WO2015101107A1 - 植入体的输送装置与植入医疗器械 - Google Patents

植入体的输送装置与植入医疗器械 Download PDF

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Publication number
WO2015101107A1
WO2015101107A1 PCT/CN2014/090603 CN2014090603W WO2015101107A1 WO 2015101107 A1 WO2015101107 A1 WO 2015101107A1 CN 2014090603 W CN2014090603 W CN 2014090603W WO 2015101107 A1 WO2015101107 A1 WO 2015101107A1
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WO
WIPO (PCT)
Prior art keywords
wire
implant
control
connecting wire
lock
Prior art date
Application number
PCT/CN2014/090603
Other languages
English (en)
French (fr)
Inventor
刘香东
陈杰
张智伟
Original Assignee
先健科技(深圳)有限公司
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Filing date
Publication date
Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to US15/108,021 priority Critical patent/US10188497B2/en
Priority to EP14875946.7A priority patent/EP3090692B1/en
Publication of WO2015101107A1 publication Critical patent/WO2015101107A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/011—Instruments for their placement or removal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Definitions

  • the present invention relates to a medical device, and more particularly to a delivery device for an implant and an implantable medical device comprising the same.
  • percutaneous interventional techniques for the treatment of diseases is an increasingly widely used treatment in the field of application.
  • catheter interventional therapy a variety of implants can be placed in the heart, arteries and veins of the human body. For example, heart defect occluder, vascular plug, vascular filter, etc.
  • the threaded connection or the wire connection is usually used between the implant and the pusher.
  • the document of Chinese Patent Application No. 201010265431.2 discloses a device for connecting a implant and a pusher using a connecting wire. As shown in Fig.
  • the device comprises an implant 1a having a head 2a and a pusher 5a, at least one lock ring 9a is provided on the implant 1a, and a lock 3a is provided at the top end of the pusher 5a, the lock 3a has an inner cavity 8a, the inner cavity 8a of the lock head 3a communicates with the lumen 6a of the pusher 5a, the lock head is provided with at least one lock hole 7a, and a control wire 4a is arranged in the lumen of the pusher 5a,
  • the control wire 4a, the lock ring 9a and the lock hole 7a cooperate to form a plug structure to realize the connection and transport of the implant and the pusher, wherein the seal serves as a fixed lock ring, the lock ring serves as a connection, and the control wire is withdrawn. 4a achieves release.
  • the aforementioned implanted medical device has the following disadvantages and limitations: 1.
  • the lock ring is formed on the implant body, and after the implant is implanted into the human body, the lock ring is also implanted into the human body, thereby causing an increase in the amount of metal remaining in the human body. .
  • An increase in the amount of metal means an increase in the release of metal elements in the human body, resulting in an unpredictable biological risk.
  • After the implant is implanted into the human body there will be a situation in which the lock ring and the surface of the implant are not tightly attached. The endothelial tissue cannot completely cover the lock ring during the climbing process, thereby causing the thrombus source of the implant. Sex.
  • the technical problem to be solved by the present invention is to provide an implantable medical device capable of reducing biological risk and avoiding thrombogenicity, and a delivery device for an implant capable of improving the success rate of surgery.
  • a technical solution adopted by the present invention is: an implant delivery device, the delivery device comprising a pusher, a control component, a connecting wire and a control wire; the pusher having a lumen and a lock communicating with the lumen a hole, one end of which is connected to the control member; one end of the control wire is connected to the control member, and the other end is movably received in the lumen of the pusher under the driving of the control member; One end is connected to the pusher or the control member, and the other end is used to pass through the implant body and enter the lock hole; the control wire is driven by the control member to pull over the connecting wire Connecting the implant and the delivery device or driving the control wire away from the connecting wire to release the implant.
  • the length of the connecting wire connected between the implant and the pusher can be adjusted by the control member.
  • the pusher comprises a conduit and a lock, one end of the conduit being connected to the control component, the lock head having one end open, having a lumen, and the open end being in communication with the other end of the conduit,
  • the locking hole is disposed in the lock head and is in perpendicular communication with the lumen.
  • control component is provided with an operation button, and one end of the control wire is fixed on the operation button.
  • control component is further provided with a limiting mechanism for restricting movement of the operating button
  • the limiting mechanism comprises a safety button, a driving component interacting with the safety button and provided with a torsion spring, and driven by the driving component and A resilient stop for limiting the movement of the operating button.
  • the unopened end face of the lock head is provided with a groove.
  • the other end of the connecting wire forms a ring through which the control wire passes.
  • the lock head is provided with a viewing aperture for confirming whether the control wire is completely against the unopened end of the lock.
  • one end of the control wire that is engaged with the connecting wire is bent into a hook structure, and when the medical device is connected, the hook structure hooks the connecting wire at the locking hole and brings the control wire to the vicinity End recovery, the connection is completed when the hook structure leaves the inner cavity of the lock, and when the wire is detached, the control wire is pushed until the hook structure passes the distal end of the lock hole.
  • Another technical solution adopted by the present invention is to provide an implantable medical device comprising an implant and a delivery device of the implant as described above, the implant having a through hole and the connecting wire One end passes through the through hole and enters the lock hole, and rides over the control wire; the control wire is driven by the control member, and the control wire is detached from the connecting wire to release the implant.
  • the implant has a mesh structure and a seal that constrains the mesh structure
  • the through hole is a gap formed by the nickel-titanium alloy wires being enclosed, or a hole formed on the instrument by a drilling process;
  • the through hole is formed by: forming a hole on the implant by a drilling process; or placing a transverse mold bar in the nickel-titanium wire mesh tube in the heat treatment setting section; or uniformly separating the nickel-titanium wire by using a wire Tied into two bundles to separate them and enclose the gap formed.
  • the conveying device of the invention does not need to add a locking ring on the surface of the device, thereby reducing the amount of metal left in the human body after being implanted in the human body, thereby reducing the potential Biological risk and thrombogenicity of the device.
  • the connecting wire and the lock head in the conveying device of the invention can be freely adjusted in length during assembly, which reduces the difficulty in controlling the length of the locking ring during the production process, and improves the production yield rate of the assembly process.
  • FIG. 1 is a schematic view showing the structure of an implanted medical device of the prior art
  • FIG. 2 is a schematic structural view of an implanted medical device according to an embodiment of the present invention.
  • Figure 3 is a cross-sectional view of Figure 2;
  • Figure 4 is a schematic view of the detachment of the pusher and the implant
  • FIG. 5 is a schematic view of one end (free end) of a connecting wire according to another embodiment of the present invention.
  • Figure 6 is a cross-sectional view showing the connection wire welding or glue fixing to the lock head according to still another embodiment of the present invention.
  • Figure 7 is a cross-sectional view showing a connecting wire fixed to a cylinder according to an embodiment of the present invention.
  • Figure 8 is a cross-sectional view of a control wire having a hook structure according to an embodiment of the present invention.
  • FIG. 9 is a schematic view showing a structure in which a side wall of a keyhole side according to an embodiment of the present invention is removed to form a groove shape
  • FIG. 10 is a schematic structural diagram of a control component according to an embodiment of the present invention.
  • One embodiment of the present invention provides an implantable medical device 100, as shown in Figures 2, 3 and 10, which includes an implant 1 and a delivery device for delivering the implant 1.
  • the delivery device mainly comprises a pusher 20 and a control member 21 (see Fig. 10), and the tail of the implant 1 is provided with a through hole.
  • the implant 1 is a cardiac occluder.
  • the pusher 20 includes a conduit 5 and a lock head 3.
  • the end of the implant 1 is provided with a closure 2 for binding the wire of the implant 1.
  • a through hole 10 is provided in the portion close to the head 2 for passing through the connecting wire 11.
  • the top end of the catheter 5 is provided with a locking head 3 having a lumen 8 , the inner cavity 8 of the locking head 3 is in communication with the lumen 6 of the catheter 5 , and the locking head 3 is provided with at least one locking hole 7
  • a control wire 4 is mounted in the lumen 6 of the catheter 5.
  • the control wire 4, the connecting wire 11, and the locking hole 7 cooperate to form a connection structure of the plug structure.
  • One end of the connecting wire 11 is fixed to the control member 21, and the connecting wire 11 is wound around the screw 19 (see FIG.
  • the other end passes through the head 2 while penetrating the implant 1, enters the lock hole 7, and fits over the control wire 4.
  • One end of the control wire 4 is fixed on the operation button 15 on the control member 21, and is fixed by the fixing screw 18, and the other end can be moved in the lumen 6 under the driving of the control member 21 until passing through the connecting wire 11 or along the original The path return is separated from the connecting wire 11. If the implant 1 and the catheter 5 need to be connected, after one end of the connecting wire 11 passes through the through hole 10 and enters the locking hole 7, the operation button 15 is pushed to move toward the lock 2 until the control wire 4 is worn. The wire 11 can be connected.
  • the control member 21 is further provided with a limiting mechanism for restricting the movement of the operation button 15, the limiting mechanism includes an insurance button 22, a rotary driving member 24 in contact with the safety button 22, and The rotary drive member 24 is driven and used to restrict the movement of the operation button 15 to the elastic stopper 26.
  • the rotary driving member 24 is rotated about its center, that is, the end in contact with the safety button 22 is moved upward, and the end in contact with the elastic stopper 26 is moved downward.
  • one end of the elastic stopper 26 is swung downward under the pressure of the rotary driving member 24, releasing the restriction on the operation button 15.
  • the rotary drive member 24 returns to the initial position by the action of the torsion spring without external force.
  • the safety button 22 is pressed against the rotary drive member 24, and the rotary drive member 24 acts on the stop member 26 to disengage the stop member 26 from the operation button 15.
  • the safety button 22 is depressed, the safety button 22 is returned to the initial position, and the rotary driving member 24 and the stopper 26 are also returned to the initial position.
  • the implant 1 can also be a vascular plug for an arteriovenous vessel, a thrombus filter, or other instrument having a trailing end, which are well known to those of ordinary skill in the art and are not described in detail herein.
  • a commonly used cardiac defect occluder or vascular plug is a mesh structure woven from a nickel-titanium wire with a head 2 at one end.
  • a through hole 10 can be heat-treated in the nickel-titanium wire alloy wire (woven wire) close to the head 2, and the shaping method of the through hole 10 can be variously selected, for example, in the heat treatment setting step.
  • a transverse mold bar is placed in the nickel-titanium wire mesh tube, or the nickel-titanium wire is evenly divided into two bundles by using a wire to separate them to form a through hole.
  • the heat treatment conditions are well known to those of ordinary skill in the art and will not be described in detail.
  • the through hole 10 may be a gap formed by a nickel-titanium alloy wire intertwined with each other, or may be formed on the instrument by a drilling process alone.
  • the implant replaces the metal lock ring with a through hole, and the metal brought by the lock ring after being implanted into the human body reduces the release amount of metal ions, and also avoids when the lock ring and the surface of the instrument are attached.
  • the tissue is not tight, the risk of the endothelium not completely covering the lock ring, thereby reducing the thrombogenicity of the device;
  • the conduit 5 can be a spring-wound spring tube welded to the top end of the conduit 5 with a lumen 8 and a keyhole 7.
  • the catheter 5 is coaxial with the lock 3, the lumen 8 of the lock 3 is in communication with the lumen 6 of the catheter 5, and a control wire 4 is mounted in the lumen 6 of the catheter 5, and the control wire 4 can be in the lumen 6 and
  • the inner chamber 8 is moved in the axial direction, and the tip end of the control wire 4 can reach the lock hole 7.
  • the distal diameter of the locking head 3 is larger than the diameter difference between the inner diameter of the delivery sheath and the head 2 of the implant 1 to ensure that the implant 1 does not fall off the lock 3 when pushed in the delivery sheath, thereby avoiding implantation.
  • the distal diameter of the lock 3 is also smaller than the inner diameter of the delivery sheath.
  • the diameter of the head 2 of the implant 1 is 1.5 mm
  • the inner diameter of the delivery sheath is 3 mm
  • the diameter of the distal end of the lock 3 must be greater than 1.5 mm.
  • the distal end of the lock 3 can be machined with a spherical recess 31 (see Fig. 4).
  • the lumen 6 of the catheter 5 is further provided with a connecting wire 11 which can be selected from a polymer yarn or a plurality of metal strands. In this embodiment, a plurality of nickel-titanium strands are preferred.
  • the end of the connecting wire 11 is merged through the inner cavity 6 of the catheter 5 to be fixed to the control member 21, so that a loop is formed at the distal end of the connecting wire 11.
  • the distal end of the connecting wire 11 passes through the through hole 10 of the implant 1 and then passes through the control wire 4 from the middle thereof, and the control wire 4 passes through the head of the connecting wire 11 and against the inner cavity 8 of the lock 3.
  • the bottom of the distal end ultimately reaches the role of connecting the implant 1 and the catheter 5.
  • the connecting wire 11 may have various structures in addition to the above structure.
  • the head of the single connecting wire 11 is added with a ring structure 28, and the ring structure 28 may have various ways, such as The tip end of the connecting wire 11 is knotted or a metal ring is welded to the head.
  • the lock head 3 is connected to the duct 5, and the inner diameter of the end of the connection between the lock head 3 and the duct 5 is equal to the outer diameter of the duct 5 and ensures that the duct 5 can be fitted into the inner cavity of the end of the lock head 3, preferably by laser welding. .
  • the other end bears against the head 2 of the instrument and its top is closed, while a spherical recess 31 is dug, just enough to accommodate the head 2 in close rotation.
  • the keyhole 7 is in the shape of a through hole, and the side wall of the side of the keyhole 7 can be removed to form a groove shape for assembly, as shown in FIG.
  • the radial dimension of the locking head 3 near the end of the implant 1 is not less than the difference between the diameter of the delivery sheath used in the surgical procedure and the diameter of the closure 2, and is smaller than the inner diameter of the delivery sheath, so that the implant 1 can be pushed inside the sheath. It will not fall off the lock head 3, thus avoiding the difficulty of pushing the instrument and improving the success rate of the operation.
  • the outer wall of the cavity at which the lock head 3 is connected to the conduit 5 can be adjusted to a thickness suitable for intensifying welding, and a suitable thickness range is 0.1 to 0.5 mm.
  • a viewing aperture 12 can be added to the front end of the lock head 3 to confirm that the control wire 4 is completely against the bottom of the distal lumen 8 of the lock head 3.
  • a certain length of the front end of the catheter 5 can be polished, and the optimal grinding length is 5% to 15% of the total length of the pusher.
  • the laser can not be too thick to be welded.
  • the laser is too thin, and the strength of the catheter 5 is ensured.
  • the optimum thickness of the catheter 5 is not more than half the wall thickness of the catheter 5.
  • the wall thickness of the conduit 5 is preferably in the range of 0.3 mm to 0.4 mm, and the preferred thickness of the polishing section of the conduit 5 is in the range of 0.2 mm to 0.3 mm.
  • the control wire 4 When the implant 1 is to be released during the procedure, the control wire 4 is withdrawn into the lumen 6 of the catheter 5, so that the head of the connecting wire 11 loses the constraint of the control wire 4 from the locking hole 7 of the lock 3. Simultaneously dragging the catheter 5, the control wire 4 can be withdrawn from the through hole 10 of the implant 1 to completely separate the implant 1 and the catheter 5.
  • the fixing method can be selected by laser welding or electric resistance welding, etc.
  • the fixing method may be selected as glue fixing.
  • one end of the connecting wire 11 is fixed on the solder joint or the glue dot 29.
  • the connecting wire 11 can also be fixed on the column 13, and the fixing manner can be fixed by screws, and the column 13 is placed in the lumen 6 of the catheter 5.
  • the cylinder 13 is a cylindrical member with a central through hole 14 having an outer diameter smaller than the diameter of the lumen 6 of the catheter 5 but larger than the diameter of the lumen 8 of the lock 3 adjacent thereto, so that the tube can be caught in the catheter 5 The distal end of the lumen 6.
  • the outer diameter of the central through hole 14 is larger than the diameter of the control wire 4, and the control wire 4 can be moved within the through hole 14.
  • the connecting wire 11 when the control wire 4 is withdrawn into the lumen 6 of the catheter 5, the connecting wire 11 is released.
  • the control wire 15 (or "hook control wire") having a hook structure is substituted for the control wire 4 of the first embodiment, and the barb The direction is towards the proximal end of the catheter 5.
  • the hook structure 16 of the hook control wire 15 is first moved to the leftmost end of the inner cavity 8 or the free end of the hook structure 16 is located at the left end of the end of the connecting wire 11.
  • the hook-shaped structure 16 of the hook-shaped control wire 15 is moved to the right (toward the direction of the control member 21), so that the hook-shaped structure 16 of the hook-shaped control wire 15 hooks the ring (or ring) at the front end of the connecting wire 11.
  • the hook-shaped control wire 15 is recovered to the proximal end (moving toward the direction of the control member 21) such that the hook-shaped control wire 15 is joined to the connecting wire 11. If it is desired to disengage the connecting wire 11, the hook-type control wire 15 is pushed until the hook-shaped structure 16 moves through the distal end of the locking hole 7, and the hook-shaped structure 16 is disengaged from the ring (or annular structure) at the front end of the connecting wire 11.

Abstract

一种植入体的输送装置，包括推送器（20）、控制部件（21）、连接丝（11）以及控制丝（4）。所述推送器（20）具有管腔（6）和与该管腔相通的锁孔（7），其一端与控制部件（21）相连。所述控制丝（4）的一端与所述控制部件（21）连接，另一端在所述控制部件的驱动下可移动地收容于所述推送器的管腔（6）中。所述连接丝（11）的一端与所述推送器（20）或所述控制部件（21）连接，另一端用于对穿所述植入体（1）后，进入所述锁孔（7）。通过该控制部件（21）驱动所述控制丝（4），套穿所述连接丝（11）而连接所述植入体（1）和所述输送装置，或者驱动所述控制丝（4）与所述连接丝（11）脱离而释放所述植入体（1）。该输送装置去掉器械上的锁环从而使得器械在植入人体后没有多余的金属。

Description

植入体的输送装置与植入医疗器械
【技术领域】
本发明涉及一种医疗器械，尤其涉及一种植入体的输送装置与包括该输送装置的植入医疗器械。
【背景技术】
利用经皮介入技术进行疾病治疗，是适用领域越来越广泛的治疗方法。采用导管介入治疗方法，可以将各种各样的植入体放置到人体的心脏、动静脉血管。比如，心脏缺损封堵器，血管塞，血管滤器等。
在通过导管介入方法把这些植入体植入到人体的心脏、动静脉血管中时，由于人体的心脏和动静脉血管的解剖结构复杂，要保证植入体准确到达预定部位，必须利用导管、导丝和推送器。导管是在导丝的导引下，首先到达预定部位。在进行此类手术时，要求非常小的柔性的导管，同时导管和导丝要设计成在X光下有很好的显影。当导管到达预定部位后，移除导丝，将植入体纳入导管内，利用推送器通过由导管建立的通道把植入体导向导管的末端。当植入体到达导管的末端时，利用推送器将植入体从导管内释放出来，最后植入体要与推送器断开，释放植入体。
现有的植入医疗器械（指器械和推送器的统称，下同）中，植入体和推送器之间通常采用螺纹连接或连接丝连接。例如，中国专利申请号为201010265431.2的文献公开了一种采用连接丝将植入体和推送器之间连接的装置。如图1所示，该装置包括具有封头2a的植入体1a和推送器5a，该植入体1a上设置至少一个锁环9a，在推送器5a的顶端设置锁头3a，该锁头3a具有内腔8a，该锁头3a的内腔8a与推送器5a的管腔6a相通，该锁头上设置有至少一个锁孔7a，在推送器5a的管腔内装有控制丝4a，该控制丝4a、锁环9a及锁孔7a三者配合形成插销结构来实现植入体与推送器的连接与输送，其中封头起固定锁环的作用，锁环起连接作用，后撤控制丝4a实现释放。
前述植入医疗器械具有以下缺点和局限性：1、锁环形成于植入体，植入体在植入人体后，锁环也植入到人体内，从而导致留在人体内的金属量增加。金属量的增加意味着金属元素在人体内的释放量增加，从而导致不可预测的生物学风险。2、植入体在植入人体后，会存在锁环和植入体表面贴合不紧密的情况，内皮组织在爬覆过程中不能完全将该锁环覆盖，从而造成植入体的血栓源性。
【发明内容】
本发明所要解决的技术问题在于提供一种能够降低生物学风险和避免血栓源性的植入医疗器械，以及一种可提高手术成功率的植入体的输送装置。
本发明采用的一种技术方案是：一种植入体的输送装置，所述输送装置包括推送器、控制部件、连接丝以及控制丝；所述推送器具有管腔和与该管腔相通的锁孔，其一端与控制部件相连；所述控制丝的一端与所述控制部件连接，另一端在所述控制部件的驱动下可移动地收容于所述推送器的管腔中；所述连接丝的一端与所述推送器或所述控制部件连接，另一端用于对穿所述植入体后，进入所述锁孔；通过该控制部件驱动所述控制丝，套穿所述连接丝而连接所述植入体和所述输送装置，或者驱动所述控制丝与所述连接丝脱离而释放所述植入体。
优选地，该连接丝的一端固定于该控制部件内时，该连接丝连接在所述植入体和所述推送器之间的长度可通过该控制部件进行调节。
优选地，该推送器包括导管和锁头，所述导管的一端部与所述控制部件相连，所述锁头的一端开口，具有内腔，且开口端与所述导管的另一端部相通，所述锁孔设于所述锁头，且与所述管腔垂直相通。
优选地，该控制部件上设有操作按钮，该控制丝的一端固定于该操作按钮上。
优选地，该控制部件上还设有限制该操作按钮移动的限位机构，该限位机构包括保险按钮、与该保险按钮相互作用且设有扭簧的驱动件、以及被该驱动件驱动且用于限制该操作按钮移动的弹性的止挡件。
优选地，该锁头的未开口的端面设有凹槽。
优选地，该连接丝的另一端形成一个让该控制丝穿过的环。
优选地，该锁头设有一个用以确认该控制丝是否完全顶住该锁头未开口端部的观察孔。
优选地，该控制丝的与该连接丝的配合的一端弯折成钩形结构，当连接该医疗器械时，该钩形结构在该锁孔处钩住该连接丝并将该控制丝往近端回收，当该钩形结构离开该锁头的内腔后即完成连接，当脱离该连接丝时，推送该控制丝直到该钩形结构通过该锁孔的远端。
本发明采用的另一种技术方案是：提供一种植入医疗器械，其包括植入体及如上所述的植入体的输送装置，所述植入体具有通孔，所述连接丝的另一端穿过所述通孔后进入所述锁孔，并套穿所述控制丝；通过该控制部件驱动所述控制丝，所述控制丝与所述连接丝脱离而释放所述植入体。
优选地，所述植入体具有网状结构和约束该网状结构的封头，所述通孔为镍钛合金丝相互围合形成的间隙，或通过钻孔工艺在器械上形成的孔；所述通孔的制作方法为：通过钻孔工艺在植入体上形成；或在热处理定型环节在镍钛丝网管内放置一个横置的模棒；或使用金属丝将镍钛丝左右均匀分开绑成两束使其间分开，围合形成的间隙。
与现有技术相比，本发明具备以下优点：1、本发明的输送装置无需在器械表面增设锁环，由此减少器械在植入人体后留在人体内的金属量，从而减小潜在的生物学风险和器械的血栓源性。2、本发明的输送装置中的连接丝和锁头在组装时可以自由调整其长度，降低了生产过程中对锁环长度的控制难度，提高了组装工序的生产良品率。
【附图说明】
图1是现有技术的一种植入医疗器械的结构示意图；
图2是本发明一实施例提供的植入医疗器械的结构示意图；
图3是图2的剖视图；
图4是推送器和植入体脱离的示意图；
图5是本发明另一实施例提供的连接丝的一端（自由端）的示意图；
图6是本发明再一实施例提供的连接丝焊接或胶水固定于锁头的剖视图；
图7是本发明一实施例提供的连接丝固定于柱体上的剖视图；
图8是本发明一实施例提供的具有钩形结构的控制丝的剖视图；
图9是将本发明一实施例提供的锁孔一侧的侧壁去除而形成槽状的结构示意图；
图10是本发明一实施例提供的控制部件的结构示意图。
【具体实施方式】
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
本发明一实施例提供了一种植入医疗器械100，如图2，图3和图10所示，其包括植入体1和用于输送植入体1的输送装置。该输送装置主要包括推送器20和控制部件21（见图10），植入体1的尾部设置有通孔。在本实施例中，该植入体1为心脏封堵器。该推送器20包括导管5和锁头3。
继续参考图4-10，该植入体1的端部设置有封头2，封头2用来束缚植入体1的金属丝。在靠近封头2的部位设置有一个通孔10用以穿过连接丝11。该导管5的顶端设置有锁头3，该锁头3具有内腔8，该锁头3的内腔8与导管5的管腔6相通，该锁头3上设置有至少一个锁孔7，在导管5的管腔6内装有控制丝4，该控制丝4、连接丝11、锁孔7三者配合形成插销结构的连接方式。该连接丝11一端固定于该控制部件21上，该连接丝11缠绕在该螺丝19（见图10）上，并由螺丝19锁定，该连接丝11长度可通过旋转螺丝19进行调节从而达到调整植入体1和锁头3的连接距离的目的，另一端在对穿植入体1的同时跨过封头2后，进入锁孔7，并套在控制丝4上。该控制丝4的一端固定于控制部件21上的操作按钮15上，并由固定螺丝18固定，另一端可在控制部件21的驱动下在管腔6内运动直至穿过连接丝11或沿原路径返回与连接丝11分离。如需要将该植入体1和导管5连接，需待连接丝11的一端穿过通孔10并进入锁孔7后，推动操作按钮15朝靠近锁头2的方向运动，直至控制丝4穿过连接丝11即可。
如图10所示，该控制部件21上还设有限制该操作按钮15移动的限位机构，该限位机构包括一保险按钮22、与该保险按钮22接触的旋转驱动件24、以及被该旋转驱动件24驱动且用于限制该操作按钮15移动的弹性止挡件26。当向上压保险按钮22时，该旋转驱动件24绕其中心旋转，即和保险按钮22接触的一端向上运动，和弹性止挡件26接触的一端向下运动。于是导致弹性止挡件26的一端在该旋转驱动件24的压力下向下摆动，解脱对操作按钮15的限制。
操作该限位机构使该操作按钮15沿着远离该导管5的方向移动，从而保证该控制丝4沿着该锁头3的内腔8朝远离该封头2的方向运动，直至该控制丝4的另一端移至该锁孔7内并与该连接丝11分离。在无外力作用下，通过扭簧的作用，该旋转驱动件24回到初始位置。按压该保险按钮22，该保险按钮22作用于该旋转驱动件24，该旋转驱动件24作用于该止挡件26，从而使该止挡件26与该操作按钮15相互脱离。取消按压该保险按钮22，该保险按钮22回到初始位置，该旋转驱动件24以及该止挡件26也回到初始位置。
操作该控制部件21，按下保险按钮22并同时将操作按钮15沿靠近螺丝19的方向推，保证该控制丝4沿着锁头3的内腔8朝远离封头2的方向运动，直至控制丝4的另一端移至锁孔7内并与连接丝11分离，该植入体1和导管5解脱。
该植入体1还可以是用于动静脉血管的血管塞，也可以是血栓过滤器，或者其他具有尾端的器械，这些器械结构已为本领域普通技术人员熟知，不在此详述。
常用的心脏缺损封堵器或血管塞为镍钛合金丝编织而成的网状结构，其一端带有一个封头2。为了实现本实施例的目的，在靠近封头2的镍钛丝合金丝（编织丝）内可以热处理定型出一个通孔10，通孔10的定型方法可以有多种选择，比如在热处理定型环节在镍钛丝网管内放置一个横置的模棒，或使用金属丝将镍钛丝左右均匀分开绑成两束使其间分开形成一个通孔。热处理条件已为本领域普通技术人员熟知，不再详述。也就是说，该通孔10可以是由镍钛合金丝相互围合形成的间隙，也可以是单独通过钻孔工艺在器械上形成。与现有技术相比，该植入体用通孔替代金属锁环，在植入人体后没有锁环带来的金属，降低了金属离子的释放量，同时也避免当锁环和器械表面贴合不紧密时内皮组织不能完全将该锁环覆盖的风险，从而减小器械的血栓源性；
该导管5可以采用金属丝密绕的弹簧管，该锁头3焊接在在导管5的顶端，且带有内腔8和锁孔7。该导管5与锁头3同轴，该锁头3的内腔8与导管5的管腔6相通，在导管5的管腔6内装有一根控制丝4，控制丝4可以在管腔6和内腔8中沿轴向运动，控制丝4的顶端可以到达锁孔7。锁头3的远端直径大于输送鞘管内径和植入体1的封头2的直径差，以保证植入体1在输送鞘管内推送时不会从锁头3上脱落，从而避免植入体1的推送困难，这样就提高手术成功率。当然，为了保证在鞘内运动，锁头3的远端直径同时也要小于输送鞘内径。比如植入体1的封头2的直径为1.5mm，输送鞘管的内径为3mm，则锁头3的远端直径必须大于1.5mm。同时为了让植入体1的封头2和锁头3的远端有良好的配合性，可以将锁头3的远端加工一个球面凹槽31（见图4）。
该导管5的管腔6内还装有连接丝11，该连接丝11可以选择高分子丝也可以选择多股金属绞丝，本实施例优选多股镍钛绞丝。该连接丝11末端合并穿过导管5的内腔6固定于控制部件21上，于是在该连接丝11远端形成一环。该连接丝11远端头部穿过植入体1的通孔10后再由控制丝4从其中间穿过，控制丝4穿过连接丝11头部后并顶住锁头3内腔8远端的底部，最终达到连接植入体1和导管5的作用。当连接好植入体1和导管5后，在拉伸状态下需保证植入体1正对导管5的锁头3。可以通过调整连接丝11的长度来调控植入体1和导管5的锁头3之间的距离。
如图5所示，该连接丝11除以上结构外，还可以有多种结构，比如单根连接丝11的头部增加一环状结构28，该环状结构28可以有多种方式比如有连接丝11的头端打结而成，或在头部焊接一金属环。
该锁头3的一端和导管5连接，锁头3和导管5连接的一端的内径和导管5的外径相等并保证导管5能装入锁头3该端的内腔内，固定方式优选激光焊接。另一端则顶住器械的封头2，并且其顶部是封闭的，同时挖有球面凹槽31，刚好可以容纳封头2紧贴着转动。本实施例中，锁孔7为通孔状，为了便于组装也可以将锁孔7一侧的侧壁去除形成槽状，如图9所示。锁头3靠近植入体1一端的径向尺寸不小于手术过程中所使用的输送鞘内径和封头2直径的差值同时小于输送鞘内径，这样可以使得植入体1在鞘管内推送时不会从锁头3上脱落，从而避免器械的推送困难，提高手术成功率。
此实施例中，为了方便锁头3和导管5的焊接可以将锁头3与导管5连接的一端的腔体外壁调整到适合激化焊接的厚度，合适的厚度范围为0.1~0.5mm。
为方便该装置的组装，可以在锁头3的前端增加一个观察孔12，用以确认控制丝4是否完全顶住锁头3远端内腔8的底部。
为改善导管5的柔软性能，可以将导管5前端的一定长度进行打磨，最佳打磨长度为推送器总长度的5%~15%，为便于激光焊接制作导管5，避免太厚了激光焊接不了，太薄了激光击穿了，以及确保导管5的强度，导管5打磨的最佳厚度范围不超过导管5的壁厚的一半。导管5的壁厚范围优选为0.3mm~0.4mm，导管5打磨段的优选厚度范围为0.2mm~0.3mm。
在手术过程中需释放植入体1时，则将控制丝4撤回导管5的管腔6内，从而让连接丝11的头部失去控制丝4的约束脱离锁头3的锁孔7。同时拖动导管5，则可以将控制丝4从植入体1的通孔10内撤离，彻底将植入体1和导管5分离。
作为本发明的第二实施例，如图6所示。本实施例二的其他机构和第一实施例一样，仅调整连接丝11的固定方式。如图6所示，连接丝11的固定端可以固定在导管5的锁头3的侧壁上，连接丝11选择为金属丝时固定方式可以选择激光焊接或电阻焊接等方式，如果连接丝11选择为非金属丝时固定方式可以选择为胶水固定，图6中，该连接丝11的一端固定在焊点或胶点29上。同时，如图7所示，也可以将连接丝11固定在柱体13上，固定方式可以采用螺丝固定的方式，柱体13置于导管5的管腔6内。柱体13为一个带中心通孔14的圆柱件，其外径小于导管5的管腔6的直径，但大于与其临近的锁头3的内腔8的直径，所以能卡在导管5的管腔6的远端。同时中心的通孔14的外径大于控制丝4的直径，已保证控制丝4能在通孔14内移动。
根据第一实施例所述，将控制丝4撤回导管5的管腔6内时，即可解脱连接丝11。对此，作为本发明的第三实施例，如图8所示，由具有钩形结构的控制丝15（或称为“钩形控制丝”）取代第一实施例中控制丝4，倒钩方向朝导管5的近端。当需要连接植入体1时，先将钩形控制丝15的钩形结构16移动至该内腔8的最左端或者移动至钩形结构16的自由端位于该连接丝11的末端的左侧，然后再向右（朝向控制部件21的方向）移动该钩形控制丝15的钩形结构16，从而使得该钩形控制丝15的钩形结构16钩住连接丝11前端的环（或者环状结构）并将钩形控制丝15往近端回收（朝向控制部件21的方向移动），这样，该钩形控制丝15就与该连接丝11就连接在一起。如需脱离连接丝11，则推送钩型控制丝15直到钩形结构16移动通过该锁孔7的远端，该钩形结构16脱离该连接丝11前端的环（或者环状结构）。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (11)

  1. 一种植入体的输送装置，其特征在于：所述输送装置包括推送器、控制部件、连接丝以及控制丝；
    所述推送器具有管腔和与该管腔相通的锁孔，其一端与控制部件相连；
    所述控制丝的一端与所述控制部件连接，另一端在所述控制部件的驱动下可移动地收容于所述推送器的管腔中；
    所述连接丝的一端与所述推送器或所述控制部件连接，另一端用于对穿所述植入体后，进入所述锁孔；
    通过该控制部件驱动所述控制丝，套穿所述连接丝而连接所述植入体和所述输送装置，或者驱动所述控制丝与所述连接丝脱离而释放所述植入体。
  2. 如权利要求1所述的植入体的输送装置，其特征在于：该连接丝的一端固定于该控制部件内时，该连接丝连接在所述植入体和所述推送器之间的长度可通过该控制部件进行调节。
  3. 如权利要求1所述的植入体的输送装置，其特征在于：该推送器包括导管和锁头，所述导管的一端部与所述控制部件相连，所述锁头的一端开口，具有内腔，且开口端与所述导管的另一端部相通，所述锁孔设于所述锁头，且与所述管腔垂直相通。
  4. 如权利要求1所述的植入体的输送装置，其特征在于：该控制部件上设有操作按钮，该控制丝的一端固定于该操作按钮上。
  5. 如权利要求5所述的植入体的输送装置，其特征在于：该控制部件上还设有限制该操作按钮移动的限位机构，该限位机构包括保险按钮、与该保险按钮相互作用且设有扭簧的驱动件、以及被该驱动件驱动且用于限制该操作按钮移动的弹性的止挡件。
  6. 如权利要求4所述的植入体的输送装置，其特征在于：该锁头的未开口的端面设有凹槽。
  7. 如权利要求1所述的植入体的输送装置，其特征在于：该连接丝的另一端形成一个让该控制丝穿过的环。
  8. 如权利要求4所述的植入体的输送装置，其特征在于：该锁头设有一个用以确认该控制丝是否完全顶住该锁头未开口端部的观察孔。
  9. 如权利要求4所述的植入体的输送装置，其特征在于：该控制丝的与该连接丝的配合的一端弯折成钩形结构，当连接该医疗器械时，该钩形结构在该锁孔处钩住该连接丝并将该控制丝往近端回收，当该钩形结构离开该锁头的内腔后即完成连接，当脱离该连接丝时，推送该控制丝直到该钩形结构通过该锁孔的远端。
  10. 一种植入医疗器械，包括植入体及如权利要求1~9任一项所述的植入体的输送装置，其特征在于，所述植入体具有通孔，所述连接丝的另一端穿过所述通孔后进入所述锁孔，并套穿所述控制丝；通过该控制部件驱动所述控制丝，所述控制丝与所述连接丝脱离而释放所述植入体。
  11. 如权利要求10所述的植入医疗器械，其特征在于，所述植入体具有网状结构和约束该网状结构的封头，所述通孔为镍钛合金丝相互围合形成的间隙，或通过钻孔工艺在器械上形成的孔；所述通孔的制作方法为：通过钻孔工艺在植入体上形成；或在热处理定型环节在镍钛丝网管内放置一个横置的模棒；或使用金属丝将镍钛丝左右均匀分开绑成两束使其间分开，围合形成的间隙。
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