WO2017024879A1 - 心耳夹及其输送装置 - Google Patents

心耳夹及其输送装置 Download PDF

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Publication number
WO2017024879A1
WO2017024879A1 PCT/CN2016/084948 CN2016084948W WO2017024879A1 WO 2017024879 A1 WO2017024879 A1 WO 2017024879A1 CN 2016084948 W CN2016084948 W CN 2016084948W WO 2017024879 A1 WO2017024879 A1 WO 2017024879A1
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WO
WIPO (PCT)
Prior art keywords
outer tube
handle
segment
liner
ear clip
Prior art date
Application number
PCT/CN2016/084948
Other languages
English (en)
French (fr)
Inventor
周庆亮
李金山
可大年
孟坚
Original Assignee
北京迈迪顶峰医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 北京迈迪顶峰医疗科技有限公司 filed Critical 北京迈迪顶峰医疗科技有限公司
Priority to JP2018524515A priority Critical patent/JP6533872B2/ja
Priority to US15/744,065 priority patent/US10905433B2/en
Priority to EP16834504.9A priority patent/EP3335644B1/en
Priority to KR1020187002890A priority patent/KR102080418B1/ko
Priority to RU2018102967A priority patent/RU2680923C1/ru
Priority to EP21190609.4A priority patent/EP3925546A1/en
Publication of WO2017024879A1 publication Critical patent/WO2017024879A1/zh
Priority to US17/132,402 priority patent/US20210128158A1/en

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    • 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
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A61B17/1227—Spring clips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • 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
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • 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
    • A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • 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
    • A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00862—Material properties elastic or resilient
    • 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
    • A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding

Definitions

  • the invention relates to the field of medical instruments, in particular to a heart ear clip and a conveying device thereof.
  • Atrial fibrillation is one of the most common arrhythmias in clinical practice. There are a large number of patients. At present, there are about 8 million patients with atrial fibrillation in China, and the number is increasing year by year. Atrial fibrillation patients have a stroke of 0.4%-1% every year. That is to say, in the 8 million patient population, between 3.2 and 80,000 people may have an ischemic stroke due to atrial fibrillation. Stroke is the greatest risk of atrial fibrillation. The study found that 15-20% of ischemic strokes are caused by atrial fibrillation, and about one in every six stroke patients is atrial fibrillation.
  • the second method is the direct resection or ligation of the auricle in the same period of cardiac surgery.
  • the main disadvantage of this method is the low rate of complete closure of the left atrial appendage. Previous studies have shown that the success rate of complete resection of the left atrial appendage is up to about 80%.
  • the third method is to close the left atrial appendage by instrument, percutaneous interventional intracardiac left atrial appendage occlusion products, such as percutaneous catheter closure of the left atrial appendage occlusion device (PLAATO), watcher occluder (WATCHMAN), Anpraze Auricular occlusion device (ACP), etc.
  • percutaneous interventional intracardiac left atrial appendage occlusion products such as percutaneous catheter closure of the left atrial appendage occlusion device (PLAATO), watcher occluder (WATCHMAN), Anpraze Auricular occlusion device (ACP), etc.
  • the object of the present invention is to design a heart ear clip and a delivery device thereof, which are placed in the left atrial appendage from the outside of the heart in a thoracotomy or minimally invasive surgery to permanently close the left atrial appendage.
  • the invention provides a heart ear clip, which comprises: two parallel clamping arms; two springs respectively located at two ends of the parallel clamping arms for connecting two ends of the two clamping arms respectively a closed loop structure and providing a clamping force that brings the two clamp arms closer to each other; wherein at least one of the two clamp arms is divided into a first segment and a second segment, and the first segment and the second segment are pivotable Ground connection or connection by flexible material.
  • the two clamping arms are divided into a first segment and a second segment, the first segment and the second segment being pivotally connected.
  • the spring is a U-shaped spring.
  • the first segment and the second segment are straight rod tubes.
  • the material of the spring and the straight rod tube may be at least one of stainless steel, cobalt-based alloy, platinum-rhodium alloy, nickel-titanium alloy, and magnesium-based alloy.
  • connection point may be combined by extrusion deformation, welding, gluing or screwing.
  • the flexible material is a nickel-titanium-lined wire
  • the two straight rod-shaped tubes of each of the clamp arms are connected by inserting the nickel-titanium-lined wire into two straight rod-shaped tubes by extrusion deformation so that the nickel-titanium-lined wire and the two straight rods are The tubes are fixed together.
  • the outermost layer of the clip arm and/or spring is wrapped by a polyester vascular or polyester braid.
  • the present invention also provides a delivery device for delivering a heart ear clip to a root of a heart, the delivery device comprising: a handle; a coupling coupled to the handle and rotatable relative to the handle; and an outer tube coupled to the coupling,
  • the outer tube rotates about a central axis of the outer tube as the coupling rotates; a liner movable along the central axis of the outer tube inside the outer tube; a trigger connected to the handle and movable relative to the handle, the trigger and An end of the liner adjacent the handle is coupled to urge the liner to move within the outer tube; pivotally coupled to upper and lower teeth on an end of the outer tube remote from the handle, the upper and lower teeth respectively associated with the liner The coupling thereby pivots relative to the outer tube as the liner moves within the outer tube such that the upper and lower teeth are scissor open and closed.
  • the upper and lower teeth have snap means for releasably securing the auricle clip.
  • the outer tube has a chute therein so that the liner can move along the chute.
  • the delivery device has a self-locking device that locks the position of the outer tube and/or the liner.
  • the self-locking device may be a fixing pin, a chute pin or the like.
  • the conveying device further comprises an unlocking button to release the locking state of the self-locking device.
  • the auricle clips are fixed in the upper and lower teeth of the delivery device by means of ligating or mutual clamping.
  • the heart ear clip provides a sustained and stable closing force, implanted in the root of the auricle, and effectively blocks blood flow in the left atrium and the left atrial appendage.
  • the conveying device transports the heart ear clip to the target position, controls the opening and closing state of the heart ear clip, and can effectively release the heart ear clip.
  • the polyester artificial blood vessel or polyester braid wrapped by the outermost layer of the clamp arm and the spring can form an outer sleeve, has good biocompatibility, is favorable for tissue climbing; soft texture, reducing the pressure of the device on the tissue, reducing the pair Tissue damage.
  • the outer sleeve is composed of a polymer material such as PET, PTFE or the like.
  • the conveying device is opened and closed by the controllable heart ear clip, and realizes the rotation function of the heart ear clip.
  • the auricle clip and the conveying device are mounted on the conveying device by tying or mutual clamping, and the free separation of the auricle clip can be realized.
  • the auricle clip is assembled on the delivery device prior to pre-assembly or prior to use.
  • the delivery device can maintain the product in an open state by a self-locking device.
  • the heart ear clip and the conveying device enter the human body part with small size and can be used for the approach of the trocar (Tocar) for minimally invasive surgery;
  • the structure of the spring of the heart ear clip can provide a stable closing force
  • the outer layer of the heart ear clip is made of polyester artificial blood vessel, the surface is easy to grow tissue, and the risk of product falling off is reduced;
  • the conveying device can be rotated around the axis to facilitate the surgical adjustment of the product.
  • FIGS. 1A-1C are plan views of an embodiment of a heart ear clip and a delivery device of the present invention
  • FIGS. 2A-2C are schematic views of a first embodiment of a heart ear clip of the present invention.
  • FIG 3 is a schematic view of a second embodiment of a heart ear clip of the present invention.
  • 101 heart ear clip
  • 102 moving head
  • 103 liner
  • 104 outer tube
  • 105 coupling
  • 106 trigger
  • 107 unlock button
  • 201 U-spring
  • 202 clamp arm
  • 301 spring
  • 302 clamp arm
  • 303 lining wire.
  • the heart ear clip of the present invention comprises: two parallel clamping arms; two springs respectively located at two ends of the parallel clamping arms for respectively connecting the two ends of the two clamping arms to form a closed loop structure and providing two The clamping force of the clamp arms close to each other.
  • at least one of the two clamping arms is divided into a first segment and a second segment, and preferably the two clamping arms are divided into a first segment and a second segment a segment, the first segment and the second segment being pivotally connected or connected by a flexible material, such as by inserting a flexible filament into the first segment and the second segment such that the first segment and the second segment are relative to each other Flexible rotation.
  • the spring can be any suitable form such as a U-shaped spring, a coil spring, a coil spring, or the like.
  • the first and second sections may be straight rod tubes.
  • the material of the spring and the straight rod tube may be at least one of stainless steel, cobalt-based alloy, platinum-rhodium alloy, nickel-titanium alloy, and magnesium-based alloy.
  • the joints can be combined by extrusion deformation, welding, gluing or screwing.
  • the flexible material is a nickel-titanium-lined wire, and the two straight rod-shaped tubes of each clamp arm are connected by inserting a nickel-titanium-lined wire into two straight rod-shaped tubes, and the nickel-titanium-lined wire is fixed with the two straight rod-shaped tubes by extrusion deformation.
  • the outermost layer of the clamp arm and/or spring is wrapped by a polyester vascular or polyester braid.
  • the delivery device of the present invention for delivering a heart ear clip to the root of the auricle may comprise: a handle; a coupling coupled to the handle and rotatable relative to the handle; an outer tube coupled to the coupling, the outer tube being coupled to the coupling Rotating around the central axis of the outer tube; a liner movable along the central axis of the outer tube in the outer tube; a trigger connected to the handle and movable relative to the handle, the trigger being coupled to the end of the liner adjacent the handle to push the lining
  • the tube moves within the outer tube; is pivotally coupled to the upper and lower teeth on one end of the outer tube remote from the handle, the upper and lower teeth being respectively coupled to the liner to pivot relative to the outer tube as the liner moves within the outer tube So that the upper and lower teeth are opened and closed by scissors.
  • the heart ear clips are fixed in the upper and lower teeth of the conveying device by tying or mutual clamping.
  • the upper and lower teeth have a snap-fit device that releasably secures the auricle clip, or the auricle clip is affixed to the upper and lower teeth.
  • the delivery device can have a self-locking device that locks the position of the outer tube and/or the liner.
  • the self-locking device may be a fixed pin, a chute pin or the like.
  • the conveying device further includes an unlock button, and the solution In addition to the locked state of the self-locking device.
  • the heart ear clip provides a sustained and stable closing force that is implanted into the base of the heart and ears to effectively block blood flow in the left atrium and the left atrial appendage.
  • the conveying device transports the heart ear clip to the target position, controls the opening and closing state of the heart ear clip, and can effectively release the heart ear clip.
  • the polyester vascular or polyester braid wrapped in the outermost layer of the clamp arm and the spring can form an outer sleeve, which has good biocompatibility and is favorable for tissue climbing; the texture is soft, the pressure of the device on the tissue is reduced, and the tissue is reduced. damage.
  • the outer sleeve can be composed of a polymer material such as PET, PTFE or the like.
  • the conveying device is opened and closed by the controllable heart ear clip, and realizes the rotation function of the heart ear clip body.
  • the heart ear clip and the conveying device are mounted on the conveying device by tying or mutual carding, and the free separation of the heart ear clip can be realized.
  • the heart ear clips are assembled on the conveyor prior to pre-assembly or use.
  • the conveyor can keep the product open by a self-locking button.
  • FIG. 1A-1C show schematic views of a heart ear clip and delivery device of the present invention.
  • 1A is a product initial state, that is, a clamped state; as shown in FIG. 1B, the heart ear clip and the conveying device include: a heart ear clip 101 and a conveying device. Description of the specific structure of the heart ear clip 101
  • the conveying device comprises: a handle; a coupling 105 coupled to the handle and rotatable relative to the handle; an outer tube 104 coupled to the coupling 105, the outer tube 104 rotating about the central axis of the outer tube 104 as the coupling rotates; a liner 103 movable along the central axis of the outer tube in the outer tube 104; a trigger 106 coupled to the handle and movable relative to the handle, the trigger 106 being coupled to the end of the liner 103 adjacent the handle to urge the liner 103 in the outer tube Movement within 104; pivotally coupled to upper and lower teeth on one end of the outer tube 104 remote from the handle, the upper and lower teeth being coupled to the liner 103, respectively, relative to the movement of the liner 103 within the outer tube 104 relative to The outer tube 104 is pivoted so that the upper and lower teeth are scissor-opened and closed.
  • the upper and lower teeth are coupled to the outer tube by a moving head 102 at the distal end of the outer tube 104.
  • the specific structure of each part of the delivery device can be seen in a similar delivery device in the prior art, such as surgery. Ultrasonic scalpel for surgery, abdominal forceps and other tools.
  • the auricle clip 101 can be fixed in the upper and lower teeth of the delivery device by means of ligating or mutual clamping.
  • the upper and lower teeth have a snap-fit device that releasably secures the auricle clip, or the auricle clip is affixed to the upper and lower teeth.
  • the delivery device can have a self-locking device that locks the position of the outer tube and/or the liner.
  • the self-locking device may be a fixed pin, a chute pin or the like. (Not shown, the specific structure can be referred to the similar structure in the prior art, and will not be described again.)
  • the conveying device further includes an unlocking button 107 to release the locking state of the self-locking device.
  • the delivery device of the present invention can operate as such.
  • the auricle clip 101 is fixed in the upper and lower teeth of the moving head 102 by means of ligating (or mutual card structure); the operator can carry the conveying device with the auricle by means of a mirror or the like in an intuitive manner or the like.
  • the clip 101 is moved to a position close to the auricle to be clamped, and the trigger 106 is pulled to open the upper and lower teeth, and the heart clip 101 is opened into a quadrilateral shape, as shown in FIG. 1B, by the self-locking device.
  • the status of the open is locked.
  • the position of the auricle clip can be adjusted by rotating the coupling 105 to rotate the auricle clip.
  • the locked state of the self-locking device is released, and the device returns to the initial state, as shown in FIG. 1A.
  • the ligature point is reduced or the buckle state is released, and the heart ear clip and the delivery device are immediately detached.
  • the heart ear clip and the delivery device of the present invention can be used for minimally invasive surgery by means of a puncturing device and a laparoscopic assisted approach.
  • a puncturing device and a laparoscopic assisted approach.
  • the heart ear clip and delivery device of the present invention are used in a thoracotomy.
  • the heart ear clip of the present invention imparts a stable closing force by a spring, and the clip arm permanently closes the left atrial appendage from the outside of the heart. Specific examples of some of the heart ear clips of the present invention are given below.
  • the heart ear clip 101 includes: two U-shaped springs 201, 2 parallel clamp arms 202.
  • Each of the clamping arms 202 is divided into a first segment and a second segment. The first segment and the second segment are connected by a hinge.
  • Two springs 201 are respectively located at both ends of the parallel clamping arms for The two ends of the clamp arms are respectively connected to form a closed loop structure and provide a clamping force that brings the two clamp arms closer to each other.
  • Two U-shaped springs 201 are respectively inserted into the left and right clamp arms, and are fixed by welding or crimping.
  • the nickel-titanium wire 203 may be lined in the hole of the clamp arm.
  • the heart ear clip is placed on the root of the left atrial appendage by the conveying device.
  • the U-shaped spring at both ends of the heart ear clip is deformed due to the thickness of the auricle, giving the clamping arm clamping force and closing the atrial appendage, and the nickel-titanium wire is beneficial to ensure The hinges of the two clamp arms are straight;
  • FIG. 2B is a schematic diagram of the auricle clip being pulled into a parallelogram;
  • FIG. 2C is a schematic exploded view of the heart ear clip structure;
  • the heart ear clip 101 includes: two parallel clamp arms 302; two springs 301 respectively located at both ends of the parallel clamp arms for the purpose of the two clamp arms The two ends are respectively connected to form a closed loop structure and provide a clamping force that brings the two clamp arms closer to each other.
  • the two clamping arms 302 are divided into a first segment and a second segment. Unlike the first embodiment, the first segment and the second segment are not connected by a hinge but are connected by a flexible material, for example.
  • the U-shaped spring 301 and the clamp arm 302 are fixed by welding or crimping, and the nickel-titanium-lined wire 303 and the clamp arm 302 are fixed by welding or crimping; when the heart-ear clip 101 is opened
  • the lining wire 303 is bent, and the heart ear clip is opened to become a quadrilateral shape. After the conveying device places the heart ear clip on the root of the heart ear, the thickness of the heart ear causes the spring to change, giving the clamping arm clamping force and closing the left atrial appendage, and the nickel titanium
  • the lining 303 ensures that the two clamp arms are straight.
  • the small size of the heart ear clip and the transport device entering the human body is small, and can be used for the approach of the trocar (Tocar) for minimally invasive surgery;
  • the structure of the spring of the heart ear clip can provide a stable closing force
  • the outer layer of the heart ear clip is made of polyester artificial blood vessel, and the surface is easy to grow and reduce. Risk of product loss;
  • the conveying device can be rotated around the axis to facilitate the surgical adjustment of the product.
  • the invention provides a heart ear clip, which comprises: two parallel clamping arms; two springs respectively located at two ends of the parallel clamping arms for connecting two ends of the two clamping arms respectively a closed loop structure and providing a clamping force that brings the two clamp arms closer to each other; wherein at least one of the two clamp arms is divided into a first segment and a second segment, and the first segment and the second segment are pivotable Ground connection or connection by flexible material.
  • the present invention also provides a delivery device for delivering a heart ear clip to a root of a heart, the delivery device comprising: a handle; a coupling coupled to the handle and rotatable relative to the handle; and an outer tube coupled to the coupling,
  • the outer tube rotates about a central axis of the outer tube as the coupling rotates; a liner movable along the central axis of the outer tube inside the outer tube; a trigger connected to the handle and movable relative to the handle, the trigger and An end of the liner adjacent the handle is coupled to urge the liner to move within the outer tube; pivotally coupled to upper and lower teeth on an end of the outer tube remote from the handle, the upper and lower teeth respectively associated with the liner The coupling thereby pivots relative to the outer tube as the liner moves within the outer tube such that the upper and lower teeth are scissor open and closed.
  • the heart ear clip of the present invention is fixed in the upper and lower teeth of the moving head by means of tying (or mutual card structure); the operator moves the conveying device with the heart ear clip to the near side by means of an intuitive method such as a cavity mirror or the like.
  • the gripped auricle position the trigger is pulled to open the upper and lower teeth scissors, and the heart ear clip is opened into a quadrilateral shape, and the open state is locked by the self-locking device.
  • the position of the auricle clip can be adjusted by rotating the coupling to rotate the heart ear clip.
  • the unlocking state of the self-locking device is released by the activation of the unlocking button, and the device is restored to the initial state.
  • the lashing point is reduced or the buckled state is released, and the heart-ear clip and the conveying device are immediately detached. Has a strong practicality.

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Abstract

一种心耳夹（101）及其输送装置。所述心耳夹（101）包括：两个平行的夹臂（202,302）；两个弹簧（201,301），其分别位于所述平行的夹臂（202,302）的两个端部，用于将两个夹臂（202,302）的两端分别连接形成闭环结构并提供使得两个夹臂（202,302）彼此靠近的夹紧力；两个夹臂（202,302）中至少一个夹臂分为第一段和第二段，第一段和第二段之间可枢转地连接或者通过柔性材料连接。输送装置包括：手柄；相对手柄可旋转的联轴器（105）；与联轴器（105）连接的外管（104），外管（104）随联轴器（105）旋转而绕所述外管（104）的中心轴线旋转；在外管（104）内沿外管（104）中心轴线可运动的衬管（103）；扳机（106），扳机（106）与衬管（103）的靠近手柄的一端相连从而可推动衬管（103）在外管（104）内运动；上齿和下齿，上齿和下齿分别与衬管（103）联接从而随衬管（103）在外管（104）内的运动而相对于外管（104）枢转以便上齿和下齿剪刀式张开和闭合。

Description

心耳夹及其输送装置 技术领域
本发明涉及医疗器械领域，具体涉及一种心耳夹及其输送装置。
背景技术
房颤是临床上最为常见的心律失常之一，患病人数众多，目前我国约有800万房颤患者，且数量逐年增加，房颤患者每年有0.4％-1％的人发生脑卒中，也就是说在800万患病人群中，每年有3.2-8万的人可能因为房颤产生缺血性脑卒中。脑卒中是房颤最大的危害，研究发现15-20％的缺血性脑卒中由房颤引起，约每6例脑卒中患者中有1个是房颤患者。非瓣膜病性房颤病人脑卒中发生率是正常人的5.6倍，瓣膜病房颤脑卒中发生率是正常人的17.6倍；而且房颤引起的脑卒中后果更为严重，死亡率和致残率达到70％。对瓣膜性房颤的病人，57％的心房血栓来源于左心耳，对于非瓣膜房颤的病人，90％的左心房血栓来源于左心耳。即使恢复窦律后，左心耳收缩顿抑，仍有可能再形成血栓。
目前临床上预防房颤缺血性脑卒中的方法主要有三种。一种方法是服用抗凝药物，如华法林，但应用华法林具有一定的出血风险，且须要频繁监测，禁忌症比较多，临床应用较为困难；另外华法林还有导致骨质疏松和软组织坏死的可能。第二种方法是心脏外科手术同期直接切除或结扎心耳，这种方法的主要不足是左心耳的完全闭合率较低，既往研究显示完全切除左心耳的成功率最高约80％。第三种方法是通过器械闭合左心耳，经皮介入心内左心耳封堵术产品，如经皮导管闭合左心耳封堵器(PLAATO)、守望者封堵器(WATCHMAN)、安普拉泽心耳封堵器(ACP)等。经心内介入封堵左心耳产品虽然众多，但操作复杂，风险较高，安全性和有效性有待验证。在前瞻性技 术设计机构(PROTECK-AF)研究中显示，安全性和有效性方面，介入左心耳封堵治疗呈现出优于华法林的趋势；但左心耳封堵治疗在手术后的一个月内有较严重不良事件，还需要进行更长期的随访，以明确封堵治疗的远期安全性和疗效。
发明内容
(一)要解决的技术问题
本发明的目的是设计一种心耳夹及其输送装置，在开胸或微创手术中将心耳夹从心脏外放置于左心耳根部，永久闭合左心耳。
(二)技术方案
本发明提供一种心耳夹，它包括：两个平行的夹臂；两个弹簧，其分别位于所述平行的夹臂的两个端部，用于将两个夹臂的两端分别连接形成闭环结构并提供使得两个夹臂彼此靠近的夹紧力；其中，所述两个夹臂中至少一个夹臂分为第一段和第二段，第一段和第二段之间可枢转地连接或者通过柔性材料连接。
优选，所述两个夹臂均分为第一段和第二段，所述第一段和第二段之间可枢转地连接。
优选，所述弹簧是U型弹簧。
优选，所述第一段和所述第二段是直杆形管。
优选，所述弹簧和直杆形管的材料可采用不锈钢、钴基合金、铂铱合金、镍钛合金、镁基合金中的至少一种。
优选，所述U型弹簧两端分别***直杆形管后，连接点可采用挤压变形的方式、焊接、胶粘或螺纹连接方式将两者组合在一起。
优选，所述柔性材料是镍钛衬丝，各个夹臂的两直杆形管连接方式为将所述镍钛衬丝***两直杆形管内通过挤压变形使得镍钛衬丝与两直杆形管固定在一起。
优选，所述夹臂和/或者弹簧最外层被聚酯人造血管或聚酯编织物包裹。
本发明还提供了一种用于将心耳夹输送到心耳根部的输送装置，输送装置包括：手柄；与手柄联接并相对于手柄可旋转的联轴器；与联轴器连接的外管，所述外管随联轴器旋转而绕所述外管的中心轴线旋转；在外管内沿外管中心轴线可运动的衬管；与手柄相连接并相对于手柄可动的扳机，所述扳机与衬管的靠近手柄的一端相连从而可推动所述衬管在外管内运动；可枢转地连接在外管的远离手柄的一端上的上齿和下齿，所述上齿和下齿分别与衬管联接从而随衬管在外管内的运动而相对于外管枢转以便所述上齿和下齿剪刀式张开和闭合。
优选，所述上齿和下齿具有可松脱地固定所述心耳夹的卡扣装置。
优选，所述外管内有滑槽从而所述衬管可沿所述滑槽运动。
优选，所述输送装置具有将外管和/或衬管位置锁定的自锁装置。所述自锁装置可以是固定销、滑槽销等。
优选，所述输送装置还包括解锁按钮，解除自锁装置的锁定状态。
优选，心耳夹通过绑扎或互卡的方式固定在输送装置的上齿、下齿中。
优选，所述心耳夹提供持续稳定闭合力，植入心耳根部，可有效阻断左心房与左心耳的血流。
优选，输送装置将心耳夹输送到目标位置，控制心耳夹的开闭状态，并能对心耳夹进行有效释放。
优选，夹臂和弹簧最外层包裹的聚酯人造血管或聚酯编织物可形成外套管，有良好的生物相容性，利于组织爬覆；质地柔软，降低器械对组织的压强，减少对组织的损伤。
优选，所述外套管可由高分子材料组成，如PET、PTFE等材料组成。
优选，所述输送装置由可控制心耳夹张开、闭合，并实现心耳夹体内旋转功能。
优选，所述心耳夹与输送装置通过绑扎或互卡的方式装在输送装置上，并可实现心耳夹的自由脱离。
优选，所述心耳夹为预装或使用前装配在输送装置上。
优选，所述输送装置可通过自锁装置将产品保持打开状态。
(三)有益效果
本发明提供的心耳夹及其输送装置，具有以下优点：
1、心耳夹及输送装置进入人体部分的外型尺寸小，可用于穿刺器(Tocar)的入路方式，进行微创手术；
2、心耳夹的弹簧的结构能够提供稳定的闭合力；
3、心耳夹外层采用聚酯人造血管，表面易于组织生长，降低产品脱落的风险；
4、输送装置可绕轴旋转，便于产品手术调整。
附图说明
图1A-1C为本发明的心耳夹及输送装置一个实施例的平面示意图；
图2A-2C为本发明的心耳夹第一种实施方式的示意图；
图3为本发明的心耳夹第二种实施方式的示意图。
图中，101：心耳夹；102：移动头；103：衬管；104：外管；105：联轴器；106：扳机；107：解锁按钮；201：U型弹簧；202：夹臂；203：镍钛丝；301：弹簧；302：夹臂；303：衬丝。
具体实施方式
下面结合附图和实施例，对本发明的具体实施方式作进一步详细描述。以下实例用于说明本发明，但不用来限制本发明的范围。
本发明的心耳夹包括：两个平行的夹臂；两个弹簧，其分别位于平行的夹臂的两个端部，用于将两个夹臂的两端分别连接形成闭环结构并提供使得两个夹臂彼此靠近的夹紧力。其中，两个夹臂中至少一个夹臂分为第一段和第二段，最好是两个夹臂均分为第一段和第二 段，第一段和第二段之间可枢转地连接或者通过柔性材料连接，例如通过将一根柔性丝***第一段和第二段中而使得第一段和第二段可相对彼此柔性转动。
弹簧可以是U型弹簧、螺旋弹簧、盘簧等任何合适的形式。
第一段和第二段可以是直杆形管。
弹簧和直杆形管的材料可采用不锈钢、钴基合金、铂铱合金、镍钛合金、镁基合金中的至少一种。
U型弹簧两端分别***直杆形管后，连接点可采用挤压变形的方式、焊接、胶粘或螺纹连接方式将两者组合在一起。
柔性材料是镍钛衬丝，各个夹臂的两直杆形管连接方式为将镍钛衬丝***两直杆形管内通过挤压变形使得镍钛衬丝与两直杆形管固定在一起。
夹臂和/或者弹簧最外层被聚酯人造血管或聚酯编织物包裹。
本发明的用于将心耳夹输送到心耳根部的输送装置可以包括：手柄；与手柄联接并相对于手柄可旋转的联轴器；与联轴器连接的外管，外管随联轴器旋转而绕外管的中心轴线旋转；在外管内沿外管中心轴线可运动的衬管；与手柄相连接并相对于手柄可动的扳机，扳机与衬管的靠近手柄的一端相连从而可推动衬管在外管内运动；可枢转地连接在外管的远离手柄的一端上的上齿和下齿，上齿和下齿分别与衬管联接从而随衬管在外管内的运动而相对于外管枢转以便上齿和下齿剪刀式张开和闭合。
心耳夹通过绑扎或互卡的方式固定在输送装置的上齿、下齿中。具体说，上齿和下齿具有可松脱地固定心耳夹的卡扣装置，或者心耳夹绑扎在上齿和下齿上。
外管内可以有滑槽从而衬管可沿滑槽运动。
输送装置可以具有将外管和/或衬管位置锁定的自锁装置。自锁装置可以是固定销、滑槽销等。此时，输送装置还包括解锁按钮，解 除自锁装置的锁定状态。
心耳夹提供持续稳定闭合力，植入心耳根部，可有效阻断左心房与左心耳的血流。
输送装置将心耳夹输送到目标位置，控制心耳夹的开闭状态，并能对心耳夹进行有效释放。
夹臂和弹簧最外层包裹的聚酯人造血管或聚酯编织物可形成外套管，有良好的生物相容性，利于组织爬覆；质地柔软，降低器械对组织的压强，减少对组织的损伤。
外套管可由高分子材料组成，如PET、PTFE等材料组成。
输送装置由可控制心耳夹张开、闭合，并实现心耳夹体内旋转功能。
心耳夹与输送装置通过绑扎或互卡的方式装在输送装置上，并可实现心耳夹的自由脱离。心耳夹为预装或使用前装配在输送装置上。输送装置可通过自锁按钮将产品保持打开状态。
图1A-1C示出了本发明的心耳夹及输送装置的示意图。图1A为产品初始状态即夹紧状态；图1B所示，心耳夹及输送装置包括：心耳夹101和输送装置。心耳夹101的具体结构的说明
输送装置包括：手柄；与手柄联接并相对于手柄可旋转的联轴器105；与联轴器105连接的外管104，外管104随联轴器旋转而绕外管104的中心轴线旋转；在外管104内沿外管中心轴线可运动的衬管103；与手柄相连接并相对于手柄可动的扳机106，扳机106与衬管103的靠近手柄的一端相连从而可推动衬管103在外管104内运动；可枢转地连接在外管104的远离手柄的一端上的上齿和下齿，上齿和下齿分别与衬管103联接从而随衬管103在外管104内的运动而相对于外管104枢转以便上齿和下齿剪刀式张开和闭合。在本实施例中，上齿和下齿通过外管104远端的移动头102连接到外管上。输送装置各个部分的具体结构可以参见现有技术中类似的输送装置，例如外科 手术用的超声刀，腹腔钳等工具。
心耳夹101可以通过绑扎或互卡的方式固定在输送装置的上齿、下齿中。具体说，上齿和下齿具有可松脱地固定心耳夹的卡扣装置，或者心耳夹绑扎在上齿和下齿上。具体的结构可以参见现有技术中的类似结构，不再赘述。
外管104内可以有滑槽从而衬管可沿滑槽运动。
输送装置可以具有将外管和/或衬管位置锁定的自锁装置。自锁装置可以是固定销、滑槽销等。(未示出，具体的结构可以参见现有技术中的类似结构，不再赘述。)此时，输送装置还包括解锁按钮107，解除自锁装置的锁定状态。
本发明的输送装置可以这样工作。如图1C所示，心耳夹101通过绑扎(或互卡结构)的方式固定在移动头102的上齿和下齿中；操作人员借助腔镜等直观方式或者其他方式，将输送装置带着心耳夹101移动到靠近要夹持的心耳位置，扳动扳机106从而使得上齿和下齿剪刀式张开，将心耳夹101撑开成四边形，如图1B所示，通过自锁装置将该张开的状态锁定。可以通过旋转联轴器105从而旋转心耳夹来调整心耳夹的位置。位置最终确定后，通过启动解锁按钮107，解除自锁装置的锁定状态，装置恢复到初始的状态，如图1A所示。手术完成后将绑扎点减掉或者解除卡扣状态，心耳夹与输送装置随即脱离。
如上所述，本发明的心耳夹及输送装置可通过穿刺器建立入路方式配合腹腔镜辅助进行微创手术。当然，也可以有其他的使用方法。例如，在开胸手术中使用本发明的心耳夹及输送装置。
本发明中的心耳夹通过弹簧给予稳定闭合力，夹臂从心外永久闭合左心耳，下面给出本发明的一些心耳夹的具体实例。
第一种实施方式的具体结构：
如图2A为心耳夹初始状态，心耳夹101包括：2个U型弹簧201、 2个平行的夹臂202。每个夹臂202分为第一段和第二段，第一段和第二段通过铰链的方式连接，两个弹簧201分别位于所述平行的夹臂的两个端部，用于将两个夹臂的两端分别连接形成闭环结构并提供使得两个夹臂彼此靠近的夹紧力。两根U型弹簧201分别***左、右两根夹臂中，通过焊接或压接的方式将其固定。
另外，夹臂的孔中可以衬有镍钛丝203。心耳夹被输送装置放置于左心耳根部，当夹住心耳后心耳夹两端的U型弹簧由于心耳的厚度产生型变，给予夹臂夹紧力，将心耳闭合，同时镍钛丝有利于保证两夹臂的铰链处平直；图2B为心耳夹被拉开成平行四边形；图2C为心耳夹结构分解示意图；
第二种实施方式的具体结构：
如图3为心耳夹初始状态，心耳夹101包括：两个平行的夹臂302；两个弹簧301，其分别位于所述平行的夹臂的两个端部，用于将两个夹臂的两端分别连接形成闭环结构并提供使得两个夹臂彼此靠近的夹紧力。其中，两个夹臂302均分为第一段和第二段，与第一个实施例不同的是，第一段和第二段之间不是通过铰链连接，而是通过柔性材料连接，例如通过镍钛衬丝303连接；U型弹簧301和夹臂302通过焊接或压接的方式固定，镍钛衬丝303和夹臂302管通过焊接或压接的方式固定；心耳夹101被打开时，衬丝303变弯曲，心耳夹被打开后成为四边形，输送装置将心耳夹放置心耳根部后，由于心耳厚度促使弹簧产生型变，给予夹臂夹紧力，将左心耳闭合，同时镍钛衬丝303保证两夹臂平直。
本发明具有以下优点：
(1)心耳夹及输送装置进入人体部分的外型尺寸小，可用于穿刺器(Tocar)的入路方式，进行微创手术；
(2)心耳夹的弹簧的结构能够提供稳定的闭合力；
(3)心耳夹外层采用聚酯人造血管，表面易于组织生长，降低 产品脱落的风险；
(4)输送装置可绕轴旋转，便于产品手术调整。
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、改进等，均应包含在本发明的保护范围之内。
工业实用性
本发明提供一种心耳夹，它包括：两个平行的夹臂；两个弹簧，其分别位于所述平行的夹臂的两个端部，用于将两个夹臂的两端分别连接形成闭环结构并提供使得两个夹臂彼此靠近的夹紧力；其中，所述两个夹臂中至少一个夹臂分为第一段和第二段，第一段和第二段之间可枢转地连接或者通过柔性材料连接。本发明还提供了一种用于将心耳夹输送到心耳根部的输送装置，输送装置包括：手柄；与手柄联接并相对于手柄可旋转的联轴器；与联轴器连接的外管，所述外管随联轴器旋转而绕所述外管的中心轴线旋转；在外管内沿外管中心轴线可运动的衬管；与手柄相连接并相对于手柄可动的扳机，所述扳机与衬管的靠近手柄的一端相连从而可推动所述衬管在外管内运动；可枢转地连接在外管的远离手柄的一端上的上齿和下齿，所述上齿和下齿分别与衬管联接从而随衬管在外管内的运动而相对于外管枢转以便所述上齿和下齿剪刀式张开和闭合。本发明的心耳夹通过绑扎(或互卡结构)的方式固定在移动头的上齿和下齿中；操作人员借助腔镜等直观方式或者其他方式，将输送装置带着心耳夹移动到靠近要夹持的心耳位置，扳动扳机从而使得上齿和下齿剪刀式张开，将心耳夹撑开成四边形，通过自锁装置将该张开的状态锁定。可以通过旋转联轴器从而旋转心耳夹来调整心耳夹的位置。位置最终确定后，通过启动解锁按钮，解除自锁装置的锁定状态，装置恢复到初始的状态，手术完成后将绑扎点减掉或者解除卡扣状态，心耳夹与输送装置随即脱离。具有较强的实用性。

Claims (13)

  1. 一种心耳夹，它包括：两个平行的夹臂；两个弹簧，其分别位于所述平行的夹臂的两个端部，用于将两个夹臂的两端分别连接形成闭环结构并提供使得两个夹臂彼此靠近的夹紧力；
    其中，所述两个夹臂中至少一个夹臂分为第一段和第二段，第一段和第二段之间可枢转地连接或者通过柔性材料连接。
  2. 如权利要求1所述的心耳夹，其特征在于，所述两个夹臂均分为第一段和第二段。
  3. 如权利要求1所述的心耳夹，其特征在于，所述弹簧是U型弹簧。
  4. 如权利要求1所述的心耳夹，其特征在于，所述第一段和所述第二段是直杆形管。
  5. 如权利要求1所述的心耳夹，其特征在于，所述弹簧和夹臂的材料采用不锈钢、钴基合金、铂铱合金、镍钛合金、镁基合金中的至少一种。
  6. 如权利要求3所述的心耳夹，其特征在于，所述U型弹簧两端分别***夹臂端部的孔后，采用挤压变形的方式、焊接、胶粘或螺纹连接方式将所述U型弹簧和夹臂组合在一起。
  7. 如权利要求1所述的心耳夹，其特征在于，所述柔性材料是镍钛衬丝，所述镍钛衬丝分别***所述第一段和第二段端部的孔中，通过挤压变形使得镍钛衬丝与第一段和第二段固定在一起。
  8. 如权利要求1所述的心耳夹，其特征在于，所述夹臂和/或者弹簧最外层被聚酯人造血管或聚酯编织物包裹。
  9. 如权利要求1所述的心耳夹，其特征在于，所述夹臂和弹簧外包裹一个外套管，所述外套管由高分子材料组成。
  10. 一种用于将权利要求1所述的心耳夹输送到心耳根部的输送装置，其中，所述输送装置包括：手柄；与手柄联接并相对于手柄可 旋转的联轴器；与联轴器连接的外管，所述外管随联轴器旋转而绕所述外管的中心轴线旋转；在外管内沿外管中心轴线可运动的衬管；与手柄相连接并相对于手柄可动的扳机，所述扳机与衬管的靠近手柄的一端相连从而可推动所述衬管在外管内运动；用于携带所述心耳夹、可枢转地连接在外管的远离手柄的一端上的上齿和下齿，所述上齿和下齿分别与衬管联接从而随衬管在外管内的运动而相对于外管枢转以便所述上齿和下齿剪刀式张开和闭合。
  11. 如权利要求10所述的输送装置，其特征在于，所述上齿和下齿具有可松脱地固定所述心耳夹的卡扣装置。
  12. 如权利要求10所述的输送装置，其特征在于，所述外管内有滑槽从而所述衬管可沿所述滑槽运动。
  13. 如权利要求10所述的输送装置，其特征在于，所述输送装置包括：将外管和/或衬管位置锁定的自锁装置；以及解锁装置，以解除自锁装置的锁定状态。
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RU2680923C1 (ru) 2019-02-28
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