WO2016192481A1 - Heart valve repair device - Google Patents

Heart valve repair device Download PDF

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Publication number
WO2016192481A1
WO2016192481A1 PCT/CN2016/079906 CN2016079906W WO2016192481A1 WO 2016192481 A1 WO2016192481 A1 WO 2016192481A1 CN 2016079906 W CN2016079906 W CN 2016079906W WO 2016192481 A1 WO2016192481 A1 WO 2016192481A1
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WO
WIPO (PCT)
Prior art keywords
valve repair
valve
artificial
puncture needle
puncture
Prior art date
Application number
PCT/CN2016/079906
Other languages
French (fr)
Chinese (zh)
Inventor
孟坚
周晓军
代高旭
周庆亮
Original Assignee
北京迈迪顶峰医疗科技有限公司
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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
Publication of WO2016192481A1 publication Critical patent/WO2016192481A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246Devices for obstructing a leak through a native valve in a closed condition

Definitions

  • the present invention relates to the field of medical device technology, and more particularly to a transapical valve repair device.
  • the normal human heart has four chambers: the left ventricle, the left atrium, the right ventricle, and the right atrium.
  • the left ventricle communicates with the left atrium, and the right ventricle communicates with the right atrium.
  • the heart has four valves.
  • the valves in the left ventricle and left ventricle are mitral valves.
  • the valves in the right ventricle and right ventricle are the tricuspid valve.
  • the valve between the left ventricle and the aorta is the aortic valve.
  • the right ventricle and the pulmonary artery The valve is the pulmonary valve.
  • the mitral valve and the three valves generally have 2-3 leaflets, the end of the leaflet is an annulus, and the leaflets are fixed by the tendon to the papillary muscle.
  • the normal valve ensures smooth flow of blood in one direction and effectively pumps the blood out of the chamber without reflow.
  • endocarditis causes lesions in the valve that impair the function of the valve.
  • Stenosis and reflux are common valvular diseases.
  • Stenosis is due to the inability of the valve to open completely, resulting in impeded blood flow, and thickening caused by calcification of the leaflets is a common cause of stenosis.
  • the reflux is due to the inability of the valve leaf to close completely, causing blood to flow back to the chamber where the blood is pumped.
  • the expansion of the annulus, prolapse of the leaflet, and obstruction of the leaflet movement are the main causes of reflux.
  • stenosis In valvular disease, stenosis often occurs in the aortic valve and pulmonary valve, while the mitral and tricuspid valves are more likely to regulate. The simultaneous presence of stenosis and reflux can greatly increase the burden on the heart and can lead to serious consequences.
  • valve repair For the stenosis of the aortic valve and pulmonary valve, because the stenosis of the leaflets can not be repaired, the traditional treatment is to replace with a biological valve or mechanical valve; In valve repair, replacement of the valve has the disadvantages of high mortality, limited valve life, and anticoagulation throughout life. Therefore, the mitral valve and the three valves are more treated with repair.
  • Traditional valvular surgery requires thoracotomy. It is necessary to establish extracorporeal circulation to stop the heart. It requires a lot of manpower coordination. The requirements of the surgeon are extremely high. The operation is extremely complicated. For example, in valve repair, it is often necessary to remove prolapse.
  • Mitral valvuloplasty and prosthetic valve replacement are the most effective methods for the treatment of mitral regurgitation, but because the surgery requires extracorporeal circulation technical support, the trauma caused by the patient is greater, for older patients and more comorbidities Patients, mortality and complications are very high.
  • the development of percutaneous mitral valve repair has been rapid, mainly involving interventional annuloplasty, vacuum aspiration suture technique and mitral valve clamping, among which MitraClip
  • the curative effect is the most reliable, and it is promoted rapidly in the clinic.
  • the method is to send an implantable clip to the vicinity of the mitral valve through the interatrial septum puncture, and fix the free edge of the anterior and posterior leaflets so that the leaflets are at the end of the systole. And good, reduce backflow.
  • the problems with MitraClip are as follows: from the femoral artery through the long sheath tube, the operation is difficult, the operation time is long; due to the use of large-sized sheath in the operation, the residual space of the interatrial septum may remain after surgery; the mitral valve mouth is changed from a single hole Double holes can lead to a reduction in the area of the mitral valve; fixing the prolapse valve and the healthy valve together may cause changes in the tension of the healthy valve and accelerate its degradation.
  • the present invention provides a minimally invasive artificial wire implant device.
  • the device can be implanted in a minimally invasive manner to repair the mitral or tricuspid valve.
  • the device is characterized by a beating heart in the heart, which can be accurately implanted with artificial imaging equipment by means of modern imaging equipment such as thoracoscopy and laparoscopy.
  • the device shortens the operation time, reduces the degree of trauma, and reduces the difficulty of surgery and the risk of surgery.
  • the present invention provides a valve repair apparatus, wherein the valve repair apparatus includes: a sealing sheath; a trap for capturing and fixing the leaflets at the distal end of the sealing sheath; and is located in the sealing sheath a puncture needle for puncturing a leaflet captured by the trap; a puncture needle penetrating into the valve, an artificial chord for repairing the valve; and a proximal end of the sealing sheath for operating the valve repair device The handle of the action.
  • the sealing sheath is comprised of a sheath tube comprising an inner tube and an outer tube.
  • one end of the sheath tube is coupled to the latching valve and the other end is in communication with the balloon, and a lumen is provided between the inner tube and the outer tube that allows fluid that causes the balloon to expand.
  • the inner tube and the outer tube are made of a metal material or a polymer material.
  • the balloon is a medical butyl rubber, natural rubber or other polymeric material.
  • the trap is mechanical capture or negative pressure capture.
  • the trap is a ring, a claw, a clip or a long tube made of a metal or polymer material.
  • the trap is in the shape of a long tube whose axis is parallel to the axis of the puncture needle.
  • the artificial chordae are loaded on the outside of the puncture needle or in the lumen of the puncture needle.
  • the needle end of the puncture needle has a barb or tennis structure that prevents the leaflets from falling off after being punctured.
  • the barb or tennis structure is a recyclable structure that is safely recovered by the trap after the artificial chord is released.
  • the artificial chordae is made of ePTFE, nickel titanium alloy or other polymeric material.
  • the structure of the artificial chordae is T-shaped, single-umbrella, double-umbrella or line-shaped.
  • the handle has an ejection release device that ejects a puncture needle for leaflet puncture and releases an artificial chord.
  • the handle has a selection device for adjusting the leaflet puncture and releasing the artificial chord for simultaneous or stepwise.
  • the ejection release means of the handle is a device that generates an ejection force and a release force by a spring, water pressure or air pressure of a high reluctance coefficient.
  • the valve repair device of the present invention has the advantage of enabling small incision insertion and repairing damaged leaflets while the heart is beating.
  • the position of the leaflets that need to be implanted with the artificial chordae is captured by the use of the trap under ultrasound guidance, the leaflet puncture and the artificial chordae are released, and the device is removed and the artificial sputum is adjusted under the ultrasound image.
  • the length of the cord is fixed at the apex of the other end, and the implantation of the artificial chord is completed.
  • Figure 1a is a general assembly diagram of the valve repair device
  • Figure 1b is a cross-sectional view of the head end of the valve repair device
  • Figure 2a is a schematic view of another simple device of the valve repair device
  • Figure 2b is a cross-sectional view of another simple device head end of the valve repair device
  • FIG. 3 is a schematic view of another mechanical trap for capturing a leaflet and performing a puncture
  • FIG. 4 is a schematic view of the T-type artificial chordae puncture release
  • Figure 5 is a schematic view of the puncture release of the elastic T-type artificial chord
  • Figure 6 is a schematic view showing the release of a single-leaf umbrella-type artificial chord
  • Figure 7 is a schematic view showing the release of the double-leaf-blocking umbrella type artificial chord
  • Figure 8 is a schematic view showing the winding of a single-wire artificial chord
  • Figure 9 is a schematic view showing the winding of a double-wired artificial chord
  • Figure 10 is a schematic view showing the release of a single-wire artificial chord
  • Figure 11 is a schematic view showing the release of a double-wired artificial chordae
  • FIG. 12 is another schematic diagram of winding and release of a single-wire artificial chord
  • Figure 13 is a schematic view of another winding and release of a double-wired artificial chord
  • Figure 14 is a schematic view showing the operating position of the valve repairing device
  • Figure 15 is a schematic view of the artificial chordae after repair.
  • T-type artificial chordae 19.
  • Elastic T-type artificial chord 20 Single-leaf occlusion umbrella artificial ⁇ Cable 21. Upper lobes 22. Lower lobes 23. Slots 24. Ropes; 25. Single-line knot artificial chords 26. Double-line knot artificial chords 27. Stitching pads 28. Apical.
  • the present invention provides a valve repair device, and more particularly to a device for performing mitral or tricuspid valve repair in a minimally invasive manner using an artificial chordae.
  • the vertical delivery path can be microscopically created and the autologous leaflets can be protected from damage during the operation, and the leaflets to be repaired can be accurately positioned and the artificial chordae can be released to reduce the damage of the patient and improve the success rate of the operation.
  • apical puncture into the ventricle using a trap to capture the position of the leaflets that need to be implanted with artificial chordae under ultrasound guidance, and to perform leaflet puncture and release of artificial chordae, the system is withdrawn after ultrasound imaging The length of the artificial chordae is adjusted, and the other end is fixed to the apex to complete the implantation of the artificial chordae.
  • the device can reduce the injury of the intraoperative patient and improve the success rate of the operation.
  • the valve repair device of the present invention may include: a sealing sheath; a trap for capturing and fixing the leaflets at the distal end of the sealing sheath; and a puncture needle for puncturing the leaflets captured by the trap in the sealing sheath A manual chord that can be inserted into the valve with the puncture needle, for repairing the valve, and a handle at the proximal end of the sealing sheath for operating the valve repair device.
  • the sealing sheath may be constructed of a sheath tube that includes an inner tube and an outer tube.
  • One end of the sheath tube may be coupled to the latching valve and the other end may be in communication with the balloon, and a lumen between the inner tube and the outer tube that allows fluid that expands the balloon to pass therethrough.
  • the inner tube and the outer tube may be made of a metal material or a polymer material.
  • the balloon may be a medical butyl rubber, natural rubber or other polymeric material.
  • the trap can be mechanical or negative pressure capture.
  • the trap may be a ring, a claw, a clip or a long tube made of a metal or polymer material.
  • the trap may be in the shape of a long tube whose axis is parallel to the axis of the puncture needle.
  • the artificial chord may be loaded on the outside of the puncture needle or the lumen of the puncture needle.
  • the puncture needle can be said to be a solid or hollow structure.
  • the needle end of the puncture needle may have a barb or tennis structure that prevents the leaflets from falling off after being punctured.
  • the barb or tennis structure may be a recyclable structure that is safely recovered by the trap after the artificial chord is released.
  • the artificial chord may be made of ePTFE, nickel titanium alloy or other polymer materials.
  • the structure of the artificial chord may be T-shaped, single-umbrella, double-umbrella or line-shaped.
  • the handle may have an ejection release device that ejects a puncture needle for leaflet puncture and releases an artificial chord.
  • the ejection release function can be accomplished using any suitable means in the prior art, and there are many such similar structures in the prior art, such as similar structures used in stent mounting devices for interventional procedures and the like.
  • the handle may have a selection device that adjusts the leaflet puncture and releases the artificial chordae in synchronism or stepwise.
  • the ejection release device of the handle is a device that generates an ejection force and a release force by a spring, water pressure or air pressure of a high reluctance coefficient.
  • distal and proximal ends described in this application refer to the distance from the operator.
  • the valve repair device mainly comprises a sealing sheath 1, a trap 2, a puncture needle 3, an artificial chord 4, a handle 5 and the like.
  • the balloon 6 at the tip end of the sealing sheath can inject a gas or a liquid through the interface 7 to form an expanded circular state after the puncture path is established, thereby preventing the valve leaf from being damaged during the operation.
  • the trap 2 can be connected to the negative pressure device through the negative pressure port 8, thereby forming a negative pressure at the head end of the heart portion, and the leaflets floating due to blood flow can be accurately captured under the guidance of an apparatus such as ultrasound.
  • the needle end of the puncture needle 3 has a tennis structure 9 that prevents the leaflets from falling off after puncture, the puncture needle 3 is in the trap 2, and can slide smoothly in the trap 2, and the puncture needle 3 has a connection with the handle 5 and
  • the push rod 10 fixed relative to the position of the puncture needle is used for puncture of the leaflet to release the artificial tendon 4, and the specific structure for realizing the release function can be Use any suitable means in the prior art.
  • the puncture needle 3 can be recovered by the trap 2, and the specific structure for realizing the recovery function can be performed by any suitable means in the prior art.
  • the artificial tendon 4 is fixed relative to the puncture needle 3, and can be inserted into the leaflet with the puncture needle 3 during the puncture.
  • the handle 5 includes an ejection structure, and the button 11 can be pressed after the trap 2 captures the leaflet, so that the puncture needle 3 punctures the leaflet, and the ejection structure of the handle can be a spring, water pressure or air pressure with a high reluctance coefficient.
  • the release button 12 can be adjusted to release the artificial chord 4 by the push rod 10 in an automatic or manual manner.
  • the release structure can be in any suitable manner already disclosed in the prior art and will not be described again.
  • Figures 2a-2b show a schematic view of the other simple device and a cross-sectional view of the head end of the valve repair device.
  • the simple device combines the trap 2 with the sealing sheath 1 , and the head end of the sealing sheath can realize the function of the trap.
  • the air bag 6 at the tip end of the sealing sheath can inject a gas or a liquid through the interface 7 to form an enlarged circle after establishing the puncture path. The shape is thus prevented from injuring the leaflets during surgery.
  • the trap 2 can be connected to the negative pressure device through the negative pressure port 8, thereby forming a negative pressure at the head end of the heart portion, and under the guidance of an apparatus such as ultrasound, the leaflets floating due to blood flow can be accurately captured. After the trap 2 captures the leaflets, the push shaft 13 is manually pushed to effect puncture of the leaflets, and then the pusher 10 is pushed to complete the release of the artificial chordae.
  • Figure 3 is a schematic illustration of another mechanical trap that captures the leaflets and performs a puncture.
  • the trap 2 is contained in the sealing sheath 1 and is slidable along the sealing sheath 1.
  • the two-shaped symmetrical U-shaped jaws 14 can be used to capture the leaflets 15 with the aid of an ultrasonic device or the like, and the U-shaped claws 14 are operated.
  • the position of the operating shaft 16 in parallel is a lumen 17, which is located in the middle of the U-shaped jaw 14, and the puncture needle 3 can pierce the leaflet 15 fixed to the U-shaped jaw 14 along the lumen 17.
  • Figure 4 shows the puncture and release of the T-type artificial chordae.
  • the trap 2 is connected to the negative pressure device through the negative pressure interface 8, and the valve leaf 15 to be implanted with the artificial chord is subjected to vacuum suction capture, and then the leaflet 15 is punctured using the puncture needle 3, and the tennis structure at the head end is punctured. It can prevent the leaflet 15 from falling off after puncture, and then use the push rod 10 to make the T-shaped person
  • the tampon 18 is released from the puncture needle 3, and the puncture needle 3 is recovered using the trap 2 to complete the implantation of the artificial chordae.
  • Figure 5-6 shows the puncture and release of the elastic T-type and single-leaf umbrella artificial chord.
  • the embodiment is the same as the T-type artificial chord 18 described above.
  • the difference is that the elastic T-type artificial chord 19 can be automatically ejected into a T-shape after being released from the puncture needle 3, and the single-leaf clogging artificial chord 20 can be automatically ejected into an umbrella after being released from the puncture needle 3. type.
  • Figure 7 shows the puncture and release of the artificial chordae of the double-leaf occlusion umbrella.
  • the embodiment before the puncture is the same as the T-type artificial chord 18 described above.
  • the puncture needle 3 punctures the leaflet 15
  • the upper stalk 21 is pushed out of the puncture needle by the push rod 10
  • the puncture needle 3 is withdrawn to the leaflet 15
  • the lower slats 22 are then released using the pusher 10 to complete the implantation of the artificial chordae.
  • Figure 8-9 is a schematic diagram of the winding of a single wire knot and a double wire knot artificial chord.
  • a slot 23 for mounting and releasing the artificial chord, and the push rod 10 is sleeved on the outside of the puncture needle 3.
  • Figure 10-11 shows the release of the single-wire and double-wire artificial chordae.
  • the trap 2 is connected to the negative pressure device through the negative pressure interface 8, and the valve leaf 15 that needs to be implanted with the artificial chord is subjected to vacuum suction capture, and then the leaflet 15 is punctured using the puncture needle 3, and the artificial chord is attached to the puncture needle.
  • the puncture needle 3 is evacuated, the position of the push rod 10 is kept unchanged, and the rope 24 of the artificial chord is pulled to form a knot, and the device is evacuated to complete the implantation of the artificial chord.
  • Fig. 12 is a schematic view showing another winding and releasing of a single-wire artificial chord.
  • the prepared single-wire artificial chord 25 is placed in the puncture needle 3, the pusher 10 is below the knot, and the trap 2 is connected to the negative pressure device through the negative pressure interface 8, for the leaflets to be implanted with the artificial chord 15 performs vacuum suction capture, and then punctures the leaflet 15 using the puncture needle 3.
  • the puncture needle 3 is evacuated, the position of the push rod 10 is kept unchanged, and the rope 24 of the artificial chord is pulled to form a knot. The evacuation completes the implantation of the artificial chord.
  • Figure 13 is a schematic view of another winding and release of a double-wired artificial chord.
  • the embodiment is the same as the single-wire knot artificial chord 25 described above. The difference lies in the double-line knot artificial chord 26 After release, it is a double knot.
  • Figure 14 is a schematic view showing the spatial position of the valve leaf during operation of the valve repair device.
  • Figure 15 is a schematic view of the artificial chordae repair after completion.
  • One end of the artificial tendon 4 is fixed to the leaflet 15 and the other end is fixed to the position of the apex 28 by a suture spacer 27.
  • a small incision is made in the proximal apex, for example, between the ribs or near the xiphoid, and the access of the device can be accessed by means of a thoracoscope; or the incision can be made through the abdomen and the septum into the apex, which can be accessed by means of a laparoscopic navigation device. It can also be directly puncture through the xiphoid into the apex.
  • Transesophageal echocardiography (TEE), transthoracic ultrasound (TTE), intracardiac ultrasound (ICE), or cardiac optical direct vision can be used to assess the heart and valve, determine the type and location of the lesion, and select the appropriate surgical procedure.
  • a small incision can be introduced into the laparoscope and thoracoscope to help the surgeon analyze the heart and chest to determine the next surgical approach and method.
  • any suitable path can be chosen to access the heart's chamber to repair the valve and heart, but ideally the apical approach enters the chamber.
  • Figure 14 is a schematic view of the valve repair device after the apex enters the ventricle
  • Figure 4 is a schematic diagram of the artificial chordae release
  • Figure 15 is a schematic diagram of the artificial chordae repair.
  • the purse is made at the apex, the conventional apical puncture is performed, the sealing sheath 1 is implanted into the ventricle, and then the balloon 6 at the tip end of the sealing sheath is filled to prevent damage to the normal leaflets during the operation, and then sealed under the guidance of ultrasound.
  • the sheath 1 has the end of the balloon 6 close to the leaflet 15 to be repaired, and then the capillaries 15 to be repaired are captured using the trap 2, and then the implantation of the artificial chordae is completed as shown in Fig. 4, and the device is withdrawn.
  • the length of the artificial chordae is adjusted under the ultrasound image, and the cord 24 is fixed to the apex 28 by the suture spacer 27, and the implantation of the artificial chordae is completed as shown in FIG.
  • the embodiment is the same as Embodiment 1.
  • the difference is that after the puncture needle 3 punctures the leaflet 15, the upper blade 21 is pushed out of the puncture needle by using the push rod 10, the puncture needle 3 is withdrawn to the leaflet 15, and then the lower umbrella 22 is released by using the push rod 10, and the completion is completed. Implantation of artificial chordae.
  • Figure 14 is a schematic view of the valve repair device after the apex enters the ventricle
  • Figure 10 is a schematic diagram of the artificial chordae release
  • Figure 15 is a schematic diagram of the artificial chordae repair.
  • the purse is made at the apex, the conventional apical puncture is performed, the sealing sheath 1 is implanted into the ventricle, and then the balloon 6 at the tip end of the sealing sheath is filled to prevent damage to the normal leaflets during the operation, and then sealed under the guidance of ultrasound.
  • the sheath 1 has the end of the balloon 6 close to the leaflet 15 to be repaired, and then the capillaries 15 to be repaired are captured using the trap 2, and then the leaflets 15 are pierced using the puncture needle 3, and the puncture needle 3 is completed after the puncture is completed.
  • the evacuation is performed, the position of the push rod 10 is kept unchanged, the rope 24 of the artificial chord is pulled to form a knot, the length of the artificial chord is adjusted under the ultrasonic image after the device is withdrawn, and the rope 24 is fixed to the apex 28 by the suture spacer 27.
  • the implantation of the artificial chordae is completed as shown in FIG.
  • Small incision insertion can be achieved while the heart is beating, repairing damaged leaflets.
  • the position is captured, the leaflet puncture and the artificial chordae are released, the length of the artificial chordae is adjusted under the ultrasound image after the device is withdrawn, and the other end is fixed to the apex to complete the implantation of the artificial chordae.
  • the operation can accurately implant artificial cables with the aid of modern imaging equipment such as thoracoscopy and laparoscopy.
  • the device shortens the operation time, reduces the degree of trauma, reduces the difficulty of surgery and the risk of surgery
  • the present invention provides a valve repair device comprising: a sealing sheath; a trap for capturing and fixing a leaflet at a distal end of the sealing sheath; and being located in the sealing sheath for piercing by the trap a puncture needle of the leaflet; a puncture into the valve with the puncture needle, an artificial chord for repairing the valve; a handle at the proximal end of the sealing sheath for operating the valve repair device.
  • the device of the present invention enables small incision insertion and repair of damaged leaflets while the heart is beating.
  • the position of the leaflets that need to be implanted with the artificial chordae is captured by the use of the trap under ultrasound guidance, the leaflet puncture and the artificial chordae are released, and the device is removed and the artificial sputum is adjusted under the ultrasound image.
  • the length of the cord is fixed at the apex of the other end, and the implantation of the artificial chord is completed.

Abstract

A heart valve repair device comprises: a sealed sheath (1); a catcher (2) located at a distal end of the sealed sheath (1) for catching and fixing a heart valve cusp (15); a puncture needle (3) located in the sealed sheath (1) for puncturing the heart valve cusp (15) caught by the catcher (2); an artificial chordae tendineae (4) capable of puncturing into the heart valve along with the puncture needle (3) and being for repairing the heart valve; and a handle (5) located at a proximal end of the sealed sheath (1) and used to operate the heart valve repair device.

Description

瓣膜修复装置Valve repair device 技术领域Technical field
本发明涉及医疗器械领域技术,尤其是指一种经心尖的瓣膜修复装置。The present invention relates to the field of medical device technology, and more particularly to a transapical valve repair device.
背景技术Background technique
正常的人体心脏有四个腔室,分别是:左心室、左心房、右心室、右心房。左心室与左心房相通,右心室与右心房相通。心脏有四个瓣膜,左心室和左心房间的瓣膜为二尖瓣,右心室和右心房间的瓣为三尖瓣,左心室与主动脉间的瓣为主动脉瓣,右心室与肺动脉间的瓣膜为肺动脉瓣。The normal human heart has four chambers: the left ventricle, the left atrium, the right ventricle, and the right atrium. The left ventricle communicates with the left atrium, and the right ventricle communicates with the right atrium. The heart has four valves. The valves in the left ventricle and left ventricle are mitral valves. The valves in the right ventricle and right ventricle are the tricuspid valve. The valve between the left ventricle and the aorta is the aortic valve. The right ventricle and the pulmonary artery. The valve is the pulmonary valve.
二尖瓣和三间瓣一般有2-3个瓣叶,瓣叶末端是瓣环,瓣叶由腱索固定于乳头肌上。The mitral valve and the three valves generally have 2-3 leaflets, the end of the leaflet is an annulus, and the leaflets are fixed by the tendon to the papillary muscle.
正常的瓣膜可保障血液单向顺畅流动,能有效将腔室的血液泵出而不回流。很多种疾病,如风湿性心脏病,心内膜炎引起瓣膜的病变使瓣膜的功能受到损害,狭窄和返流是常见的瓣膜性疾病。狭窄是由于瓣膜不能完全打开,导致血流受阻,瓣叶的钙化导致的增厚是引起狭窄的常见原因。返流是由于瓣叶不能完全关闭,导致血液回流到泵血的腔室,瓣环扩张、瓣叶脱垂、瓣叶活动受阻是引起返流的主要原因。The normal valve ensures smooth flow of blood in one direction and effectively pumps the blood out of the chamber without reflow. In many diseases, such as rheumatic heart disease, endocarditis causes lesions in the valve that impair the function of the valve. Stenosis and reflux are common valvular diseases. Stenosis is due to the inability of the valve to open completely, resulting in impeded blood flow, and thickening caused by calcification of the leaflets is a common cause of stenosis. The reflux is due to the inability of the valve leaf to close completely, causing blood to flow back to the chamber where the blood is pumped. The expansion of the annulus, prolapse of the leaflet, and obstruction of the leaflet movement are the main causes of reflux.
瓣膜性疾病中,狭窄常出现在主动脉瓣膜和肺动脉瓣膜,而二尖瓣和三尖瓣更多的出现返流。狭窄和返流同时出现会大大增加心脏的负担,会导致严重的后果。In valvular disease, stenosis often occurs in the aortic valve and pulmonary valve, while the mitral and tricuspid valves are more likely to regulate. The simultaneous presence of stenosis and reflux can greatly increase the burden on the heart and can lead to serious consequences.
瓣膜性疾病的治疗方案有两种:更换或修复。There are two treatment options for valvular disease: replacement or repair.
对于主动脉瓣和肺动脉瓣的狭窄,由于瓣叶的狭窄损害没法修复,因此传统的治疗方式是用生物瓣膜或机械瓣膜进行更换;相对 于瓣膜修复,更换瓣膜存在死亡率高、瓣膜使用寿命有限、终生抗凝等缺点,因此,二尖瓣和三间瓣膜更多的采用修复的方式治疗。传统的瓣膜修复术要行开胸术,要建立体外循环使心脏停跳,需要大量的人力配合,对术者的要求极高,手术极为复杂,例如在瓣膜修复术中,常常需要切除脱垂部分,行瓣环成形术,或植入人工腱索,有时候这些方法需要综合使用,给术者带来了极大的挑战。心脏停跳需要借助心肺机建立体外循环,容易引起并发症,例如中风、心肌顿抑、肺功能下降等。由于手术是在心脏停跳完成的,因此很难估计植入的人工腱索的长短,植入人工腱索过长或过短会使病情恶化,术者只能凭经验来判断植入人工腱索的长短,这给术者带来极大的挑战。For the stenosis of the aortic valve and pulmonary valve, because the stenosis of the leaflets can not be repaired, the traditional treatment is to replace with a biological valve or mechanical valve; In valve repair, replacement of the valve has the disadvantages of high mortality, limited valve life, and anticoagulation throughout life. Therefore, the mitral valve and the three valves are more treated with repair. Traditional valvular surgery requires thoracotomy. It is necessary to establish extracorporeal circulation to stop the heart. It requires a lot of manpower coordination. The requirements of the surgeon are extremely high. The operation is extremely complicated. For example, in valve repair, it is often necessary to remove prolapse. Part of the annuloplasty, or the implantation of artificial chordae, sometimes these methods need to be combined, posing a great challenge for the surgeon. Cardiac arrest requires the use of a cardiopulmonary machine to establish extracorporeal circulation, which is prone to complications such as stroke, myocardial stunning, and decreased lung function. Because the operation is stopped at the heart, it is difficult to estimate the length of the artificial chordae implanted. If the artificial chord is too long or too short, the condition will deteriorate. The surgeon can only judge the implantation of artificial sputum by experience. The length of the cable, which brings great challenges to the surgeon.
二尖瓣直视成形术及人工瓣膜置换术是治疗二尖瓣关闭不全的最有效方法,但是由于手术需要体外循环技术支持,给病人带来的创伤较大,对于高龄患者和较多合并症患者,死亡率和并发症很高,近年来,经皮二尖瓣修复术的发展较为快速,主要有介入瓣环成形术、负压抽吸缝合技术及二尖瓣钳夹术,其中MitraClip的疗效最为可靠,在临床上推广较快,其方式是通过房间隔穿刺将一个可以植入的夹子送至二尖瓣附近,将前后瓣叶的游离边缘夹持固定,使瓣叶在收缩末期对和良好,减少返流。Mitral valvuloplasty and prosthetic valve replacement are the most effective methods for the treatment of mitral regurgitation, but because the surgery requires extracorporeal circulation technical support, the trauma caused by the patient is greater, for older patients and more comorbidities Patients, mortality and complications are very high. In recent years, the development of percutaneous mitral valve repair has been rapid, mainly involving interventional annuloplasty, vacuum aspiration suture technique and mitral valve clamping, among which MitraClip The curative effect is the most reliable, and it is promoted rapidly in the clinic. The method is to send an implantable clip to the vicinity of the mitral valve through the interatrial septum puncture, and fix the free edge of the anterior and posterior leaflets so that the leaflets are at the end of the systole. And good, reduce backflow.
MitraClip存在的问题如下:从股动脉经过长鞘管介入,操作困难,手术时间长;由于手术中采用大尺寸鞘管,术后可能残留房间隔残余漏;将二尖瓣口由单孔变成双孔,会导致二尖瓣瓣口面积缩小;将脱垂瓣膜和健康瓣膜固定在一起,有可能引起健康瓣膜健索张力的改变,加速其退化。The problems with MitraClip are as follows: from the femoral artery through the long sheath tube, the operation is difficult, the operation time is long; due to the use of large-sized sheath in the operation, the residual space of the interatrial septum may remain after surgery; the mitral valve mouth is changed from a single hole Double holes can lead to a reduction in the area of the mitral valve; fixing the prolapse valve and the healthy valve together may cause changes in the tension of the healthy valve and accelerate its degradation.
迫切需要一种微创的心脏不停跳的手术方法和装置来完成瓣膜的修复,该过程可容易测算植入的人工腱索的长短,可降低对术者手术强度和难度。There is an urgent need for a minimally invasive cardiac surgery method and device to complete the repair of the valve, which can easily measure the length of the implanted artificial chordae, which can reduce the surgical strength and difficulty of the surgeon.
为了解决上述问题,本发明提供了一种微创的人工健索植入装 置。该装置可以微创的方式植入人工腱索,对二尖瓣或三尖瓣进行修复。该装置的特点是在心脏不停跳完成手术,该手术可以借助现代影像设备如胸腔镜、腹腔镜的导航功能准确的植入人工健索。该装置缩短了手术时间,降低创伤程度,降低了手术难度和手术风险。In order to solve the above problems, the present invention provides a minimally invasive artificial wire implant device. Set. The device can be implanted in a minimally invasive manner to repair the mitral or tricuspid valve. The device is characterized by a beating heart in the heart, which can be accurately implanted with artificial imaging equipment by means of modern imaging equipment such as thoracoscopy and laparoscopy. The device shortens the operation time, reduces the degree of trauma, and reduces the difficulty of surgery and the risk of surgery.
发明内容Summary of the invention
(一)要解决的技术问题(1) Technical problems to be solved
本发明的目的是提供一种瓣膜修复装置,该装置缩短了手术时间,降低创伤程度,降低了手术难度和手术风险。It is an object of the present invention to provide a valve repair device that reduces the time of surgery, reduces the degree of trauma, and reduces the difficulty of surgery and the risk of surgery.
(二)技术方案(2) Technical plan
为了解决上述技术问题,本发明提供一种瓣膜修复装置,其中,该瓣膜修复装置包括:密封鞘;位于密封鞘远端的用于捕捉、固定瓣叶的捕捉器;位于所述密封鞘内用于穿刺被所述捕捉器捕捉的瓣叶的穿刺针;可随所述穿刺针穿刺进瓣膜、用于修复瓣膜的人工腱索;位于所述密封鞘近端、用于操作所述瓣膜修复装置的动作的手柄。In order to solve the above technical problem, the present invention provides a valve repair apparatus, wherein the valve repair apparatus includes: a sealing sheath; a trap for capturing and fixing the leaflets at the distal end of the sealing sheath; and is located in the sealing sheath a puncture needle for puncturing a leaflet captured by the trap; a puncture needle penetrating into the valve, an artificial chord for repairing the valve; and a proximal end of the sealing sheath for operating the valve repair device The handle of the action.
优选,围绕所述密封鞘的远端有气囊。Preferably, there is a balloon around the distal end of the sealing sheath.
优选,所述密封鞘由鞘管构成,所述鞘管包括内管和外管。Preferably, the sealing sheath is comprised of a sheath tube comprising an inner tube and an outer tube.
优选,所述鞘管的一端与闭锁阀门连接,另一端与所述气囊相通,所述的内管和外管之间具有允许使得所述气囊膨胀的流体通过的腔隙。Preferably, one end of the sheath tube is coupled to the latching valve and the other end is in communication with the balloon, and a lumen is provided between the inner tube and the outer tube that allows fluid that causes the balloon to expand.
优选,所述内管和外管由金属材料或高分子材料制成。Preferably, the inner tube and the outer tube are made of a metal material or a polymer material.
优选,所述气囊为医用丁基橡胶、天然橡胶或其他高分子材料。Preferably, the balloon is a medical butyl rubber, natural rubber or other polymeric material.
优选,所述捕捉器为机械捕捉或负压捕捉。Preferably, the trap is mechanical capture or negative pressure capture.
优选,所述捕捉器为使用金属或高分子材料制成的圈、爪、夹或长管。Preferably, the trap is a ring, a claw, a clip or a long tube made of a metal or polymer material.
优选,所述捕捉器为长管的形状,该长管的轴与穿刺针的轴平行。Preferably, the trap is in the shape of a long tube whose axis is parallel to the axis of the puncture needle.
优选,所述人工腱索装载在所述穿刺针的外侧或所述穿刺针的内腔。 Preferably, the artificial chordae are loaded on the outside of the puncture needle or in the lumen of the puncture needle.
优选,所述穿刺针的针头端具有防止瓣叶被穿刺后脱落的倒刺或网球结构。Preferably, the needle end of the puncture needle has a barb or tennis structure that prevents the leaflets from falling off after being punctured.
优选,所述的倒刺或网球结构为在所述人工腱索被释放后通过所述捕捉器进行安全回收的可回收结构。Preferably, the barb or tennis structure is a recyclable structure that is safely recovered by the trap after the artificial chord is released.
优选,所述人工腱索由ePTFE、镍钛合金或其他高分子材料制成。Preferably, the artificial chordae is made of ePTFE, nickel titanium alloy or other polymeric material.
优选,所述人工腱索的结构为T型、单伞形、双伞形或线结形。Preferably, the structure of the artificial chordae is T-shaped, single-umbrella, double-umbrella or line-shaped.
优选,所述手柄具有弹射穿刺针进行瓣叶穿刺及释放人工腱索的弹射释放装置。Preferably, the handle has an ejection release device that ejects a puncture needle for leaflet puncture and releases an artificial chord.
优选,所述手柄具有调节瓣叶穿刺与释放人工腱索为同步进行或分步进行的选择装置。Preferably, the handle has a selection device for adjusting the leaflet puncture and releasing the artificial chord for simultaneous or stepwise.
优选,所述手柄的弹射释放装置为通过高倔强系数的弹簧、水压或气压产生弹射力和释放力的装置。Preferably, the ejection release means of the handle is a device that generates an ejection force and a release force by a spring, water pressure or air pressure of a high reluctance coefficient.
(三)有益效果(3) Beneficial effects
本发明的瓣膜修复装置的优点是可在心脏不停跳下实现小切口插入,修复损坏的瓣叶。通过心尖穿刺进入心室,在超声导航下使用捕捉器对需要植入人工腱索的瓣叶位置进行捕捉,进行瓣叶穿刺及人工腱索的释放,将装置撤出后在超声影像下调整人工腱索的长短,将另一头固定于心尖,完成人工腱索的植入。The valve repair device of the present invention has the advantage of enabling small incision insertion and repairing damaged leaflets while the heart is beating. Through the apical puncture into the ventricle, the position of the leaflets that need to be implanted with the artificial chordae is captured by the use of the trap under ultrasound guidance, the leaflet puncture and the artificial chordae are released, and the device is removed and the artificial sputum is adjusted under the ultrasound image. The length of the cord is fixed at the apex of the other end, and the implantation of the artificial chord is completed.
附图说明DRAWINGS
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍。显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments or the prior art description will be briefly described below. Obviously, the drawings in the following description are only some embodiments of the present invention, and those skilled in the art can obtain other drawings according to the drawings without any creative work.
图1a为瓣膜修复装置的总装图;Figure 1a is a general assembly diagram of the valve repair device;
图1b为瓣膜修复装置头端剖视图;Figure 1b is a cross-sectional view of the head end of the valve repair device;
图2a为瓣膜修复装置的另一种简易装置总装图; Figure 2a is a schematic view of another simple device of the valve repair device;
图2b为瓣膜修复装置的另一种简易装置头端剖视图;Figure 2b is a cross-sectional view of another simple device head end of the valve repair device;
图3为另一种机械捕捉器捕捉瓣叶并进行穿刺示意图;3 is a schematic view of another mechanical trap for capturing a leaflet and performing a puncture;
图4为T型人工腱索穿刺释放示意图;Figure 4 is a schematic view of the T-type artificial chordae puncture release;
图5为弹性T型人工腱索穿刺释放示意图;Figure 5 is a schematic view of the puncture release of the elastic T-type artificial chord;
图6为单叶封堵伞型人工腱索释放示意图;Figure 6 is a schematic view showing the release of a single-leaf umbrella-type artificial chord;
图7为双叶封堵伞型人工腱索释放示意图;Figure 7 is a schematic view showing the release of the double-leaf-blocking umbrella type artificial chord;
图8为单线结人工腱索的绕线示意图;Figure 8 is a schematic view showing the winding of a single-wire artificial chord;
图9为双线结人工腱索的绕线示意图;Figure 9 is a schematic view showing the winding of a double-wired artificial chord;
图10为单线结人工腱索的释放示意图;Figure 10 is a schematic view showing the release of a single-wire artificial chord;
图11为双线结人工腱索的释放示意图;Figure 11 is a schematic view showing the release of a double-wired artificial chordae;
图12为单线结人工腱索的另一种绕线及释放示意图;12 is another schematic diagram of winding and release of a single-wire artificial chord;
图13为双线结人工腱索的另一种绕线及释放示意图;Figure 13 is a schematic view of another winding and release of a double-wired artificial chord;
图14为瓣膜修复装置操作位置示意图;Figure 14 is a schematic view showing the operating position of the valve repairing device;
图15为人工腱索修复完后示意图。Figure 15 is a schematic view of the artificial chordae after repair.
附图中的标记如下:1.密封鞘 2.捕捉器 3.穿刺针 4.人工腱索 5.手柄 6.气囊 7.接口 8.负压接口 9.网球结构 10.推杆;11.按键 12.释放按键 13.推轴 14.U型爪 15.瓣叶 16.操作轴 17.管腔 18.T型人工腱索;19.弹性T型人工腱索 20.单叶封堵伞人工腱索 21.上伞叶 22.下伞叶 23.开槽 24.绳索;25.单线结人工腱索 26.双线结人工腱索 27.缝合垫片 28.心尖。The markings in the drawing are as follows: 1. Sealing sheath 2. Capturer 3. Puncture needle 4. Artificial chord 5. Handle 6. Airbag 7. Interface 8. Negative pressure interface 9. Tennis structure 10. Push rod; 12. Release button 13. Push shaft 14. U-shaped claw 15. Leaf blade 16. Operation shaft 17. Tube cavity 18. T-type artificial chordae; 19. Elastic T-type artificial chord 20. Single-leaf occlusion umbrella artificial 腱Cable 21. Upper lobes 22. Lower lobes 23. Slots 24. Ropes; 25. Single-line knot artificial chords 26. Double-line knot artificial chords 27. Stitching pads 28. Apical.
具体实施方式detailed description
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。The specific embodiments of the present invention are further described in detail below with reference to the drawings and embodiments. The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.
本发明提供一种瓣膜修复装置,更确切地说提供一种利用人工腱索以微创的方式实施二尖瓣或三尖瓣修复的装置。可微创建立输送通路并保护自体瓣叶在术中不受损伤,同时可对需修复的瓣叶进行精确定位并释放人工腱索,降低患者损伤并提高手术成功率。The present invention provides a valve repair device, and more particularly to a device for performing mitral or tricuspid valve repair in a minimally invasive manner using an artificial chordae. The vertical delivery path can be microscopically created and the autologous leaflets can be protected from damage during the operation, and the leaflets to be repaired can be accurately positioned and the artificial chordae can be released to reduce the damage of the patient and improve the success rate of the operation.
本发明的目的在于提供一种瓣膜修复装置可在心脏不停跳的情 况下,通过心尖穿刺进入心室,在超声导航下使用捕捉器对需要植入人工腱索的瓣叶位置进行捕捉,并进行瓣叶穿刺及人工腱索的释放,将系统撤出后在超声影像下调整人工腱索的长短,将另一头固定于心尖,完成人工腱索的植入,该装置可降低术中患者的损伤并提高手术成功率。It is an object of the present invention to provide a valve repair device that can be kept in the heart. In the case of apical puncture into the ventricle, using a trap to capture the position of the leaflets that need to be implanted with artificial chordae under ultrasound guidance, and to perform leaflet puncture and release of artificial chordae, the system is withdrawn after ultrasound imaging The length of the artificial chordae is adjusted, and the other end is fixed to the apex to complete the implantation of the artificial chordae. The device can reduce the injury of the intraoperative patient and improve the success rate of the operation.
本发明的瓣膜修复装置可以包括:密封鞘;位于密封鞘远端的用于捕捉、固定瓣叶的捕捉器;位于所述密封鞘内用于穿刺被所述捕捉器捕捉的瓣叶的穿刺针;可随所述穿刺针穿刺进瓣膜、用于修复瓣膜的人工腱索;位于所述密封鞘近端、用于操作所述瓣膜修复装置的动作的手柄。The valve repair device of the present invention may include: a sealing sheath; a trap for capturing and fixing the leaflets at the distal end of the sealing sheath; and a puncture needle for puncturing the leaflets captured by the trap in the sealing sheath A manual chord that can be inserted into the valve with the puncture needle, for repairing the valve, and a handle at the proximal end of the sealing sheath for operating the valve repair device.
围绕所述密封鞘的远端可以有气囊。There may be a balloon around the distal end of the sealing sheath.
所述密封鞘可以由鞘管构成,所述鞘管包括内管和外管。The sealing sheath may be constructed of a sheath tube that includes an inner tube and an outer tube.
所述鞘管的一端可以与闭锁阀门连接,另一端与所述气囊相通,所述的内管和外管之间具有允许使得所述气囊膨胀的流体通过的腔隙。One end of the sheath tube may be coupled to the latching valve and the other end may be in communication with the balloon, and a lumen between the inner tube and the outer tube that allows fluid that expands the balloon to pass therethrough.
所述内管和外管可以由金属材料或高分子材料制成。The inner tube and the outer tube may be made of a metal material or a polymer material.
所述气囊可以为医用丁基橡胶、天然橡胶或其他高分子材料。The balloon may be a medical butyl rubber, natural rubber or other polymeric material.
所述捕捉器可以为机械捕捉或负压捕捉。The trap can be mechanical or negative pressure capture.
所述捕捉器可以为使用金属或高分子材料制成的圈、爪、夹或长管。The trap may be a ring, a claw, a clip or a long tube made of a metal or polymer material.
所述捕捉器可以为长管的形状,该长管的轴与穿刺针的轴平行。The trap may be in the shape of a long tube whose axis is parallel to the axis of the puncture needle.
所述人工腱索可以装载在所述穿刺针的外侧或所述穿刺针的内腔。穿刺针可以说实心或者空心的结构。The artificial chord may be loaded on the outside of the puncture needle or the lumen of the puncture needle. The puncture needle can be said to be a solid or hollow structure.
所述穿刺针的针头端可以具有防止瓣叶被穿刺后脱落的倒刺或网球结构。The needle end of the puncture needle may have a barb or tennis structure that prevents the leaflets from falling off after being punctured.
所述的倒刺或网球结构可以为在所述人工腱索被释放后通过所述捕捉器进行安全回收的可回收结构。 The barb or tennis structure may be a recyclable structure that is safely recovered by the trap after the artificial chord is released.
所述人工腱索可以由ePTFE、镍钛合金或其他高分子材料制成。The artificial chord may be made of ePTFE, nickel titanium alloy or other polymer materials.
所述人工腱索的结构可以为T型、单伞形、双伞形或线结形。The structure of the artificial chord may be T-shaped, single-umbrella, double-umbrella or line-shaped.
所述手柄可以具有弹射穿刺针进行瓣叶穿刺及释放人工腱索的弹射释放装置。The handle may have an ejection release device that ejects a puncture needle for leaflet puncture and releases an artificial chord.
该弹射释放的功能可以使用现有技术中任何合适的方式来实现,在现有技术中有很多这样的类似结构,比如用于介入治疗的支架安装装置等中使用的类似结构。The ejection release function can be accomplished using any suitable means in the prior art, and there are many such similar structures in the prior art, such as similar structures used in stent mounting devices for interventional procedures and the like.
所述手柄可以具有调节瓣叶穿刺与释放人工腱索为同步进行或分步进行的选择装置。The handle may have a selection device that adjusts the leaflet puncture and releases the artificial chordae in synchronism or stepwise.
所述手柄的弹射释放装置为通过高倔强系数的弹簧、水压或气压产生弹射力和释放力的装置。The ejection release device of the handle is a device that generates an ejection force and a release force by a spring, water pressure or air pressure of a high reluctance coefficient.
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。The technical solutions in the embodiments of the present invention are clearly and completely described in the following with reference to the accompanying drawings in the embodiments of the present invention. It is obvious that the described embodiments are only a part of the embodiments of the present invention, but not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative efforts are within the scope of the present invention.
本申请中所述的远端和近端指相对于操作者的距离远近而定。The distal and proximal ends described in this application refer to the distance from the operator.
请参阅图1a-1b,其给出了瓣膜修复装置的总装图及头端剖面图。瓣膜修复装置主要包括密封鞘1、捕捉器2、穿刺针3、人工腱索4、手柄5等。密封鞘1头端的气囊6可在建立穿刺通路后通过接口7注入气体或液体形成膨大圆形状态,从而防止术中损伤瓣叶。捕捉器2可通过负压接口8连接负压设备,从而在进入心脏部分的头端形成负压,在超声等设备的引导下可对因血液流动而漂浮的瓣叶进行精确捕捉。穿刺针3的针头端具有防止瓣叶穿刺后脱落的网球结构9,穿刺针3在捕捉器2中,并可在捕捉器2中顺畅滑动,且穿刺针3中具有与手柄5相连且与在穿刺过程中相对穿刺针位置固定的推杆10用于穿刺瓣叶后进行人工腱索4的释放,实现释放功能的具体结构可以使 用现有技术中任何合适的方式。人工腱索4释放后可通过捕捉器2对穿刺针3进行回收,实现回收功能的具体结构可以使用现有技术中的任何合适的方式。人工腱索4相对于穿刺针3固定,穿刺过程中可随穿刺针3穿刺进瓣叶中。手柄5包括弹射结构,可在捕捉器2捕捉到瓣叶后按动按键11,使穿刺针3对瓣叶进行穿刺,所述手柄的弹射结构可以为通过高倔强系数的弹簧、水压或气压产生弹射力和释放力的装置。这样的结构在现有技术中是公知的,不再赘述。Please refer to Figures 1a-1b for a general assembly view and a cross-sectional view of the head end of the valve repair device. The valve repair device mainly comprises a sealing sheath 1, a trap 2, a puncture needle 3, an artificial chord 4, a handle 5 and the like. The balloon 6 at the tip end of the sealing sheath can inject a gas or a liquid through the interface 7 to form an expanded circular state after the puncture path is established, thereby preventing the valve leaf from being damaged during the operation. The trap 2 can be connected to the negative pressure device through the negative pressure port 8, thereby forming a negative pressure at the head end of the heart portion, and the leaflets floating due to blood flow can be accurately captured under the guidance of an apparatus such as ultrasound. The needle end of the puncture needle 3 has a tennis structure 9 that prevents the leaflets from falling off after puncture, the puncture needle 3 is in the trap 2, and can slide smoothly in the trap 2, and the puncture needle 3 has a connection with the handle 5 and During the puncture, the push rod 10 fixed relative to the position of the puncture needle is used for puncture of the leaflet to release the artificial tendon 4, and the specific structure for realizing the release function can be Use any suitable means in the prior art. After the artificial chordae 4 is released, the puncture needle 3 can be recovered by the trap 2, and the specific structure for realizing the recovery function can be performed by any suitable means in the prior art. The artificial tendon 4 is fixed relative to the puncture needle 3, and can be inserted into the leaflet with the puncture needle 3 during the puncture. The handle 5 includes an ejection structure, and the button 11 can be pressed after the trap 2 captures the leaflet, so that the puncture needle 3 punctures the leaflet, and the ejection structure of the handle can be a spring, water pressure or air pressure with a high reluctance coefficient. A device that produces ejection and release forces. Such a structure is well known in the prior art and will not be described again.
释放按键12可调节自动或手动方式通过推杆10对人工腱索4进行释放。释放结构可以采用现有技术中已经公开的任何合适的方式,不再赘述。The release button 12 can be adjusted to release the artificial chord 4 by the push rod 10 in an automatic or manual manner. The release structure can be in any suitable manner already disclosed in the prior art and will not be described again.
图2a-2b给出了瓣膜修复装置的另一种简易装置总装图及头端剖面图。该简易装置将捕捉器2与密封鞘1结合在一起,密封鞘的头端可实现捕捉器的功能,密封鞘1头端的气囊6可在建立穿刺通路后通过接口7注入气体或液体形成膨大圆形状态从而防止术中损伤瓣叶。捕捉器2可通过负压接口8连接负压设备,从而在进入心脏部分的头端形成负压,在超声等设备的引导下,可对因血液流动而漂浮的瓣叶进行精确捕捉。在捕捉器2捕捉到瓣叶后手动按动推轴13实现对瓣叶的穿刺,然后推动推杆10完成人工腱索的释放。Figures 2a-2b show a schematic view of the other simple device and a cross-sectional view of the head end of the valve repair device. The simple device combines the trap 2 with the sealing sheath 1 , and the head end of the sealing sheath can realize the function of the trap. The air bag 6 at the tip end of the sealing sheath can inject a gas or a liquid through the interface 7 to form an enlarged circle after establishing the puncture path. The shape is thus prevented from injuring the leaflets during surgery. The trap 2 can be connected to the negative pressure device through the negative pressure port 8, thereby forming a negative pressure at the head end of the heart portion, and under the guidance of an apparatus such as ultrasound, the leaflets floating due to blood flow can be accurately captured. After the trap 2 captures the leaflets, the push shaft 13 is manually pushed to effect puncture of the leaflets, and then the pusher 10 is pushed to complete the release of the artificial chordae.
图3为另一种机械捕捉器捕捉瓣叶并进行穿刺的示意图。捕捉器2包含在密封鞘1中,且可沿密封鞘1顺畅滑动,在超声等设备的辅助下可使用上下对称的两个U型爪14对瓣叶15进行捕捉,与操作U型爪14的操作轴16平行的位置有管腔17,其位于U型爪14的中间,穿刺针3可沿管腔17对U型爪14固定的瓣叶15进行穿刺。Figure 3 is a schematic illustration of another mechanical trap that captures the leaflets and performs a puncture. The trap 2 is contained in the sealing sheath 1 and is slidable along the sealing sheath 1. The two-shaped symmetrical U-shaped jaws 14 can be used to capture the leaflets 15 with the aid of an ultrasonic device or the like, and the U-shaped claws 14 are operated. The position of the operating shaft 16 in parallel is a lumen 17, which is located in the middle of the U-shaped jaw 14, and the puncture needle 3 can pierce the leaflet 15 fixed to the U-shaped jaw 14 along the lumen 17.
图4给出了T型人工腱索的穿刺及释放示意图。将捕捉器2通过负压接口8连接负压设备,对需要植入人工腱索的瓣叶15进行负压吸附捕捉,然后使用穿刺针3对瓣叶15进行穿刺,穿刺中头端的网球结构9可以防止穿刺后瓣叶15的脱落,然后使用推杆10将T型人 工腱索18从穿刺针3中释放出来,使用捕捉器2对穿刺针3进行回收,完成人工腱索的植入。Figure 4 shows the puncture and release of the T-type artificial chordae. The trap 2 is connected to the negative pressure device through the negative pressure interface 8, and the valve leaf 15 to be implanted with the artificial chord is subjected to vacuum suction capture, and then the leaflet 15 is punctured using the puncture needle 3, and the tennis structure at the head end is punctured. It can prevent the leaflet 15 from falling off after puncture, and then use the push rod 10 to make the T-shaped person The tampon 18 is released from the puncture needle 3, and the puncture needle 3 is recovered using the trap 2 to complete the implantation of the artificial chordae.
图5-6给出了弹性T型和单叶封堵伞人工腱索的穿刺及释放示意图。其实施方式与上述T型人工腱索18相同。不同之处在于弹性T型人工腱索19在从穿刺针3中释放出来后可自动弹成T型,单叶封堵伞人工腱索20在从穿刺针3中释放出来后可自动弹成伞型。Figure 5-6 shows the puncture and release of the elastic T-type and single-leaf umbrella artificial chord. The embodiment is the same as the T-type artificial chord 18 described above. The difference is that the elastic T-type artificial chord 19 can be automatically ejected into a T-shape after being released from the puncture needle 3, and the single-leaf clogging artificial chord 20 can be automatically ejected into an umbrella after being released from the puncture needle 3. type.
图7给出了双叶封堵伞人工腱索的穿刺及释放示意图。其在穿刺前的实施方式与上述T型人工腱索18相同,穿刺针3穿刺瓣叶15后使用推杆10将其上伞叶21推出穿刺针,后撤穿刺针3到瓣叶15下,然后使用推杆10将下伞叶22释放,完成人工腱索的植入。Figure 7 shows the puncture and release of the artificial chordae of the double-leaf occlusion umbrella. The embodiment before the puncture is the same as the T-type artificial chord 18 described above. After the puncture needle 3 punctures the leaflet 15, the upper stalk 21 is pushed out of the puncture needle by the push rod 10, and the puncture needle 3 is withdrawn to the leaflet 15 The lower slats 22 are then released using the pusher 10 to complete the implantation of the artificial chordae.
图8-9为单线结和双线结人工腱索的绕线示意图。穿刺针的中间有一个开槽23用于安装和释放人工腱索,推杆10套在穿刺针3的外侧。Figure 8-9 is a schematic diagram of the winding of a single wire knot and a double wire knot artificial chord. In the middle of the puncture needle, there is a slot 23 for mounting and releasing the artificial chord, and the push rod 10 is sleeved on the outside of the puncture needle 3.
图10-11为单线结和双线结人工腱索的释放示意图。将捕捉器2通过负压接口8连接负压设备,对需要植入人工腱索的瓣叶15进行负压吸附捕捉,然后使用穿刺针3对瓣叶15进行穿刺,人工腱索附着在穿刺针3上,完成穿刺后将穿刺针3撤离,保持推杆10的位置不变,拉动人工腱索的绳索24形成线结,将装置撤离完成人工腱索的植入。Figure 10-11 shows the release of the single-wire and double-wire artificial chordae. The trap 2 is connected to the negative pressure device through the negative pressure interface 8, and the valve leaf 15 that needs to be implanted with the artificial chord is subjected to vacuum suction capture, and then the leaflet 15 is punctured using the puncture needle 3, and the artificial chord is attached to the puncture needle. 3, after the puncture is completed, the puncture needle 3 is evacuated, the position of the push rod 10 is kept unchanged, and the rope 24 of the artificial chord is pulled to form a knot, and the device is evacuated to complete the implantation of the artificial chord.
图12为单线结人工腱索的另一种绕线及释放示意图。将编制好的单线结人工腱索25置入穿刺针3中,线结的下方为推杆10,将捕捉器2通过负压接口8连接负压设备,对需要植入人工腱索的瓣叶15进行负压吸附捕捉,然后使用穿刺针3对瓣叶15进行穿刺,完成穿刺后将穿刺针3撤离,保持推杆10的位置不变,拉动人工腱索的绳索24形成线结,将装置撤离完成人工腱索的植入。Fig. 12 is a schematic view showing another winding and releasing of a single-wire artificial chord. The prepared single-wire artificial chord 25 is placed in the puncture needle 3, the pusher 10 is below the knot, and the trap 2 is connected to the negative pressure device through the negative pressure interface 8, for the leaflets to be implanted with the artificial chord 15 performs vacuum suction capture, and then punctures the leaflet 15 using the puncture needle 3. After the puncture is completed, the puncture needle 3 is evacuated, the position of the push rod 10 is kept unchanged, and the rope 24 of the artificial chord is pulled to form a knot. The evacuation completes the implantation of the artificial chord.
图13为双线结人工腱索的另一种绕线及释放示意图。其实施方式与上述单线结人工腱索25相同。不同之处在于双线结人工腱索26 释放后为双线结。Figure 13 is a schematic view of another winding and release of a double-wired artificial chord. The embodiment is the same as the single-wire knot artificial chord 25 described above. The difference lies in the double-line knot artificial chord 26 After release, it is a double knot.
图14为瓣膜修复装置操作过程中与瓣叶空间位置示意图。Figure 14 is a schematic view showing the spatial position of the valve leaf during operation of the valve repair device.
图15为人工腱索修复完成后的示意图。人工腱索4的一端固定在瓣叶15上,另一端通过缝合垫片27固定在心尖28的位置。Figure 15 is a schematic view of the artificial chordae repair after completion. One end of the artificial tendon 4 is fixed to the leaflet 15 and the other end is fixed to the position of the apex 28 by a suture spacer 27.
在近心尖的部位做小切口,例如在肋骨间或剑突附近,可借助胸腔镜来导航装置的进入;也可经腹和隔膜做切口进入心尖,可借助腹腔镜导航装置进入。也可经剑突直接穿刺进入心尖。经食道心脏超声(TEE),经胸腔超声(TTE),心内超声(ICE),或心脏光学直视的方法可用来评估心脏及瓣膜,判断病变的类型和位置,从而选择适当的手术过程。如若需要,可做小切口导入腹腔镜和胸腔镜,可帮助术者对心脏和胸腔进行分析,以决定下一步的手术途径和方法。借助超声导航,可以选取任何合适的路径进入心脏的腔室修复瓣膜和心脏,但是最理想的是经心尖的途径进入腔室。A small incision is made in the proximal apex, for example, between the ribs or near the xiphoid, and the access of the device can be accessed by means of a thoracoscope; or the incision can be made through the abdomen and the septum into the apex, which can be accessed by means of a laparoscopic navigation device. It can also be directly puncture through the xiphoid into the apex. Transesophageal echocardiography (TEE), transthoracic ultrasound (TTE), intracardiac ultrasound (ICE), or cardiac optical direct vision can be used to assess the heart and valve, determine the type and location of the lesion, and select the appropriate surgical procedure. If necessary, a small incision can be introduced into the laparoscope and thoracoscope to help the surgeon analyze the heart and chest to determine the next surgical approach and method. With ultrasound navigation, any suitable path can be chosen to access the heart's chamber to repair the valve and heart, but ideally the apical approach enters the chamber.
实施例1:Example 1:
参见图14、4、15,图14为瓣膜修复装置经心尖进入心室后对瓣叶进行捕捉示意图,图4为人工腱索进行释放示意图,图15为人工腱索修复完成示意图。Referring to Figures 14, 4, and 15, Figure 14 is a schematic view of the valve repair device after the apex enters the ventricle, Figure 4 is a schematic diagram of the artificial chordae release, and Figure 15 is a schematic diagram of the artificial chordae repair.
在心尖做荷包,进行常规心尖穿刺,将密封鞘1植入心室内,然后对密封鞘1头端的气囊6进行充盈,防止在操作过程中损伤到正常瓣叶,然后在超声的引导下使密封鞘1具有气囊6的那端接近需要修复的瓣叶15,然后使用捕捉器2对需要修复的瓣叶15进行捕捉,然后按照图4所示完成人工腱索的植入,将装置撤出后在超声影像下调整人工腱索的长短,将绳索24通过缝合垫片27固定于心尖28处,如图15所示完成人工腱索的植入。The purse is made at the apex, the conventional apical puncture is performed, the sealing sheath 1 is implanted into the ventricle, and then the balloon 6 at the tip end of the sealing sheath is filled to prevent damage to the normal leaflets during the operation, and then sealed under the guidance of ultrasound. The sheath 1 has the end of the balloon 6 close to the leaflet 15 to be repaired, and then the capillaries 15 to be repaired are captured using the trap 2, and then the implantation of the artificial chordae is completed as shown in Fig. 4, and the device is withdrawn. The length of the artificial chordae is adjusted under the ultrasound image, and the cord 24 is fixed to the apex 28 by the suture spacer 27, and the implantation of the artificial chordae is completed as shown in FIG.
实施例2:Example 2:
参见图14、5、15,其实施方式与实施例1相同。Referring to Figures 14, 5 and 15, the embodiment is the same as that of Embodiment 1.
实施例3: Example 3:
参见图14、6、15,其实施方式与实施例1相同。Referring to Figures 14, 6, and 15, the embodiment is the same as Embodiment 1.
实施例4:Example 4:
参见图14、7、15,其实施方式与实施例1相同。不同的是,穿刺针3穿刺瓣叶15后使用推杆10将其上伞叶21推出穿刺针,后撤穿刺针3到瓣叶15下,然后使用推杆10将下伞叶22释放,完成人工腱索的植入。Referring to Figures 14, 7, and 15, the embodiment is the same as Embodiment 1. The difference is that after the puncture needle 3 punctures the leaflet 15, the upper blade 21 is pushed out of the puncture needle by using the push rod 10, the puncture needle 3 is withdrawn to the leaflet 15, and then the lower umbrella 22 is released by using the push rod 10, and the completion is completed. Implantation of artificial chordae.
实施例5:Example 5:
参见图14、10、15,图14为瓣膜修复装置经心尖进入心室后对瓣叶进行捕捉示意图,图10为人工腱索进行释放示意图,图15为人工腱索修复完成示意图。Referring to Figures 14, 10 and 15, Figure 14 is a schematic view of the valve repair device after the apex enters the ventricle, Figure 10 is a schematic diagram of the artificial chordae release, and Figure 15 is a schematic diagram of the artificial chordae repair.
在心尖做荷包,进行常规心尖穿刺,将密封鞘1植入心室内,然后对密封鞘1头端的气囊6进行充盈,防止在操作过程中损伤到正常瓣叶,然后在超声的引导下使密封鞘1具有气囊6的那端接近需要修复的瓣叶15,然后使用捕捉器2对需要修复的瓣叶15进行捕捉,然后使用穿刺针3对瓣叶15进行穿刺,完成穿刺后将穿刺针3撤离,保持推杆10的位置不变,拉动人工腱索的绳索24形成线结,将装置撤出后在超声影像下调整人工腱索的长短,将绳索24通过缝合垫片27固定于心尖28处,如图15所示完成人工腱索的植入。The purse is made at the apex, the conventional apical puncture is performed, the sealing sheath 1 is implanted into the ventricle, and then the balloon 6 at the tip end of the sealing sheath is filled to prevent damage to the normal leaflets during the operation, and then sealed under the guidance of ultrasound. The sheath 1 has the end of the balloon 6 close to the leaflet 15 to be repaired, and then the capillaries 15 to be repaired are captured using the trap 2, and then the leaflets 15 are pierced using the puncture needle 3, and the puncture needle 3 is completed after the puncture is completed. The evacuation is performed, the position of the push rod 10 is kept unchanged, the rope 24 of the artificial chord is pulled to form a knot, the length of the artificial chord is adjusted under the ultrasonic image after the device is withdrawn, and the rope 24 is fixed to the apex 28 by the suture spacer 27. At the same time, the implantation of the artificial chordae is completed as shown in FIG.
实施例6:Example 6
参见图14、11、15,其实施方式与实施例5相同。Referring to Figures 14, 11, and 15, the embodiment is the same as that of Embodiment 5.
实施例7:Example 7
参见图14、12、15,其实施方式与实施例5相同。Referring to Figures 14, 12 and 15, the embodiment is the same as that of Embodiment 5.
实施例8:Example 8
参见图14、13、15,其实施方式与实施例5相同。Referring to Figures 14, 13, and 15, the embodiment is the same as that of Embodiment 5.
本发明具有以下优点:The invention has the following advantages:
可在心脏不停跳下实现小切口插入,修复损坏的瓣叶。通过心尖穿刺进入心室,在超声导航下使用捕捉器对需要植入人工腱索的瓣叶 位置进行捕捉,进行瓣叶穿刺及人工腱索的释放,将装置撤出后在超声影像下调整人工腱索的长短,将另一头固定于心尖,完成人工腱索的植入。该手术可以借助现代影像设备如胸腔镜、腹腔镜的导航功能准确的植入人工健索。该装置缩短了手术时间,降低创伤程度,降低了手术难度和手术风险Small incision insertion can be achieved while the heart is beating, repairing damaged leaflets. Through the apical puncture into the ventricle, using the trap under ultrasound guidance to the leaflets that need to be implanted with artificial chordae The position is captured, the leaflet puncture and the artificial chordae are released, the length of the artificial chordae is adjusted under the ultrasound image after the device is withdrawn, and the other end is fixed to the apex to complete the implantation of the artificial chordae. The operation can accurately implant artificial cables with the aid of modern imaging equipment such as thoracoscopy and laparoscopy. The device shortens the operation time, reduces the degree of trauma, reduces the difficulty of surgery and the risk of surgery
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。The above is only the preferred embodiment of the present invention, and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., which are included in the spirit and scope of the present invention, should be included in the present invention. Within the scope of protection.
工业实用性Industrial applicability
本发明提供一种瓣膜修复装置,该瓣膜修复装置包括:密封鞘;位于密封鞘远端的用于捕捉、固定瓣叶的捕捉器;位于所述密封鞘内用于穿刺被所述捕捉器捕捉的瓣叶的穿刺针;可随所述穿刺针穿刺进瓣膜、用于修复瓣膜的人工腱索;位于所述密封鞘近端、用于操作所述瓣膜修复装置的动作的手柄。本发明的装置可在心脏不停跳下实现小切口插入,修复损坏的瓣叶。通过心尖穿刺进入心室,在超声导航下使用捕捉器对需要植入人工腱索的瓣叶位置进行捕捉,进行瓣叶穿刺及人工腱索的释放,将装置撤出后在超声影像下调整人工腱索的长短,将另一头固定于心尖,完成人工腱索的植入。 The present invention provides a valve repair device comprising: a sealing sheath; a trap for capturing and fixing a leaflet at a distal end of the sealing sheath; and being located in the sealing sheath for piercing by the trap a puncture needle of the leaflet; a puncture into the valve with the puncture needle, an artificial chord for repairing the valve; a handle at the proximal end of the sealing sheath for operating the valve repair device. The device of the present invention enables small incision insertion and repair of damaged leaflets while the heart is beating. Through the apical puncture into the ventricle, the position of the leaflets that need to be implanted with the artificial chordae is captured by the use of the trap under ultrasound guidance, the leaflet puncture and the artificial chordae are released, and the device is removed and the artificial sputum is adjusted under the ultrasound image. The length of the cord is fixed at the apex of the other end, and the implantation of the artificial chord is completed.

Claims (17)

  1. 一种瓣膜修复装置,其特征在于:该瓣膜修复装置包括:密封鞘;位于密封鞘远端的用于捕捉、固定瓣叶的捕捉器;位于所述密封鞘内用于穿刺被所述捕捉器捕捉的瓣叶的穿刺针;可随所述穿刺针穿刺进瓣膜、用于修复瓣膜的人工腱索;位于所述密封鞘近端、用于操作所述瓣膜修复装置的动作的手柄。A valve repair device, comprising: a sealing sheath; a trap for capturing and fixing a leaflet at a distal end of the sealing sheath; and being located in the sealing sheath for piercing the trap a puncture needle of the captured leaflet; a puncture into the valve with the puncture needle, an artificial chord for repairing the valve; a handle at the proximal end of the sealing sheath for operating the valve repair device.
  2. 如权利要求1所述的瓣膜修复装置,其特征在于:围绕所述密封鞘的远端有气囊。The valve repair device of claim 1 wherein there is a balloon around the distal end of the sealing sheath.
  3. 如权利要求2所述的瓣膜修复装置,其特征在于:所述密封鞘由鞘管构成,所述鞘管包括内管和外管。The valve repair apparatus according to claim 2, wherein said sealing sheath is composed of a sheath tube, and said sheath tube comprises an inner tube and an outer tube.
  4. 如权利要求3所述的瓣膜修复装置,其特征在于:所述鞘管的一端与闭锁阀门连接,另一端与所述气囊相通,所述的内管和外管之间具有允许使得所述气囊膨胀的流体通过的腔隙。A valve repair apparatus according to claim 3, wherein one end of said sheath tube is connected to the lock valve and the other end is in communication with said air bag, and said inner tube and said outer tube are allowed to allow said air bag The cavity through which the expanding fluid passes.
  5. 如权利要求4所述的瓣膜修复装置,其特征在于:所述内管和外管由金属材料或高分子材料制成。A valve repairing apparatus according to claim 4, wherein said inner tube and outer tube are made of a metal material or a polymer material.
  6. 如权利要求2所述的瓣膜修复装置,其特征在于:所述气囊为医用丁基橡胶、天然橡胶或其他高分子材料。The valve repair device according to claim 2, wherein the air bag is medical butyl rubber, natural rubber or other polymer material.
  7. 如权利要求1所述的瓣膜修复装置,其特征在于:所述捕捉器为机械捕捉或负压捕捉。The valve repair device of claim 1 wherein said catcher is mechanically captured or vacuum captured.
  8. 如权利要求7所述的瓣膜修复装置,其特征在于:所述捕捉器为使用金属或高分子材料制成的圈、爪、夹或长管。A valve repair apparatus according to claim 7, wherein said trap is a ring, a claw, a clip or a long tube made of a metal or polymer material.
  9. 如权利要求1所述的瓣膜修复装置,其特征在于:所述捕捉器为长管的形状,该长管的轴与穿刺针的轴平行。A valve repair apparatus according to claim 1, wherein said trap is in the shape of a long tube whose axis is parallel to the axis of the puncture needle.
  10. 如权利要求1所述的瓣膜修复装置,其特征在于:所述人工腱索装载在所述穿刺针的外侧或所述穿刺针的内腔。A valve repair apparatus according to claim 1, wherein said artificial chordae are loaded on the outer side of said puncture needle or the inner cavity of said puncture needle.
  11. 如权利要求1所述的瓣膜修复装置,其特征在于:所述穿刺针的针头端具有防止瓣叶被穿刺后脱落的倒刺或网球结构。 The valve repair device according to claim 1, wherein the needle end of the puncture needle has a barb or tennis structure that prevents the leaflets from falling off after being punctured.
  12. 如权利要求11所述的瓣膜修复装置,其特征在于:所述的倒刺或网球结构为在所述人工腱索被释放后通过所述捕捉器进行安全回收的可回收结构。A valve repair apparatus according to claim 11, wherein said barb or tennis structure is a recyclable structure that is safely recovered by said trap after said artificial chord is released.
  13. 如权利要求1所述的瓣膜修复装置,其特征在于:所述人工腱索由ePTFE、镍钛合金或其他高分子材料制成。A valve repair apparatus according to claim 1, wherein said artificial chordae are made of ePTFE, nickel titanium alloy or other polymer material.
  14. 如权利要求1所述的瓣膜修复装置,其特征在于:所述人工腱索的结构为T型、单伞形、双伞形或线结形。A valve repair apparatus according to claim 1, wherein said artificial chordae is T-shaped, single-umbrella, double-umbrella or knot-shaped.
  15. 如权利要求1所述的瓣膜修复装置,其特征在于:所述手柄具有弹射穿刺针进行瓣叶穿刺及释放人工腱索的弹射释放装置。The valve repair device according to claim 1, wherein said handle has an ejection release device that ejects a puncture needle for leaflet puncture and releases an artificial chord.
  16. 如权利要求1所述的瓣膜修复装置,其特征在于:所述手柄具有调节瓣叶穿刺与释放人工腱索为同步进行或分步进行的选择装置。A valve repair apparatus according to claim 1, wherein said handle has a selection means for adjusting the leaflet puncture and releasing the artificial chordae in synchronism or stepwise.
  17. 如权利要求15所述的瓣膜修复装置,其特征在于:所述手柄的弹射释放装置为通过高倔强系数的弹簧、水压或气压产生弹射力和释放力的装置。 The valve repairing device according to claim 15, wherein the ejection releasing means of the handle is a device for generating an ejection force and a releasing force by a spring, water pressure or air pressure of a high reluctance coefficient.
PCT/CN2016/079906 2015-06-02 2016-04-21 Heart valve repair device WO2016192481A1 (en)

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109124809A (en) * 2018-09-19 2019-01-04 贵州医科大学附属医院 A kind of Neonatal Mouse heart infarction model puncture outfit
KR20200052915A (en) * 2017-10-20 2020-05-15 베이징 메드 지니스 메디컬 사이언티픽 컴퍼니., 리미티드 System applied to minimally invasive surgery to perform valve repair
US10765515B2 (en) 2017-04-06 2020-09-08 University Of Maryland, Baltimore Distal anchor apparatus and methods for mitral valve repair
US10864080B2 (en) 2015-10-02 2020-12-15 Harpoon Medical, Inc. Distal anchor apparatus and methods for mitral valve repair
US11026672B2 (en) 2017-06-19 2021-06-08 Harpoon Medical, Inc. Method and apparatus for cardiac procedures
US11065120B2 (en) 2017-10-24 2021-07-20 University Of Maryland, Baltimore Method and apparatus for cardiac procedures
US11413033B2 (en) 2011-06-27 2022-08-16 University Of Maryland, Baltimore Heart valve repair using suture knots
US11517435B2 (en) 2018-05-04 2022-12-06 Edwards Lifesciences Corporation Ring-based prosthetic cardiac valve
US11678872B2 (en) 2014-01-03 2023-06-20 University Of Maryland, Baltimore Method and apparatus for transapical procedures on a mitral valve

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104873307A (en) * 2015-06-02 2015-09-02 北京迈迪顶峰医疗科技有限公司 Valve repair device
CN109152573B (en) * 2015-10-02 2021-04-13 哈珀恩医疗有限公司 Distal anchor apparatus and methods for mitral valve repair
CN109394392B (en) * 2017-08-17 2023-11-10 杭州德晋医疗科技有限公司 Artificial tendon implantation system
CN109806029B (en) * 2017-11-21 2021-02-09 杭州德晋医疗科技有限公司 Artificial chordae tendineae implanting system with negative pressure device
CN109833117B (en) * 2017-11-28 2020-12-25 杭州德晋医疗科技有限公司 Bilateral artificial chordae tendineae implantation system
CN112773472B (en) * 2019-12-02 2021-11-09 北京领健医疗科技有限公司 Puncture needle, coupler, guide device and repair instrument
CN111450387A (en) * 2020-05-15 2020-07-28 四川大学华西第二医院 Double-cavity fixed catheter for endocardium puncture injection and use method thereof

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070112422A1 (en) * 2005-11-16 2007-05-17 Mark Dehdashtian Transapical heart valve delivery system and method
US7442207B2 (en) * 2006-04-21 2008-10-28 Medtronic Vascular, Inc. Device, system, and method for treating cardiac valve regurgitation
WO2010070649A1 (en) * 2008-12-21 2010-06-24 Mor Research Applications Ltd. Elongated body for deployment in a coronary sinus
US20110264208A1 (en) * 2010-04-27 2011-10-27 Medtronic, Inc. Prosthetic Heart Valve Devices and Methods of Valve Repair
WO2013003228A1 (en) * 2011-06-27 2013-01-03 University Of Maryland, Baltimore Transapical mitral valve repair device
CN104873307A (en) * 2015-06-02 2015-09-02 北京迈迪顶峰医疗科技有限公司 Valve repair device
CN204798060U (en) * 2015-06-02 2015-11-25 北京迈迪顶峰医疗科技有限公司 Valve prosthetic devices

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2187930Y (en) * 1994-03-30 1995-01-25 上海长征医院 Puncture needle with barb for tracheotomy
US9510948B2 (en) * 2011-09-09 2016-12-06 Emory University Systems, devices and methods for repair of heart valve lesions
CN203208094U (en) * 2013-04-11 2013-09-25 邓晓俊 Puncture outfit

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070112422A1 (en) * 2005-11-16 2007-05-17 Mark Dehdashtian Transapical heart valve delivery system and method
US7442207B2 (en) * 2006-04-21 2008-10-28 Medtronic Vascular, Inc. Device, system, and method for treating cardiac valve regurgitation
WO2010070649A1 (en) * 2008-12-21 2010-06-24 Mor Research Applications Ltd. Elongated body for deployment in a coronary sinus
US20110264208A1 (en) * 2010-04-27 2011-10-27 Medtronic, Inc. Prosthetic Heart Valve Devices and Methods of Valve Repair
WO2013003228A1 (en) * 2011-06-27 2013-01-03 University Of Maryland, Baltimore Transapical mitral valve repair device
CN104873307A (en) * 2015-06-02 2015-09-02 北京迈迪顶峰医疗科技有限公司 Valve repair device
CN204798060U (en) * 2015-06-02 2015-11-25 北京迈迪顶峰医疗科技有限公司 Valve prosthetic devices

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11413033B2 (en) 2011-06-27 2022-08-16 University Of Maryland, Baltimore Heart valve repair using suture knots
US11678872B2 (en) 2014-01-03 2023-06-20 University Of Maryland, Baltimore Method and apparatus for transapical procedures on a mitral valve
US11672662B2 (en) 2015-10-02 2023-06-13 Harpoon Medical, Inc. Short-throw tissue anchor deployment
US10864080B2 (en) 2015-10-02 2020-12-15 Harpoon Medical, Inc. Distal anchor apparatus and methods for mitral valve repair
US10765515B2 (en) 2017-04-06 2020-09-08 University Of Maryland, Baltimore Distal anchor apparatus and methods for mitral valve repair
US11026672B2 (en) 2017-06-19 2021-06-08 Harpoon Medical, Inc. Method and apparatus for cardiac procedures
KR102376568B1 (en) * 2017-10-20 2022-03-21 베이징 메드-지니스 메디컬 사이언티픽 코퍼레이션 리미티드 A system that performs valve leaf repair applied to minimally invasive surgery
EP3698759A4 (en) * 2017-10-20 2021-08-04 Beijing Med Zenith Medical Scientific Co., Ltd. Valve leaflet repair system for use in performing minimally invasive surgery
US20200297490A1 (en) * 2017-10-20 2020-09-24 Beijing Med Zenith Medical Scientific Co., Ltd. System for repairing valve leaflets in minimally invasive surgery
US11678984B2 (en) 2017-10-20 2023-06-20 Beijing Med Zenith Medical Scientific Co., Ltd. System for repairing valve leaflets in minimally invasive surgery
KR20200052915A (en) * 2017-10-20 2020-05-15 베이징 메드 지니스 메디컬 사이언티픽 컴퍼니., 리미티드 System applied to minimally invasive surgery to perform valve repair
US11065120B2 (en) 2017-10-24 2021-07-20 University Of Maryland, Baltimore Method and apparatus for cardiac procedures
US11833048B2 (en) 2017-10-24 2023-12-05 Harpoon Medical, Inc. Method and apparatus for cardiac procedures
US11517435B2 (en) 2018-05-04 2022-12-06 Edwards Lifesciences Corporation Ring-based prosthetic cardiac valve
CN109124809A (en) * 2018-09-19 2019-01-04 贵州医科大学附属医院 A kind of Neonatal Mouse heart infarction model puncture outfit
CN109124809B (en) * 2018-09-19 2023-09-01 贵州医科大学附属医院 Neonatal suckling mouse myocardial infarction model puncture outfit

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