WO2019205625A1 - 心腔内心肌切割器 - Google Patents

心腔内心肌切割器 Download PDF

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Publication number
WO2019205625A1
WO2019205625A1 PCT/CN2018/118017 CN2018118017W WO2019205625A1 WO 2019205625 A1 WO2019205625 A1 WO 2019205625A1 CN 2018118017 W CN2018118017 W CN 2018118017W WO 2019205625 A1 WO2019205625 A1 WO 2019205625A1
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WIPO (PCT)
Prior art keywords
protective sleeve
outer protective
myocardial
inner layer
cutter
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PCT/CN2018/118017
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English (en)
French (fr)
Inventor
魏翔
Original Assignee
Wei Xiang
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Publication of WO2019205625A1 publication Critical patent/WO2019205625A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320052—Guides for cutting instruments

Definitions

  • the invention belongs to the technical field of minimally invasive cardiac surgical instruments, and in particular relates to an intracardiac myocardial cutter.
  • Hypertrophic obstructive cardiomyopathy is a disease of myocardial morphological abnormality.
  • the incidence rate in the population is about 0.02% to 0.2%, that is, one in about 500 people suffers from this disease.
  • the cause may be related to gene mutation, abnormal myocardial calcium kinetics and catecholamine. Increased secretion of substances.
  • the pathological manifestation of the disease is asymmetrical ventricular septal hypertrophy, the hypertrophic myocardium protrudes into the left chamber, the left ventricular volume is reduced, the left ventricular outflow tract pressure step is significantly increased, and the mitral systolic forward motion (SAM sign) is further aggravated.
  • SAM sign mitral systolic forward motion
  • Left ventricular outflow obstruction which leads to obstruction of left ventricular discharge and progressive deterioration of cardiac function.
  • the clinical symptoms of the disease mainly include symptoms of heart failure such as chest pain, dyspnea and syncope.
  • the untreated disease mortality rate is 1.
  • Glan and modified Morrow Current treatments for hypertrophic obstructive cardiomyopathy include drug therapy, dual-chamber pacing, coronary ventricular septal alcohol ablation, and open ventricular septal myocardial resection (Morrow and modified Morrow).
  • drug and dual-chamber pacing therapy can only reduce the myocardial oxygen consumption and alleviate the symptoms of heart failure, enhance the exercise tolerance of patients, and can not completely remove the cause, so the treatment effect is limited.
  • Alcohol ablation is performed by injecting absolute alcohol into the first septal branch of the left anterior descending coronary artery, causing partial myocardial infarction, which makes the hypertrophic ventricular septal basal segment thinner, and achieves the treatment of reducing hypertrophic obstruction and reducing the pressure gradient.
  • this method still has a lot of limitations: 1 may lead to abnormal myocardial infarction caused by non-target myocardial infarction, aggravating the condition; 2 due to myocardial scar formation, atrioventricular block and ventricular arrhythmia and other complications are high (about 10 %); 3 due to the variation of the first spacer branch, about 5% to 8% of patients are not suitable for alcohol ablation; 4 short-term and long-term efficacy are inferior to open ventricular septal myocardial resection; 5 can not handle mitral papillary muscle Malformation and complicated valve structure abnormalities. In addition, a small number of cardiac centers attempted ventricular septal radiofrequency ablation through percutaneous catheters, but they have not been deployed on a large scale due to more complications. Therefore, ventricular septal myocardial resection is still the best treatment for hypertrophic obstructive cardiomyopathy.
  • ventricular septal myocardial resection still faces many challenges and problems: 1 Because the heart undergoes resection in the state of stoppage, the thickness and texture of the heart are different from those of the beating state, and the resection range is difficult to assess before surgery. , and completely dependent on the experience of the surgeon, so only a few experienced heart centers can do the surgery better, it is difficult to promote; 2 can not be used to evaluate the resection effect in real time after resection, if the resection range is too wide may lead to perforation of interventricular septum And conduction beam injury, and incomplete resection leads to poor surgical outcome; 3 middle chest opening, open heart surgery and extracorporeal circulation caused by surgical trauma, myocardial injury and systemic inflammatory response. Therefore, the surgical approach of ventricular septal myocardial resection is still in need of improvement.
  • the intracardiac myocardial cutter comprises an outer protective sleeve and an inner layer cutter, the upper end of the outer protective sleeve is of a bullet type, and the outer end of the outer protective sleeve is provided with a venting hole, and the outer protective sleeve is provided with a venting hole
  • the upper side wall is provided with a cutting window, the upper edge of the cutting window is provided with a downward hook, the outer side wall of the outer protective sleeve is provided with a handle, and the side wall of the outer protective sleeve is provided with an axial sliding a groove;
  • the inner layer knife is installed in the outer protective sleeve, the inner layer knife and the outer layer protection sleeve are slidingly matched, and an annular sealing ring is installed between the inner layer knife tube and the outer layer protection sleeve, and the inner layer
  • the upper end of the knife barrel is provided with an annular cutting edge with an edge upward, the lower end of the inner layer knife
  • the outer protective sleeve is mounted with a silicone gasket fitted to the annular blade, the silicone gasket being located on the upper edge of the cutting window, the hook being located on the inner side of the silicone gasket; the inner layer After the knife is moved up to close the annular blade and the silicone gasket, the hook is located inside the annular blade.
  • the hook is inclined outward according to actual needs, and the inclination angle is between 0 degrees and 90 degrees.
  • the upper end and the lower end of the sliding slot are respectively provided with horizontal bayonet ports.
  • the lower end of the outer protective sleeve is connected to the lower end of the inner layer barrel by a compression spring.
  • the lower end of the outer protective sleeve is screwed with an end cap, and the compression spring is located between the end cap and the inner layer cutter.
  • the outer side of the end cover is provided with a collar.
  • the handle has two handles, and the two handles are respectively located on the left and right sides of the sliding slot, and the handle is provided with a collar.
  • a syringe interface is disposed on the hollow passage of the hollow handle.
  • the present invention also discloses a preferred technical solution:
  • the intracardiac myocardial cutter comprises an outer protective sleeve, an inner layer cutter and a core push rod, wherein the upper end of the outer protective sleeve is of a bullet type, and the outer end of the outer protective sleeve is provided with a venting hole,
  • the upper side wall of the layer protection sleeve is provided with a cutting window, the upper edge of the cutting window is provided with a downward hook, and the side wall of the outer layer protection sleeve is provided with an axial sliding groove;
  • the inner layer knife sleeve is sleeved in the outer layer protection sleeve, the inner layer knife tube and the outer layer protection sleeve are slidingly matched, and an annular sealing ring is installed between the inner layer knife tube and the outer layer protection sleeve, and the inner layer knife is installed
  • the upper end of the barrel is provided with an annular cutting edge with an edge upward, the lower end of the inner layer barrel protrudes from the lower end of the outer protective sleeve, and the lower end of the inner layer barrel is provided with an operating handle;
  • the core layer push rod is sleeved in the inner layer cutter tube, the core layer push rod is slidably matched with the inner layer cutter tube, and an annular seal ring is installed between the core layer push rod and the inner layer cutter tube, and the core layer push rod is installed
  • the upper end is provided with a puncture needle for use with the hook, the lower end of the core push rod protrudes from the lower end of the inner layer, and the lower part of the core push rod is provided with a stopper for use with the chute, the stopper is opened There is a water injection passage that penetrates to the front end of the core push rod.
  • the lower end of the core push rod is provided with a guide wire passage penetrating through the front end thereof.
  • the outer surface of the outer protective sleeve is coated with a coating that prevents the metal from producing acoustic shadows under ultrasound.
  • the invention has the advantages of simple structure, convenient operation and reliable use, can significantly shorten the operation time, and opens up a new minimally invasive surgical method for treating hypertrophic obstructive cardiomyopathy; through the esophagus ultrasound guidance, the surgical resection effect can be evaluated in real time, on the one hand avoiding
  • the problem of excessive myocardial resection can be caused by restoscopic cardiac resection, avoiding the risk of iatrogenic interventricular septal perforation, and avoiding the problem of insufficient surgical resection and poor efficacy, reducing the excessive experience of the surgeon.
  • the structure designed by the invention integrates the functions of tissue excision and recovery, prevents the excision of the excised tissue and causes peripheral arterial embolization;
  • the hook of the head end of the invention can stably anchor the myocardial in the target area, and avoid the off-target cutting of the myocardium;
  • the invention is made of a material with good ultrasonic compatibility, and is convenient for guiding the ultrasound of the esophagus;
  • the small incision of the left front chest wall avoids the surgical trauma caused by the middle thoracotomy, and the patient recovers quickly after the operation;
  • the heart does not stop the surgery to avoid the conventional heart Application of cardiopulmonary bypass in open surgery, thereby avoiding myocardial ischemia and reperfusion Injection-related and extracorporeal circulation-related complications; if unpredictable complications occur during surgery, routine thoracotomy can be performed in time to greatly avoid fatal complications caused by alcohol ablation and radiofrequency ablation.
  • FIG. 1 is a schematic structural view of a first embodiment of the present invention.
  • Fig. 2 is a cross-sectional view taken along line A-A of Fig. 1;
  • Fig. 3 is an enlarged schematic view showing a portion B of Fig. 2;
  • Fig. 4 is a schematic view showing the state of use of the first embodiment of the present invention.
  • FIG. 5 is a schematic structural view of Embodiment 2 of the present invention.
  • Fig. 6 is a cross-sectional view taken along line A-A of Fig. 5;
  • Figure 7 is a schematic view showing the structure of an outer protective sleeve in the second embodiment of the present invention.
  • Figure 8 is a schematic view showing the structure of an inner layer cutter in the second embodiment of the present invention.
  • Figure 9 is a schematic view showing the structure of a core pusher in the second embodiment of the present invention.
  • Embodiment 1 is a diagrammatic representation of Embodiment 1:
  • the intracardiac myocardial cutter of the embodiment includes an outer protective sleeve 1 and an inner layer cutter 2, and the upper end of the outer protective sleeve 1 is of a bullet type, and the outer protective sleeve 1
  • the top end is provided with a venting hole, and the end of the bullet type facilitates insertion into the heart tissue while minimizing damage to the tissue
  • the upper side wall of the outer protective sleeve 1 is provided with a cutting window capable of protruding convex obstruction The part is loaded, and the wall of the back side of the cutting window can protect the heart tissue behind the cutter from being accidentally injured by the inner knife 2;
  • the upper edge of the cutting window is provided with a downward hook 10 for anchoring the pre-cut
  • the target area is thickened by the myocardium, preventing the cutter from slipping off, fixing the cutting thickness and providing the reverse shear force to the inner layer cutter 2;
  • the outer side wall of the outer protective sleeve 1 is provided with the handle 3 for convenient operation
  • the method of use of the embodiment is as follows: in the process of performing hypertrophic myocardial resection, the patient enters the pericardium through a small incision in the 4th and 5th intercostal spaces of the left anterior chest wall, exposes the apex, and makes a purse at the apex of the heart, and uses a sharp knife at the center of the purse to open a A small incision to the left ventricular cavity, then tighten the purse.
  • the inner layer knife 2 is pushed to the upper end, the cutting window is closed, and the hollow operating handle 6 is connected to the syringe for pre-filling the heparin saline to remove the air in the outer protective sleeve 1.
  • the upper end of the present invention is sent to the left ventricular chamber along the apical incision, and is positioned under the guidance of esophageal ultrasound and esophage three-dimensional ultrasound to the hypertrophic septal base segment to be resected, and the cutting window of the outer protective sleeve 1 is aligned with the resection target.
  • the hollow handle 6 is pulled down to open the cutting window, the hook 10 is pierced into the myocardial tissue of the target area and anchored, and it is confirmed under three-dimensional ultrasound that the chordae and the papillary muscles are not injured, and the hollow handle 6 is pushed up.
  • the annular blade 11 cuts the myocardial tissue of the target region, confirming that the tissue is removed and slowly withdrawing from the present invention.
  • the exiting invention opens and removes the excised myocardial tissue, and heparin saline flushes the outer protective sleeve 1 and the inner layer knife 2.
  • the resection effect was examined under esophageal ultrasound, and the left ventricular outflow tract pressure difference was measured by Doppler ultrasound. If the resection range is not satisfactory, repeat the above cutting process to expand the cutting range until the surgical results are satisfactory.
  • the hollow operating handle 6 can be connected to a pressure measuring catheter, and the left ventricular outflow tract pressure difference can be measured by the present invention.
  • the apical incision was closed and the chest wall incision was closed layer by layer.
  • the outer protective sleeve 1 is provided with a silicone gasket 9 fitted to the annular blade 11, the silicone gasket 9 is located at the upper edge of the cutting window, and the hook 10 is located inside the silicone gasket 9; After the layer cutter 2 is moved up to close the annular blade 11 and the silicone gasket 9, the hook 10 is located inside the annular blade 11, and it is possible to avoid accidentally injuring the passing tissue when the present invention is fed into the heart.
  • the silicone liner 9 facilitates the provision of a reverse shear force to the annular blade 11 as a chopping board when cutting tissue, making it easier to cut muscle tissue while providing a liquid seal for the inner blade 2.
  • the hook 10 is inclined outward, and the inclination can be designed to be different angles according to the thickness of the myocardium to be removed, and the angle of the hook to the axis of the present invention is larger, and the cutting is performed.
  • the thicker the thickness, the angle of inclination can be selected between 0 and 90 degrees.
  • the upper end and the lower end of the chute 4 are respectively provided with lateral bayonet ports.
  • the upper end of the bayonet is a safety device for ensuring the normally closed state of the cutting window, preventing the cutting window from opening and accidentally injuring other tissues, and preventing the cutting window from opening after the cutting is completed, so that the cut tissue is detached;
  • the lower end of the bayonet is a fixing device and enters the heart chamber.
  • the lower end of the outer protective sleeve 1 is connected to the lower end of the inner layer barrel 2 by a compression spring 8 for maintaining the normally closed state of the cutting window.
  • the lower end of the outer protective sleeve 1 is screwed with an end cap 5, and the compression spring 8 is located between the end cap 5 and the inner layer knife 2.
  • the outer side of the end cover 5 is provided with a collar, and at the same time, it is convenient for hand-held operation.
  • the handle 3 is provided with a collar, and the fingers are inserted into the collar for convenient operation.
  • a syringe interface is provided on the hollow passage of the hollow operation handle 6.
  • Embodiment 2 is a diagrammatic representation of Embodiment 1:
  • the intracardiac myocardial cutter of the embodiment includes an outer protective sleeve 1, an inner layer knife 2 and a core push rod 12, and the upper end protective sleeve 1 has a bullet type at the upper end.
  • the end of the bullet type facilitates insertion into the heart tissue while minimizing damage to the tissue;
  • the top of the outer protective sleeve 1 is provided with a venting hole;
  • the upper side wall of the outer protective sleeve 1 is provided with a cutting window, The convex hypertrophic obstruction is inserted, and the wall of the posterior side of the cutting window can protect the heart tissue behind the cutter from being accidentally injured by the inner knife 2;
  • the upper edge of the cutting window is provided with a downward hook 10 for Anchoring the pre-cut target area to thicken the myocardium, preventing the cutter from slipping, fixing the cutting thickness and providing the reverse shear force to the inner layer cutter 2;
  • the side wall of the outer protective sleeve 1 is provided with the axial sliding groove 4
  • the inner layer cutter 2 is sleeved in the outer protective sleeve 1, and the inner layer cutter 2 is slidably engaged with the outer protective sleeve 1, so that the inner layer cutter 2 can be moved back and forth
  • an annular sealing ring 7 is installed between the inner layer cutter 2 and the outer protective sleeve 1 to prevent cutting
  • the intracardiac high pressure blood leaks along the gap between the inner and outer sleeves
  • the upper end of the inner layer knife 2 is provided with an annular cutting edge 11 with a cutting edge for cutting upward
  • the lower end of the inner knife 2 is from the outer layer
  • the lower end of the protective sleeve 1 is extended, and the lower end of the inner layer cutter 2 is provided with an operation handle 13 for pushing the inner layer cutter 2 upward, and on the other hand, rotating the inner cutter 2 for cutting
  • the core push rod 12 The core layer push rod 12 is slidably engaged with the inner layer knife barrel 2, and an annular sealing ring 7 is installed between the core layer push rod 12 and the inner layer knife barrel 2 to prevent the cutter from entering.
  • the posterior intracardiac blood is leaked along the gap between the core pusher 12 and the inner layer cutter 2; the upper end of the core pusher 12 is mounted with a puncture needle 14 for use with the hook 10, and the hook 10 and the puncture needle 14 can be
  • the upper and lower directions penetrate the myocardial tissue of the target region to ensure the stability of the anchoring.
  • the lower end of the core push rod 12 protrudes from the lower end of the inner layer cutter 2, and the lower portion of the core push rod 12 is provided for use with the chute 4.
  • the stopper 15 and the stopper 15 can only move in the axial direction in the chute 4, thereby ensuring the puncture needle 14 and The positional relationship of the hooks 10, the stopper 15 is provided with a water injection passage penetrating to the front end of the core pusher 12, which can be used for liquid sealing of the heparin brine to remove air in the cavity.
  • the method of use of the embodiment is as follows: in the process of performing hypertrophic myocardial resection, the patient enters the pericardium through a small incision in the 4th and 5th intercostal spaces of the left anterior chest wall, exposes the apex, and makes a purse at the apex of the heart, and punctures the sheath at the center of the purse to The left ventricle, feeding the guide wire, exiting the sheath, using the dilator to expand the apical inlet along the guide wire, and withdrawing the dilator while tightening the purse.
  • the inner layer knife 2 is pushed to the upper end by the operating handle 13, the cutting window is closed, and the water injection passage of the stopper 15 is connected to the syringe to perform a heparin saline pre-filling liquid seal to exclude the air in the outer protective sleeve 1.
  • the upper end of the present invention is fed into the left ventricular chamber along the guide wire, and is guided to the hypertrophic septal base segment to be resected under transesophageal ultrasound and transesophageal three-dimensional ultrasound guidance, and the cutting window of the outer protective sleeve 1 is aligned.
  • the target area is removed, the operation handle 13 is pulled down to open the cutting window, the hook 10 is inserted into the myocardial tissue of the target area and anchored, and it is confirmed under three-dimensional ultrasound that the chordae and the papillary muscles are not injured, and the core pusher 12 is pushed up.
  • the puncture needle 14 is inserted into the myocardial tissue of the target region from the bottom to the top and anchored; then the operating handle 13 is pushed up to move upward, and the operating handle 13 can be rotated around the central axis at the same time, so that the annular cutting edge 11 cuts the myocardial tissue of the target region. It was confirmed that the present invention was slowly withdrawn after the tissue was cut.
  • the exiting invention opens and removes the excised myocardial tissue, and heparin saline flushes the outer protective sleeve 1 and the inner layer knife 2.
  • the resection effect was examined under esophageal ultrasound, and the left ventricular outflow tract pressure difference was measured by Doppler ultrasound. If the resection range is not satisfactory, repeat the above cutting process to expand the cutting range until the surgical results are satisfactory. If necessary, the water injection channel of the stopper 15 can be connected to the pressure measuring catheter, and the left ventricular outflow channel pressure difference can be measured by the present invention. The apical incision was closed and the chest wall incision was closed layer by layer.
  • the operating handle 13 can be designed to be circular, the operating handle 13 is coaxial with the inner layer cutter 2, and the operating handle 13 is fixedly coupled to the inner layer cutter 2 by a connecting arm.
  • the lower end of the core push rod 12 is provided with a guide wire passage penetrating through the front end thereof, and the guide wire can penetrate from the top end opening, and is worn from the lower end of the core layer push rod 12. Out.
  • the outer surface of the outer protective sleeve 1 is coated with a coating that prevents the metal from generating sound shadows under ultrasound.
  • the outer protective sleeve 1 is provided with a silicone gasket 9 fitted to the annular blade 11, the silicone gasket 9 is located at the upper edge of the cutting window, and the hook 10 is located inside the silicone gasket 9; After the layer cutter 2 is moved up to close the annular blade 11 and the silicone gasket 9, the hook 10 is located inside the annular blade 11, and it is possible to avoid accidentally injuring the passing tissue when the present invention is fed into the heart.
  • the silicone liner 9 facilitates the provision of a reverse shear force to the annular blade 11 as a chopping board when cutting tissue, making it easier to cut muscle tissue while providing a liquid seal for the inner knife 2.
  • the hook 10 is inclined outward, and the inclination can be designed to be different angles according to the thickness of the myocardium to be removed, and the angle of the hook to the axis of the present invention is larger, and the cutting is performed.
  • the thicker the thickness, the angle of inclination can be selected between 0 and 90 degrees.
  • a syringe interface is provided on the water injection passage of the stopper 15.

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Abstract

心腔内心肌切割器包括外层保护套筒（1）和内层刀筒（2）。外层保护套筒（1）的上部侧壁开设有切割窗口，切割窗口的上沿设有向下的挂钩（10）；外层保护套筒（1）的侧壁开设有轴向的滑槽（4）。内层刀筒（2）安装在外层保护套筒（1）内，内层刀筒（2）的上端设有刃口向上的环形刀刃（11）。内层刀筒（2）的侧壁设置有空心操作柄（6），空心操作柄（6）从滑槽（4）伸出。这种心腔内心肌切割器无需体外循环即可实施手术，显著缩短手术时间，减小传统正中开胸手术创伤，避免了体外循环相关的并发症。更重要的是，手术得以在心脏不停跳状态下对切除范围和切除效果进行实时监测和评估，避免了室间隔穿孔和切除范围不够等并发症，改善了此类病人的手术治疗效果。

Description

心腔内心肌切割器 技术领域
本发明属于微创心脏外科手术器械技术领域，具体涉及一种心腔内心肌切割器。
背景技术
肥厚梗阻型心肌病是一种心肌形态异常疾病，人群中发病率约0.02％～0.2％，即约500人中即有一人患此病，发病原因可能与基因突变，心肌钙动力学异常及儿茶酚胺类物质分泌增多有关。该病病理表现为非对称性室间隔肥厚，肥厚心肌向左室内突出使得左室容积减小，左室流出道压力阶差显著增高，二尖瓣收缩期前向运动(SAM征)并进一步加剧左室流出道梗阻，进而导致左室排血受阻，心功能进行性恶化。该病临床症状主要表现为胸痛、呼吸困难和晕厥等心力衰竭症状，未经治疗年病死率1.7％～4％，多为恶性心律失常所致猝死，自然预后差。
目前肥厚梗阻型心肌病的治疗方法主要包括药物治疗，双腔起搏治疗，经冠脉室间隔酒精消融术和开放室间隔心肌切除(Morrow术式及改良Morrow术式)。其中药物和双腔起搏治疗仅能一定限度降低心肌耗氧量和缓解心衰症状，增强患者运动耐量，尚不能从根本上去除病因，因此治疗效果有限。酒精消融术通过向冠脉左前降支的第一间隔支内注入无水酒精，造成部分心肌梗死，使得肥厚室间隔基底段变薄，实现减少肥厚梗阻和降低压力阶差的病因治疗。然 而该方法目前仍然有很大局限性：①可能导致非靶区心肌梗死造成心肌运动异常，加重病情；②由于心肌疤痕形成造成房室传导阻滞及室性心律失常等并发症高发(约10％)；③由于第一间隔支的变异使得约5％～8％的患者不适用酒精消融术；④近期及远期疗效均劣于开放室间隔心肌切除术；⑤无法处理二尖瓣乳头肌畸形及并发的瓣膜结构异常。此外，少数心脏中心尝试通过经皮导管进行室间隔射频消融术，但由于并发症较多尚未大规模展开应用。因此，室间隔心肌切除术目前仍然是肥厚梗阻型心肌病的最佳治疗方法。
尽管如此，传统室间隔心肌切除术仍然面临着诸多挑战和问题：①由于心脏在停跳状态下进行切除手术，此时心脏厚薄及质地已不同于跳动状态下的心脏，切除范围难以术前评估，而完全依赖于术者经验，因此只有极少数经验丰富的心脏中心能够比较好的完成该手术，难以推广；②切除后无法实时对切除效果进行评估，如果切除范围过广可能导致室间隔穿孔及传导束损伤，而切除不完全则导致手术疗效欠佳；③正中开胸，开放心脏手术及体外循环造成的手术创伤，心肌损伤及全身炎性反应。因此，室间隔心肌切除术手术方式仍然亟待改进。
发明内容
为了解决现有技术存在的上述问题，本发明目的在于提供一种心腔内心肌切割器。
本发明所采用的技术方案为：
心腔内心肌切割器，包括外层保护套筒和内层刀筒，所述外层保护套筒上 端呈子弹头型，外层保护套筒顶端设有排气孔，外层保护套筒的上部侧壁开设有切割窗口，所述切割窗口的上沿设有向下的挂钩，所述外层保护套筒的外侧壁设有把手，外层保护套筒的侧壁开设有轴向的滑槽；所述内层刀筒安装在外层保护套筒内，内层刀筒与外层保护套筒滑动配合，内层刀筒与外层保护套筒之间安装有环形的密封环，内层刀筒的上端设有刃口向上的环形刀刃，内层刀筒的下端封闭，内层刀筒的侧壁设置有空心操作柄，所述空心操作柄与内层刀筒内空腔连通，空心操作柄从滑槽伸出。
优选的，所述外层保护套筒上安装有一圈与环形刀刃适配的硅胶衬垫，所述硅胶衬垫位于切割窗口的上沿，所述挂钩位于硅胶衬垫的内侧；所述内层刀筒上移使环形刀刃与硅胶衬垫闭合后，挂钩位于环形刀刃的内侧。
优选的，所述挂钩根据实际需求向外倾斜，倾斜角度为0度至90度之间。
进一步的，所述滑槽的上端和下端分别设有横向的卡口。
进一步的，所述外层保护套筒的下端通过压缩弹簧与内层刀筒的下端连接。
优选的，所述外层保护套筒的下端通过螺纹连接有端盖，所述压缩弹簧位于端盖与内层刀筒之间。
优选的，所述端盖的外侧设有套环。
进一步的，所述把手有两个，两个把手分别位于滑槽的左右两侧，把手上设有套环。
进一步的，所述空心操作柄的空心通道上设有注射器接口。
为了进一步提升切割的稳定性，本发明还公开一种优选的技术方案：
心腔内心肌切割器，包括外层保护套筒、内层刀筒和芯层推杆，所述外层保护套筒上端呈子弹头型，外层保护套筒顶端设有排气孔，外层保护套筒的上部侧壁开设有切割窗口，所述切割窗口的上沿设有向下的挂钩，外层保护套筒的侧壁开设有轴向的滑槽；
所述内层刀筒套接在外层保护套筒内，内层刀筒与外层保护套筒滑动配合，内层刀筒与外层保护套筒之间安装有环形的密封环，内层刀筒的上端设有刃口向上的环形刀刃，内层刀筒的下端从外层保护套筒下端伸出，内层刀筒的下端设置有操作手柄；
所述芯层推杆套接在内层刀筒内，芯层推杆与内层刀筒滑动配合，芯层推杆与内层刀筒之间安装有环形的密封环，芯层推杆的上端安装有与挂钩配合使用的穿刺针，芯层推杆的下端从内层刀筒下端伸出，芯层推杆的下部设置有与滑槽配合使用的限位器，所述限位器开设有贯通至芯层推杆前端的注水通道。
进一步的，所述芯层推杆的下端开设有与其前端贯通的导丝通道。
优选的，所述外层保护套筒的外表面包覆有防止金属在超声下产生声影的涂层。
本发明的有益效果为：
本发明结构简单，操作方便，使用可靠，能够显著缩短手术时间，开创了一种治疗肥厚梗阻性心肌病全新微创的手术方式；通过食道超声引导，手术切 除效果得以实时评估，一方面避免了静止心脏行切除术可能导致的心肌切除过多的问题，规避了医源性室间隔穿孔的风险，另一方面也避免了手术切除范围不够疗效不佳的问题，减少了对术者经验的过度依赖，显著提升了手术疗效；本发明所设计的结构集成了组织切取及回收的功能，防止切取组织脱落导致外周动脉栓塞；本发明头端的挂钩可以稳定锚定靶区心肌，避免脱靶切取心肌；本发明由超声相容性好的材质制成，方便进行食道超声引导；通过左前胸壁小切口，避免了正中开胸所致的手术创伤，病人术后恢复快；心脏不停跳手术避免常规心脏开放手术中体外循环的应用，从而避免了心肌缺血再灌注损伤及体外循环相关并发症；术中若出现不可预知的并发症，可及时中转常规开胸手术，极大地避免发生酒精消融和射频消融手术所致的致命并发症。
附图说明
图1是本发明实施例一的结构示意图。
图2是图1的A-A剖视图。
图3是图2的B部放大示意图。
图4是本发明实施例一的使用状态示意图。
图5是本发明实施例二的结构示意图。
图6是图5的A-A剖视图。
图7是本发明实施例二中外层保护套筒的结构示意图。
图8是本发明实施例二中内层刀筒的结构示意图。
图9是本发明实施例二中芯层推杆的结构示意图。
图中：1-外层保护套筒；2-内层刀筒；3-把手；4-滑槽；5-端盖；6-空心操作柄；7-密封环；8-压缩弹簧；9-硅胶衬垫；10-挂钩；11-环形刀刃；12-芯层推杆；13-操作手柄；14-穿刺针；15-限位器。
具体实施方式
下面结合附图及具体实施例对本发明作进一步阐述。
实施例一：
如图1-4所示，本实施例的心腔内心肌切割器，包括外层保护套筒1和内层刀筒2，外层保护套筒1上端呈子弹头型，外层保护套筒1顶端设有排气孔，子弹头型的端部利于插入心脏组织，同时最大程度减少对组织的损伤；外层保护套筒1的上部侧壁开设有切割窗口，能够将凸出的肥厚梗阻部位装入，同时切割窗口后侧的筒壁能够保护切割器后面的心脏组织，防止被内层刀筒2误伤；切割窗口的上沿设有向下的挂钩10，用于锚定预切割的靶区肥厚心肌，防止切割器滑脱，固定切割厚度并为内层刀筒2提供反向剪切力；外层保护套筒1的外侧壁设有把手3，方便操作；外层保护套筒1的侧壁开设有轴向的滑槽4，滑槽4的长度限定了内层刀筒2的移动距离；内层刀筒2安装在外层保护套筒1内，内层刀筒2与外层保护套筒1滑动配合，因此内层刀筒2可沿着外层保护套筒1的轴向来回滑动；内层刀筒2与外层保护套筒1之间安装有环形的密封环7，能够防止切割器进入后心内高压血液沿内外套筒间空隙漏出；内层刀筒2 的上端设有刃口向上的环形刀刃11，用于上行时实施切割；内层刀筒2的下端封闭，进而与外层保护套筒1共同形成空腔；内层刀筒2的侧壁设置有空心操作柄6，空心操作柄6与内层刀筒2内空腔连通，可用于肝素盐水液封，排除空腔内的空气；空心操作柄6从滑槽4伸出，方便操作。
本实施例的使用方法如下：在实施肥厚心肌切除的过程中，患者经左前胸壁第4、5肋间隙小切口进入心包，暴露心尖，在心尖做一荷包，于荷包中央处用尖刀划开一小切口至左室腔，随即束紧荷包。将内层刀筒2推至上端，封闭切割窗口，并将空心操作柄6连接注射器进行肝素盐水预充液封，排除外层保护套筒1内空气。沿心尖切口将本发明的上端送入左室心腔，在食道超声及食道三维超声引导下定位至需要切除的肥厚室间隔基底段，并将外层保护套筒1的切割窗口对准切除靶区，向下拉空心操作柄6以打开切割窗口，将挂钩10刺入靶区心肌组织并锚定，再次于三维超声下确认不会伤及腱索及乳头肌，向上推空心操作柄6使之向上移动，让环形刀刃11切割靶区心肌组织，确认切下组织后缓慢退出本发明。将退出的本发明打开并取出切下的心肌组织，肝素盐水冲净外层保护套筒1和内层刀筒2。于食道超声下检查切除效果，多普勒超声测量左室流出道压差。若切除范围不满意则再次进入重复上述切割过程来扩大切割范围，直至手术效果满意。必要时可以将空心操作柄6连接测压导管，利用本发明测量左室流出道压差。术闭缝合心尖切口，逐层关闭胸壁切口。
为了方便将组织切断，外层保护套筒1上安装有一圈与环形刀刃11适配的硅胶衬垫9，硅胶衬垫9位于切割窗口的上沿，挂钩10位于硅胶衬垫9的内侧；内层刀筒2上移使环形刀刃11与硅胶衬垫9闭合后，挂钩10位于环形刀刃11的内侧，能够避免将本发明送入心脏时误伤经过的组织。硅胶衬垫9便于在切 割组织时作为案板为环形刀刃11提供反向剪切力，更易于切断肌肉组织，同时可为内层刀筒2提供液封。
为了使挂钩10更容易固定挂住的待切割组织，挂钩10向外倾斜，根据需要切除的心肌的厚薄，该倾斜可设计成不同角度，该挂钩与本发明轴心的角度越大，则切割厚度越厚，倾斜角度可在0度至90度之间选择。
为了提高安全性，滑槽4的上端和下端分别设有横向的卡口。上端卡口为保险装置，用于确保切削窗口的常闭状态，防止切削窗口打开误伤其他组织，同时防止切割完成后切削窗口打开使得切下的组织脱落；下端卡口为固定装置，进入心腔内目标位置后，下拉空心操作柄6，将空心操作柄6卡入下端卡口，保持切削窗口打开状态，便于操作钩挂10固定目标心肌组织。
为了进一步提高安全性，外层保护套筒1的下端通过压缩弹簧8与内层刀筒2的下端连接，用于保持切削窗口的常闭状态。
为了方便安装和更换压缩弹簧8，外层保护套筒1的下端通过螺纹连接有端盖5，压缩弹簧8位于端盖5与内层刀筒2之间。
为了方便旋紧端盖5，端盖5的外侧设有套环，同时还方便手持操作。
为了方便操作，把手3有两个，两个把手3分别位于滑槽4的左右两侧，把手3上设有套环，手指伸入套环内，操作更方便。
为了保证内层刀筒2的液封，排气，测压及冲洗，空心操作柄6的空心通道上设有注射器接口。
实施例二：
如图5-9所示，本实施例的心腔内心肌切割器，包括外层保护套筒1、内层刀筒2和芯层推杆12，外层保护套筒1上端呈子弹头型，子弹头型的端部利于插入心脏组织，同时最大程度减少对组织的损伤；外层保护套筒1顶端设有排气孔；外层保护套筒1的上部侧壁开设有切割窗口，能够将凸出的肥厚梗阻部位装入，同时切割窗口后侧的筒壁能够保护切割器后面的心脏组织，防止被内层刀筒2误伤；切割窗口的上沿设有向下的挂钩10，用于锚定预切割的靶区肥厚心肌，防止切割器滑脱，固定切割厚度并为内层刀筒2提供反向剪切力；外层保护套筒1的侧壁开设有轴向的滑槽4；内层刀筒2套接在外层保护套筒1内，内层刀筒2与外层保护套筒1滑动配合，因此内层刀筒2可沿着外层保护套筒1的轴向来回滑动；内层刀筒2与外层保护套筒1之间安装有环形的密封环7，能够防止切割器进入后心内高压血液沿内外套筒间空隙漏出；内层刀筒2的上端设有刃口向上的环形刀刃11，用于上行时实施切割；内层刀筒2的下端从外层保护套筒1下端伸出，内层刀筒2的下端设置有操作手柄13，一方面可以推动内层刀筒2上行，另一方面可以旋转内层刀筒2实施切割；芯层推杆12套接在内层刀筒2内，芯层推杆12与内层刀筒2滑动配合，芯层推杆12与内层刀筒2之间安装有环形的密封环7，能够防止切割器进入后心内高压血液沿芯层推杆12与内层刀筒2之间的空隙漏出；芯层推杆12的上端安装有与挂钩10配合使用的穿刺针14，挂钩10与穿刺针14能够从上下两个方向刺入靶区心肌组织进而保证锚定的稳定性，芯层推杆12的下端从内层刀筒2下端伸出，芯层推杆12的下部设置有与滑槽4配合使用的限位器15，限位器15只能够在滑槽4内沿轴向移动，进而保证了穿刺针14与挂钩10的位置关系，限位器15开 设有贯通至芯层推杆12前端的注水通道，可用于肝素盐水液封，排除空腔内的空气。
本实施例的使用方法如下：在实施肥厚心肌切除的过程中，患者经左前胸壁第4、5肋间隙小切口进入心包，暴露心尖，在心尖做一荷包，于荷包中央处用鞘管穿刺至左心室，送入导丝，退出鞘管，利用扩张器沿导丝扩大心尖入口，退出扩张器的同时随即束紧荷包。利用操作手柄13将内层刀筒2推至上端，封闭切割窗口，并将限位器15的注水通道连接注射器进行肝素盐水预充液封，排除外层保护套筒1内空气。沿导丝将本发明的上端送入左室心腔，在经食道超声及经食道三维超声引导下定位至需要切除的肥厚室间隔基底段，并将外层保护套筒1的切割窗口对准切除靶区，向下拉操作手柄13以打开切割窗口，将挂钩10刺入靶区心肌组织并锚定，再次于三维超声下确认不会伤及腱索及乳头肌，向上推芯层推杆12，使穿刺针14从下往上刺入靶区心肌组织并锚定；然后向上推操作手柄13使之向上移动，可以同时绕中心轴旋转操作手柄13，让环形刀刃11切割靶区心肌组织，确认切下组织后缓慢退出本发明。将退出的本发明打开并取出切下的心肌组织，肝素盐水冲净外层保护套筒1和内层刀筒2。于食道超声下检查切除效果，多普勒超声测量左室流出道压差。若切除范围不满意则再次进入重复上述切割过程来扩大切割范围，直至手术效果满意。必要时可以将限位器15的注水通道连接测压导管，利用本发明测量左室流出道压差。术闭缝合心尖切口，逐层关闭胸壁切口。
为了方便进行旋转操作，操作手柄13可以设计为圆环形，操作手柄13与内层刀筒2同轴，操作手柄13通过连接臂与内层刀筒2固定连接。
为了增加切割器的定位准确性，增加导丝引导功能，芯层推杆12的下端开设有与其前端贯通的导丝通道，导丝可以从顶端开口穿入，从芯层推杆12的下端穿出。
为了避免金属材质的切割器对超声图像产生影响，外层保护套筒1的外表面包覆有防止金属在超声下产生声影的涂层。
为了方便将组织切断，外层保护套筒1上安装有一圈与环形刀刃11适配的硅胶衬垫9，硅胶衬垫9位于切割窗口的上沿，挂钩10位于硅胶衬垫9的内侧；内层刀筒2上移使环形刀刃11与硅胶衬垫9闭合后，挂钩10位于环形刀刃11的内侧，能够避免将本发明送入心脏时误伤经过的组织。硅胶衬垫9便于在切割组织时作为案板为环形刀刃11提供反向剪切力，更易于切断肌肉组织，同时可为内层刀筒2提供液封。
为了使挂钩10更容易固定挂住的待切割组织，挂钩10向外倾斜，根据需要切除的心肌的厚薄，该倾斜可设计成不同角度，该挂钩与本发明轴心的角度越大，则切割厚度越厚，倾斜角度可在0度至90度之间选择。
为了保证内层刀筒2的液封，排气，测压及冲洗，限位器15的注水通道上设有注射器接口。
本发明不局限于上述可选实施方式，任何人在本发明的启示下都可得出其他各种形式的产品，但不论在其形状或结构上作任何变化，凡是落入本发明权利要求界定范围内的技术方案，均落在本发明的保护范围之内。

Claims (12)

  1. 心腔内心肌切割器，其特征在于：包括外层保护套筒(1)和内层刀筒(2)，所述外层保护套筒(1)上端呈子弹头型，外层保护套筒(1)顶端设有排气孔，外层保护套筒(1)的上部侧壁开设有切割窗口，所述切割窗口的上沿设有向下的挂钩(10)，所述外层保护套筒(1)的外侧壁设有把手(3)，外层保护套筒(1)的侧壁开设有轴向的滑槽(4)；所述内层刀筒(2)安装在外层保护套筒(1)内，内层刀筒(2)与外层保护套筒(1)滑动配合，内层刀筒(2)与外层保护套筒(1)之间安装有环形的密封环(7)，内层刀筒(2)的上端设有刃口向上的环形刀刃(11)，内层刀筒(2)的下端封闭，内层刀筒(2)的侧壁设置有空心操作柄(6)，所述空心操作柄(6)与内层刀筒(2)内空腔连通，空心操作柄(6)从滑槽(4)伸出。
  2. 根据权利要求1所述的心腔内心肌切割器，其特征在于：所述外层保护套筒(1)上安装有一圈与环形刀刃(11)适配的硅胶衬垫(9)，所述硅胶衬垫(9)位于切割窗口的上沿，所述挂钩(10)位于硅胶衬垫(9)的内侧；所述内层刀筒(2)上移使环形刀刃(11)与硅胶衬垫(9)闭合后，挂钩(10)位于环形刀刃(11)的内侧。
  3. 根据权利要求1所述的心腔内心肌切割器，其特征在于：所述挂钩(10)向外倾斜，倾斜角度为0度至90度之间。
  4. 根据权利要求1所述的心腔内心肌切割器，其特征在于：所述滑槽(4)的上端和下端分别设有横向的卡口。
  5. 根据权利要求4所述的心腔内心肌切割器，其特征在于：所述外层保护 套筒(1)的下端通过压缩弹簧(8)与内层刀筒(2)的下端连接。
  6. 根据权利要求5所述的心腔内心肌切割器，其特征在于：所述外层保护套筒(1)的下端通过螺纹连接有端盖(5)，所述压缩弹簧(8)位于端盖(5)与内层刀筒(2)之间。
  7. 根据权利要求6所述的心腔内心肌切割器，其特征在于：所述端盖(5)的外侧设有套环。
  8. 根据权利要求1所述的心腔内心肌切割器，其特征在于：所述把手(3)有两个，两个把手(3)分别位于滑槽(4)的左右两侧，把手(3)上设有套环。
  9. 根据权利要求1-8任意一项所述的心腔内心肌切割器，其特征在于：所述空心操作柄(6)的空心通道上设有注射器接口。
  10. 心腔内心肌切割器，其特征在于：包括外层保护套筒(1)、内层刀筒(2)和芯层推杆(12)，所述外层保护套筒(1)上端呈子弹头型，外层保护套筒(1)顶端设有排气孔，外层保护套筒(1)的上部侧壁开设有切割窗口，所述切割窗口的上沿设有向下的挂钩(10)，外层保护套筒(1)的侧壁开设有轴向的滑槽(4)；
    所述内层刀筒(2)套接在外层保护套筒(1)内，内层刀筒(2)与外层保护套筒(1)滑动配合，内层刀筒(2)与外层保护套筒(1)之间安装有环形的密封环(7)，内层刀筒(2)的上端设有刃口向上的环形刀刃(11)，内层刀筒(2)的下端从外层保护套筒(1)下端伸出，内层刀筒(2)的下端设置有操作手柄(13)；
    所述芯层推杆(12)套接在内层刀筒(2)内，芯层推杆(12)与内层刀筒(2)滑动配合，芯层推杆(12)与内层刀筒(2)之间安装有环形的密封环(7)，芯层推杆(12)的上端安装有与挂钩(10)配合使用的穿刺针(14)，芯层推杆(12)的下端从内层刀筒(2)下端伸出，芯层推杆(12)的下部设置有与滑槽(4)配合使用的限位器(15)，所述限位器(15)开设有贯通至芯层推杆(12)前端的注水通道。
  11. 根据权利要求10所述的心腔内心肌切割器，其特征在于：所述芯层推杆(12)的下端开设有与其前端贯通的导丝通道。
  12. 根据权利要求11所述的心腔内心肌切割器，其特征在于：所述外层保护套筒(1)的外表面包覆有防止金属在超声下产生声影的涂层。
PCT/CN2018/118017 2018-04-28 2018-11-28 心腔内心肌切割器 WO2019205625A1 (zh)

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