WO2017024879A1 - 心耳夹及其输送装置 - Google Patents
心耳夹及其输送装置 Download PDFInfo
- 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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- Prior art keywords
- outer tube
- handle
- segment
- liner
- ear clip
- Prior art date
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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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- Surgical Instruments (AREA)
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Abstract
Description
Claims (13)
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
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JP2018524515A JP6533872B2 (ja) | 2015-08-11 | 2016-06-06 | 心耳クランプ及びその送達装置 |
US15/744,065 US10905433B2 (en) | 2015-08-11 | 2016-06-06 | Auricle clamp and delivery device thereof |
EP16834504.9A EP3335644B1 (en) | 2015-08-11 | 2016-06-06 | Auricle clamp and delivery device therefor |
KR1020187002890A KR102080418B1 (ko) | 2015-08-11 | 2016-06-06 | 심방 클램프 및 이의 전달 장치 |
RU2018102967A RU2680923C1 (ru) | 2015-08-11 | 2016-06-06 | Зажим для ушка предсердия и устройство для его доставки |
EP21190609.4A EP3925546A1 (en) | 2015-08-11 | 2016-06-06 | Auricle clamp and delivery device thereof |
US17/132,402 US20210128158A1 (en) | 2015-08-11 | 2020-12-23 | Auricle clamp and delivery device thereof |
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CN201510505137.7A CN105193471B (zh) | 2015-08-11 | 2015-08-11 | 心耳夹及其输送装置 |
CN201510505137.7 | 2015-08-11 |
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US15/744,065 A-371-Of-International US10905433B2 (en) | 2015-08-11 | 2016-06-06 | Auricle clamp and delivery device thereof |
US17/132,402 Continuation US20210128158A1 (en) | 2015-08-11 | 2020-12-23 | Auricle clamp and delivery device thereof |
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WO2017024879A1 true WO2017024879A1 (zh) | 2017-02-16 |
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US (2) | US10905433B2 (zh) |
EP (2) | EP3925546A1 (zh) |
JP (1) | JP6533872B2 (zh) |
KR (1) | KR102080418B1 (zh) |
CN (1) | CN105193471B (zh) |
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WO (1) | WO2017024879A1 (zh) |
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Also Published As
Publication number | Publication date |
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US10905433B2 (en) | 2021-02-02 |
CN105193471B (zh) | 2017-10-27 |
JP2018526164A (ja) | 2018-09-13 |
KR20180025912A (ko) | 2018-03-09 |
EP3335644A1 (en) | 2018-06-20 |
EP3925546A1 (en) | 2021-12-22 |
US20210128158A1 (en) | 2021-05-06 |
EP3335644B1 (en) | 2021-09-22 |
EP3335644A4 (en) | 2019-08-07 |
CN105193471A (zh) | 2015-12-30 |
RU2680923C1 (ru) | 2019-02-28 |
KR102080418B1 (ko) | 2020-02-21 |
US20180199945A1 (en) | 2018-07-19 |
JP6533872B2 (ja) | 2019-06-19 |
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