装载过程中，瓣膜支架9会由扩张状态被压缩而装载入鞘管56，鞘管56朝向瓣膜支架9进入的一端(头端)因受到瓣膜支架9径向支撑力的作用，其头端会发生轻度的形态变化(扩张)，此时扩口结构120的存在，即为鞘管56的头端提供支撑，鞘管56的头端与扩口结构120相贴合，避免鞘管56的头端过度扩张而发生破坏，此外，扩口结构120可以实现在对瓣膜支架9的压缩过程中向瓣膜支架9提供压握应变，可减小对瓣膜支架9的磨损。需理解，扩口结构120的母线不限于图3中的直线，还可以是曲线，如朝向保护管100内部的凸曲线等，或者由直线与曲线共同组成等，本发明对此不作限制。优选地，扩口结构120在轴向上的长度为鞘管长度的10％-30％。
更进一步，所述保护管100的近端101设置有防脱结构110，所述防脱结构110用以限定所述鞘管56在装载瓣膜支架9的过程中，不超出所述保护管100的近端101。优选的，所述保护管100的内壁上具有向所述保护管100的内部延伸的凸起部，所述凸起部构成所述防脱结构110。优选的，所述凸起部呈环状，设置于保护管100的近端101或靠近近端101的内壁上。该凸起部的内径a略小于所述保护管100的内径c，大于等于鞘管56在正常状态下的外径x，小于等于鞘管56的端部在扩张状态下的外径x’。内径a大于等于鞘管56在正常状态下的外径x，可以实现在未装载瓣膜支架9时，确保鞘管56可穿过保护管100，以便于锥形头(锥形头的最大外径与鞘管56的外径基本相同)可以穿过保护管100。而设置内径a小于等于鞘管56的端部在扩张状态下的外径x’的目的是：在装载过程中，由于鞘管56受到瓣膜支架9径向支撑力的作用，其头端会发生轻度的形态变化，即扩张，此时鞘管56的端部在扩张状态下的外径x’大于鞘管56在正常状态下的外径x，只有设置内径a小于等于鞘管56的端部在扩张状态下的外径x’，才可以实现将鞘管56限位 于凸起部的远端侧。防脱结构110的设置，目的在于使鞘管56由远端102穿入后，在装载瓣膜支架9时被限位于保护管100的内部而不超出近端101，避免鞘管56超出保护管100的近端101而在装载瓣膜支架9时发生破损，具体的，在瓣膜支架9的装载过程中，瓣膜支架9与鞘管56两者为相向运动，当瓣膜支架9在装载入鞘管56的过程中，鞘管56会产生与瓣膜支架9运动方向相反的运动趋势，在防脱结构110的阻挡下，即可保证鞘管56在轴向上被限位于保护管100的内部。需理解，凸起部的内径a小于所述保护管100的内径c，指凸起部的内径小于保护管100与凸起部临接部分的内径，在保护管100的近端101设置有扩口结构120的情况下，即凸起部的内径a小于扩口结构120靠近近端101处之内径b。此时扩口结构120保证了凸起部的内径不小于保护管100内径，鞘管56可以与保护管100更加贴近，固定了鞘管56在保护管100中的径向位置，有利于实现保护管100、保护套200和压缩装置的同轴；优选的，防脱结构110的凸起部、扩口结构120与保护管100一体成型，其具有较高的结构强度。在其它的一些实施例中，凸起部可以不为环状而为围绕保护管100之轴线分布的多个凸齿，其也能实现类似的效果。
请参考图3和图6，并结合图16，所述保护管100上设置有第二连接部，所述第二连接部用于与所述保护套200连接，以限定所述保护管100相对于所述保护套200朝向所述远端102的轴向位移；优选的，所述第二连接部具有第一限位面130，所述第一限位面130凸出于所述保护管100的外周面；所述保护套200具有第二限位面230，所述第一限位面130用于与所述第二限位面230相抵靠。当保护套200套设于保护管100上时，两者通过相对的第一限位面130与第二限位面230的抵靠，限位了保护管100相对于保护套200朝向所述远端102的轴向位移。如图3、图6和图16所示，保护管100相对于保护套200被限定了由保护管之近端101向远端102方向的轴向位移。配合着保护套内腔210与保护管100的装配关系(即保护套200可活动地套设于保护管100上)，保护管100相对于保护套200即被限定了轴向(朝向远端102方向)和径向的自由度。通过保护套200的第一连接部与导引盖300的第三连接部连接，可保证保护管100与导引盖300保持同轴，以便于将瓣膜支 架9装载入鞘管56中。优选的，如图6所示，保护套200中的第一连接部的部分具有比保护套内腔210之内径更大的槽腔，该槽腔用于容纳凸出于保护管100之外周面的第二连接部。该槽腔的轴截面形状包括但不限于矩形或梯形等。需理解，第二连接部不限于采用第一限位面130的方式与保护套200进行连接，还可以通过如过盈配合、螺纹配合或卡扣配合等方式将保护管100与保护套200可拆卸地连接起来，只需保证保护管100相对保护套200无轴向(朝向远端102方向)和径向的自由度即可。优选的，保护套200的外部可为台阶状，以利于操作者抓握和施力，但保护套200的外部形态不限于台阶状，还可以是诸如筒体状、锥体状甚至不规则状等，本发明对此并不作限制。
请参考图9至图14，导引盖300具有相对的第一端301和第二端302，导引盖300还具有贯通的第一内腔310，导引座400具有相对的第三端401与第四端402；所述导引座400用于沿所述第三端401向所述第四端402的方向，由所述第一端301穿入所述第一内腔310，以形成一装配体，用于对瓣膜支架9进行压缩。优选的，所述第一内腔310的横截面由所述第一端301向所述第二端302逐渐减小。需理解，第一内腔310的横截面由所述第一端301向所述第二端302逐渐减小，是指第一内腔310的横截面由第一端301向第二端302为一减小的趋势，而非限定第一内腔310中任一横截面必须大于位于该横截面更靠近第二端302一侧的横截面。
优选的，如图10所示，导引盖300的第一内腔310由第一端301向第二端302包括依次连接的第一区和第二区；第一区及第二区的横截面均为圆形，所述第一区的内径沿导引盖300之轴向保持不变(即图10中的e截面以右部分)。第二区的内径由靠近第一端301的一侧向靠近第二端302的一侧减小(即图10中的e截面的内径大于d截面的内径)。第二区的母线(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)可为直线，也可以为曲线，如朝向导引盖300内部的凸曲线或凹曲线，也可以是直线与曲线的结合等，更优选的，第一区的母线与第二区的母线光滑过渡。实际中，第一区用于与导引座400相接触、抵靠或连接，第二区用于压缩瓣膜 支架9。更优选的，所述第一区靠近所述第一端301的端部沿周向开设有多个齿槽331，每两个齿槽331之间形成一段槽间部，以使第一区能方便地通过扩张与导引座400相连接。
进一步，所述导引盖300具有第四连接部330；所述导引座400具有第五连接部430和第六连接部440，所述第五连接部430相对于所述第六连接部440更靠近所述第四端402；其中，所述第四连接部330用于分别与所述第五连接部430和所述第六连接部440可拆卸地连接，以限定所述导引盖300相对于所述导引座400的径向位移和轴向位移。其中，由于第五连接部430距离第四端402更近，第四连接部330与第五连接部430连接的动作先于第四连接部330与第六连接部440的连接，且第四连接部330与第六连接部440连接于第四连接部330与第五连接部430相分离后。当第四连接部330与第五连接部430连接时，导引盖300与导引座400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5之锥形头54的套入，以便于对瓣膜支架9进行下一步压缩，还能防止瓣膜支架9在压缩过程中发生倾斜或磨损。而当第四连接部330与第六连接部440连接时，即相对第四连接部330与第五连接部430连接时，导引座400更深入导引盖300的第一内腔310，此时形成的装配体即完成对瓣膜支架9的初步压缩。
优选的，第四连接部330包括多个设置在槽间部靠近第一端301处的卡扣，而第五连接部430与第六连接部440均为与第四连接部330的卡扣相匹配的卡扣座(如沿导引座400之周向设置的环状卡槽)。采用卡扣与卡扣座匹配卡合的方式连接导引盖300与导引座400，装配和操作较方便，也便于拆卸，提高了瓣膜支架9的压缩效率。由于导引盖300之第一区被多个齿槽331沿周向分为多个子部分。在推动导引座400进入导引盖300的第一内腔310的过程中，所述多个子部分均容易在导引座400的引导下发生弹性形变而沿径向向导引盖300的外部扩张，直至第四连接部330的卡扣与第五连接部430或第六连接部440的卡扣座匹配卡合，而限定导引座400相对导引盖300无径向位移。可以理解的，齿槽331的数量可根据需要而选取不同的数量，如2个～12个。齿槽331优选围绕所述导引盖300之周向均匀分布，使得多个槽间 部在导引盖300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，第四连接部330的卡扣可在所有的槽间部上均设置，优选地也可仅在部分槽间部上设置，以便实现既可保证同轴固定，也便于拆卸；更为优选的，卡扣围绕所述导引盖300之周向中心对称分布，以确保导引盖300与导引座400结合时受力均匀，不发生倾斜。而在其它的一些实施例中，第四连接部330与第五连接部430和第六连接部440还可以通过摩擦力固定或者过盈配合等方式连接，本发明对此不限。
请参考图12，所述导引座400具有沿轴向贯通的第二内腔410，所述第二内腔410的横截面由所述第三端401向所述第四端402逐渐减小。同样的，此处第二内腔410的横截面由第三端401向第四端402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410由所述第三端401向所述第四端402包括相连接的第三区与第四区；所述第三区靠近所述第三端401的内径大于所述第三区靠近所述第四端402的内径；所述第四区靠近所述第三端401的内径等于所述第三区靠近所述第四端402的内径，且不小于所述第四区靠近所述第四端402的内径。实际中，第三区用于压缩植入物。
优选的，所述第三区以及第四区的横截面均为圆形，所述第三区以及第四区的母线均为直线，即第三区为较大的底面朝向第三端401的圆台形，第四区为圆柱形或圆台形。更优选的，所述第三区以及第四区的母线之间光滑过渡。如此配置的第二内腔410用于压缩瓣膜支架9，能取得较好的效果。当然第三区以及第四区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；亦或者，第三区和第四区的母线中的一个或两个为曲线，实际使用中亦能取得较好的效果，本发明对此亦不作限制。
进一步，如图12所示，所述导引座400的外壁沿周向设有具有开口的固定槽420，所述固定槽420的开口朝向所述第四端402的方向。该固定槽420用于供瓣膜支架9(主要为瓣膜支架9的流入道93)插入并抵靠，以限定瓣膜支架9朝向第三端401方向的轴向位移。
以下对所述植入物的装载系统的使用方式，以及所述装载系统的结构和原理进行说明。
请参考图15，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通过连接件与手柄连接，鞘管56在手柄的控制下可活动地套设于固定头55上。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。
所述植入物的装载系统在使用中，首先将瓣膜支架9的流入道93放置在导引座400的固定槽420上，而后将导引盖300从瓣膜支架9的流出道92向导引座400的方向按压(即导引座400穿入第一内腔310)，使导引盖300的第四连接部330与导引座400的第五连接部430连接，使导引盖300与导引座400的轴向和径向相对固定。此时瓣膜支架9由于一端被固定槽420限位，故被导引盖300的第二区进行了第一次压缩。此时由于第四连接部330与第五连接部430连接，导引盖300与导引座400形成第一锁定状态，导引盖300、导引座400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，如图13和图14所示。
如图15至图18所示，将固定头55通过手柄操作伸出鞘管56。然后将锥形头54由导引座400的第四端402穿入第二内腔410(此时导引盖300与导引座400为第一锁定状态，导引盖300与导引座400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300向导引座400的方向继续推送，使第四连接部330与第六连接部440卡合，完成对瓣膜支架9的进一步压缩。此过程中，部分瓣膜支架9的流出道92以及挂耳91被推出导引盖300之第二端302，形成导引盖300、导引座400和瓣膜支架9三者的固定配合，以便于将挂耳91卡在固定头55的凹槽中。
如图16至图18所示。在确认挂耳91卡入固定头55的凹槽后，通过保护套200的第一连接部与导引盖300的第三连接部将两者连接，形成保护管100、保护套200、导引盖300与瓣膜支架9同轴，这使得挂耳91与固定头55的凹槽结合紧密、固定稳定、牢靠，操作者可以解放双手，去操作另一端的手柄，实现了单人操作。通过手柄操作，将鞘管56向流入道93的方向(即导引座400之第三端401的方向，图中右侧)运动；相对地，固定头55即带 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，瓣膜支架9先接触保护管100之近端101，避免了瓣膜支架9直接与鞘管56的端部发生挤压和摩擦，故而保护管100分散了瓣膜支架9对鞘管56的作用力，对鞘管56产生了保护作用。如图19和图20所示，随着瓣膜支架9之流出道92被慢慢装载入鞘管56中，鞘管56因相对运动趋势被推向导引盖300的方向，当鞘管56的端部到达保护管100之防脱结构110时，被防脱结构110阻挡，使鞘管56不会超出保护管100的保护范围。此外，鞘管56靠近导引盖300的头端(即瓣膜支架9进入的一端)因受到瓣膜支架9的径向支撑力，会发生轻度的形态变化(扩张)，进而贴合保护管100的近端处的扩口结构120，使保护管100更好地保护鞘管56的头端。当瓣膜支架9被装载入鞘管56至一预定距离后(预定距离可根据不同的植入物而进行不同的设定)，如图20所示，即完成瓣膜支架9第一阶段的装载。在完成瓣膜支架9第一阶段的装载后，将导引座400和导引盖300分离，保护套200与导引盖300均向所述保护管100的远端102移动，直至暴露出所述保护管100的近端101(亦即暴露出瓣膜支架9)，以对瓣膜支架9的另一部分进行装载。该过程中，保护套200与导引盖300可相互分离，亦可整体一起移动。
请参考图21，在完成瓣膜支架9第一阶段的装载并拆离保护套200与导引盖300，暴露出保护管100的近端101后，将导引座400倒置(即将第三端401与第四端402的方向调换)，以第四端402朝向第三端401的方向，向鞘管56的方向(图中左侧)移动，通过导引座400的第三区，将瓣膜支架9的流入道93推入第四区，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。
综上，瓣膜支架9装入本发明提供的植入物的压缩装置之后，通过保护套200的第一连接部与导引盖300的第三连接部的连接，使保护管100、保护套200、导引盖300保持同轴，有利于实现瓣膜支架9的挂耳91固定到的固定头55上，装载工具与压缩装置的固定稳定、牢靠，操作者可以解放双手， 去操作另一端的手柄，实现了单人操作。同时，也进一步提高了装载效率和装载效果，避免了瓣膜支架9在压缩过程中发生倾斜或破损。
实施例二
请参考图4、图7及图8，本发明实施例二提供的植入物的装载工具、压缩装置及装载系统与实施例一基本相同，对于相同部分不再叙述，以下仅针对不同点进行描述。
如图4所示，本实施例中，所述保护管100的近端101设有一防脱卡扣140，该防脱卡扣140的材料硬度相比保护管100的材料硬度更低。如可采用硅胶或橡胶等。防脱卡扣140的轴截面为一L形，一端套设于保护管100之近端101的外周，L形的另一端沿保护管100的径向向保护管100内延伸，构成一限位部，该限位部即形成所述防脱结构110。同样的，该限位部优选为环状，其内径a小于与之相邻的保护管100之近端101的内径b。如此设置，由于防脱结构110为柔性结构，在瓣膜支架9通过时，能更好地保护瓣膜支架9，避免防脱结构110损坏瓣膜支架9。此外，柔性的防脱结构110也能较好地保护鞘管56的头端，避免鞘管56的头端被挤压而损坏。
如图7和图8所示，本实施例中，保护套200的第一连接部具有设置于所述保护套200的内壁上的内螺纹250，而与之相匹配的，压缩装置中，所述第三连接部具有设置于所述导引盖300的外壁上的外螺纹，该外螺纹与所述内螺纹250相匹配连接后，可以限定所述保护套200相对于所述压缩装置的轴向位移和径向位移，即可使保护管100与所述压缩装置保持径向和轴向的固定。
此外，本实施例中，保护套200的外壁上设有防滑结构240，以增大摩擦力，便于操作者抓握。该防滑结构240例如可以为防滑凹槽或防滑凸齿等，本发明对防滑结构240的具体构造不作特别的限定，其只要能便于抓握或增大与操作者之间的摩擦力即可。
需要说明的是，本说明书中各个实施例之间不同的部分也可互相组合使用，本发明对此不作限定。
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 (16)

  1. 一种植入物的装载工具，用于与一植入物的压缩装置相配合，将一植入物装载入一输送装置，其特征在于，包括：
    保护管，用于供所述输送装置穿设于其中，所述保护管具有相对的近端和远端，所述近端用于供所述植入物穿入；以及
    保护套，可活动地套设于所述保护管上，且所述保护套具有与所述植入物的压缩装置可拆卸地连接的第一连接部；
    其中，所述保护管被配置为通过所述第一连接部与所述植入物的压缩装置的连接，而与所述植入物的压缩装置保持同轴。
  2. 根据权利要求1所述的植入物的装载工具，其特征在于，所述输送装置包括鞘管，所述保护管设置有防脱结构，所述防脱结构用以限定所述鞘管不超出所述保护管的近端。
  3. 根据权利要求2所述的植入物的装载工具，其特征在于，所述保护管的内壁上具有向所述保护管的内部延伸的凸起部，所述凸起部构成所述防脱结构。
  4. 根据权利要求2所述的植入物的装载工具，其特征在于，所述保护管的近端套设有防脱卡扣，所述防脱卡扣具有向所述保护管的内部延伸的限位部，所述限位部构成所述防脱结构。
  5. 根据权利要求1所述的植入物的装载工具，其特征在于，所述保护管的近端为扩口结构，所述扩口结构的内径由所述保护管的远端向近端方向逐渐增大。
  6. 根据权利要求1所述的植入物的装载工具，其特征在于，所述保护管上设置有第二连接部，所述第二连接部用于与所述保护套连接，以限定所述保护管相对于所述保护套朝向所述保护管的远端的轴向位移。
  7. 根据权利要求6所述的植入物的装载工具，其特征在于，所述第二连接部具有第一限位面，所述第一限位面凸出于所述保护管的外周面；所述保护套具有第二限位面，所述第一限位面用于与所述第二限位面相抵靠，以限 定所述保护管相对于所述保护套朝向所述保护管的远端的轴向位移。
  8. 根据权利要求1所述的植入物的装载工具，其特征在于，所述第一连接部包括多个卡合齿，所述多个卡合齿沿所述保护套的周向设置于所述保护套的内壁，用于与所述植入物的压缩装置上的卡合槽相匹配。
  9. 根据权利要求1所述的植入物的装载工具，其特征在于，所述第一连接部具有设置于所述保护套的内壁上的内螺纹，用于与所述植入物的压缩装置上的外螺纹相匹配。
  10. 根据权利要求1所述的植入物的装载工具，其特征在于，所述保护套的外壁上设有防滑结构。
  11. 一种植入物的压缩装置，用于与根据权利要求1～10中任一项所述的植入物的装载工具相配合，其特征在于，包括：
    导引盖，具有第三连接部，所述第三连接部用于与所述第一连接部相配合连接，以使所述保护管与所述导引盖保持同轴；以及
    导引座，与所述导引盖可拆卸地连接，以压缩所述植入物。
  12. 根据权利要求11所述的植入物的压缩装置，其特征在于，所述第三连接部包括多个卡合槽，所述多个卡合槽沿所述导引盖的周向设置于所述导引盖的外壁，用于与所述装载工具上的卡合齿相匹配。
  13. 根据权利要求11所述的植入物的压缩装置，其特征在于，所述第三连接部具有设置于所述导引盖的外壁上的外螺纹。
  14. 根据权利要求11所述的植入物的压缩装置，其特征在于，所述导引盖具有相对的第一端和第二端；所述导引盖还具有贯通的第一内腔，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；所述导引座具有相对的第三端与第四端；所述导引座用于沿所述第三端向所述第四端的方向，由所述第一端穿入所述第一内腔。
  15. 一种植入物的装载系统，其特征在于，包括：
    根据权利要求1～10中任一项所述的植入物的装载工具；
    根据权利要求11～14中任一项所述的植入物的压缩装置；以及
    输送装置，所述植入物的装载工具和所述植入物的压缩装置用于与所述 输送装置相配合，以将一植入物装载于所述输送装置中；其中，所述保护管的近端与所述导引盖的第二端面对面设置；所述保护套的第一连接部与所述导引盖的第三连接部连接，以使所述保护管与所述导引盖保持同轴。
  16. 根据权利要求15所述的植入物的装载系统，其特征在于，所述植入物为瓣膜支架；所述输送装置包括一鞘管，所述瓣膜支架用于装载入所述鞘管中。
PCT/CN2020/072134 2019-01-24 2020-01-15 植入物的装载工具、压缩装置及装载系统 Ceased WO2020151538A1 (zh)

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