WO2021135352A1 - Système de pose d'implant et son procédé d'utilisation - Google Patents

Système de pose d'implant et son procédé d'utilisation Download PDF

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Publication number
WO2021135352A1
WO2021135352A1 PCT/CN2020/113617 CN2020113617W WO2021135352A1 WO 2021135352 A1 WO2021135352 A1 WO 2021135352A1 CN 2020113617 W CN2020113617 W CN 2020113617W WO 2021135352 A1 WO2021135352 A1 WO 2021135352A1
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WO
WIPO (PCT)
Prior art keywords
inner tube
main body
implant
protrusion
stent
Prior art date
Application number
PCT/CN2020/113617
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English (en)
Chinese (zh)
Inventor
朱清
刘梦钦
姬庆茹
袁振宇
Original Assignee
上海鸿脉医疗科技有限公司
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Publication date
Application filed by 上海鸿脉医疗科技有限公司 filed Critical 上海鸿脉医疗科技有限公司
Publication of WO2021135352A1 publication Critical patent/WO2021135352A1/fr

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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 invention relates to the technical field of medical devices, in particular to an implant delivery system and its inner tube.
  • Stents and stent grafts are used to support various tubular passages in the body, including arteries, veins, and air. Tract, gastrointestinal tract and bile duct.
  • the preferred method of stent placement is to use a professional delivery system to accurately place and deploy the stent at the desired treatment site through the body's own channel. With the help of the smaller outer diameter of the delivery system, the doctor can minimize the surgical incision to achieve minimally invasive operations.
  • Stents can generally be plastically deformed (e.g., "balloon expandable” stents) or elastically deformed (e.g., "self-expanding" stents) in order to recover from a compressed state to a diameter in an expanded state.
  • the stent is installed on the delivery system by radial compression and delivered into the human body, and then the release of the stent is controlled by the manipulating mechanism of the external part of the delivery system to restore the stent to its functional diameter.
  • the commonly used technique is to place the stent radially compressed and placed in the annular space between two concentric catheters.
  • the inner tube is used for the guide wire to pass.
  • the outer tube is pulled back relative to the inner tube and passes through the inner tube. The relative axial displacement of the outer tube releases the stent, and at this time the stent elastically returns to a predetermined diameter.
  • a coaxial intermediate tube between the inner tube and the outer tube, which is located at the proximal end of the stent and is in axial contact with the stent.
  • the middle tube remains motionless, so that the stent is restricted from withdrawing with the outer tube, so that the stent can be released smoothly. Due to the existence of this limit, the stent is bound to be subjected to the axial compression force applied to it by the outer tube and the middle tube during the release process, which usually causes the stent to shorten and lead to inaccurate positioning of the stent.
  • this release method also requires the stent to have strong axial rigidity in the compressed state.
  • the stent will be severely shortened during the release process, and may even cause serious damage to the stent.
  • the design of the stent is greatly restricted, and it is usually necessary to add axial connecting rods between the stent segments to solve the problem of axial rigidity of the stent.
  • the axial connecting rod will adversely affect the axial fatigue and bending performance of the stent, and greatly reduce the overall performance of the stent.
  • One of the methods to solve the above problems is to optimize or change the force state of the stent when it is released, to change the stent from an axially compressed state to a tensioned state, or to minimize the axial compressive force received during the stent release process.
  • the stent delivery system described in Comparative Document 1 Publication No. CN102499801A
  • the stent delivery system described in Comparative Document 2 Publication No. CN104706449A
  • this method is generally only suitable for systems with a larger outer tube diameter due to the larger volume of the rear release mechanism.
  • the inner tube bears a large axial compression force during the release process, it is easy to bend instably during the release process.
  • the above delivery system requires multiple parts to be operated to release the stent, and after the stent is released, an operating mechanism is also required to release the post-release constraint of the distal end, which has the disadvantage of complicated and difficult release.
  • the purpose of the present invention is to provide an implant delivery system and its inner tube, which can enable accurate and stable release and positioning of the implant without causing axial shortening, and at the same time can ensure the safe withdrawal of the delivery system.
  • the present invention provides an inner tube for transporting an implant.
  • the inner tube includes an inner tube main body, and at least one protrusion located outside the inner tube main body; each protrusion
  • the raised portion includes a plurality of protruding monomers, one end of the protruding monomer is connected to the inner tube main body, and the other end extends toward the distal end of the inner tube main body.
  • the included angle between the convex monomer and the axis of the inner tube main body is 10 degrees to 80 degrees.
  • the material of the protrusion is a polymer material or a metal material.
  • the protrusion is integrally formed with the inner tube body by 3D printing or laser cutting.
  • the inner tube main body is provided with a groove
  • the protrusion is located at the groove
  • one end of the protruding monomer is connected to the inner tube main body in the groove
  • the other end Extend from the groove.
  • the axial length of the convex monomer is 1mm-3mm.
  • the protruding portion includes a plurality of the protruding monomers spaced apart along the axial and/or circumferential direction of the inner tube main body.
  • the distance between two adjacent convex monomers in the axial direction of the inner tube main body is 2mm-5mm; the distance between two adjacent convex monomers in the circumferential direction of the inner tube main body is 0.1mm-1.5mm.
  • the shape of the axial cross-section of the convex monomer is quadrilateral, triangle or trapezoid.
  • the protrusion is located at the distal end of the inner tube.
  • the inner tube includes at least two protrusions, and at least two protrusions are spaced apart along the axial direction of the inner tube main body.
  • the present invention also provides an implant delivery system, including a handle, an outer tube, and the above inner tube.
  • the outer tube has an axially penetrating inner cavity, and the inner tube is located in the inner cavity and Extending along the axial direction of the inner cavity, a gap for accommodating the implant is formed between the outer tube and the inner tube, and both the outer tube and the inner tube are connected with the handle, so The handle controls the movement of the outer tube and the inner tube in the axial direction.
  • the implant delivery system further includes an implant that is accommodated in a gap formed between the outer tube and the inner tube and covers at least a part of the protrusion.
  • the present invention has the following beneficial effects: the implant delivery system and its inner tube provided by the present invention provide protrusions on the outer surface of the inner tube, so that the inner tube and the implant are unidirectionally occluded, thereby providing
  • the large static friction force required for the release of the implant makes the release positioning of the implant accurate and stable, without axial shortening; at the same time, due to the directional design of the protrusion on the inner tube, this structure can effectively reduce the delivery system
  • the friction force between the inner tube and the implant body during withdrawal prevents the transfer system from retreating to drive the implant body to shift, making the operation safer; in addition, the present invention improves the ease of product realization and practicability, and the implant body can be used in a wide range of applications. Including all arterial or venous branch and peripheral stents, and other applicable implants.
  • Figure 1 is a schematic diagram of the overall structure of a stent delivery system in an embodiment of the present invention
  • Fig. 2 is an enlarged schematic diagram of a partial cross-section at A in Fig. 1;
  • Figure 3 is a schematic partial cross-sectional view of an inner tube in an embodiment of the present invention.
  • FIG. 4 is an enlarged schematic diagram of a partial cross-section of an inner tube in an embodiment of the present invention.
  • FIG. 5 is an enlarged schematic diagram of a partial cross-section of an inner tube in another embodiment of the present invention.
  • Figure 6 is a schematic diagram of the distribution of the convex monomers in the circumferential direction of the inner tube
  • Fig. 7 is a schematic diagram of the angle formed by the convex monomer at B1 in Fig. 4 and the axis of the inner tube;
  • Fig. 8 is a schematic diagram of the angle formed by the convex monomer at B2 in Fig. 5 and the axis of the inner tube.
  • proximal means the end close to the operator during the operation
  • distal refers to the end far away from the operator
  • axial direction refers to the direction of the axis of the inner tube.
  • one idea is to significantly increase the friction between the inner tube and the stent. If the friction between the inner tube and the stent is large enough, when the stent is released, the inner tube provides the axial support force and axial limit required during the release process. As long as the axial rigidity of the inner tube is sufficient, the inner tube itself does not shrink, and the stent will not shrink or shift during the release process. Furthermore, there are two main ways to increase friction: one is to increase the positive pressure of the contact surface; two, to increase the friction coefficient of the contact surface.
  • the positive pressure between the inner tube and the stent can be increased by compressing the stent in a thinner outer tube or increasing the outer diameter of the inner tube. But doing so will increase the positive pressure between the stent and the inner tube, but also significantly increase the positive pressure between the outer tube and the stent, resulting in increased friction between the stent and the outer tube. If the friction between the inner tube and the stent is less than the friction between the outer tube and the stent, the stent still cannot be released normally.
  • the friction between the inner tube and the support can be increased by changing the inner tube material. But this introduces a new problem.
  • the delivery system needs to be withdrawn from the body. During the withdrawal process, the inner tube will inevitably come into contact with the inner wall of the stent. Due to the large friction coefficient of the inner tube, it is very easy to drive the stent to withdraw and shift together, which can cause vascular damage in severe cases.
  • the present invention provides a method for realizing a large difference in the friction coefficient of the inner tube surface along the proximal and distal directions by processing the inner tube surface or adding convex monomers.
  • the implant in this embodiment is described by taking a blood vessel stent as an example.
  • the blood vessel stent is made of a cylindrical polyester sheet or other polymer materials and a plurality of self-expanding alloy stent segments sutured or heat-melted, or only contains alloy Bracket part.
  • the implant delivery system and its inner tube provided by the present invention, by providing a protrusion on the inner tube, the friction force between the stent and the inner tube is relatively large during the release of the vascular stent, and the outer tube will not change when the outer tube is withdrawn.
  • the axial length of the stent may make the entire stent move backward. When the stent is released and the inner tube is withdrawn, the friction between the inner tube and the positioned stent is small, and it can be withdrawn safely.
  • the implant delivery system provided in this embodiment includes a handle 1, an outer tube 2 and an inner tube 3.
  • the outer tube 2 has an axially penetrating lumen, and the inner tube 3 is located in the lumen And extending along the axial direction of the inner cavity, a gap for accommodating the stent 4 is formed between the outer tube 2 and the inner tube 3.
  • the handle 1 is provided with a rotating release mechanism 11 and a rotatable control dial 12 to control the movement of the outer tube 2 in the axial direction, thereby controlling the release of the bracket 4; the control dial 12 is fixed on the dial seat 13.
  • the distal end of the handle 1 is provided with an infusion tube 15 and a one-way valve 14.
  • a syringe filled with physiological saline is connected to the one-way valve 14, and the physiological saline in the syringe is passed through the one-way valve 14, the infusion tube 15, and the internal
  • the gap between the tube 3 and the outer tube 2 and the stent 4 finally flow out from the distal end of the outer tube 2 to completely exhaust the air inside the delivery system and avoid the formation of air embolism.
  • the proximal end of the handle is provided with a steel tube 33 and an inner tube tail end connecting piece 32.
  • the bracket 4 is compressed and installed between the inner tube 3 and the outer tube 2.
  • the outer tube 2 is retracted by rotating the release mechanism 11 to complete the release of the stent 4.
  • the entire delivery system is withdrawn from the body through the entire retracement of the delivery system.
  • the present invention does not particularly limit the structure of the handle 1 and its components.
  • the handle 1 can be a handle of various structures.
  • the present invention mainly aims at improving the outer surface of the contact between the inner tube 3 and the bracket 4.
  • Fig. 2 is an enlarged cross-sectional view of the stent area of the delivery system at A in Fig. 1.
  • the inner tube 3 includes an inner tube main body 30, and at least one protrusion 31 located outside the inner tube main body 30; each protrusion 31 includes a plurality of protrusion monomers 311, the protrusion monomers One end of the 311 is connected to the inner tube main body 31, and the other end extends toward the distal end of the inner tube main body 30. Further, the protrusion 31 is located at the distal end of the inner tube 3.
  • the bracket 4 is placed and covered on the protrusion 31, and the protrusion 31 contacts and engages with the inner surface of the bracket 4.
  • the protrusion 31 is unidirectionally protruding toward the distal end, during the release of the stent 4, the friction between the stent 4 and the inner tube 3 is large, and the withdrawal of the outer tube 2 will not change the axial length of the stent 4 or make The stent 4 moves toward the proximal direction as a whole.
  • the friction between the inner tube 3 and the positioned stent 4 is small, and it can be withdrawn safely.
  • the protrusion 31 and the inner tube main body 30 are integrally processed and formed.
  • the inner tube 3 with the protrusion 31 can be directly printed by 3D printing. Or first make the inner tube body 30 with the same outer diameter, and cut the protrusion 31 on the outer wall of the distal end of the inner tube body 30 by laser cutting; or use other precision processing techniques to integrally form, integrally formed protrusions
  • the part 31, like the inner tube body 30, is made of polymer materials or metal materials, such as nickel-titanium, cobalt-chromium alloy, stainless steel and the like.
  • the protrusion 31 can also be fixedly connected to the outer surface of the distal end of the inner tube main body 30 by bonding, and the specific processing method of the protrusion 31 is not particularly limited in the present invention.
  • the inner tube main body 30 is provided with a groove 34
  • the protrusion 31 is located at the groove 34
  • the protrusion unit 311 includes opposite first and second ends, so The first end is connected to the inner tube main body 30 in the groove 34, and the second end extends from the groove 34.
  • the vertical height from the second end to the bottom of the groove 34 is greater than the depth of the groove 34, that is, at the protrusion 31, the outer diameter d2 of the inner tube 3 It is larger than the maximum outer diameter d1 of the inner tube main body 31.
  • the extension length of the protrusion 31 in the axial direction and the radial direction of the inner tube main body 30 only needs to ensure that the inner tube 3 contacts and engages with the inner surface of the stent 4 through the protrusion 31.
  • the protrusion 31 is formed by arranging a plurality of protrusion monomers 311.
  • the shape of the axial cross section of the convex monomer 311 may be a triangle, a quadrilateral, a trapezoid, or the like.
  • the shape of the axial section of the convex monomer 311 may be a right-angled trapezoid, as shown in FIG. 4; the shape of the axial section of the convex monomer 311 may also be a parallelogram, as shown in FIG. 5;
  • the shape of the monomer 311 is not particularly limited. Please refer to FIG.
  • the protrusion 31 includes a plurality of protrusion monomers 311 spaced apart along the axial and/or circumferential direction of the inner tube main body 30.
  • the plurality of convex monomers 311 are evenly distributed at equal intervals in the axial direction and the circumferential direction.
  • the distance between two adjacent convex monomers 311 in the axial direction can be determined according to the structural design of the stent 4, preferably 2mm-5mm, and the distance between two adjacent convex monomers 311 in the circumferential direction is preferably 0.1mm -1.5mm.
  • the thickness h of the convex unit 31 in the radial direction is preferably 0.1 mm to 0.5 mm, and the length of the convex unit 31 in the axial direction is 1 mm to 3 mm.
  • the angles ⁇ 1 and ⁇ 2 formed between the convex monomer 311 and the axis of the inner tube main body 30 are preferably 10 degrees to 80 degrees.
  • the inner tube 3 includes at least two protrusions 31, at least two protrusions 31 are distributed along the axial direction of the inner tube main body 30, or at least two protrusions 31 are along the inner tube main body 30.
  • the axial direction is spirally distributed; or distributed in any other way.
  • the protrusion 31 on the inner tube 3 contacts the inner surface of the stent 4 and engages each other, which can provide enough The large axial support force effectively prevents the stent 4 from axial deformation and displacement.
  • the inner tube 3 is withdrawn (the inner tube 3 moves to the left in Figs. 1 and 2).
  • the protrusion 31 on the inner tube 3 is directional, although there is still the same as the stent 4 Certain contact, but the two contact surfaces will not bite each other, so the friction between the inner tube 3 and the stent 4 is small, and the retraction of the inner tube 3 will not cause the stent 4 to shift together.
  • the one-way friction force of the inner tube 3 is increased by the protrusion 31 on the inner tube 3.
  • the implant delivery system and its inner tube provided in this embodiment have at least the following advantages:
  • this structure can effectively reduce the friction between the inner tube and the implant when the inner tube is withdrawn, avoiding the displacement of the implant caused by the withdrawal of the delivery system, making the operation safer;
  • the present invention improves the ease of realization and practicability of the product, and the scope of use can include all arterial and venous branch and peripheral stents, as well as other types of applicable implants.

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

Abstract

L'invention concerne un système de pose d'implant et un tube interne (3) de celui-ci. Le système de pose d'implant comporte un manche(1), un tube externe (2) et un tube interne (3). Le tube externe (2) et le tube interne (3) sont tous deux raccordés au manche (1), et le manche (1) commande le mouvement du tube externe (2) et du tube interne (3) dans une direction axiale. Le tube interne (3) comprend un corps de tube interne (30), et au moins une partie saillante (31) située sur un côté externe du corps de tube interne (30). Chaque partie saillante (31) comprend une pluralité de corps saillants uniques (311), une extrémité de chaque corps saillant unique (311) est reliée au corps de tube interne (30), et l'autre extrémité de chaque corps saillant s'étend vers une extrémité distale du corps de tube interne (30). Dans le système de pose d'implant selon l'invention, le tube interne (3) et un implant (4) s'engagent dans une seule direction, fournissant ainsi une grande force de frottement statique requise pour la libération de l'implant (4), de sorte que la libération et le positionnement de l'implant (4) sont précis et stables, et ne produisent pas de rétraction axiale. De plus, cette structure peut réduire efficacement la force de frottement entre le tube interne (3) et l'implant (4) lors du retrait du tube interne (3), et éviter le déplacement de l'implant (4) provoqué par le retrait du système de pose, de telle sorte que son fonctionnement est plus sûr.
PCT/CN2020/113617 2019-12-31 2020-09-04 Système de pose d'implant et son procédé d'utilisation WO2021135352A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201911422858.6 2019-12-31
CN201911422858.6A CN113116619A (zh) 2019-12-31 2019-12-31 一种植入体输送系统及其内管

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WO2021135352A1 true WO2021135352A1 (fr) 2021-07-08

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AR (1) AR120647A1 (fr)
WO (1) WO2021135352A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115054326B (zh) * 2022-07-26 2022-11-15 上海鸿脉医疗科技有限公司 旋磨系统、旋磨组件及其旋磨头

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US20060184225A1 (en) * 2005-02-11 2006-08-17 Medtronic Vascular, Inc. Force distributing system for delivering a self-expanding stent
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CN109700572A (zh) * 2018-12-29 2019-05-03 先健科技(深圳)有限公司 用于输送器的止缩装置及其输送器
CN110225729A (zh) * 2017-01-19 2019-09-10 柯惠有限合伙公司 用于医疗装置递送系统的联接单元

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US20090264978A1 (en) * 2008-03-27 2009-10-22 Dieck Martin S Friction-Release Distal Latch Implant Delivery System and Components
CN204147401U (zh) * 2014-07-24 2015-02-11 深圳市金瑞凯利生物科技有限公司 一种带棘突的球囊导管
US20170304097A1 (en) * 2016-04-21 2017-10-26 Medtronic Vascular, Inc. Stent-graft delivery system having an inner shaft component with a loading pad or covering on a distal segment thereof for stent retention
CN211674739U (zh) * 2019-12-31 2020-10-16 上海微创心脉医疗科技股份有限公司 一种植入体输送系统及其内管

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Publication number Priority date Publication date Assignee Title
US20030114915A1 (en) * 1999-03-31 2003-06-19 Wayne Mareiro Stent security balloon/balloon catheter
US6607551B1 (en) * 1999-05-20 2003-08-19 Scimed Life Systems, Inc. Stent delivery system with nested stabilizer
US20150305866A1 (en) * 2003-04-28 2015-10-29 C. R. Bard, Inc. Loading and delivery of self-expanding stents
US20060184225A1 (en) * 2005-02-11 2006-08-17 Medtronic Vascular, Inc. Force distributing system for delivering a self-expanding stent
CN106659576A (zh) * 2014-08-15 2017-05-10 W.L.戈尔及同仁股份有限公司 带有改善的收回效果的内置假体递送系统
CN110225729A (zh) * 2017-01-19 2019-09-10 柯惠有限合伙公司 用于医疗装置递送系统的联接单元
CN109700572A (zh) * 2018-12-29 2019-05-03 先健科技(深圳)有限公司 用于输送器的止缩装置及其输送器

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CN113116619A (zh) 2021-07-16

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