WO2021129195A1 - 一种植入体输送装置及其内管组件、导管 - Google Patents

一种植入体输送装置及其内管组件、导管 Download PDF

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Publication number
WO2021129195A1
WO2021129195A1 PCT/CN2020/127488 CN2020127488W WO2021129195A1 WO 2021129195 A1 WO2021129195 A1 WO 2021129195A1 CN 2020127488 W CN2020127488 W CN 2020127488W WO 2021129195 A1 WO2021129195 A1 WO 2021129195A1
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WO
WIPO (PCT)
Prior art keywords
inner tube
implant
protection component
tube assembly
stent
Prior art date
Application number
PCT/CN2020/127488
Other languages
English (en)
French (fr)
Inventor
吴旭闻
梅杰
石若璘
邱尧
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 KR1020227015621A priority Critical patent/KR102676440B1/ko
Priority to EP20907386.5A priority patent/EP4018976A4/en
Priority to US17/757,134 priority patent/US20230000651A1/en
Priority to JP2022519537A priority patent/JP7455200B2/ja
Publication of WO2021129195A1 publication Critical patent/WO2021129195A1/zh

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436Deployment by retracting a sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9522Means for mounting a stent or stent-graft onto or into a placement instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9528Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9534Instruments specially adapted for placement or removal of stents or stent-grafts for repositioning of stents

Definitions

  • the invention relates to an implant delivery system, in particular to an implant delivery device, its inner tube assembly, and a catheter.
  • Implants such as self-expanding stents, need to have a specific structure during the loading and release process to be fixed to the corresponding structure of the conveyor by means of shape fit or pull wire. It can be fixed at one end or at both ends. So as to realize the stable compression and release of the implant body by the conveyor.
  • This specific structure on the implant is called a hanger, and the corresponding structure on the delivery system is called a fixed head.
  • Hanging ears can appear at any node on the bracket. If it is a single-layer bracket, the hanging ear is usually set on one end of the bracket; if it is a double-layer bracket, the hanging ear is usually set on one end of the inner or outer bracket.
  • the mounting ears are not necessarily at the top after the double-layer bracket is pressed and held. You can set the mounting ears on all the nodes in the circumferential direction of the end of the bracket, or only set the mounting ears at some nodes. The rest of the nodes without mounting ears are located on the bracket rod. It is called an earless rod. According to whether there are hanging ears at the nodes, the bracket rods with hanging ears can be called anchor rods, and the bracket rods without hanging ears are called non-anchor rods. If it is a double-layer bracket, there are two types of anchor rods and non-anchor rods. It may be on different stent layers.
  • the problem with the existing delivery system is that when the valve stent is a circumferentially symmetrical stent, the number of nodes on the fixed head that fits or pulls the wire is in most cases less than the number of nodes corresponding to the anchor rods on the stent, so the loading process
  • the middle lug is tightly integrated in the groove, the anchor rod is pressed and held by the sheath/loading tool and the support force of the fixed head, while the non-anchor rod only receives the pressure and grip force, and due to the existence of the axial height difference, the hanging ear
  • the height of itself or the height difference formed by the notch at the end of the stent body causes the anchor rod and the non-anchor rod to be inconsistent in force, which causes the non-anchor rod to easily cause inward retraction during the loading and release process, and the stent is directly applied.
  • valve leaflets can easily cause damage to the valve leaflets, affecting the function of the prosthesis, and uneven force on the implant body, causing the implant body to tilt, damage or even fail to load or the implant body cannot be used.
  • the valve stent is a non-circumferentially symmetrical stent design, the above phenomenon will be more serious.
  • the rigidity of a certain area of the stent is less than the rigidity of other areas, or the notch is set asymmetrically, which will result in uneven force of the valve stent. , It is easier to tilt, twist, and damage during the loading and release process, which may cause loading failure or unusable implants.
  • Common fixed heads are generally round tables or wedge-shaped bodies with grooves, and the shape of the ears on the implants matches the grooves, and they are connected by shape matching.
  • the existing implant loading process is that after the implant is partially crimped, the ear hangers are fixed in the groove of the fixed head, and then the catheter is driven forward to gradually cover the implant completely.
  • the entire loading process especially the asymmetric stents in the circumferential direction, due to the poor uniformity of the force, the implant is prone to tilt and damage; while the self-expanding stent has large supporting force, short axial height, and non-circumferential symmetry, etc. , Will exacerbate the problem of poor uniformity of force on the stent.
  • the implant may be twisted, indented, damaged or even unable to be used normally during the release process.
  • the stent will squeeze the valve leaflets during the loading and release process, causing damage to the valve leaflets and affecting its use.
  • the solution is complicated, the cycle is long, and the cost is high; the role of the fixed head in it is ignored.
  • the technical problem to be solved by the present invention is to provide an implant delivery device, its inner tube assembly, and a catheter, which can provide support for the implant and prevent the implant from collapsing during the delivery process.
  • the technical solution adopted by the present invention to solve the above-mentioned technical problems is to provide an inner tube assembly of an implant delivery device.
  • the inner tube assembly includes an implant protection component, an inner tube and a fixed head connected to the inner tube,
  • the implant protection component is connected with the inner tube or/and the fixed head, and the implant protection component is configured to be in contact with the implant to support the implant.
  • the implant protection component includes at least one protection body, and the protection body is in the shape of a ring sheet or a circular arc sheet.
  • the implant protection component is connected to the inner tube
  • the implant protection component includes a connector and a protector
  • the connector is connected to the inner tube
  • the protector is connected to the inner tube.
  • the fixed head is provided with a groove, and the groove and the protective body are arranged opposite to each other in the axial direction.
  • the implant protection component includes a first protection body and a second protection body connected to each other, the second protection body is connected to the first protection body, and the first protection body is connected to the second protection body.
  • One of the protectors is connected to the fixed head.
  • the inner tube assembly includes a first implant protection component and a second implant protection component, the first implant protection component is connected to the fixed head, and the first implant protection
  • the component has a first protector; the second implant protector is connected to the inner tube, and the second implant protector includes a connector and a second protector.
  • the connector is connected to the inner tube.
  • the pipe is connected, and the second protection body is connected to the connecting piece; and the first protection body and the second protection body are arranged opposite to each other in the axial direction.
  • the connecting piece is a cylindrical body with a hole in the middle, and the connecting piece is circumferentially connected to the inner tube at the hole.
  • the first protective body is in the shape of a circular ring sheet
  • the second protective body is in the shape of a circular arc sheet.
  • a gap is formed between the implant protection component and the inner tube.
  • Another technical solution adopted by the present invention to solve the above-mentioned technical problems is to provide a catheter of an implant delivery device, which includes an outer tube and the above-mentioned inner tube assembly, and the inner tube assembly is pierced in the outer tube.
  • an implant delivery device comprising a handle, an outer tube, and the above-mentioned inner tube assembly, the inner tube assembly is pierced in the outer tube, and the The handle is used to drive the outer tube to move axially relative to the inner tube assembly.
  • the implant delivery device and its inner tube assembly and catheter provided by the present invention can support the valve stent circumferentially by arranging the implant protection component on the fixed head or inner tube Areas with weak supporting force, such as non-anchoring rods and notches, avoid tilting and damage of the valve stent during the loading process, as well as distortion and indentation during the release process; especially the diameter between the implant protection component and the inner tube
  • the hollowed-out internal space can be used to accommodate the valve leaflets.
  • the implant protection component separates the valve support and the valve leaflets, effectively protecting the valve leaflets and avoiding the squeezing of the valve leaflets, This effectively solves the problem of the stent squeezing the valve leaflet during the loading and releasing process, and ensures the leaflet fatigue performance.
  • the material of the protective body constituting the protective component of the implant is a soft material
  • the soft material can further reduce damage to the stent or valve while providing a certain supporting force.
  • Figure 1a is a schematic diagram of the structure of the implant delivery device in an embodiment of the present invention
  • Figure 1b is a schematic diagram of the structure of the inner tube assembly of the implant delivery device in an embodiment of the present invention
  • Figure 1c is a schematic diagram of the implant delivery device in an embodiment of the present invention A schematic cross-sectional view of the inner tube assembly of the device;
  • 2a, 2b, 2c, and 2d are schematic diagrams of various shapes of the protector in the embodiment of the present invention.
  • 3a, 3b, 3c, 3d, and 3e are schematic cross-sectional views obtained by bisecting the cross-section of the catheter in the embodiment of the present invention.
  • FIG. 4a, 4b, and 4c are schematic diagrams of the distribution of protectors in an embodiment of the present invention, and FIG. 4b, 4c are schematic diagrams of a plurality of protectors symmetrically arranged;
  • FIG. 5 is a schematic diagram of asymmetrical arrangement of multiple protectors of the implant delivery device in the embodiment of the present invention.
  • Figure 6 is a schematic view of the structure of the connection between the implant protection component and the inner tube in the embodiment of the present invention.
  • Figure 7 is a schematic view of the structure of the connection between the implant protection component and the fixed head in the embodiment of the present invention.
  • Fig. 8 is a schematic diagram showing the structure of two implant protection components connected to the inner tube and the fixed head respectively in the embodiment of the present invention.
  • Fig. 9 is a schematic structural diagram of the stent compressed until the sheath is in contact with the protective component of the implant in the embodiment of the present invention.
  • Figures 10a, 10b, and 10c are respectively structural schematic diagrams with a gap at the end of the stent, a gap at the middle, and asymmetrical arrangement of the inflow channel in the embodiment of the present invention.
  • 1-Implant protection component 2-Fixed head, 3-inner tube, 4-tapered head, 1a-first implant protection component, 1b-second implant protection component, 11, 11a, 11b- Protector, 111-first protector, 112-second protector, 12-connector, 21-hanging lug groove, 22-base, 31-proximal inner tube, 32-distal inner tube, 5-bracket , 6-sheath, 7-notch, 8-hanger, 901-inflow tract, 902-transition section, 903-outflow tract, 9011-shaped area, 51-non-anchoring rod, 52-anchoring rod, 100-catheter, 200-handle.
  • proximal means the end close to the operator during the operation; “distal” Indicates the end far away from the operator, and the axial direction indicates the direction of the axis of the inner tube.
  • proximal means the end close to the operator during the operation; “distal” Indicates the end far away from the operator, and the axial direction indicates the direction of the axis of the inner tube.
  • distal Indicates the end far away from the operator, and the axial direction indicates the direction of the axis of the inner tube.
  • the term “or” is usually used to include the meaning of "and/or” unless the content clearly indicates otherwise.
  • the implant in this embodiment is described with a valve stent as an example.
  • the present invention provides an implant delivery device, its inner tube assembly, and a catheter.
  • the fixed head or/and the inner tube is provided with an implant protection component, which avoids the tilt, damage and release of the valve stent during the loading process Distortion and indentation in the process.
  • Fig. 1a is a schematic diagram of the structure of an implant delivery device.
  • an implant delivery device can be applied to carry a valve prosthesis to perform operations such as loading, delivery, release, and recovery of a heart prosthetic valve (such as aortic valve prosthetic valve).
  • the above-mentioned device may include a catheter 100 and a control handle 200 connected to the proximal end of the catheter 100; the catheter 100 described above may include an outer tube, an inner tube assembly, etc. that are sleeved in sequence.
  • the inner tube assembly of the implant delivery device includes an implant protection component 1, a fixed head 2, an inner tube 3, and a tapered head 4.
  • the heads 4 are all connected to the inner tube 3.
  • the inner tube 3 includes a proximal inner tube 31 and a distal inner tube 32.
  • the proximal inner tube 31, the fixed head 2, the distal inner tube 32 and the tapered head 4 are from the proximal end to the distal end.
  • the ends are connected in sequence, and the inner tube 3 has a through cavity for the guide wire to pass through.
  • the implant protection component 1 may be connected to the fixed head 2 or fixedly connected to the inner tube 3.
  • the fixing method may be integrally connected or connected by welding, adhesion, etc.
  • the connection method in this embodiment There are no special restrictions.
  • the implant protection component 1 is mainly used to contact the non-anchoring rod of the valve stent in the crimped state, and play a supporting role.
  • the number of fixed heads 2 can be one or more. It is understood that those skilled in the art can set the implant protection component 1 according to the support force requirements of the end of the stent, and choose the implant
  • the protective component 1 is arranged on one fixed head, multiple fixed heads, inner tube, or both the fixed head and the inner tube, and the number of implant protection parts 1 can be set to one or more according to different installation positions.
  • the implant protection component 1 includes at least one protection body 11.
  • the protective body 11 is in the shape of a circular ring sheet or a circular arc sheet.
  • the shape of the protective body 11 in the shape of a circular ring sheet means that the projection of the protective body 11 in the circumferential direction is a circular ring, such as the second protective body 112 in FIG. 7.
  • the shape of the protective body 11 in the shape of a circular arc sheet means that the projection of the protective body 11 in the circumferential direction is a circular arc shape, as shown in FIGS. 4a to 4c and 5.
  • the protective body 11 can have a variety of shapes, and its planar shape after being expanded in the circumferential direction is shown in Figures 2a-2d. Of course, the protective body 11 is not limited to the four shapes shown in Figures 2a-2d.
  • the length and width in the radial direction are determined according to the position and structure of the non-anchoring rod of the valve stent to be supported. As long as the protector 11 is in contact with the non-anchor rod at the top of the valve stent frame, it provides support and avoids the collapse of the stent. However, this structure is particularly suitable for the top end of the stent frame with an imperfectly symmetrical structure, such as the loading and release of a valve stent with a gap.
  • the arrangement of the implant protection component 1 is described in terms of the protection body 11 constituting the implant protection component 1 falling on a two-dimensional plane of a basic unit, which is a cross-sectional view obtained by bisecting the cross-section of the catheter, preferably 1-8 basic units; more preferably 2-6 basic units, as shown in Figures 3a-3e.
  • the protector 11 can be arranged in one basic unit, as shown in Fig. 4a; it can also be arranged in multiple basic units, as shown in Figs. 4b and 4c.
  • the shape of the protector 11 in different basic units may be the same or different.
  • the protective body 11 When the protective body 11 is arranged in different basic units, it can be arranged symmetrically or asymmetrically.
  • the two protective bodies 11 in Fig. 4b and the three protective bodies 11 in Fig. 4c are all symmetrically arranged; the asymmetrical arrangement is mainly aimed at the situation where the end of the valve stent body is asymmetrical.
  • Two or more protective bodies 11 can also be provided in a basic unit at the same time. As shown in FIG. 5, it includes two protective bodies 11a and 11b. Of course, the shapes of the protective bodies 11 provided in different basic units may be the same or different.
  • the implant protection component 1 is connected to the inner tube 3.
  • the implant protection component 1 includes a connector 12 and a protector 11.
  • the connector 12 It is a cylinder with a hole in the middle.
  • the connecting piece 12 is circumferentially connected to the inner tube 3 at the opening and is arranged coaxially with the inner tube 3.
  • the protective body 11 is connected to the connecting piece 12.
  • the shape of the connecting piece 12 is not in the present invention.
  • the protector 11 can be connected to the bracket at the position where it needs to be fixed and supported, and the size does not affect the loading and release of the bracket; preferably, the groove 21 on the fixed head 2 and the protector 11 are arranged oppositely in the axial direction, that is, the opening direction of the groove 21 is opposite to the direction in which the protector 11 is arranged in the axial direction on the connecting piece 12.
  • This arrangement can be applied to brackets with ears and notches at different ends.
  • the bracket at one end of the bracket is matched with the groove 21, and the gap at the other end of the bracket is matched and arranged in contact with the protector 11.
  • the implant protection component 1 is arranged on the inner tube 3, and by providing supporting force to the notch, the stent can be effectively prevented from twisting or indentation.
  • the number can be one or more, and more preferably one or two.
  • the arrangement on the inner tube 3 depends on what needs to be covered when the stent is pressed and held.
  • the position where the support is weaker in the circumferential direction is determined by the non-anchor rod position, that is, relative to the fixed head 2, the protector 11 can be arranged on both sides of the fixed head 2. At this time, at least two protectors 11 are required.
  • At least two protective bodies 11 can also be arranged on one side of the fixed head 2 to cover the position where the support is weaker in the circumferential direction. Taking the notched bracket as an example, the protective body 11 covers the non-limiting position of the notch. Anchor rod.
  • the implant protection component 1 and the fixed head 2 are directly connected, as shown in FIGS. 1b, 1c and 7; the fixed head 2 includes a base 22 and a groove 21, and the base 22 is connected to the implant
  • the protective component 1, the implant protective component 1 shown in Figures 1b and 1c includes a plurality of protective bodies 11 in the shape of a circular arc; the implant protective component 1 shown in Figure 7 includes a first connected to each other.
  • the number of the protection body 111 and the second protection body 112 is one or more, which is in the shape of a circular arc sheet; the number of the second protection body 112 is one, which is in the shape of a ring sheet.
  • the two protection bodies 112 are connected to the fixed head 2, and the first protection body 111 is connected to the second protection body 112.
  • This structure can be applied to the loading and release of valve stents with the hanging ear and the notch at the same end, and can provide support for the notch and the non-anchoring rod at the same time, which is more conducive to uniform force of the stent.
  • the inner tube assembly includes a first implant protection component 1a and a second implant protection component 1b.
  • the second implant protection component 1b has a second protection Body 112, the second protection body 112 is in the shape of a ring sheet, the second protection body 112 is connected to the fixed head 2;
  • the first implant protection component 1a includes a connector 12 and at least one first protection body 111, and the connector 12 Connected to the inner tube 3,
  • the connecting piece 12 is preferably a cylindrical body with a hole in the middle, the connecting piece 12 is circumferentially connected to the inner tube 3 at the opening and is arranged coaxially with the inner tube 3,
  • the first implant protection component 1a Connected to the connecting member 12 the first protective body 111 is in the shape of a circular arc sheet, and the first protective body 111 and the second protective body 112 are arranged opposite to each other in the axial direction, that is, the first protective body 111 is arranged on the connecting member 12 along the axis.
  • the installation direction of the second protective body 112 is opposite to the axial installation direction of the second protective body 112 on the fixed head 2.
  • the inner tube assembly of this structure can provide supporting force to the non-anchoring rods at both ends of the stent at the same time, which is more conducive to the uniform force of the stent.
  • the implant protection component 1 is in contact with one end of the stent frame, so that a part of the implant protection component 1 overlaps the valve stent in the axial direction, and plays a role of supporting the valve stent.
  • the length of the overlapping contact surface of the implant protection component 1 and the stent in the axial direction is determined according to the position of the non-anchoring rod of the stent, and the length of the covering non-anchoring rod is preferably less than 5 mm, more preferably 1-2 mm.
  • the material of the implant protection component 1 is not limited, and it can be a hard metal material or a soft material. While the soft material provides a certain supporting force for the stent, it can also further reduce the damage to the valve stent or valve.
  • the protector 11 is in the shape of a thin sheet, and a hollowed-out internal space is formed radially between the protector and the inner tube, that is, a gap is formed between the protector and the inner tube, and the hollowed-out internal space can be used to accommodate valve leaflets and implant protection components.
  • a hollowed-out internal space can be used to accommodate valve leaflets and implant protection components. 1. Separating the valve stent and the valve leaflets can protect the valve leaflets, prevent the valve leaflets from being crushed and damaged, and ensure the fatigue performance of the valve leaflets.
  • the valve stent 5 includes a non-anchoring rod 51 and an anchoring rod 52.
  • the stent 5 subjected to the pressing force may squeeze the inner valve leaflets, and the implant protection component 1 prevents the non-anchoring rod 51 from Inward movement.
  • the non-anchoring rod 51 still in the sheath 6 will deform due to the outward supporting force of the stent rod outside the sheath 6, and then collapse into the stent and squeeze the valve leaflets.
  • the implant protection component 1 provides a supporting force to the non-anchoring rod 51 in the sheath 6, avoiding the squeezing of the valve leaflets.
  • the gap formed between the implant protection component 1 and the inner tube can also be used to place the free skirt, avoiding the free skirt squeezing; when the stent is In the case of a double-layer stent, the gap can also be used to place the inner stent of the double-layer stent, avoiding the squeezing of the inner stent.
  • the protector When the stent is loaded or released, when a gap is formed between the protector and the inner tube, the protector also plays a certain buffering effect, which is more conducive to the gentle holding or release of the stent.
  • Figure 10a shows a mitral valve replacement stent.
  • the main structure of the stent includes a hanging ear 8, an inflow channel 901, a transition section 902, an outflow channel 903, and a gap 7.
  • the gap 7 and the hanging ear 8 are respectively provided at both ends of the stent .
  • the axial height of the stent is short, and there are gaps, and the uniformity of the force of the stent during the loading process is poor, and the stent is very prone to tilt, twist, collapse, and even damage.
  • the mesh at the gap 7 is in contact with the implant protection component 1 during the loading process, which can ensure the stent
  • the force of the outflow channel 903 is balanced, which avoids the occurrence of tilting, twisting, and collapse of the stent.
  • Figure 10b shows another stent.
  • a gap 7 is provided in the middle of the main structure of the stent.
  • An implant protection component 1 can be provided at a position corresponding to the gap 7 on the inner tube assembly of the delivery system. At least a part of the grid around the notch is contacted to provide a supporting force, thereby ensuring a balanced force on the stent, and avoiding the occurrence of tilting, twisting, and collapsing of the stent.
  • Fig. 10c shows a top view of another stent.
  • the inflow channel 901 of the stent has a special-shaped area 9011, which is arranged asymmetrically.
  • the implant protection component 1 is set on the inner tube assembly of the delivery system at a position corresponding to the deformed area 9011.
  • the implant protection component 1 is in contact with the deformed area 9011 of the stent, which can ensure that the inflow channel 901 is balanced in force and avoid the stent. Inclination, distortion, collapse, etc.
  • the implant delivery device provided by this embodiment provides an implant protection component 1 in its inner tube assembly, and the protection body 11 solves the problems of the self-expanding stent due to its large supporting force, short axial height, and asymmetrical.
  • the problem of poor uniformity of force brought about realizes the high-quality release of the artificial valve at the diseased location.
  • the present invention is also applicable to when the bracket is a circumferentially asymmetric bracket, for example, the rigidity of a certain area of the bracket is less than the rigidity of other regions, or the notch is set asymmetrically, which results in uneven force of the bracket, which is easier to produce during the loading and release process.
  • Tilting, twisting, and damage may lead to loading failure or unusable implants; by setting a protector on the inner tube component corresponding to this part of the area, the support can be provided to the stent to ensure its loading and release.
  • the requirements of each part of the stent on the supporting force are also different, and different implant protection components can also be selected according to the requirements of each part.

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Abstract

一种植入体输送装置及其内管组件、导管(100),内管组件包括植入体保护部件(1)、内管(3)和与内管(3)连接的固定头(2),植入体保护部件(1)与内管(3)或/和固定头(2)连接,植入体保护部件(1)用于与植入体接触设置以支撑植入体;保护体(11,11a,11b)呈圆环片状或圆弧片状。提供的植入体输送装置通过设置植入体保护部件(1),能够支撑瓣膜支架(5)周向支撑力较弱的非锚固杆,避免了瓣膜支架(5)在装载过程中的倾斜、受损以及释放过程中的扭曲、内陷。

Description

一种植入体输送装置及其内管组件、导管 技术领域
本发明涉及一种植入体输送系统,尤其涉及一种植入体输送装置及其内管组件、导管。
背景技术
植入体,如自膨式支架,在装载与释放的过程中需要具有特定结构通过形状契合或拉线等方式与输送器的对应结构进行固定,可以是一端固定,也可以是两端均固定,从而实现输送器对植入体的稳定压握与释放。植入体上的这种特定结构被称为挂耳,输送系统上的对应结构被称为固定头。挂耳可出现在支架上的任意节点,若为单层支架,挂耳通常设置在支架的某一端侧;若为双层支架,挂耳通常设置在内层或外层支架的某一端侧,但双层支架压握后挂耳并非一定在顶端,可以在支架端侧的周向所有节点均设置挂耳,也可仅在部分节点设置挂耳,剩余未设置挂耳的节点所在支架杆被称为无挂耳杆。根据节点处是否设置有挂耳,可将带有挂耳的支架杆称为锚固杆,将未设置挂耳的支架杆称为非锚固杆,如果是双层支架,锚固杆和非锚固杆有可能处于不同的支架层。
技术问题
现有输送系统的问题在于,当瓣膜支架为周向对称支架时,固定头上的形状契合或拉线的节点数,在多数情况下会少于支架上锚固杆所对应的节点数,那么装载过程中挂耳紧密结合在凹槽之中,锚固杆受到鞘管/装载工具的压握和固定头的支撑力,而非锚固杆仅受压握力,并且由于轴向高度差异的存在,即挂耳本身高度或者支架主体端部设置有缺口所形成的高度差,导致锚固杆与非锚固杆的受力往往不一致,进而导致非锚固杆在装载、释放过程很容易造成向内内收,支架直接施力于瓣叶,易造成瓣叶损伤,影响假体功能,且植入体受力不均匀,导致植入体倾斜、受损甚至装载失败或植入体不能使用。当瓣膜支架为非周向对称的支架设计时,上述现象会更为严重,例如支架的某部分区域的刚性小于其他区域的刚性,或者缺口非对称性设置,这将导致瓣膜支架受力不均匀,更容易在装载释放过程中产生倾斜、扭曲、受损,进而导致装载失败或植入体不能使用。
常见的固定头一般为带有凹槽的圆台或楔形体,植入体上的挂耳外形与凹槽相匹配,通过形状契合进行连接。临床应用中,现有的植入体装载流程为植入体部分压握之后,将挂耳固定在固定头的凹槽之中,然后驱动导管前进,逐步将植入体包覆完全。在整个装载过程中,特别是周向不对称的支架,因受力均匀性差,容易发生植入体倾斜、受损;而自膨胀支架的大支撑力、轴向高度短、非周向对称等,都会加剧支架受力均匀性差的问题。同时,释放过程中植入体也可能会发生扭曲、内陷、损伤甚至不能正常使用的情况。另外,当自膨式支架的瓣叶的某一端面与支架端面等高,或高度接近时,在装载、释放过程中支架会挤压瓣叶,造成瓣叶损伤,影响其使用。现有技术中,一般通过对输送器导管、植入体或装载工具进行改进,方案复杂,周期长,成本高;而忽视了固定头在其中的作用。 
因此,有必要开发一种新的植入体输送装置及其内管组件,可以解决上述问题。
技术解决方案
本发明所要解决的技术问题是提供一种植入体输送装置及其内管组件、导管,能够为植入体提供支撑力,避免植入体在输送过程中塌陷。
本发明为解决上述技术问题而采用的技术方案是提供一种植入体输送装置的内管组件,所述内管组件包括植入体保护部件、内管和与所述内管连接的固定头,所述植入体保护部件与所述内管或/和所述固定头连接,所述植入体保护部件用于与植入体接触设置以支撑所述植入体。
优选地,所述植入体保护部件包括至少一个保护体,所述保护体呈圆环片状或圆弧片状。
优选地,所述植入体保护部件和所述内管连接,所述植入体保护部件包括连接件和保护体,所述连接件连接在所述内管上,所述保护体连接在所述连接件上。
优选地,所述固定头上具有凹槽,所述凹槽与所述保护体在轴向上相对设置。
优选地,所述植入体保护部件包括相互连接的第一保护体和第二保护体,所述第二保护体与所述第一保护体连接,所述第一保护体与所述第二保护体中的一者与所述固定头连接。
优选地,所述内管组件包括第一植入体保护部件和第二植入体保护部件,所述第一植入体保护部件连接在所述固定头上,所述第一植入体保护部件具有第一保护体;所述第二植入体保护部件连接在所述内管上,所述第二植入体保护部件包括连接件和第二保护体,所述连接件与所述内管连接,所述第二保护体连接在所述连接件上;且所述第一保护体与所述第二保护体在轴向上相对设置。
优选地,所述连接件为中间开孔的圆柱体,所述连接件在开孔处周向连接在所述内管上。
优选地,所述第一保护体为圆环片状,所述第二保护体为圆弧片状。
优选地,所述植入体保护部件与内管之间形成有空隙。
本发明为解决上述技术问题而采用的另一技术方案是提供一种植入体输送装置的导管,包括外管以及上述内管组件,所述内管组件穿设在所述外管中。
本发明为解决上述技术问题而采用的又一技术方案是提供一种植入体输送装置,包括手柄、外管以及上述内管组件,所述内管组件穿设在所述外管中,所述手柄用于驱动所述外管相对于所述内管组件做轴向运动。
有益效果
本发明对比现有技术有如下的有益效果:本发明提供的植入体输送装置及其内管组件、导管,通过在固定头或内管上设置植入体保护部件,能够支撑瓣膜支架周向支撑力较弱的区域,如非锚固杆、缺口,避免了瓣膜支架在装载过程中的倾斜、受损以及释放过程中的扭曲、内陷;特别是植入体保护部件与内管之间径向形成镂空的内部空间,所述镂空的内部空间可用于容纳瓣叶,因此,所述植入体保护部件将瓣膜支架和瓣叶分隔,有效保护瓣叶,避免了对瓣叶的挤压,有效解决了装载、释放过程支架挤压瓣叶的问题,保证瓣叶疲劳性能。当构成植入体保护部件的保护体的材质为软性材料时,软性材料在提供一定支撑力的同时,还能进一步减小对支架或瓣膜的损伤。随着支架研究技术的发展,根据心脏原生生理结构而设计的带有缺口或其他类型的不规则的支架会越来越多,该植入体保护部件的应用范围会越来越广。
附图说明
图1a为本发明实施例中植入体输送装置的结构示意图,图1b为本发明实施例中植入体输送装置的内管组件的结构示意图,图1c为本发明实施例中植入体输送装置的内管组件的剖面示意图;
图2a、2b、2c、2d为本发明实施例中保护体的多种不同形状示意图;
图3a、3b、3c、3d、3e为本发明实施例中将导管的横截面进行平分所得的剖面示意图;
图4a、4b、4c为本发明实施例中保护体的分布示意图,其中图4b、图4c为多个保护体对称设置的示意图;
图5为本发明实施例中植入体输送装置的多个保护体的非对称设置的示意图;
图6为本发明实施例中植入体保护部件和内管连接的结构示意图;
图7为本发明实施例中植入体保护部件和固定头连接的结构示意图;
图8为本发明实施例中两个植入体保护部件分别与内管、固定头连接的结构示意图。
图9为本发明实施例中支架压缩到鞘管与植入体保护部件接触的结构示意图。
图10a、10b、10c分别为本发明实施例中支架的端部存在缺口、中部存在缺口及流入道非对称设置的结构示意图。
图中:
1-植入体保护部件,2-固定头,3-内管,4-锥形头,1a-第一植入体保护部件,1b-第二植入体保护部件,11、11a、11b-保护体,111-第一保护体,112-第二保护体,12-连接件,21-挂耳凹槽,22-底座,31-近端内管,32-远端内管,5-支架,6-鞘管,7-缺口,8-挂耳,901-流入道,902-过渡段,903-流出道,9011-异型区域,51-非锚固杆,52-锚固杆,100-导管,200-手柄。
本发明的实施方式
下面结合附图和实施例对本发明作进一步的描述。
在以下描述中,为了提供本发明的透彻理解,阐述了很多具体的细节。然而,本发明可以在没有这些具体的细节的情况下实践,这对本领域普通技术人员来说将是显而易见的。因此,具体的细节阐述仅仅是示例性的,具体的细节可以由奔放的精神和范围而变化并且仍被认为是在本发明的精神和范围内。
需要说明的是,当元件被称为“固定于”另一个元件,它可以直接固定在另一个元件上或者也可以存在中间元件,即一元件通过该中间元件与另一元件进行间接固定。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在中间元件,即一元件通过该中间元件与另一个元件进行间接连接。为了更加清楚地描述本发明的结构特征,采用“近端”、“远端”、“轴向”作为方位词,其中“近端”表示在手术过程中靠近操作者的一端;“远端”表示远离操作者的一端,轴向表示内管的轴线所在的方向。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。
本实施例中的植入体以瓣膜支架为例进行说明。本发明提供的一种植入体输送装置及其内管组件、导管,在固定头或/和内管上设置有植入体保护部件,避免了瓣膜支架在装载过程中的倾斜、受损以及释放过程中的扭曲、内陷。
图1a是一种植入体输送装置的结构示意图。如图1a所示,一种植入体输送装置,可应用于承载瓣膜假体以进行心脏人工瓣膜(诸如主动脉瓣人工瓣膜)的装载、输送、释放、回收等操作,上述的装置可包括导管100及与该导管100近端连接的控制手柄200;上述的导管100可包括依次套接的外管、内管组件等。
请参见图1b和图1c,本实施例提供的植入体输送装置的内管组件,包括植入体保护部件1、固定头2、内管3和锥形头4,固定头2、锥形头4均与内管3连接,内管3包括近端内管31和远端内管32,近端内管31、固定头2、远端内管32和锥形头4从近端到远端依次连接,内管3具有贯通的内腔,以供导丝穿过。在具体实施例中,植入体保护部件1可与固定头2连接,也可与内管3固定相连,固定方式可为一体连接或通过焊接、黏连等方式连接,本实施例对连接方式不做特别限制。植入体保护部件1主要用于接触压握状态的瓣膜支架的非锚固杆,起到支撑的作用。在输送系统中,固定头2的数目可以为1个也可以为多个,可以理解的是,本领域技术人员可根据支架端部支撑力需求设置植入体保护部件1,选择将植入体保护部件1设置在一个固定头、多个固定头、内管或者同时设置在固定头和内管上,植入体保护部件1的个数可随设置位置不同设置为1个或多个。
植入体保护部件1至少包括一个保护体11。在本发明的实施例中,保护体11呈圆环片状或圆弧片状。保护体11呈圆环片状是指保护体11在周向上的投影为圆环状,如图7中的第二保护体112。保护体11呈圆弧片状是指保护体11在周向上的投影为圆弧状,如图4a-图4c、图5所示。
保护体11可以有多种形态,其沿周向展开后的平面形状如图2a-2d所示,当然保护体11并不局限于图2a-2d所示的4种形状,其在轴向上的长度、在径向上的宽度依据其所需支撑的瓣膜支架非锚固杆位置及结构来确定,只要确保保护体11与瓣膜支架框架顶端的非锚固杆相接触,提供支撑力,避免支架塌陷即可,该结构尤其适用于支架框架顶端为不完全对称结构,例如有缺口的瓣膜支架的装载和释放。
植入体保护部件1的排列,以构成植入体保护部件1的保护体11落于基本单元的二维平面来描述,所述基本单元为将导管的横截面进行平分所得的剖面图,优选1-8个基本单元;更优选为2-6个基本单元,如图3a-3e所示。
保护体11可设置在一个基本单元中,如图4a所示;也可设置在多个基本单元中,如图4b和4c所示。不同的基本单元中的保护体11的形状可以相同,也可以不相同。当保护体11在不同的基本单元中设置时,可对称设置,也可非对称设置。如图4b中的2个保护体11、图4c中的3个保护体11均为对称设置;非对称设置主要针对瓣膜支架主体端部非对称的情况。
一个基本单元中也可同时设置有两个或两个以上保护体11,如图5所示,其包括两个保护体11a和11b。当然,不同的基本单元中所设置的保护体11的形状可相同也可不同。
请参见图6,在一实施方式中,植入体保护部件1连接在内管3上,植入体保护部件1包括连接件12和保护体11,在一较佳实施例中,连接件12为中间开孔的圆柱体,连接件12在开孔处周向连接在内管3上且与内管3同轴设置,保护体11连接在连接件12上,连接件12的形状本发明不做特别限制,只要能将保护体11连接在与支架上需要固定支撑的位置且尺寸上不影响支架的装载、释放等操作即可;较佳地,固定头2上的凹槽21和保护体11在轴向上相对设置,即凹槽21的开口方向和保护体11在连接件12上沿轴向的设置方向相反,这种设置可应用于挂耳与缺口存在于不同端部的支架,使得支架一端的挂耳与凹槽21匹配设置,支架另一端的缺口与保护体11匹配接触设置,挂耳与缺口存在于不同支架端部时,更容易出现支架扭曲或内陷的问题,所以将植入体保护部件1设置在内管3上,通过对缺口处提供支撑力,可有效避免支架扭曲或内陷。植入体保护部件1与内管3连接时,其数量可以是一个或多个,更优选为1个或2个,其在内管3上的设置方式根据支架压握时,所需覆盖的支架周向支撑力较弱的位置,如非锚固杆位置而确定,即,相对固定头2而言,保护体11可设置在固定头2的两侧,此时,至少需要两个保护体11;至少两个保护体11也可设置在固定头2的一侧,以其能够覆盖支架周向支撑力较弱的位置而设置,以带缺口的支架为例,保护体11覆盖缺口所在的非锚固杆。
在另一实施方式中,植入体保护部件1和固定头2直接连接,如图1b、图1c和图7所示;固定头2包括底座22和凹槽21,底座22上连接植入体保护部件1,如图1b和图1c所示的植入体保护部件1包括多个呈圆弧片状的保护体11;如图7所示的植入体保护部件1包括互相连接的第一保护体111和第二保护体112,较佳地,第一保护体111的数量为一个或多个,呈圆弧片状;第二保护体112的数量为一个,呈圆环片状,第二保护体112连接在固定头2上,第一保护体111与第二保护体112连接。该结构可应用于挂耳与缺口在同一末端的瓣膜支架的装载和释放,能够同时对缺口和非锚固杆提供支撑力,更有利于支架受力均匀。
在又一实施方式中,请参见图8,内管组件包括第一植入体保护部件1a和第二植入体保护部件1b,较佳地,第二植入体保护部件1b具有第二保护体112,第二保护体112为圆环片状,第二保护体112连接在固定头2上;第一植入体保护部件1a包括连接件12和至少一个第一保护体111,连接件12与内管3连接,连接件12优选为中间开孔的圆柱体,连接件12在开孔处周向连接在内管3上且与内管3同轴设置,第一植入体保护部件1a连接在连接件12上,第一保护体111呈圆弧片状,且第一保护体111与第二保护体112在轴向上相对设置,即第一保护体111在连接件12上沿轴向的设置方向和第二保护体112在固定头2上沿轴向的设置方向相反。该结构的内管组件可同时对支架两端的非锚固杆提供支撑力,更有利于支架受力均匀。
在本发明中,植入体保护部件1和支架框架的一端接触,使得植入体保护部件1在轴向上有一部分与瓣膜支架重叠,起到支撑瓣膜支架的作用。植入体保护部件1和支架重叠的接触面在轴向上的长度根据支架的非锚固杆位置确定,以覆盖非锚固杆长度小于5mm为佳,更优选为1-2mm。
植入体保护部件1的材质不限,可为材质较硬的金属材料,也可为软性材料。软性材料在为支架提供一定支撑力的同时,还能进一步减小对瓣膜支架或瓣膜的损伤。
优选地,保护体11呈薄片状,与内管之间径向形成镂空的内部空间,即保护体与内管之间形成有空隙,镂空的内部空间可用于容纳瓣叶,植入体保护部件1将瓣膜支架和瓣叶分隔,可保护瓣叶、防止瓣叶被挤压损伤,保证瓣叶疲劳性能。请参见图9,瓣膜支架5包括非锚固杆51和锚固杆52,在装载过程中,受到压握力的支架5可能挤压内部的瓣叶,植入体保护部件1阻止了非锚固杆51的向内运动。在释放过程中,现有技术中,仍在鞘管6内的非锚固杆51会因为鞘管6外的支架杆向外支撑力的作用而发生形变,进而向支架内部收拢,挤压瓣叶,而植入体保护部件1对鞘管6内的非锚固杆51提供了支撑力,避免了对瓣叶的挤压。当支架设置有朝向支架的轴线方向的游离裙边时,植入体保护部件1与内管之间形成的空隙还可用于放置该游离裙边,避免了游离裙边的挤压;当支架为双层支架时,该空隙还可用于放置双层支架的内层支架,避免了对内层支架的挤压。当装载或释放支架时,保护体与内管之间形成有空隙时,保护体还起到了一定的缓冲作用,更有利于支架的平缓压握或释放。
图10a示出了一种二尖瓣瓣膜置换支架,支架主体结构包括挂耳8、流入道901、过渡段902、流出道903和缺口7,缺口7与挂耳8分别设置在支架的两端,该支架的轴向高度短、且存在缺口,在装载过程中支架受力均匀性差,非常容易出现支架倾斜、扭曲、塌陷,甚至受损。当在输送系统的内管组件上在与缺口7对应的位置处设置植入体保护部件1时,在装载过程中,缺口7处的网格与植入体保护部件1相接触,能够保证支架流出道903受力均衡,避免了支架倾斜、扭曲、塌陷等情况的发生。
图10b示出了另一种支架,支架主体结构的中部设置有缺口7,可在输送系统的内管组件上与缺口7对应的位置处设置植入体保护部件1,植入体保护部件1接触缺口周边的至少部分网格以提供支撑力,进而保证支架受力均衡,避免了支架倾斜、扭曲、塌陷等情况的发生。
图10c示出了另一种支架的俯视图,支架的流入道901具有异型区域9011,为非对称性设置。在输送系统的内管组件上与异型区域9011对应的位置设置植入体保护部件1,植入体保护部件1与支架的异型区域9011相接触,能够保证流入道901受力均衡,避免了支架倾斜、扭曲、塌陷等情况的发生。
因此,本实施例提供的植入体输送装置通过在其内管组件设置植入体保护部件1,其中的保护体11解决了自膨胀支架的大支撑力、轴向高度短、非对称等所带来的受力均匀性差的问题,实现人工瓣膜高质量地释放于病变位置。本发明还适用于当支架为周向非对称支架时,例如支架的某部分区域的刚性小于其他区域的刚性,或者缺口非对称性设置,这导致支架受力不均匀,更容易在装载释放过程中产生倾斜、扭曲、受损,进而导致装载失败或植入体不能使用;通过对这部分区域对应的内管组件上设置保护体即可实现对支架提供支撑力,保证其装载和释放。更进一步地,随着支架种类的多样化,例如分体式支架时,各部分支架对支撑力的要求也不同,也可根据各部分需求选取不同的植入体保护部件。
虽然本发明已以较佳实施例揭示如上,然其并非用以限定本发明,任何本领域技术人员,在不脱离本发明的精神和范围内,当可作些许的修改和完善,因此本发明的保护范围当以权利要求书所界定的为准。

Claims (11)

  1. 一种植入体输送装置的内管组件,其特征在于,所述内管组件包括植入体保护部件、内管和与所述内管连接的固定头,所述植入体保护部件与所述内管或/和所述固定头连接,所述植入体保护部件用于与植入体接触设置以支撑所述植入体。
  2. 根据权利要求1所述的内管组件,其特征在于,所述植入体保护部件包括至少一个保护体,所述保护体呈圆环片状或圆弧片状。
  3. 根据权利要求1所述的内管组件,其特征在于,所述植入体保护部件和所述内管连接,所述植入体保护部件包括连接件和保护体,所述连接件连接在所述内管上,所述保护体连接在所述连接件上。
  4. 根据权利要求3所述的内管组件,其特征在于,所述固定头具有凹槽,所述凹槽与所述保护体在轴向上相对设置。
  5. 根据权利要求1所述的内管组件,其特征在于,所述植入体保护部件包括相互连接的第一保护体和第二保护体,所述第一保护体与所述第二保护体中的一者与所述固定头连接。
  6. 根据权利要求1所述的内管组件,其特征在于,所述内管组件包括第一植入体保护部件和第二植入体保护部件,所述第一植入体保护部件连接在所述固定头上,所述第一植入体保护部件具有第一保护体;所述第二植入体保护部件连接在所述内管上,所述第二植入体保护部件包括连接件和第二保护体,所述连接件与所述内管连接,所述第二保护体连接在所述连接件上;且所述第一保护体与所述第二保护体在轴向上相对设置。
  7. 根据权利要求3或6所述的内管组件,其特征在于,所述连接件为中间开孔的圆柱体,所述连接件在开孔处周向连接在所述内管上。
  8. 根据权利要求5或6所述的内管组件,其特征在于,所述第一保护体为圆环片状,所述第二保护体为圆弧片状。
  9. 根据权利要求1所述的内管组件,其特征在于,所述植入体保护部件与内管之间形成有空隙。
  10. 一种植入体输送装置的导管,其特征在于,包括外管以及权利要求1-9任一项所述的内管组件,所述内管组件穿设在所述外管中。
  11. 一种植入体输送装置,其特征在于,包括手柄、外管以及权利要求1-9任一项所述的内管组件,所述内管组件穿设在所述外管中,所述手柄用于驱动所述外管相对于所述内管组件做轴向运动。
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