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WO2018120750A1 - Self-expanding stent delivery system and related components thereof - Google Patents

Self-expanding stent delivery system and related components thereof Download PDF

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Publication number
WO2018120750A1
WO2018120750A1 PCT/CN2017/092498 CN2017092498W WO2018120750A1 WO 2018120750 A1 WO2018120750 A1 WO 2018120750A1 CN 2017092498 W CN2017092498 W CN 2017092498W WO 2018120750 A1 WO2018120750 A1 WO 2018120750A1
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WO
WIPO (PCT)
Prior art keywords
gear
inner tube
bracket
outer tube
tube
Prior art date
Application number
PCT/CN2017/092498
Other languages
French (fr)
Chinese (zh)
Inventor
刘浩
魏继昌
龚霄雁
Original Assignee
苏州茵络医疗器械有限公司
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
Priority claimed from CN201621454714.0U external-priority patent/CN206852686U/en
Priority claimed from CN201621455696.8U external-priority patent/CN206852687U/en
Priority claimed from CN201611237539.4A external-priority patent/CN108245291A/en
Priority claimed from CN201611236566.XA external-priority patent/CN107518968B/en
Application filed by 苏州茵络医疗器械有限公司 filed Critical 苏州茵络医疗器械有限公司
Publication of WO2018120750A1 publication Critical patent/WO2018120750A1/en

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    • 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
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Definitions

  • the present invention relates to the field of medical devices, and more particularly to a self-expanding stent delivery system and a catheter assembly thereof, a gear drive assembly.
  • the stent treatment is a minimally invasive interventional procedure with stent treatment, which has less trauma, less complications and good effect, and has become the main method for treating peripheral vascular stenosis.
  • the stent delivery system generally includes an interconnected catheter assembly and a handle portion.
  • the catheter assembly generally includes an outer tube and an inner tube.
  • the outer tube and the inner tube are both hollow, and the inner tube can be used for guiding the guide wire.
  • a bracket loading area is formed between the tube and the outer tube, and the bracket in the contracted state is received in the bracket loading area, the handle portion includes a housing adapted to be gripped and a drive assembly for driving the movement of the inner tube or the outer tube.
  • the doctor uses the guide wire to guide the delivery system preloaded with the stent in the contracted state to reach the lesion, and the release position of the stent is determined by the development point on the stent or the delivery system, after which the inner tube is fixed and the drive assembly is operated.
  • the tube is retracted backwards in the axial direction, so that the stent is released from the stent loading area and enters the blood vessel, and the released stent expands in an expanded state by its own expansion force, and is attached to the inner wall of the blood vessel.
  • a self-expanding stent For a self-expanding stent, it is in a contracted state prior to release, in the stent loading region between the inner wall of the outer tube and the outer wall of the inner tube, due to its high shrinkage (especially a braided stent), During the release process of the stent into the blood vessel, the released stent is prone to shrinkage, resulting in inaccurate positioning of the stent, and the relative movement of the stent and the outer wall of the inner tube is easy to occur, resulting in inaccurate stent release. At this time, if the bracket is not positioned properly or the bracket has other product problems, it is difficult for the user to retract the bracket to the outer tube to reposition the release bracket or retract the delivery system.
  • the stent In the early stage of stent release, the stent needs to be released slowly because of the need for precise positioning; after the stent is positioned accurately, it can be released quickly.
  • the existing stent delivery system mainly controls the release speed of the stent through the experience and feel of the doctor, which is easy to cause the stent to be released and positioned inaccurately, and also has high requirements for the doctor's experience.
  • the present invention provides a self-expanding stent delivery system, and a catheter assembly thereof, a gear drive assembly.
  • a catheter assembly for a self-expanding stent delivery system including an inner tube and an outer tube, the outer tube sleeve being outside of at least a portion of the inner tube, The inner tube and the outer tube are configured to be movable relative to each other in the axial direction, and a bracket loading area for housing the bracket in a contracted state is formed between an inner wall of the outer tube and an outer wall of the inner tube, the duct assembly Also included is at least one restriction member disposed on an outer wall of the inner tube and located in the bracket loading area, the restriction member being configured to be able to jam when the inner tube and the outer tube are relatively moved The bracket in the rack loading area.
  • the catheter assembly further includes a push step disposed on an outer wall of the inner tube, the push step being located at a proximal end of the stent loading region, configured to move relative to the outer tube when the inner tube is opposite the outer tube
  • a proximal end face of the stent can be placed to transport the stent out.
  • the restraining member can be an elastic annular member that fits over the inner tube and that has an interference fit with the outer tube and the stent in a collapsed state.
  • the annular member is in a state in which the outer surface is rounded, or the annular member is a hollow cone.
  • the ring member is made of the following materials: silica gel, TPU, rubber, PI, Pebax, nylon, PC or PE, and the like.
  • the annular member is glued or welded to be sheathed outside the inner tube, or the inner tube is injection molded integrally with the annular member by injection molding.
  • the restricting member may also be a barbed member, the barb member being composed of a sleeve portion and an elastic portion extending from the sleeve portion, the sleeve portion being sleeved outside the inner tube,
  • the elastic portion is configured to be able to catch the bracket housed in the rack loading area when the inner tube and the outer tube move relative to each other.
  • the sleeve portion is glued or welded by glue
  • the sleeve is fixed outside the inner tube.
  • the elastic portion is a semi-fan structure, or the elastic portion is composed of two semi-fan structures and a gap between the two semi-fan structures, or the elastic portion is a semi-sector structure.
  • the scallop of the semi-sector structure has at least one serration, or the elastic portion is a semi-sector structure and the sides of the semi-sector structure have serrations.
  • a gear drive assembly for a self-expanding stent delivery system includes a catheter assembly, the catheter assembly including an inner tube and an outer tube, The outer tube is sleeved outside at least a portion of the inner tube, the inner tube and the outer tube are configured to be movable relative to each other in the axial direction, and the inner wall of the outer tube and the outer wall of the inner tube are formed to be in a contracted state a rack loading area of the bracket, the gear drive assembly includes a first gear and a second gear disposed coaxially, the first gear being coupled to the outer tube by a first rack, the second gear passing A second rack is coupled to the inner tube to drive the outer tube and the inner tube to move axially relative to each other by rotating the first gear and the second gear.
  • the gear drive assembly further includes a roller disposed coaxially with the first gear and the second gear, the first gear and the second gear being rotated by rotating the roller.
  • the diameter ratio of the first gear and the second gear is equal to or close to the shortening ratio of the loaded bracket.
  • the diameter of the roller is greater than the diameter of the first gear and the second gear.
  • the diameter ratio of the first gear to the second gear may be 10:1 to 1:10.
  • the gear drive assembly may further include a push button configured to be coupled to the second rack for urging the second rack to move to move the inner tube; or The racks are coupled for urging the movement of the first rack to drive the outer tube to move.
  • a self-expanding stent delivery system including the catheter assembly described above is also provided.
  • a self-expanding stent delivery system including the aforementioned gear drive assembly is also provided.
  • a self-expanding stent delivery system including the catheter assembly and gear drive assembly described above is also provided.
  • the self-expanding stent delivery system of the invention can be used for conveying an intravenous stent, a peripheral vascular stent, a carotid artery stent, an aortic stent graft, an intra-orbital stent graft, a radial artery stent graft, an intestinal stent, a biliary stent, and the like.
  • the bracket Due to the restriction member provided on the outer wall of the inner tube, the bracket can be clamped and fixed during the withdrawal of the outer tube and the release of the bracket, so that the bracket can be pushed forward to the outer tube at any time before the release is completed, and the bracket is repositioned. . At the same time, it can also avoid the relative movement of the stent with the outer wall of the inner tube and the inner wall of the outer tube during the release process, thereby increasing the accuracy of the stent release.
  • the driving component of the conveying system is a gear driving component
  • the outer tube and the inner tube can be driven to move in opposite directions at the same time, thereby solving the problem that the bracket is not released due to the shortening of the bracket, and the moving speed of the inner and outer tubes can be Controlled by precise calculations.
  • the stent can be released at different rates during the operation, for example, the stent is slowly released in the early stage of the stent release, and the stent is quickly released in the later stage.
  • FIG. 1 is a schematic structural view of a self-expanding stent delivery system according to an embodiment of the present invention
  • FIG. 2 is a schematic structural view of a self-expanding stent delivery system for removing a housing according to an embodiment of the present invention
  • FIG. 3 is a schematic structural view of a first gear, a second gear, and a roller of the gear drive assembly of FIG. 2;
  • Figure 4 is a schematic structural view of the gear drive assembly of Figure 2 connected to the outer tube;
  • Figure 5 is a structural schematic view showing the gear drive assembly of Figure 2 connected to the inner tube;
  • FIG. 6 is a schematic structural view of a catheter assembly for removing an outer tube according to an embodiment of the present invention.
  • FIG. 7 is a schematic structural view of a catheter assembly for removing an outer tube according to another embodiment of the present invention.
  • FIG. 8 is a partial enlarged schematic view of a catheter assembly when a stent is loaded, in accordance with an embodiment of the present invention
  • FIG. 9A is a schematic structural view of a restricting member and an inner tube according to an embodiment of the present invention.
  • 9B is a schematic structural view of a restricting member and an inner tube according to another embodiment of the present invention.
  • 9C is a schematic structural view of a restricting member and an inner tube according to still another embodiment of the present invention.
  • Figure 10A is a schematic illustration of a restraining member in accordance with an embodiment of the present invention.
  • Figure 10B is a schematic illustration of a restraining member in accordance with another embodiment of the present invention.
  • Figure 10C is a schematic illustration of a restraining member in accordance with yet another embodiment of the present invention.
  • Figure 10D is a schematic illustration of a restraining member in accordance with yet another embodiment of the present invention.
  • a delivery system for delivering a self-expanding stent to a body includes: a housing 1, a catheter assembly mainly composed of an outer tube 2 and an inner tube 3, and a gear drive assembly 4.
  • a part of the inner tube 3 is located in the casing 1, a part of which protrudes into the inside of the outer tube 2, the outer tube 2 is sleeved outside at least a part of the inner tube 3, and the inner wall of the outer tube 2 and the outer wall of the inner tube 3 form a useful relationship.
  • the bracket tube loading area (not shown) for accommodating the bracket in the contracted state, the inner tube 3 and the outer tube 2 are configured to be relatively movable in the axial direction, and the bracket can be loaded from the bracket loading area by the relative movement of the inner tube and the outer tube Delivered and expanded.
  • the gear drive assembly 4 may include a first gear 41 and a second gear 42 disposed coaxially, wherein the first gear 41 is coupled to the outer tube 2 through the first rack 411, and the second gear 42 is passed through the second
  • the rack 421 is connected to the inner tube 3, and the outer tube 2 and the inner tube 3 are respectively driven to move relative to each other in the axial direction by rotating the first gear 41 and the second gear 42, and the moving speed ratio of the outer tube 2 and the inner tube 3 is first.
  • the diameter ratio of the gear 41 and the second gear 42 is first.
  • the ratio of the diameter of the first gear to the diameter of the second gear is approximately equal to the shortening ratio of the bracket (the shortening ratio of the bracket is the difference between the length of the bracket in the compressed state and the length of the expanded state and the length in the expanded state)
  • the ratio can be better to prevent the release of the stent from shortening and better ensure that the stent can be accurately positioned.
  • the diameter ratio of the first gear to the second gear may be 10:1 to 1:10.
  • the gear drive assembly 4 may further include a first gear
  • the two gear coaxial roller 43 (shown in FIG. 3) can drive the coaxial rotary motion of the first gear 41 and the second gear 42 through the rolling roller 43, thereby driving the inner tube 3 and the outer tube 2 in the axial direction. mobile.
  • the diameter of the roller 43 may be larger than the diameters of the first gear 41 and the second gear 42 to ensure slow rotation of the first gear and the second gear.
  • the gear drive assembly 4 may further include a push button 44 located at one end of the second rack 421 and connected to the second rack 421.
  • a push button 44 located at one end of the second rack 421 and connected to the second rack 421.
  • the second rack is directly moved to drive the inner tube to move, and the outer tube is also relatively moved, so that the bracket can be quickly released and retracted.
  • the push button is pushed forward by 10 mm, the inner tube is advanced by 10 mm, the outer tube is simultaneously withdrawn by 20 mm, and the entire bracket is released by 30 mm.
  • the push button is located at one end of the first rack 411 and is connected to the first rack 411.
  • the first rack can be directly moved to drive the outer tube to move. Allows the stent to be released and retracted quickly.
  • the outer tube and the inner tube can simultaneously move in the opposite direction in the axial direction, that is, the outer tube 2 can be retracted while the inner tube 3 can push the bracket toward Push forward to compensate for the shortening of the bracket.
  • the speed ratio of the outer tube to the inner tube can also be determined, so that the bracket can be positioned more accurately when the diameter of the gear is shorter than the diameter of the bracket.
  • the additionally disposed roller 43 can drive the first gear and the second gear to rotate slowly, and the additionally provided push button 44 connected to the first rack or the second rack can quickly push the first rack or the second rack.
  • the rotating wheel 43 can rotate the gear slowly, and the inner tube and the outer tube move slowly relative to each other to realize the slow release of the bracket; in the later stage of the bracket release, the push button 44 can be pushed to directly push the inner tube or The outer tube is used to rapidly rotate the gear, and the inner tube and the outer tube move relatively quickly to achieve rapid release of the bracket.
  • an outer joint 21 can also be connected at the proximal end of the outer tube 2, and the outer tube 2 is connected to the first rack 411 via the outer joint 21.
  • the flushing port 22 can also be connected to the outer pipe joint 21, and the three-way valve can be connected to the port 22 through the hose, and the flushing liquid or the contrast agent is introduced into the outer tube 2 through the interface during the operation.
  • the outer tube 2 may be a flexible plastic tube or a plastic metal composite tube.
  • the inner tube 3 has a hollow structure to facilitate the passage of the guide wire, and the proximal end of the inner tube A luer connector 31 is provided for connecting the syringe to introduce the flushing liquid to flush the inner lumen of the inner tube 3 or to inject the contrast medium into the inner tube 3.
  • the distal end of the inner tube 3 is provided with a tapered head (TIP head) 32 which extends beyond the distal end of the outer tube 2 and can be used to guide the catheter assembly to move therein.
  • TIP head tapered head
  • Figures 6 and 7 show two embodiments of a catheter assembly with an outer tube removed, respectively.
  • a restricting member 33 may be provided on the outer wall of the inner tube 3, and the proximal end of the bracket is caught by the restricting member 33 in the gap between the inner tube 3 and the outer tube 2.
  • the restricting member 33 may be disposed at the distal end of the inner tube 3 at the loading area of the bracket, and when the outer tube 2 and the inner tube 3 are relatively moved, as long as the proximal end of the bracket is still in the bracket loading area, the limiting member 33 will keep in contact with the bracket and catch the bracket in the loading area of the bracket, for example, the proximal part of the bracket, when the bracket needs to be retracted, the bracket can be retracted by clamping the proximal end of the bracket In the outer tube.
  • the outer wall of the distal end of the inner tube 3 is further provided with a pushing step 34, and the pushing step 34 is located at the proximal end of the loading area of the bracket.
  • the pushing step 34 abuts against the proximal end surface of the bracket, and when the inner tube moves distally, the pushing step pushing bracket moves together distally to push and release the bracket from the bracket loading area.
  • the restriction member 33 can be disposed between the TIP head 32 and the push step 34.
  • the bracket 5 is loaded between the TIP head 32 and the pushing step 34, the pushing step 34 abuts against the proximal end surface of the bracket 5, and the restricting member 33 catches the proximal end portion of the bracket 5, after a part of the bracket is released, If the stent needs to be withdrawn, the outer tube is pushed distally, the inner tube moves to the proximal side, the proximal end portion of the stent is caught by the restriction member, and the stent can be retracted into the outer tube.
  • the restricting member 33 may be an elastic annular member (as shown in FIG. 6), for example, may be made of silica gel, TPU (thermoplastic polyurethane elastomer), rubber, PI (polyimide), Pebax. (block polyether amide elastomer), nylon, PC (polycarbonate) or PE (polyethylene) or the like.
  • an annular member is fixed outside the inner tube, and has good friction performance and elasticity.
  • the proximal end of the bracket is fixedly fixed, so that the bracket can be retracted at any time before being released completely, and the bracket can be repositioned at the same time; at the same time, the bracket accommodated in the loading area of the bracket during the release of the bracket can be ensured.
  • the annular member may be glued or welded to be fixed to the inner tube, or the inner tube may be injection molded integrally with the annular member by injection molding.
  • the annular member may have a smooth outer surface or may have a hollow cone or other shape.
  • the restricting member 33 may be a barb (as shown in FIG. 7), and the barb member is composed of a sleeve portion 331 and an elastic portion 332 extending from the sleeve portion 331.
  • the portion 331 is sleeved outside the inner tube 3, and the elastic portion 332 is used to clamp the proximal end portion of the bracket to restrict its movement.
  • the elastic portion may face the proximal end or the distal end.
  • the cuff portion may be glued or welded to be secured to the inner tube.
  • the bracket in the contracted state can be caught in the bracket loading area by the elastic portion of the barb piece, so that the bracket can be retracted at any time before the bracket is released, and the bracket stored in the rack loading area during the bracket release process can also be ensured. There is no relative movement between the outer wall of the inner tube and the inner wall of the outer tube, which increases the accuracy of the release of the stent.
  • the elastic portion 332 of the barb member may be a half-sector structure, or may be composed of two half-sector structures and have a gap between the two semi-sector structures, or a semi-sector structure.
  • the scallop of the semi-sector structure has at least one serration, or a semi-sector structure and the side wall of the semi-sector structure has at least one serration.
  • the restricting member 33 can adopt various structures, and is not limited to the annular member or the barb member.
  • one, two or more restraining members may also be attached to the inner tube.
  • catheter assembly may also be employed in alternative embodiments.

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Abstract

Provided are a system for use in self-expanding stent delivery, and a catheter assembly and a gear drive assembly (4) thereof. The catheter assembly comprises: an inner tube (3) and an outer tube (2), the outer tube (2) being sleeved over at least a portion of the inner tube (3), while the inner tube (3) and the outer tube (2) are configured to move oppositely in the axial direction; a stent loading area which accommodates a stent in a contracted state is formed between an inner wall of the outer tube (2) and an outer wall of the inner tube; the catheter assembly further comprises at least one restriction member (33), wherein the restriction member (33) is disposed on the outer wall of the inner tube (3) and is located in the stent loading area, the restriction member (33) being configured to hold the stent which is accommodated in the stent loading area when the inner tube (3) and the outer tube (2) move oppositely. The gear drive assembly (4) further comprises: a first gear (41) and a second gear (42), which are disposed coaxially, the first gear (41) being connected to the outer tube (2) by means of a first rack (411), while the second gear (42) is connected to the inner tube by means of a second rack (421), the outer tube (2) and the inner tube (3) being driven to move oppositely in the axial direction by means of the first gear (41) and the second gear (42) rotating.

Description

自膨胀支架输送系统及其相关组件Self-expanding stent delivery system and related components
相关申请的交叉引用Cross-reference to related applications
本申请要求于2016年12月28日提交的申请号为201611237539.4的中国发明专利申请、申请号为201621454714.0的中国实用新型专利申请、申请号为201611236566.X的中国发明专利申请、申请号为201621455696.8的中国实用新型专利申请的权益和优先权,上述中国专利申请的全部内容通过引用并入本文。The present application claims the Chinese invention patent application with the application number 201611237539.4, the Chinese utility model patent application with the application number 201621454714.0, the Chinese invention patent application with the application number 201611236566.X, and the application number 201621455696.8, which is filed on December 28, 2016. The rights and priority of the Chinese Utility Model Patent Application, the entire contents of which are incorporated herein by reference.
技术领域Technical field
本发明涉及医疗器械领域,更为具体而言,涉及一种自膨胀支架输送系统及其导管组件、齿轮驱动组件。The present invention relates to the field of medical devices, and more particularly to a self-expanding stent delivery system and a catheter assembly thereof, a gear drive assembly.
背景技术Background technique
支架治疗法是采用支架治疗的微创介入手术,创伤小,并发症少,效果好,成为目前治疗周边血管狭窄的主要办法。The stent treatment is a minimally invasive interventional procedure with stent treatment, which has less trauma, less complications and good effect, and has become the main method for treating peripheral vascular stenosis.
支架治疗法通常需要运用输送系统以将自膨胀支架植入到体内。在现有技术中,支架输送系统一般包括相互连接的导管组件和手柄部,导管组件通常包括外管和内管,外管与内管均为中空设置,内管中可供导丝通过,内管和外管之间形成有支架装载区,处于收缩状态的支架收纳在该支架装载区中,手柄部包括适于握持的壳体以及用于驱动内管或外管移动的驱动组件。Stent therapy typically requires the use of a delivery system to implant a self-expanding stent into the body. In the prior art, the stent delivery system generally includes an interconnected catheter assembly and a handle portion. The catheter assembly generally includes an outer tube and an inner tube. The outer tube and the inner tube are both hollow, and the inner tube can be used for guiding the guide wire. A bracket loading area is formed between the tube and the outer tube, and the bracket in the contracted state is received in the bracket loading area, the handle portion includes a housing adapted to be gripped and a drive assembly for driving the movement of the inner tube or the outer tube.
在手术过程中,医生利用导丝引导预装有处于收缩状态的支架的输送系统到达病变部位,通过支架或输送系统上的显影点确定支架的释放位置,之后固定内管,操作驱动组件使外管沿轴向向后回撤,使支架从支架装载区中释放出来进入血管,释放的支架依靠自身的膨胀力展开呈膨胀状态,与血管贴合并支承于血管内壁。During the operation, the doctor uses the guide wire to guide the delivery system preloaded with the stent in the contracted state to reach the lesion, and the release position of the stent is determined by the development point on the stent or the delivery system, after which the inner tube is fixed and the drive assembly is operated. The tube is retracted backwards in the axial direction, so that the stent is released from the stent loading area and enters the blood vessel, and the released stent expands in an expanded state by its own expansion force, and is attached to the inner wall of the blood vessel.
对于自膨胀支架而言,其释放之前呈收缩状态,位于外管的内壁和内管的外壁之间的支架装载区中,由于其具有高收缩性(特别是编织支架),在 支架进入血管的释放过程中,释放出来的支架容易发生短缩,造成支架定位不准,并且支架与内管外壁容易发生相对运动,造成支架释放不精确。此时,如发现支架定位不准或者支架还有其他产品问题时,使用者难以将支架回撤至外管重新定位释放支架或者收回输送系统。For a self-expanding stent, it is in a contracted state prior to release, in the stent loading region between the inner wall of the outer tube and the outer wall of the inner tube, due to its high shrinkage (especially a braided stent), During the release process of the stent into the blood vessel, the released stent is prone to shrinkage, resulting in inaccurate positioning of the stent, and the relative movement of the stent and the outer wall of the inner tube is easy to occur, resulting in inaccurate stent release. At this time, if the bracket is not positioned properly or the bracket has other product problems, it is difficult for the user to retract the bracket to the outer tube to reposition the release bracket or retract the delivery system.
在手术过程中,在支架释放前期,因为需要精准定位,支架需缓慢释放;在支架定位准确后,则可以快速释放。现有的支架输送系统主要是通过医生的经验和手感来控制支架释放速度,这样容易造成支架释放定位不准,同时也对医生的经验要求较高。During the operation, in the early stage of stent release, the stent needs to be released slowly because of the need for precise positioning; after the stent is positioned accurately, it can be released quickly. The existing stent delivery system mainly controls the release speed of the stent through the experience and feel of the doctor, which is easy to cause the stent to be released and positioned inaccurately, and also has high requirements for the doctor's experience.
发明内容Summary of the invention
鉴于上述技术缺陷,本发明提供了一种自膨胀支架输送系统,及其导管组件、齿轮驱动组件。In view of the above technical deficiencies, the present invention provides a self-expanding stent delivery system, and a catheter assembly thereof, a gear drive assembly.
根据本发明的一种实施方式,提供了一种用于自膨胀支架输送系统的导管组件,所述导管组件包括内管和外管,所述外管套在所述内管的至少一部分外,所述内管和外管配置成能够沿轴向相对移动,所述外管的内壁与所述内管的外壁之间形成有收纳处于收缩状态的所述支架的支架装载区,所述导管组件还包括至少一个限制部件,所述限制部件设置于所述内管的外壁并位于所述支架装载区,所述限制部件配置成当所述内管与所述外管相对移动时能够卡住收纳于所述支架装载区的所述支架。所述导管组件还包括设置于所述内管的外壁的推送台阶,所述推送台阶位于所述支架装载区的近端端部,其配置成当所述内管与所述外管相对移动时能够抵靠所述支架的近端端面以将所述支架输送出。例如,所述限制部件可为弹性环状部件,所述环状部件固套在所述内管外并且与所述外管及处于收缩状态的所述支架过盈配合。可选地,所述环状部件呈外表面圆滑的状态,或者所述环状部件为中空的圆锥体。所述环状部件由下述材料制成:硅胶,TPU,橡胶,PI,Pebax,尼龙,PC或PE等。所述环状部件通过胶水粘接或焊接以固套在所述内管外,或者通过注塑使所述内管与所述环状部件注塑成一体。例如,所述限制部件也可为倒刺件,所述倒刺件由圆套部和自所述圆套部延伸的弹性部组成,所述圆套部固套在所述内管外,所述弹性部配置成当所述内管与所述外管相对移动时能够卡住收纳于所述支架装载区的支架。所述圆套部通过胶水粘接或焊接 以固套在所述内管外。可选地,所述弹性部为半扇形结构体,或者所述弹性部为由两个半扇形结构体组成并且两个半扇形结构体之间具有缝隙,或者所述弹性部为半扇形结构体并且半扇形结构体的扇边具有至少一个锯齿,或者所述弹性部为半扇形结构体并且半扇形结构体的侧边具有锯齿。In accordance with an embodiment of the present invention, a catheter assembly for a self-expanding stent delivery system is provided, the catheter assembly including an inner tube and an outer tube, the outer tube sleeve being outside of at least a portion of the inner tube, The inner tube and the outer tube are configured to be movable relative to each other in the axial direction, and a bracket loading area for housing the bracket in a contracted state is formed between an inner wall of the outer tube and an outer wall of the inner tube, the duct assembly Also included is at least one restriction member disposed on an outer wall of the inner tube and located in the bracket loading area, the restriction member being configured to be able to jam when the inner tube and the outer tube are relatively moved The bracket in the rack loading area. The catheter assembly further includes a push step disposed on an outer wall of the inner tube, the push step being located at a proximal end of the stent loading region, configured to move relative to the outer tube when the inner tube is opposite the outer tube A proximal end face of the stent can be placed to transport the stent out. For example, the restraining member can be an elastic annular member that fits over the inner tube and that has an interference fit with the outer tube and the stent in a collapsed state. Alternatively, the annular member is in a state in which the outer surface is rounded, or the annular member is a hollow cone. The ring member is made of the following materials: silica gel, TPU, rubber, PI, Pebax, nylon, PC or PE, and the like. The annular member is glued or welded to be sheathed outside the inner tube, or the inner tube is injection molded integrally with the annular member by injection molding. For example, the restricting member may also be a barbed member, the barb member being composed of a sleeve portion and an elastic portion extending from the sleeve portion, the sleeve portion being sleeved outside the inner tube, The elastic portion is configured to be able to catch the bracket housed in the rack loading area when the inner tube and the outer tube move relative to each other. The sleeve portion is glued or welded by glue The sleeve is fixed outside the inner tube. Optionally, the elastic portion is a semi-fan structure, or the elastic portion is composed of two semi-fan structures and a gap between the two semi-fan structures, or the elastic portion is a semi-sector structure. And the scallop of the semi-sector structure has at least one serration, or the elastic portion is a semi-sector structure and the sides of the semi-sector structure have serrations.
根据本发明的另一种实施方式,提供了一种用于自膨胀支架输送系统的齿轮驱动组件,其中,自膨胀支架输送系统包括导管组件,所述导管组件包括内管和外管,所述外管套在所述内管的至少一部分外,所述内管和外管配置成能够沿轴向相对移动,所述外管的内壁与所述内管的外壁之间形成有收纳处于收缩状态的所述支架的支架装载区,所述齿轮驱动组件包括同轴设置的第一齿轮和第二齿轮,所述第一齿轮通过第一齿条与所述外管连接,所述第二齿轮通过第二齿条与所述内管连接,通过旋转所述第一齿轮和所述第二齿轮以驱动所述外管与所述内管沿轴向相对移动。所述齿轮驱动组件还包括与所述第一齿轮、所述第二齿轮同轴设置的滚轮,通过旋转所述滚轮以旋转所述第一齿轮和所述第二齿轮。例如,所述第一齿轮和第二齿轮的直径比等于或接近所装载支架的短缩率。所述滚轮的直径大于所述第一齿轮和第二齿轮的直径。所述第一齿轮与第二齿轮的直径比可以为10:1至1:10。齿轮驱动组件还可包括推送按钮,所述推送按钮设置为:与所述第二齿条相连接以用于推动所述第二齿条移动以带动所述内管移动;或者与所述第一齿条相连接以用于推动所述第一齿条移动以带动所述外管移动。In accordance with another embodiment of the present invention, a gear drive assembly for a self-expanding stent delivery system is provided, wherein the self-expanding stent delivery system includes a catheter assembly, the catheter assembly including an inner tube and an outer tube, The outer tube is sleeved outside at least a portion of the inner tube, the inner tube and the outer tube are configured to be movable relative to each other in the axial direction, and the inner wall of the outer tube and the outer wall of the inner tube are formed to be in a contracted state a rack loading area of the bracket, the gear drive assembly includes a first gear and a second gear disposed coaxially, the first gear being coupled to the outer tube by a first rack, the second gear passing A second rack is coupled to the inner tube to drive the outer tube and the inner tube to move axially relative to each other by rotating the first gear and the second gear. The gear drive assembly further includes a roller disposed coaxially with the first gear and the second gear, the first gear and the second gear being rotated by rotating the roller. For example, the diameter ratio of the first gear and the second gear is equal to or close to the shortening ratio of the loaded bracket. The diameter of the roller is greater than the diameter of the first gear and the second gear. The diameter ratio of the first gear to the second gear may be 10:1 to 1:10. The gear drive assembly may further include a push button configured to be coupled to the second rack for urging the second rack to move to move the inner tube; or The racks are coupled for urging the movement of the first rack to drive the outer tube to move.
根据本发明的又一种实施方式,还提供了一种包括前述的导管组件的自膨胀支架输送系统。In accordance with yet another embodiment of the present invention, a self-expanding stent delivery system including the catheter assembly described above is also provided.
根据本发明的再一种实施方式,还提供了一种包括前述的齿轮驱动组件的自膨胀支架输送系统。In accordance with still another embodiment of the present invention, a self-expanding stent delivery system including the aforementioned gear drive assembly is also provided.
根据本发明的还一种实施方式,还提供了一种包括前述的导管组件和齿轮驱动组件的自膨胀支架输送系统。In accordance with yet another embodiment of the present invention, a self-expanding stent delivery system including the catheter assembly and gear drive assembly described above is also provided.
本发明的自膨胀支架输送系统可用于输送静脉支架、外周血管支架、颈动脉支架、主动脉覆膜支架、髂内覆膜支架、髂动脉覆膜支架、肠道支架、胆道支架等。The self-expanding stent delivery system of the invention can be used for conveying an intravenous stent, a peripheral vascular stent, a carotid artery stent, an aortic stent graft, an intra-orbital stent graft, a radial artery stent graft, an intestinal stent, a biliary stent, and the like.
采用本发明实施方式,具有如下有益效果: By adopting the embodiment of the invention, the following beneficial effects are obtained:
由于内管外壁设置的限制部件,在外管回撤、支架释放过程中可以卡住并固定支架,使得支架在释放完全前,可以随时往前推动外管将支架回撤至外管内,进行重新定位。同时,还可以避免支架在释放过程中与内管外壁、外管内壁发生相对运动,增加了支架释放的精度。Due to the restriction member provided on the outer wall of the inner tube, the bracket can be clamped and fixed during the withdrawal of the outer tube and the release of the bracket, so that the bracket can be pushed forward to the outer tube at any time before the release is completed, and the bracket is repositioned. . At the same time, it can also avoid the relative movement of the stent with the outer wall of the inner tube and the inner wall of the outer tube during the release process, thereby increasing the accuracy of the stent release.
由于输送系统的驱动组件为齿轮驱动组件,可以带动外管和内管同时相对反向运动,解决了因为支架短缩造成的支架释放定位不准的问题,还使得内、外管的移动速度可以被精确计算控制。同时,通过滚轮和推送按钮的设计,使得手术操作过程中,可以实现不同速率释放支架,例如在支架释放前期缓慢释放支架,后期快速释放支架等。Since the driving component of the conveying system is a gear driving component, the outer tube and the inner tube can be driven to move in opposite directions at the same time, thereby solving the problem that the bracket is not released due to the shortening of the bracket, and the moving speed of the inner and outer tubes can be Controlled by precise calculations. At the same time, through the design of the roller and the push button, the stent can be released at different rates during the operation, for example, the stent is slowly released in the early stage of the stent release, and the stent is quickly released in the later stage.
附图说明DRAWINGS
图1是根据本发明一种实施方式的自膨胀支架输送系统的结构示意图;1 is a schematic structural view of a self-expanding stent delivery system according to an embodiment of the present invention;
图2是根据本发明一种实施方式的去除壳体的自膨胀支架输送系统的结构示意图;2 is a schematic structural view of a self-expanding stent delivery system for removing a housing according to an embodiment of the present invention;
图3是图2中的齿轮驱动组件的第一齿轮、第二齿轮和滚轮的结构示意图;3 is a schematic structural view of a first gear, a second gear, and a roller of the gear drive assembly of FIG. 2;
图4是图2中的齿轮驱动组件与外管连接的结构示意图;Figure 4 is a schematic structural view of the gear drive assembly of Figure 2 connected to the outer tube;
图5是图2中的齿轮驱动组件与内管连接的结构示意图;Figure 5 is a structural schematic view showing the gear drive assembly of Figure 2 connected to the inner tube;
图6是根据本发明一种实施方式的去除外管的导管组件的结构示意图;6 is a schematic structural view of a catheter assembly for removing an outer tube according to an embodiment of the present invention;
图7是根据本发明另一种实施方式的去除外管的导管组件的结构示意图;7 is a schematic structural view of a catheter assembly for removing an outer tube according to another embodiment of the present invention;
图8是根据本发明一种实施方式的装载有支架时的导管组件的局部放大示意图;8 is a partial enlarged schematic view of a catheter assembly when a stent is loaded, in accordance with an embodiment of the present invention;
图9A是根据本发明一种实施方式的限制部件和内管的结构示意图;9A is a schematic structural view of a restricting member and an inner tube according to an embodiment of the present invention;
图9B是根据本发明另一种实施方式的限制部件和内管的结构示意图;9B is a schematic structural view of a restricting member and an inner tube according to another embodiment of the present invention;
图9C是根据本发明又一种实施方式的限制部件和内管的结构示意图;9C is a schematic structural view of a restricting member and an inner tube according to still another embodiment of the present invention;
图10A是根据本发明一种实施方式的限制部件的示意图;Figure 10A is a schematic illustration of a restraining member in accordance with an embodiment of the present invention;
图10B是根据本发明另一种实施方式的限制部件的示意图;Figure 10B is a schematic illustration of a restraining member in accordance with another embodiment of the present invention;
图10C是根据本发明又一种实施方式的限制部件的示意图;Figure 10C is a schematic illustration of a restraining member in accordance with yet another embodiment of the present invention;
图10D是根据本发明再一种实施方式的限制部件的示意图。 Figure 10D is a schematic illustration of a restraining member in accordance with yet another embodiment of the present invention.
具体实施方式detailed description
以下结合附图和具体实施方式对本发明的各个方面进行详细阐述。其中,附图中的各部件并非一定是按比例进行绘制,其重点在于对本发明的原理进行举例说明。The various aspects of the invention are described in detail below with reference to the drawings and specific embodiments. The components in the drawings are not necessarily drawn to scale, and the emphasis is on the principles of the invention.
在本发明的各个实施方式中,众所周知的结构、材料或操作没有示出或未作详细说明。并且,所描述的特征、结构或特性可在一个或多个实施方式中以任何方式组合。此外,本领域技术人员应当理解,下述的各种实施方式只用于举例说明,而非用于限制本发明的保护范围。还可以容易理解,本文所述和附图所示的各实施方式中的元件或部件可以按多种不同配置进行布置和设计。本发明说明书和所附的权利要求中所涉及的数值均可理解为由“约”修饰,除非明确地指出或从上下文明显得到,“约”应理解为在本领域的正常误差范围内,例如,在规定值的±5%内。In various embodiments of the invention, well-known structures, materials, or operations are not shown or described in detail. Also, the described features, structures, or characteristics may be combined in any manner in one or more embodiments. In addition, those skilled in the art should understand that the various embodiments described below are for illustrative purposes only and are not intended to limit the scope of the invention. It will also be readily understood that the elements or components of the various embodiments described herein and illustrated in the Figures can be arranged and designed in a variety of different configurations. The numerical values referred to in the present specification and the appended claims are to be understood as being modified by the "about" unless specifically indicated or apparent from the context, "about" is understood to be within the normal tolerances of the art, for example Within ±5% of the specified value.
参考图1,其示出了根据本发明的一种实施方式的自膨胀支架输送系统。在本实施方式中,用于将自膨胀支架输送至体内的输送系统,即自膨胀支架输送系统,包括:壳体1、主要由外管2和内管3构成的导管组件、以及齿轮驱动组件4。其中,内管3的一部分位于壳体1内,一部分伸入外管2的内部,外管2套在内管3的至少一部分外,外管2的内壁与内管3的外壁之间形成有用于收纳处于收缩状态的支架的支架装载区(未示出),内管3和外管2配置成能够沿轴向相对移动,通过内管、外管的相对移动可以将支架从支架装载区中输送出并呈膨胀状态。Referring to Figure 1, a self-expanding stent delivery system in accordance with an embodiment of the present invention is illustrated. In the present embodiment, a delivery system for delivering a self-expanding stent to a body, that is, a self-expanding stent delivery system, includes: a housing 1, a catheter assembly mainly composed of an outer tube 2 and an inner tube 3, and a gear drive assembly 4. Wherein, a part of the inner tube 3 is located in the casing 1, a part of which protrudes into the inside of the outer tube 2, the outer tube 2 is sleeved outside at least a part of the inner tube 3, and the inner wall of the outer tube 2 and the outer wall of the inner tube 3 form a useful relationship. The bracket tube loading area (not shown) for accommodating the bracket in the contracted state, the inner tube 3 and the outer tube 2 are configured to be relatively movable in the axial direction, and the bracket can be loaded from the bracket loading area by the relative movement of the inner tube and the outer tube Delivered and expanded.
图2是去除壳体后的自膨胀支架输送系统的结构示意图。结合图2可知,齿轮驱动组件4可包括同轴设置的第一齿轮41和第二齿轮42,其中,第一齿轮41通过第一齿条411与外管2连接,第二齿轮42通过第二齿条421与内管3连接,通过旋转第一齿轮41和第二齿轮42可以分别驱动外管2与内管3沿轴向相对移动,外管2与内管3的移动速度比为第一齿轮41和第二齿轮42的直径比。例如,当第一齿轮的直径与第二齿轮的直径之比约等于支架的短缩率时(支架的短缩率为支架压缩状态下的长度与膨胀状态的长度之差与膨胀状态下的长度之比),可以更好地防止释放出的支架短缩,更好地保证支架能够准确定位。例如,第一齿轮与第二齿轮的直径比可为10:1至1:10。2 is a schematic view showing the structure of a self-expanding stent delivery system after removing the housing. 2, the gear drive assembly 4 may include a first gear 41 and a second gear 42 disposed coaxially, wherein the first gear 41 is coupled to the outer tube 2 through the first rack 411, and the second gear 42 is passed through the second The rack 421 is connected to the inner tube 3, and the outer tube 2 and the inner tube 3 are respectively driven to move relative to each other in the axial direction by rotating the first gear 41 and the second gear 42, and the moving speed ratio of the outer tube 2 and the inner tube 3 is first. The diameter ratio of the gear 41 and the second gear 42. For example, when the ratio of the diameter of the first gear to the diameter of the second gear is approximately equal to the shortening ratio of the bracket (the shortening ratio of the bracket is the difference between the length of the bracket in the compressed state and the length of the expanded state and the length in the expanded state) The ratio can be better to prevent the release of the stent from shortening and better ensure that the stent can be accurately positioned. For example, the diameter ratio of the first gear to the second gear may be 10:1 to 1:10.
在本发明的一些实施方式中,齿轮驱动组件4还可包括与第一齿轮、第 二齿轮同轴的滚轮43(如图3所示),通过滚动滚轮43,可带动第一齿轮41和第二齿轮42的同轴旋转运动,进而带动内管3和外管2沿轴向相对移动。例如,滚轮43的直径可以大于第一齿轮41和第二齿轮42的直径,以保证第一齿轮、第二齿轮的缓慢旋转。In some embodiments of the present invention, the gear drive assembly 4 may further include a first gear, The two gear coaxial roller 43 (shown in FIG. 3) can drive the coaxial rotary motion of the first gear 41 and the second gear 42 through the rolling roller 43, thereby driving the inner tube 3 and the outer tube 2 in the axial direction. mobile. For example, the diameter of the roller 43 may be larger than the diameters of the first gear 41 and the second gear 42 to ensure slow rotation of the first gear and the second gear.
在本发明的一些实施方式中,齿轮驱动组件4还可包括推送按钮44,该推送按钮位于第二齿条421的一端,与第二齿条421相连接,通过推或拉此按钮44,可以直接移动第二齿条以带动内管移动,同时外管也相对移动,使得支架能够快速释放和回撤。例如,假设第一齿轮、第二齿轮的直径比为2:1时,推动推送按钮前进10mm,则内管前进10mm,外管会同时后撤20mm,整个支架被释放出30mm。In some embodiments of the present invention, the gear drive assembly 4 may further include a push button 44 located at one end of the second rack 421 and connected to the second rack 421. By pushing or pulling the button 44, The second rack is directly moved to drive the inner tube to move, and the outer tube is also relatively moved, so that the bracket can be quickly released and retracted. For example, if the diameter ratio of the first gear and the second gear is 2:1, the push button is pushed forward by 10 mm, the inner tube is advanced by 10 mm, the outer tube is simultaneously withdrawn by 20 mm, and the entire bracket is released by 30 mm.
在本发明的一些实施方式中,推送按钮位于第一齿条411的一端,与第一齿条411相连接,通过推或拉此按钮44,可以直接移动第一齿条,带动外管移动,使得支架能够快速释放和回撤。In some embodiments of the present invention, the push button is located at one end of the first rack 411 and is connected to the first rack 411. By pushing or pulling the button 44, the first rack can be directly moved to drive the outer tube to move. Allows the stent to be released and retracted quickly.
在手术过程中,通过齿轮驱动组件4的第一齿轮和第二齿轮,外管和内管可以同时沿轴向进行反向运动,即外管2回撤的同时内管3可推着支架往前推进,以补偿支架的短缩。通过控制第一齿轮和第二齿轮的直径比,还可以确定外管和内管的速度比,这样,当齿轮的直径比≈支架短缩率时,支架可以更精准地定位。During the operation, through the first gear and the second gear of the gear drive assembly 4, the outer tube and the inner tube can simultaneously move in the opposite direction in the axial direction, that is, the outer tube 2 can be retracted while the inner tube 3 can push the bracket toward Push forward to compensate for the shortening of the bracket. By controlling the diameter ratio of the first gear and the second gear, the speed ratio of the outer tube to the inner tube can also be determined, so that the bracket can be positioned more accurately when the diameter of the gear is shorter than the diameter of the bracket.
此外,额外设置的滚轮43可以带动第一齿轮和第二齿轮缓慢旋转,额外设置的与第一齿条或第二齿条相连接的推送按钮44可以快速推动第一齿条或第二齿条。这样,在支架释放前期,通过旋转滚轮43,可以缓慢旋转齿轮,内管、外管缓慢地相对移动,实现支架的缓慢释放;在支架释放后期,通过推动推送按钮44,可以直接推动内管或外管,从而快速旋转齿轮,内管、外管快速地相对移动,实现支架的快速释放。In addition, the additionally disposed roller 43 can drive the first gear and the second gear to rotate slowly, and the additionally provided push button 44 connected to the first rack or the second rack can quickly push the first rack or the second rack. . In this way, in the early stage of the stent release, the rotating wheel 43 can rotate the gear slowly, and the inner tube and the outer tube move slowly relative to each other to realize the slow release of the bracket; in the later stage of the bracket release, the push button 44 can be pushed to directly push the inner tube or The outer tube is used to rapidly rotate the gear, and the inner tube and the outer tube move relatively quickly to achieve rapid release of the bracket.
结合图4所示,在外管2的近端还可连接有外管接头21,外管2通过外管接头21与第一齿条411相连接。外管接头21上还可连接冲洗接口22,该接口22上可通过软管连接三通阀,在手术过程中,通过此接口向外管2内部导入冲洗液或造影剂。在本发明中,外管2可以是具有韧性的塑料管或塑料金属复合管。As shown in FIG. 4, an outer joint 21 can also be connected at the proximal end of the outer tube 2, and the outer tube 2 is connected to the first rack 411 via the outer joint 21. The flushing port 22 can also be connected to the outer pipe joint 21, and the three-way valve can be connected to the port 22 through the hose, and the flushing liquid or the contrast agent is introduced into the outer tube 2 through the interface during the operation. In the present invention, the outer tube 2 may be a flexible plastic tube or a plastic metal composite tube.
结合图5所示,内管3为中空结构,以便于导丝穿过,内管的近端端部 设置有鲁尔接头31,用于连接注射器,以导入冲洗液冲洗内管3的内腔或向内管3内注射造影剂。内管3的远端端部设置有锥形头(TIP头)32,TIP头32伸出外管2的远端外,可用于引导所述导管组件在内移动。As shown in Fig. 5, the inner tube 3 has a hollow structure to facilitate the passage of the guide wire, and the proximal end of the inner tube A luer connector 31 is provided for connecting the syringe to introduce the flushing liquid to flush the inner lumen of the inner tube 3 or to inject the contrast medium into the inner tube 3. The distal end of the inner tube 3 is provided with a tapered head (TIP head) 32 which extends beyond the distal end of the outer tube 2 and can be used to guide the catheter assembly to move therein.
在可选的实施方式中,也可以采用其他形式的驱动组件,驱动内管或外管移动。In alternative embodiments, other forms of drive assembly may be employed to drive the inner or outer tube movement.
图6和图7分别示出了去除外管的导管组件的两种实施方式。如图6和图7所示,还可以在内管3的外壁设置限制部件33,通过限制部件33将支架的近端卡在内管3和外管2的间隙中。具体而言,该限制部件33可设置在内管3的远端,位于支架的装载区,当外管2与内管3相对移动时,只要支架的近端还处于支架装载区中,限制部件33就会与支架保持接触并卡住支架位于支架装载区中的部位,例如卡住支架的近端部位,在需要收回支架时,也可以通过卡住支架的近端部位,将支架重新回撤至外管内。Figures 6 and 7 show two embodiments of a catheter assembly with an outer tube removed, respectively. As shown in FIGS. 6 and 7, a restricting member 33 may be provided on the outer wall of the inner tube 3, and the proximal end of the bracket is caught by the restricting member 33 in the gap between the inner tube 3 and the outer tube 2. Specifically, the restricting member 33 may be disposed at the distal end of the inner tube 3 at the loading area of the bracket, and when the outer tube 2 and the inner tube 3 are relatively moved, as long as the proximal end of the bracket is still in the bracket loading area, the limiting member 33 will keep in contact with the bracket and catch the bracket in the loading area of the bracket, for example, the proximal part of the bracket, when the bracket needs to be retracted, the bracket can be retracted by clamping the proximal end of the bracket In the outer tube.
内管3的远端的外壁还设置有推送台阶34,推送台阶34位于支架装载区的近端端部,当外管2与内管3相对移动时,只要支架的近端还处于支架装载区中,推送台阶34就会抵靠支架的近端端面,在内管向远侧移动时,推送台阶推送支架一起向远侧移动,以将支架从支架装载区中推送出并释放。限制部件33可设置在TIP头32和推送台阶34之间。The outer wall of the distal end of the inner tube 3 is further provided with a pushing step 34, and the pushing step 34 is located at the proximal end of the loading area of the bracket. When the outer tube 2 and the inner tube 3 are relatively moved, as long as the proximal end of the bracket is still in the loading area of the bracket In the middle, the pushing step 34 abuts against the proximal end surface of the bracket, and when the inner tube moves distally, the pushing step pushing bracket moves together distally to push and release the bracket from the bracket loading area. The restriction member 33 can be disposed between the TIP head 32 and the push step 34.
结合图8所示,支架5装载在TIP头32和推送台阶34之间,推送台阶34抵靠支架5的近端端面,限制部件33卡住支架5的近端部位,在支架释放一部分后,如需要回撤支架时,则往远侧推动外管,内管向近侧移动,支架的近端部位被限制部件卡住,支架可重新回撤至外管中。As shown in Fig. 8, the bracket 5 is loaded between the TIP head 32 and the pushing step 34, the pushing step 34 abuts against the proximal end surface of the bracket 5, and the restricting member 33 catches the proximal end portion of the bracket 5, after a part of the bracket is released, If the stent needs to be withdrawn, the outer tube is pushed distally, the inner tube moves to the proximal side, the proximal end portion of the stent is caught by the restriction member, and the stent can be retracted into the outer tube.
在本发明的一些实施方式中,限制部件33可以为弹性环状部件(如图6所示),例如可以由硅胶、TPU(热塑性聚氨酯弹性体)、橡胶、PI(聚酰亚胺)、Pebax(嵌段聚醚酰胺弹性体)、尼龙、PC(聚碳酸酯)或PE(聚乙烯)等制成。这样的环状部件固定套在内管外,其摩擦性能和弹性良好,在支架以收缩状态收纳入内、外管之间的支架装载区时,支架、限制部件和外管之间可以形成过盈配合。通过此三者间的摩擦力以固定卡住支架的近端部位,使得支架在释放完全前,可以随时回撤,进行重新定位;同时也能保证在支架释放过程中收纳于支架装载区的支架与内管外壁、外管内壁之间无相对运动, 增加支架释放的精度。在一些实施方式中,环状部件可以通过胶水粘接或焊接以与内管相固定,或者,也可以通过注塑使所述内管与所述环状部件注塑成一体。In some embodiments of the present invention, the restricting member 33 may be an elastic annular member (as shown in FIG. 6), for example, may be made of silica gel, TPU (thermoplastic polyurethane elastomer), rubber, PI (polyimide), Pebax. (block polyether amide elastomer), nylon, PC (polycarbonate) or PE (polyethylene) or the like. Such an annular member is fixed outside the inner tube, and has good friction performance and elasticity. When the bracket is housed in a contracted state into the bracket loading area between the inner and outer tubes, the bracket, the restricting member and the outer tube can be formed. Fit. Through the friction between the three, the proximal end of the bracket is fixedly fixed, so that the bracket can be retracted at any time before being released completely, and the bracket can be repositioned at the same time; at the same time, the bracket accommodated in the loading area of the bracket during the release of the bracket can be ensured. There is no relative movement between the outer wall of the inner tube and the inner wall of the outer tube. Increase the accuracy of the stent release. In some embodiments, the annular member may be glued or welded to be fixed to the inner tube, or the inner tube may be injection molded integrally with the annular member by injection molding.
如图9A至图9C所示,环状部件还可以呈外表面圆滑的状态,或者可以呈中空的圆锥体,也可以是其他形状。As shown in FIGS. 9A to 9C, the annular member may have a smooth outer surface or may have a hollow cone or other shape.
在本发明的另一些实施方式中,限制部件33可以为倒刺件(如图7所示),倒刺件由圆套部331和自圆套部331延伸出的弹性部332组成,圆套部331固套于内管3外,弹性部332用于卡住支架的近端部位限制其移动,例如弹性部可以朝向近端也可以朝向远端。在一些实施方式中,圆套部可以通过胶水粘接或焊接以与内管相固定。通过倒刺件的弹性部可以在支架装载区中卡扣住处于收缩状态的支架,这样,支架释放完成前,可随时回撤支架;同时也能保证支架释放过程中收纳于支架装载区的支架与内管外壁、外管内壁之间无相对运动,增加支架释放的精度。In other embodiments of the present invention, the restricting member 33 may be a barb (as shown in FIG. 7), and the barb member is composed of a sleeve portion 331 and an elastic portion 332 extending from the sleeve portion 331. The portion 331 is sleeved outside the inner tube 3, and the elastic portion 332 is used to clamp the proximal end portion of the bracket to restrict its movement. For example, the elastic portion may face the proximal end or the distal end. In some embodiments, the cuff portion may be glued or welded to be secured to the inner tube. The bracket in the contracted state can be caught in the bracket loading area by the elastic portion of the barb piece, so that the bracket can be retracted at any time before the bracket is released, and the bracket stored in the rack loading area during the bracket release process can also be ensured. There is no relative movement between the outer wall of the inner tube and the inner wall of the outer tube, which increases the accuracy of the release of the stent.
如图10A至图10D所示,倒刺件的弹性部332可以是半扇形结构体,或者由两个半扇形结构体组成并且两个半扇形结构体之间具有缝隙,或者是半扇形结构体并且半扇形结构体的扇边具有至少一个锯齿,或者是半扇形结构体并且半扇形结构体的侧壁具有至少一个锯齿。As shown in FIGS. 10A to 10D, the elastic portion 332 of the barb member may be a half-sector structure, or may be composed of two half-sector structures and have a gap between the two semi-sector structures, or a semi-sector structure. And the scallop of the semi-sector structure has at least one serration, or a semi-sector structure and the side wall of the semi-sector structure has at least one serration.
在采用相同原理的情况下,限制部件33可以采用多种结构,不限于环状部件或倒刺件。在可选的实施方式中,内管上也可以固定有一个、两个或多个限制部件。In the case where the same principle is employed, the restricting member 33 can adopt various structures, and is not limited to the annular member or the barb member. In an alternative embodiment, one, two or more restraining members may also be attached to the inner tube.
在可选的实施方式中,也可以采用其他形式的导管组件。Other forms of catheter assembly may also be employed in alternative embodiments.
需要说明的是,以上是用于阐述本发明的思想、概念或原理的实施方式,本发明并不局限于上述实施方式。本领域技术人员根据本发明思想、概念或原理可以对上述实施方式进行各种改变,得到更多的实施方式。It is to be noted that the above is an embodiment for explaining the idea, concept or principle of the present invention, and the present invention is not limited to the above embodiment. Various modifications may be made to the above-described embodiments in accordance with the inventive concept, concept or principle, and more embodiments are obtained.
本发明说明书中使用的术语和措辞仅仅为了举例说明,并不意味构成限定。本领域技术人员应当理解,在不脱离所公开的实施方式的基本原理的前提下,对上述实施方式中的各细节可进行各种变化。因此,本发明的保护范围只由权利要求确定,在权利要求中,除非另有说明,所有的术语应按最宽泛合理的意思进行理解。 The terms and words used in the description are for the purpose of illustration and description It will be understood by those skilled in the art that various changes may be made in the details of the embodiments described above without departing from the basic principles of the disclosed embodiments. Therefore, the scope of the invention is to be determined by the appended claims, and the claims

Claims (18)

  1. 一种用于自膨胀支架输送系统的导管组件,所述导管组件包括内管和外管,所述外管套在所述内管的至少一部分外,所述内管和外管配置成能够沿轴向相对移动,所述外管的内壁与所述内管的外壁之间形成有收纳处于收缩状态的支架的支架装载区,其特征在于,A catheter assembly for a self-expanding stent delivery system, the catheter assembly including an inner tube and an outer tube, the outer tube being outside of at least a portion of the inner tube, the inner tube and the outer tube being configured to be capable of a relatively axial movement, a bracket loading region for receiving a bracket in a contracted state is formed between an inner wall of the outer tube and an outer wall of the inner tube, wherein
    所述导管组件还包括至少一个限制部件,所述限制部件设置于所述内管的外壁并位于所述支架装载区,所述限制部件配置成当所述内管与所述外管相对移动时能够卡住收纳于所述支架装载区的支架。The catheter assembly further includes at least one restriction member disposed on an outer wall of the inner tube and located in the bracket loading region, the restriction member configured to move relative to the outer tube when the inner tube is opposite to the outer tube The bracket accommodated in the loading area of the bracket can be caught.
  2. 如权利要求1所述的导管组件,其特征在于,所述导管组件还包括设置于所述内管的外壁的推送台阶,所述推送台阶位于所述支架装载区的近端端部,其配置成当所述内管与所述外管相对移动时能够抵靠所述支架的近端端面以将所述支架输送出。The catheter assembly of claim 1 wherein said catheter assembly further comprises a push step disposed on an outer wall of said inner tube, said push step being located at a proximal end of said stent loading region, the configuration When the inner tube and the outer tube move relative to each other, the proximal end surface of the bracket can be abutted to transport the bracket out.
  3. 如权利要求1所述的导管组件,其特征在于,所述限制部件为弹性环状部件,所述环状部件固套在所述内管外并且与所述外管及处于收缩状态的所述支架过盈配合。The catheter assembly according to claim 1, wherein said restricting member is an elastic annular member, said annular member being sleeved outside said inner tube and said outer tube and said in a contracted state The bracket has an interference fit.
  4. 如权利要求3所述的导管组件,其特征在于,所述环状部件呈外表面圆滑的状态,或者所述环状部件为中空的圆锥体。The catheter assembly according to claim 3, wherein the annular member is in a state in which the outer surface is rounded, or the annular member is a hollow cone.
  5. 如权利要求3所述的导管组件,其特征在于,所述环状部件由下述材料制成:硅胶,TPU,橡胶,PI,Pebax,尼龙,PC或PE。The catheter assembly of claim 3 wherein said annular member is made of the following materials: silicone, TPU, rubber, PI, Pebax, nylon, PC or PE.
  6. 如权利要求3所述的导管组件,其特征在于,所述环状部件通过胶水粘接或焊接以固套在所述内管外,或者通过注塑使所述内管与所述环状部件注塑成一体。A catheter assembly according to claim 3, wherein said annular member is glued or welded to be sheathed outside said inner tube, or said inner tube and said annular member are injection molded by injection molding. In one.
  7. 如权利要求1所述的导管组件,其特征在于,所述限制部件为倒刺件, 所述倒刺件由圆套部和自所述圆套部延伸的弹性部组成,所述圆套部固套在所述内管外,所述弹性部配置成当所述内管与所述外管相对移动时能够卡住收纳于所述支架装载区的支架。The catheter assembly of claim 1 wherein said restricting member is a barbed member. The barb member is composed of a sleeve portion and an elastic portion extending from the sleeve portion, the sleeve portion is sleeved outside the inner tube, and the elastic portion is configured to be when the inner tube is When the outer tube is relatively moved, the bracket accommodated in the loading area of the bracket can be caught.
  8. 如权利要求7所述的导管组件,其特征在于,所述圆套部通过胶水粘接或焊接以固套在所述内管外。The catheter assembly of claim 7 wherein said cuff portion is glued or welded to fit over said inner tube.
  9. 如权利要求7所述的导管组件,其特征在于,所述弹性部为半扇形结构体,或者所述弹性部为由两个半扇形结构体组成并且两个半扇形结构体之间具有缝隙,或者所述弹性部为半扇形结构体并且半扇形结构体的扇边具有至少一个锯齿,或者所述弹性部为半扇形结构体并且半扇形结构体的侧边具有锯齿。The catheter assembly according to claim 7, wherein said elastic portion is a half-sector structure, or said elastic portion is composed of two semi-fan-shaped structures and having a gap between the two semi-sector structures. Or the elastic portion is a half-sector structure and the scallops of the semi-sector structure have at least one serration, or the elastic portion is a semi-sector structure and the sides of the semi-sector structure have serrations.
  10. 一种用于自膨胀支架输送系统的齿轮驱动组件,其中,所述自膨胀支架输送系统包括导管组件,所述导管组件包括内管和外管,所述外管套在所述内管的至少一部分外,所述内管和外管配置成能够沿轴向相对移动,所述外管的内壁与所述内管的外壁之间形成有收纳处于收缩状态的支架的支架装载区,其特征在于,所述齿轮驱动组件包括:A gear drive assembly for a self-expanding stent delivery system, wherein the self-expanding stent delivery system includes a catheter assembly, the catheter assembly including an inner tube and an outer tube, the outer tube being at least over the inner tube In part, the inner tube and the outer tube are configured to be movable relative to each other in the axial direction, and a bracket loading region for accommodating the stent in a contracted state is formed between the inner wall of the outer tube and the outer wall of the inner tube, characterized in that The gear drive assembly includes:
    同轴设置的第一齿轮和第二齿轮,其中,所述第一齿轮通过第一齿条与所述外管连接,所述第二齿轮通过第二齿条与所述内管连接,通过旋转所述第一齿轮和所述第二齿轮以驱动所述外管与所述内管沿轴向相对移动。a first gear and a second gear disposed coaxially, wherein the first gear is coupled to the outer tube by a first rack, and the second gear is coupled to the inner tube by a second rack by rotation The first gear and the second gear drive the outer tube and the inner tube to move relative to each other in the axial direction.
  11. 如权利要求10所述的齿轮驱动组件,其特征在于,所述齿轮驱动组件还包括与所述第一齿轮、所述第二齿轮同轴设置的滚轮,通过旋转所述滚轮以旋转所述第一齿轮和所述第二齿轮。A gear drive assembly according to claim 10, wherein said gear drive assembly further includes a roller disposed coaxially with said first gear and said second gear, said wheel being rotated to rotate said first a gear and the second gear.
  12. 如权利要求11所述的齿轮驱动组件,其特征在于,所述滚轮的直径大于所述第一齿轮的直径和所述第二齿轮的直径。The gear drive assembly of claim 11 wherein said roller has a diameter greater than a diameter of said first gear and a diameter of said second gear.
  13. 如权利要求10所述的齿轮驱动组件,其特征在于,所述第一齿轮的 直径与第二齿轮的直径之比约等于所述支架的短缩率。A gear drive assembly according to claim 10, wherein said first gear The ratio of the diameter to the diameter of the second gear is approximately equal to the shortening of the bracket.
  14. 如权利要求13所述的齿轮驱动组件,其特征在于,所述第一齿轮与第二齿轮的直径比为10:1至1:10。The gear drive assembly of claim 13 wherein said first gear and said second gear have a diameter ratio of from 10:1 to 1:10.
  15. 如权利要求10所述的齿轮驱动组件,其特征在于,所述齿轮驱动组件还包括推送按钮,所述推送按钮设置为:与所述第二齿条相连接以用于推动所述第二齿条移动以带动所述内管移动;或者与所述第一齿条相连接以用于推动所述第一齿条移动以带动所述外管移动。A gear drive assembly according to claim 10, wherein said gear drive assembly further comprises a push button, said push button being arranged to be coupled to said second rack for pushing said second tooth The strip moves to drive the inner tube to move; or is coupled to the first rack for pushing the first rack to move the outer tube to move.
  16. 一种自膨胀支架输送系统,其特征在于,包括:A self-expanding stent delivery system characterized by comprising:
    按照权利要求1至9中任意一项所述的导管组件。A catheter assembly according to any one of claims 1 to 9.
  17. 一种自膨胀支架输送系统,其特征在于,包括:A self-expanding stent delivery system characterized by comprising:
    按照权利要求10至15中任意一项所述的齿轮驱动组件。A gear drive assembly according to any one of claims 10 to 15.
  18. 一种自膨胀支架输送系统,其特征在于,包括:A self-expanding stent delivery system characterized by comprising:
    按照权利要求1至9中任意一项所述的导管组件;以及a catheter assembly according to any one of claims 1 to 9;
    按照权利要求10至15中任意一项所述的齿轮驱动组件。 A gear drive assembly according to any one of claims 10 to 15.
PCT/CN2017/092498 2016-12-28 2017-07-11 Self-expanding stent delivery system and related components thereof WO2018120750A1 (en)

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CN201621454714.0U CN206852686U (en) 2016-12-28 2016-12-28 Self-expanding stent induction system and its conduit tube component
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CN201621455696.8U CN206852687U (en) 2016-12-28 2016-12-28 Self-expanding stent induction system and its gear drive component
CN201611237539.4A CN108245291A (en) 2016-12-28 2016-12-28 Self-expanding stent transport system and its conduit tube component
CN201611236566.X 2016-12-28
CN201611237539.4 2016-12-28
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