WO2021035961A1 - Balloon catheter sheath - Google Patents

Balloon catheter sheath Download PDF

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Publication number
WO2021035961A1
WO2021035961A1 PCT/CN2019/116434 CN2019116434W WO2021035961A1 WO 2021035961 A1 WO2021035961 A1 WO 2021035961A1 CN 2019116434 W CN2019116434 W CN 2019116434W WO 2021035961 A1 WO2021035961 A1 WO 2021035961A1
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WO
WIPO (PCT)
Prior art keywords
balloon
channel
sheath
catheter sheath
balloon catheter
Prior art date
Application number
PCT/CN2019/116434
Other languages
French (fr)
Chinese (zh)
Inventor
崔东哲
Original Assignee
香港大学深圳医院
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 香港大学深圳医院 filed Critical 香港大学深圳医院
Publication of WO2021035961A1 publication Critical patent/WO2021035961A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065Functions of balloons
    • A61B2017/22067Blocking; Occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance

Definitions

  • the application relates to the field of medical equipment, in particular to a balloon catheter sheath.
  • Deep vein thrombosis of the lower extremities is a common peripheral vascular disease.
  • the obstruction of venous return of the lower extremities and the concurrent pulmonary embolism caused by deep vein thrombosis of the lower extremities are a major danger to the patient's labor and life safety.
  • the existing treatment equipment for lower extremity venous thrombosis uses common catheter sheaths and inferior vena cava filters to perform venous thrombectomy, but this method has poor treatment safety, complex procedures, and high costs.
  • the purpose of the present invention is to provide a balloon catheter sheath, which has the advantages of making the surgical treatment of deep vein thrombosis of lower limbs safer, simpler and lower in cost.
  • the present application provides a balloon catheter sheath.
  • the balloon catheter sheath includes a sheath tube and an external interface of the balloon catheter sheath.
  • the outer wall of the sheath is provided with a balloon, and the outer interface of the balloon catheter sheath is provided with 3 channels.
  • the 3 channels are the first channel, the second channel, and the third channel.
  • One of the three channels is A channel communicates with the balloon, and the channel can inflate or deflate the balloon.
  • the balloon is located at the port position of the sheath.
  • the other two channels among the three channels are respectively a liquid flushing channel and a thrombus suction catheter channel.
  • the beneficial effect of the present invention is that the principle of the present application is to add a balloon and an inflation and deflation channel corresponding to the balloon in the ordinary catheter sheath, so that the catheter in the balloon catheter sheath passes through the deep vein of the contralateral lower extremity ( When the iliac vein extends into the deep vein (iliac vein) of the affected side, the balloon is in a deflated state and will not affect the extension of the balloon catheter sheath into the blood vessel. When it extends into the iliac vein opening of the affected lower extremity, the balloon passes through The channel is inflated, so that after the balloon is inflated, the deep venous vessels of the affected leg will be temporarily blocked.
  • the other two channels are used to flush the fluid and the other to suck the thrombus.
  • the balloon After the balloon is inflated, the deep venous vessels of the affected leg will be temporarily sealed. Therefore, the deep venous thrombosis of the affected side will not bypass the balloon catheter sheath and enter the inferior vena cava, and will not cause the serious consequences of secondary pulmonary embolism, so that the deep venous thrombosis of the affected leg can be safely aspirated.
  • the balloon is deflated, and the balloon is restored to its original size, so that it can be taken out along with the balloon catheter sheath.
  • This kind of structure is simple and completely avoids thrombus shedding and secondary pulmonary embolism that may be caused in the process of thrombus aspiration.
  • the structure does not retain any substance in the body, and improves the quality of life of the patient.
  • the inferior vena cava filter needs to be inserted before the operation and the inferior vena cava filter needs to be removed after the operation, this patented product simplifies the operation process and completely eliminates the possibility of thrombosis during the aspiration process Sex.
  • the inferior vena cava filter After the inferior vena cava filter is installed, due to the large number of thrombosis and technical inability to remove the filter, 30-40% of the inferior vena cava filter cannot be removed and remains in the patient's body for life. It is necessary to take anticoagulant for the rest of the patient's life. Health risks and economic pressure.
  • Figure 1 is a schematic diagram of the structure of a human lower limb venous system.
  • Figure 2 is a schematic diagram of the structure of a common catheter sheath.
  • Fig. 3 is a schematic diagram of the structure of the balloon catheter sheath provided by the present invention.
  • FIG. 1 is a schematic diagram of the lower extremity veins of the human body.
  • the lower extremity veins of the human body have three main parts, the inferior vena cava 10, the left lower extremity deep vein 11, and the right lower extremity deep vein 12.
  • Deep vein thrombosis of the lower extremity is a common disease. In most patients, thrombosis occurs in only one deep vein, such as the deep vein 11 of the left lower extremity or the deep vein 12 of the right lower extremity as shown in Figure 1.
  • the existing treatment method for venous thrombosis of the lower extremities is to extend a catheter sheath from the femoral vein of the healthy lower extremity.
  • the catheter sheath has two ports, a first port 21 and a second port 22.
  • the first port flushes liquid (usually normal saline) inward to keep the catheter sheath unobstructed.
  • the second port The port 22 is inserted into the vein of the affected limb with a thrombus aspiration catheter, usually an Angiojet thrombus aspiration catheter to aspirate the thrombus, so that the deep vein thrombosis of the affected side is drawn out of the body through the Angiojet thrombus aspiration catheter, and then the venous thrombosis is treated.
  • a thrombus aspiration catheter usually an Angiojet thrombus aspiration catheter to aspirate the thrombus, so that the deep vein thrombosis of the affected side is drawn out of the body through the Angiojet thrombus aspiration catheter, and then the venous thrombosis is treated.
  • this method has a problem. In the process of aspirating thrombus, some thrombus will inevitably bypass the catheter sheath and reach the vena cava 10. Since the inferior vena cava of the human body is much thicker than the veins of the lower limbs,
  • the thrombus will pass through the right atrium and right ventricle, and then enter the pulmonary artery, causing secondary embolism of the pulmonary artery, seriously affecting the body's health and even causing death.
  • the medical community has provided a solution, that is, the inferior vena cava filter is inserted before the operation.
  • the filter is a macroporous mesh structure.
  • the filter is placed in the inferior vena cava before the operation.
  • the vena cava filter filters part of the thrombus bypassing the catheter sheath to achieve the purpose of preventing pulmonary embolism.
  • the existing vena cava filter has a hollow structure, which can only filter larger thrombus. Blood clots cannot be filtered.
  • the vena cava filter placed in the body is a disposable product, and about 30%-40% of patients cannot remove the vena filter after surgery.
  • the inferior vena cava filter is more prone to thrombosis, and the patient needs to be treated with oral medication for life.
  • the price of the vena cava filter is very expensive, and the price of a single vena cava filter is more than 10,000 yuan, which puts a lot of economic pressure on the patient.
  • Figure 3 provides a balloon catheter sheath
  • the balloon catheter sheath includes: a sheath 30, a balloon catheter sheath outer interface 31, the outer wall of the sheath 30 is provided with a balloon 301, the balloon catheter
  • the sheath outer interface 31 is provided with three channels, the three channels are respectively the first channel 310, the second channel 311 and the third channel 312, wherein one channel of the three channels is connected to the balloon 301, and the one channel can
  • the balloon 301 is inflated or deflated.
  • the present application provides a balloon catheter sheath.
  • the balloon catheter sheath includes a common double-lumen vascular catheter sheath, a blocking balloon is arranged at the head end of the catheter sheath, and the balloon inflation port is located at the end of the sheath (external end).
  • the balloon catheter sheath is a three-channel device, channel 1 is a balloon inflation channel; channel 2 is a sheath flushing channel; channel 3 is a delivery catheter channel.
  • the principle of this application is to add a balloon and an inflation and deflation channel corresponding to the balloon at the end of the ordinary catheter sheath, so that when the sheath of the balloon catheter sheath extends into the affected iliac vein, the balloon In order to deflate, it will not affect the extension of the balloon catheter sheath into the blood vessel.
  • the balloon When it extends into the affected iliac vein, the balloon is inflated through the channel, so that the deep vein lumen of the lower extremity will be temporarily blocked after the balloon is inflated. At this time, one flushes the fluid through the other two channels, and the other is inserted into the Angiojet thrombus suction catheter to suck the thrombus.
  • the thrombus will not bypass the balloon catheter sheath, and thus can be more effective.
  • the balloon is deflated, and the balloon returns to its original size, so that it can be taken out along with the balloon catheter sheath.
  • the structure is simple, and the venous thrombosis is cleaned very cleanly, and this structure does not retain any substance in the body, improves the health of the patient, and improves the treatment effect.
  • the other two channels among the above-mentioned three channels are respectively a liquid flushing channel and a channel passing through a plug-suction catheter.
  • the balloon 301 is located at the port position of the catheter 30, and the purpose of setting the port position of the catheter 30 is that the closer it is to the port, the closer the cleaned thrombus is to the thrombus suction channel, and the better the absorption of the thrombus.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)

Abstract

A balloon catheter sheath. The balloon catheter sheath comprises a common dual-lumen vascular catheter sheath. An occlusion balloon (301) is disposed at a head end of the catheter sheath. An inflation port of the balloon (301) is located at a sheath tail end (31). The balloon catheter sheath is a three-channel apparatus. A first channel (310) is a balloon inflation channel; a second channel (311) is a sheath catheter cleaning channel; and a third channel (312) is a delivery catheter channel. The balloon catheter sheath makes safe, convenient and low-cost deep vein thrombectomy become possible.

Description

球囊导管鞘Balloon catheter sheath 技术领域Technical field
本申请涉及医疗设备领域,具体涉及一种球囊导管鞘。The application relates to the field of medical equipment, in particular to a balloon catheter sheath.
背景技术Background technique
下肢深静脉血栓是常见的周围血管疾病,下肢深静脉血栓导致的下肢静脉回流受阻及并发的肺栓塞是病人劳动力及生命安全的一个重大危险。现有的下肢静脉血栓的治疗器材是通过普通导管鞘和下腔静脉滤器来实施静脉取栓术,但是此种方法的治疗安全性差,过程复杂,费用高。Deep vein thrombosis of the lower extremities is a common peripheral vascular disease. The obstruction of venous return of the lower extremities and the concurrent pulmonary embolism caused by deep vein thrombosis of the lower extremities are a major danger to the patient's labor and life safety. The existing treatment equipment for lower extremity venous thrombosis uses common catheter sheaths and inferior vena cava filters to perform venous thrombectomy, but this method has poor treatment safety, complex procedures, and high costs.
技术问题technical problem
本发明的目的在于提供一种球囊导管鞘,该技术方案具有使下肢深静脉血栓的手术治疗更安全、更简便、费用更低的优点。The purpose of the present invention is to provide a balloon catheter sheath, which has the advantages of making the surgical treatment of deep vein thrombosis of lower limbs safer, simpler and lower in cost.
技术解决方案Technical solutions
本发明所采取的技术方案是:The technical scheme adopted by the present invention is:
本申请提供一种球囊导管鞘,该球囊导管鞘包括:鞘管、球囊导管鞘外部接口, The present application provides a balloon catheter sheath. The balloon catheter sheath includes a sheath tube and an external interface of the balloon catheter sheath.
所述鞘管的外壁设置有球囊,所述球囊导管鞘外部接口设置有3个通道, 3个通道分别为第一通道、第二通道和第三通道,其中,3个通道中的一个通道与所述球囊连通,该通道能够对所述球囊充气或放气。The outer wall of the sheath is provided with a balloon, and the outer interface of the balloon catheter sheath is provided with 3 channels. The 3 channels are the first channel, the second channel, and the third channel. One of the three channels is A channel communicates with the balloon, and the channel can inflate or deflate the balloon.
可选的,所述球囊位于所述鞘管的端口位置。Optionally, the balloon is located at the port position of the sheath.
可选的,所述3个通道中的另二个通道分别为冲液体通道以及吸血栓导管通道。Optionally, the other two channels among the three channels are respectively a liquid flushing channel and a thrombus suction catheter channel.
有益效果Beneficial effect
本发明的有益效果是,本申请的原理为,在普通导管鞘中增加一个球囊以及与球囊对应的充放气通道,这样,在该球囊导管鞘的导管经健侧下肢深静脉(髂静脉)伸入患侧深静脉(髂静脉)血管时,球囊为放气状态,不会影响球囊导管鞘伸入血管,当伸入到患侧下肢髂静脉开口时,该球囊通过通道充气,这样球囊充气后会将患侧下肢深静脉血管暂时封堵,此时通过另外二个通道一个冲液体,一个吸血栓,由于球囊充气后会将患侧下肢深静脉血管暂时封堵,因此患侧深静脉血栓不会绕过球囊导管鞘进入下腔静脉,不会引起继发性的肺动脉栓塞的严重后果,进而能够安全的对患侧下肢深静脉血栓进行抽吸,当处理完毕以后,将该球囊放气,则该球囊恢复成原来的大小,这样可以随着球囊导管鞘取出。此种结构简单,完全避免了吸栓过程中可能导致的血栓脱落和继发性肺动脉栓塞。本结构不会滞留体内任何物质,提高了患者的生活质量。相对于目前进行的传统深静脉血栓吸栓术前需进行下腔静脉滤器的置入,和术后需要取出下腔静脉滤器,本专利产品简化了手术过程,完全排除吸栓过程中血栓脱落可能性。下腔静脉滤器安置后因为滤器有大量血栓和技术性无法取出等原因,有30-40%下腔静脉滤器无法取出,终生留置于病人体内,需终生服用抗凝剂,给病人的余生带来巨大的健康隐患和经济压力。The beneficial effect of the present invention is that the principle of the present application is to add a balloon and an inflation and deflation channel corresponding to the balloon in the ordinary catheter sheath, so that the catheter in the balloon catheter sheath passes through the deep vein of the contralateral lower extremity ( When the iliac vein extends into the deep vein (iliac vein) of the affected side, the balloon is in a deflated state and will not affect the extension of the balloon catheter sheath into the blood vessel. When it extends into the iliac vein opening of the affected lower extremity, the balloon passes through The channel is inflated, so that after the balloon is inflated, the deep venous vessels of the affected leg will be temporarily blocked. At this time, the other two channels are used to flush the fluid and the other to suck the thrombus. After the balloon is inflated, the deep venous vessels of the affected leg will be temporarily sealed. Therefore, the deep venous thrombosis of the affected side will not bypass the balloon catheter sheath and enter the inferior vena cava, and will not cause the serious consequences of secondary pulmonary embolism, so that the deep venous thrombosis of the affected leg can be safely aspirated. After the treatment is completed, the balloon is deflated, and the balloon is restored to its original size, so that it can be taken out along with the balloon catheter sheath. This kind of structure is simple and completely avoids thrombus shedding and secondary pulmonary embolism that may be caused in the process of thrombus aspiration. The structure does not retain any substance in the body, and improves the quality of life of the patient. Compared with the current traditional deep vein thrombosis, the inferior vena cava filter needs to be inserted before the operation and the inferior vena cava filter needs to be removed after the operation, this patented product simplifies the operation process and completely eliminates the possibility of thrombosis during the aspiration process Sex. After the inferior vena cava filter is installed, due to the large number of thrombosis and technical inability to remove the filter, 30-40% of the inferior vena cava filter cannot be removed and remains in the patient's body for life. It is necessary to take anticoagulant for the rest of the patient's life. Health risks and economic pressure.
附图说明Description of the drawings
为了更清楚地说明本申请实施例中的技术方案,下面将对实施例描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图是本申请的一些实施例,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 describe the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings needed in the description of the embodiments. Obviously, the drawings in the following description are some embodiments of the present application. A person of ordinary skill in the art can obtain other drawings based on these drawings without creative work.
图1为人的下肢静脉系结构示意图。Figure 1 is a schematic diagram of the structure of a human lower limb venous system.
图2为一种普通导管鞘的结构示意图。Figure 2 is a schematic diagram of the structure of a common catheter sheath.
图3为本发明提供的球囊导管鞘的结构示意图。Fig. 3 is a schematic diagram of the structure of the balloon catheter sheath provided by the present invention.
本发明的实施方式Embodiments of the present invention
下面将结合本申请实施例中的附图,对本申请实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本申请一部分实施例,而不是全部的实施例。基于本申请中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本申请保护的范围。The technical solutions in the embodiments of the present application will be described clearly and completely in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of them. Based on the embodiments in this application, all other embodiments obtained by a person of ordinary skill in the art without creative work shall fall within the protection scope of this application.
本申请的说明书和权利要求书及所述附图中的术语“第一”、“第二”、“第三”和“第四”等是用于区别不同对象,而不是用于描述特定顺序。此外,术语“包括”和“具有”以及它们任何变形,意图在于覆盖不排他的包含。例如包含了一系列步骤或单元的过程、方法、系统、产品或设备没有限定于已列出的步骤或单元,而是可选地还包括没有列出的步骤或单元,或可选地还包括对于这些过程、方法、产品或设备固有的其它步骤或单元。The terms "first", "second", "third" and "fourth" in the specification and claims of the application and the drawings are used to distinguish different objects, rather than describing a specific order . In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but optionally includes unlisted steps or units, or optionally also includes Other steps or units inherent in these processes, methods, products or equipment.
在本文中提及“实施例”意味着,结合实施例描述的特定特征、结构或特性可以包含在本申请的至少一个实施例中。在说明书中的各个位置出现该短语并不一定均是指相同的实施例,也不是与其它实施例互斥的独立的或备选的实施例。本领域技术人员显式地和隐式地理解的是,本文所描述的实施例可以与其它实施例相结合。Reference to "embodiments" herein means that a specific feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various places in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment mutually exclusive with other embodiments. Those skilled in the art clearly and implicitly understand that the embodiments described herein can be combined with other embodiments.
参阅图1,图1为人体的下肢静脉示意图,如图1所示,人体下肢静脉具有3个主要的部分,下腔静脉10、左下肢深静脉11以及右下肢深静脉12。下肢深静脉血栓属于一种常见的病,在大多数患者一般只有一侧的深静脉产生血栓,例如图1所示的,左下肢深静脉11或右下肢深静脉12。现有的下肢静脉血栓的治疗方式为从健侧下肢股静脉伸入一种导管鞘,如图2所示,该导管鞘具有二个接口,第一接口21和第二接口22,当导管鞘的头端伸入患侧下肢髂静脉的位置(该位置可以通过手术中的DSA设备检测出来)时,第一接口向内冲液体(一般为生理盐水),保持导管鞘通畅,此时第二接口22向患肢静脉内置入吸栓导管,通常为Angiojet吸栓导管抽吸血栓,这样患侧深静脉血栓经过Angiojet吸栓导管抽出体外,进而对静脉血栓进行治疗。但是此种方式具有一个问题,吸栓过程中必然有部分血栓会绕过导管鞘而到达腔静脉10,由于人体的下腔静脉比下肢静脉粗很多,因此一般不会在下腔静脉10形成二次栓塞,但是经过下腔静脉10后血栓会通过右心房、右心室,进而进入肺动脉,导致肺动脉二次栓塞,严重影响人体的身体健康甚至引起死亡。Refer to FIG. 1, which is a schematic diagram of the lower extremity veins of the human body. As shown in FIG. 1, the lower extremity veins of the human body have three main parts, the inferior vena cava 10, the left lower extremity deep vein 11, and the right lower extremity deep vein 12. Deep vein thrombosis of the lower extremity is a common disease. In most patients, thrombosis occurs in only one deep vein, such as the deep vein 11 of the left lower extremity or the deep vein 12 of the right lower extremity as shown in Figure 1. The existing treatment method for venous thrombosis of the lower extremities is to extend a catheter sheath from the femoral vein of the healthy lower extremity. As shown in Figure 2, the catheter sheath has two ports, a first port 21 and a second port 22. When the tip of the tube is inserted into the position of the iliac vein of the lower limb on the affected side (this position can be detected by the DSA device in the operation), the first port flushes liquid (usually normal saline) inward to keep the catheter sheath unobstructed. At this time, the second port The port 22 is inserted into the vein of the affected limb with a thrombus aspiration catheter, usually an Angiojet thrombus aspiration catheter to aspirate the thrombus, so that the deep vein thrombosis of the affected side is drawn out of the body through the Angiojet thrombus aspiration catheter, and then the venous thrombosis is treated. However, this method has a problem. In the process of aspirating thrombus, some thrombus will inevitably bypass the catheter sheath and reach the vena cava 10. Since the inferior vena cava of the human body is much thicker than the veins of the lower limbs, it is generally not formed in the inferior vena cava 10. Embolism, but after passing through the inferior vena cava 10, the thrombus will pass through the right atrium and right ventricle, and then enter the pulmonary artery, causing secondary embolism of the pulmonary artery, seriously affecting the body's health and even causing death.
为了解决这种问题, 医学界提供了一种方案,即术前置入下腔静脉过滤器的方案,该滤器为大孔网格状结构,术前将该滤器安置在下腔静脉内,可通过该腔静脉过滤器对绕过导管鞘的部分血栓进行过滤以达到防止肺栓塞的目的,但是现有的腔静脉过滤器为镂空结构,该镂空结构只能过滤较大的血栓,对于较小的血栓无法过滤。另外,安置于体内的腔静脉过滤器为一次性用品,并且有30%-40%左右的患者的静脉过滤器术后无法取出。如果滤器无法取出,这样下腔静脉滤器更容易产生血栓,需要病人终生口服药物抗凝治疗。并且腔静脉过滤器的价格非常昂贵,单个腔静脉过滤器的价格都超过1万元人民币,这对于患者的经济压力大。In order to solve this problem, the medical community has provided a solution, that is, the inferior vena cava filter is inserted before the operation. The filter is a macroporous mesh structure. The filter is placed in the inferior vena cava before the operation. The vena cava filter filters part of the thrombus bypassing the catheter sheath to achieve the purpose of preventing pulmonary embolism. However, the existing vena cava filter has a hollow structure, which can only filter larger thrombus. Blood clots cannot be filtered. In addition, the vena cava filter placed in the body is a disposable product, and about 30%-40% of patients cannot remove the vena filter after surgery. If the filter cannot be removed, the inferior vena cava filter is more prone to thrombosis, and the patient needs to be treated with oral medication for life. In addition, the price of the vena cava filter is very expensive, and the price of a single vena cava filter is more than 10,000 yuan, which puts a lot of economic pressure on the patient.
参阅图3,图3提供了一种球囊导管鞘,该球囊导管鞘包括:鞘管30、球囊导管鞘外部接口31,该鞘管30的外壁设置有球囊301,该球囊导管鞘外部接口31设置有3个通道, 3个通道分别为第一通道310、第二通道311和第三通道312,其中,3个通道中的一个通道与该球囊301连通,该一个通道能够对该球囊301充气或放气。Referring to Figure 3, Figure 3 provides a balloon catheter sheath, the balloon catheter sheath includes: a sheath 30, a balloon catheter sheath outer interface 31, the outer wall of the sheath 30 is provided with a balloon 301, the balloon catheter The sheath outer interface 31 is provided with three channels, the three channels are respectively the first channel 310, the second channel 311 and the third channel 312, wherein one channel of the three channels is connected to the balloon 301, and the one channel can The balloon 301 is inflated or deflated.
本申请提供了一种球囊导管鞘,该球囊导管鞘包括:普通的双腔血管导管鞘、导管鞘的头端安置有阻断球囊,球囊充气口位于鞘末端(体外端)。该球囊导管鞘为三通道装置,通道1为球囊充气通道;通道2为鞘管冲洗通道;通道3为输送导管通道。本申请提供的技术方案使安全、便捷、低费用的深静脉取栓手术成为可能。The present application provides a balloon catheter sheath. The balloon catheter sheath includes a common double-lumen vascular catheter sheath, a blocking balloon is arranged at the head end of the catheter sheath, and the balloon inflation port is located at the end of the sheath (external end). The balloon catheter sheath is a three-channel device, channel 1 is a balloon inflation channel; channel 2 is a sheath flushing channel; channel 3 is a delivery catheter channel. The technical solution provided by this application makes deep vein thrombus removal surgery possible in a safe, convenient, and low-cost manner.
本申请的原理为,在普通导管鞘鞘管的末端增加一个球囊以及与球囊对应的充放气通道,这样,在该球囊导管鞘的鞘管伸入患侧髂静脉时,球囊为放气状态,不会影响球囊导管鞘伸入血管,当伸入到患侧髂静脉内时,该球囊通过通道充气,这样球囊充气后会将下肢深静脉管腔暂时封堵,此时通过另外二个通道一个冲液体,一个置入Angiojet吸栓导管抽吸血栓,由于球囊充气后会将下肢静脉血管暂时封堵,因此血栓不会绕过球囊导管鞘,进而能够较好的对下肢静脉血栓抽吸和预防肺动脉栓塞。当血栓抽吸完毕以后,将该球囊放气,则该球囊恢复成原来的大小,这样可以随着球囊导管鞘取出。此种结构简单,并且静脉血栓清理很干净,并且此种结构不会滞留体内任何物质,提高了患者的健康,提高了治疗效果。The principle of this application is to add a balloon and an inflation and deflation channel corresponding to the balloon at the end of the ordinary catheter sheath, so that when the sheath of the balloon catheter sheath extends into the affected iliac vein, the balloon In order to deflate, it will not affect the extension of the balloon catheter sheath into the blood vessel. When it extends into the affected iliac vein, the balloon is inflated through the channel, so that the deep vein lumen of the lower extremity will be temporarily blocked after the balloon is inflated. At this time, one flushes the fluid through the other two channels, and the other is inserted into the Angiojet thrombus suction catheter to suck the thrombus. Because the balloon will temporarily block the veins of the lower extremities after the balloon is inflated, the thrombus will not bypass the balloon catheter sheath, and thus can be more effective. Good for aspiration of venous thrombosis of lower extremities and prevention of pulmonary embolism. After the thrombus is sucked, the balloon is deflated, and the balloon returns to its original size, so that it can be taken out along with the balloon catheter sheath. The structure is simple, and the venous thrombosis is cleaned very cleanly, and this structure does not retain any substance in the body, improves the health of the patient, and improves the treatment effect.
可选的,上述3个通道中的另二个通道分别为冲液体通道以及通过吸栓导管通道。Optionally, the other two channels among the above-mentioned three channels are respectively a liquid flushing channel and a channel passing through a plug-suction catheter.
可选的,上述球囊301位于导管30的端口位置,设置在导管30的端口位置的目的是离端口越近,则清洗的血栓离吸血栓通道越近,血栓的吸收越好。Optionally, the balloon 301 is located at the port position of the catheter 30, and the purpose of setting the port position of the catheter 30 is that the closer it is to the port, the closer the cleaned thrombus is to the thrombus suction channel, and the better the absorption of the thrombus.
以上对本申请实施例进行了详细介绍,本文中应用了具体个例对本申请的原理及实施方式进行了阐述,以上实施例的说明只是用于帮助理解本申请的方法及其核心思想;同时,对于本领域的一般技术人员,依据本申请的思想,在具体实施方式及应用范围上均会有改变之处,综上所述,本说明书内容不应理解为对本申请的限制。The embodiments of the application are described in detail above, and specific examples are used in this article to illustrate the principles and implementation of the application. The descriptions of the above embodiments are only used to help understand the methods and core ideas of the application; at the same time, for Those of ordinary skill in the art, based on the ideas of the application, will have changes in the specific implementation and the scope of application. In summary, the content of this specification should not be construed as limiting the application.

Claims (3)

  1. 一种球囊导管鞘,该球囊导管鞘包括:鞘管、球囊导管鞘外部接口,其特征在于,A balloon catheter sheath comprising: a sheath tube and an external interface of the balloon catheter sheath, characterized in that:
    所述鞘管的头端外壁设置有球囊,所述球囊导管鞘外部接口设置有3个通道, 3个通道分别为第一通道、第二通道和第三通道,其中,3个通道中的一个通道与所述球囊连通,该通道能够对所述球囊充气或放气。The outer wall of the head end of the sheath is provided with a balloon, and the outer interface of the balloon catheter sheath is provided with 3 channels. The 3 channels are the first channel, the second channel, and the third channel. One of the channels communicates with the balloon, and the channel can inflate or deflate the balloon.
  2. 根据权利要求1所述的球囊导管鞘,其特征在于,The balloon catheter sheath of claim 1, wherein:
    所述球囊位于所述鞘管的端口位置。The balloon is located at the port position of the sheath.
  3. 根据权利要求1或2所述的球囊导管鞘,其特征在于,The balloon catheter sheath of claim 1 or 2, wherein:
    所述3个通道中的另二个通道分别为冲液体通道以及吸血栓导管通道。The other two channels among the three channels are respectively a liquid flushing channel and a thrombus suction catheter channel.
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CN112823817A (en) * 2019-11-21 2021-05-21 崔永锡 Double-balloon catheter sheath
WO2021097741A1 (en) * 2019-11-21 2021-05-27 崔永锡 Double-balloon internal drainage catheter sheath
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