WO2021097741A1 - 双球囊内引流导管鞘 - Google Patents
双球囊内引流导管鞘 Download PDFInfo
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- WO2021097741A1 WO2021097741A1 PCT/CN2019/119869 CN2019119869W WO2021097741A1 WO 2021097741 A1 WO2021097741 A1 WO 2021097741A1 CN 2019119869 W CN2019119869 W CN 2019119869W WO 2021097741 A1 WO2021097741 A1 WO 2021097741A1
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- balloon
- sheath
- channel
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- catheter sheath
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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
- A61B17/22—Implements 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
Definitions
- the application relates to the field of medical equipment, in particular to a double-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.
- Existing therapeutic equipment for lower extremity venous thrombosis uses an inferior vena cava filter to prevent thrombus from falling off.
- this method has poor treatment safety, complex procedures, and high costs.
- the purpose of the present invention is to provide a double-balloon catheter sheath, which has the advantages of safer, simpler, and lower cost for the thrombus removal surgical treatment of deep vein thrombosis of lower limbs.
- the present application provides a double-balloon catheter sheath
- the double-ended catheter sheath includes: a catheter sheath, a double-balloon catheter sheath external interface, the outer wall of the sheath is provided with two balloons, the double-balloon catheter sheath external interface
- a first channel, a second channel, and a third channel are provided, wherein the first channel is in communication with the first balloon, the first channel can inflate or deflate the first balloon, and the second channel is connected to the first balloon.
- the two balloons are connected, the second channel can inflate or deflate the second balloon, and the third channel is the main channel of the sheath, which is connected with the flushing channel of the outer interface of the sheath and the catheter insertion inlet.
- the wall of the sheath tube is also provided with a third channel fluid-passing part.
- the distal end of the first balloon of the third channel is connected to the inferior vena cava.
- the fluid-passing part is located at the proximal end of the second balloon so that the first balloon
- the distal inferior vena cava is in blood communication with the proximal iliac vein of the second balloon.
- the liquid passage part is a through hole or a through hole with a filter screen.
- the beneficial effect of the present invention is that two balloons and a fluid-passing part are added to the ordinary catheter sheath, so that when the two balloons of the double-balloon catheter sheath are in a deflated state, they extend into the patient
- the inferior vena cava will not affect the extension of the double-balloon catheter sheath into the blood vessel.
- the first balloon When extending into the patient’s inferior vena cava, the first balloon is inflated through the channel, so that after the balloon is inflated, the inferior vena cava will be blocked, and the second balloon is inflated through the second channel to remove the contralateral iliac vein Block, at this time, from the affected side of the patient Intravenous or small saphenous vein puncture is inserted into the ordinary catheter sheath shown in Figure 2 for Angiojet embolization treatment.
- the emboli will not fall off to the inferior vena cava And the contralateral iliac vein, and the double-balloon catheter sheath has a blood circulation channel, and the blood of the contralateral lower limb vein can flow into the inferior vena cava through the fluid passage 316 and the channel 2.
- the double balloon is deflated, and the balloon returns to its original size, so that the entire double balloon catheter sheath can be taken out of the body.
- This structure is simple, and it can completely prevent the thrombus from falling off into the inferior vena cava when venous thrombosis is cleaned, and compared with the filter scheme to prevent the thrombus from falling off, this structure will not retain any substances in the body after the operation, which improves the health of the patient and improves treatment effect.
- Figure 1 is a schematic diagram of the structure of a human lower extremity vein system.
- Figure 2 is a schematic diagram of the structure of a common catheter sheath.
- Figure 3 Schematic diagram of the current plan for preventing thrombus shedding with the inferior vena cava filter.
- Figure 4 is a schematic diagram of the structure of the double-balloon catheter sheath provided by the present invention.
- Figure 5 A schematic diagram of the operation using a double-balloon catheter sheath to prevent thrombus from falling off.
- 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 deep vein of the right lower extremity 11, and the deep vein of the left lower extremity 12.
- Deep vein thrombosis of the lower extremities is a common disease. In most patients, thrombosis occurs in only one deep vein, such as the deep vein 11 of the right lower extremity or the deep vein 12 of the left lower extremity as shown in Figure 1.
- the existing treatment for venous thrombosis of the lower extremities is to extend a catheter sheath (as shown in Figure 2) from the femoral vein of the contralateral lower extremity.
- the catheter sheath has two ports, a first port 22 and a second port 21.
- the first port flushes fluid (usually normal saline) inward to keep the catheter sheath unobstructed
- the second interface 21 inserts a thrombus aspiration catheter into the vein of the affected limb, usually an Angiojet thrombus aspiration catheter to suck 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.
- the first problem is that part of the thrombus will inevitably bypass the catheter sheath and reach the inferior vena cava 10 during aspiration. Since the inferior vena cava of the human body is much thicker than the veins of the lower extremities, it is generally not A secondary embolism is formed in the inferior vena cava 10, 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 sudden death.
- the medical community has provided a solution, that is, the inferior vena cava filter is inserted before the operation, as shown in Figure 3.
- the filter is a large-porous grid structure.
- the filter is placed in the inferior vena cava before surgery.
- the vena cava filter can intercept part of the thrombus that has fallen off to prevent pulmonary embolism.
- the existing inferior vena cava filter It is a hollow structure, which can only filter larger thrombus and cannot intercept smaller thrombus. Therefore, there are still many thrombi that fall off to the pulmonary artery during the thrombus aspiration operation.
- the inferior vena cava filter placed in the body is a disposable product, and about 30%-40% of patients cannot remove the filter after surgery. If the filter cannot be removed, the inferior vena cava filter itself is more likely to induce thrombosis, and the patient needs to be treated with oral medication for life.
- the price of the inferior vena cava filter is very expensive, and the price of a single inferior vena cava filter is more than 10,000 yuan, which puts a lot of financial pressure on patients.
- Figure 3 provides a schematic diagram of the filter preventing thrombus shedding. As shown in Figure 3, after the guide wire of the catheter sheath 88 ascends to the position of the thrombus 80, the thrombus is cleaned, but the blood flow in the iliac vein is upward, that is, to Flow in the direction of the inferior vena cava, so that the detached thrombus will pass through the filter 81 and enter the inferior vena cava.
- Figure 4 provides a double-balloon catheter sheath.
- the double-balloon catheter sheath includes a sheath 30 and a double-balloon catheter sheath outer interface 31.
- the outer wall of the sheath 30 is provided with two balloons.
- the outer interface 31 of the double-balloon catheter sheath is provided with a first channel 311, a second channel 312, and a third channel.
- the first channel 311 communicates with the first balloon 301, and the first channel 311 can communicate with the first channel 311.
- the balloon 301 is inflated or deflated, the second channel 312 is in communication with the second balloon 302, the second channel 312 can inflate or deflate the second balloon 302, the third channel is the main channel of the sheath, and
- the flushing channel of the outer port of the sheath is connected to the catheter insertion inlet, and a liquid-passing part 316 is provided on the wall of the sheath.
- the wall of the sheath tube 30 is also provided with a liquid-passing portion 316, which is located at the proximal end of the second balloon.
- the present application provides a double-balloon catheter sheath.
- the double-balloon catheter sheath includes a blocking first balloon arranged at the end, the balloon inflation port is located at the head end of the sheath (external end), and the blocking second balloon is arranged in the middle. Balloon (located in the middle of the sheath).
- the double-balloon catheter sheath is a three-channel device, the channel 1 is the first balloon inflation channel; the channel 2 is the second balloon inflation channel.
- the channel 3 isolates the space between the two balloons and establishes a channel connecting the blood flow between the distal end of the distal balloon and the proximal end of the proximal balloon.
- the technical solution provided by this application can completely prevent the thrombus from falling off during deep vein thrombectomy operations, making it possible for safe, convenient, and low-cost deep vein thrombectomy operations.
- the principle of this application is (see Figure 5), two balloons are added to the outside of the ordinary catheter sheath, and a fluid-passing part is added to the tube wall.
- the sheath end of the double-balloon catheter sheath extends into the inferior vena cava of the patient, the two balloons are in a deflated state, which will not affect the extension of the double-balloon catheter sheath into the blood vessel.
- the first balloon is inflated through the channel, so that after the balloon is inflated, the inferior vena cava is blocked, and the second balloon is inflated through the second channel to block the iliac vein on the contralateral side.
- the vein or small saphenous vein is punctured and inserted into a common catheter sheath, and the Angiojet embolization catheter is introduced for aspiration. Since the inferior vena cava and the other side of the iliac vein have been blocked at this time, the embolism will not enter the inferior vena cava and the other side of the iliac vein, and the blood of the other side of the iliac vein can pass through the fluid passage 316 and channel 2. Flow into the inferior vena cava. After the thrombus is aspirated, the two balloons are deflated, and the balloons return to their original size, so that they can be taken out with the double-balloon catheter sheath.
- the bilateral iliac veins returned to normal flow into the inferior vena cava.
- This kind of structure is simple. It can fully prevent the thrombus from falling off the affected side during the Angiojet thrombus aspiration operation, and even can fully prevent part of the inferior vena cava thrombus from falling off, and this structure will not retain any substance in the body, which improves the health of the patient and improves treatment effect.
- the above-mentioned liquid passage portion 316 is a through hole or a through hole with a filter screen.
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Abstract
一种双球囊导管鞘,包括:导管鞘管(30)、双球囊导管鞘外部接口(31),鞘管(30)的外壁设置有两个球囊(301,302),双球囊导管鞘外部接口(31)设置有第一通道(311)、第二通道(312)和第三通道,其中,第一通道(311)与第一球囊(301)连通,第一通道(311)能够对第一球囊(301)充气或放气,第二通道(312)与第二球囊(302)连通,第二通道(312)能够对第二球囊(302)充气或放气。第三通道为鞘管主通道,与鞘管外部接口(31)的冲洗通道和导管置入口相连,鞘管壁上有一个通液部(316)。双球囊导管鞘具有可完全阻断Angiojet吸栓手术中患侧下肢深静脉血栓和部分下腔静脉血栓脱落的作用、不妨碍健侧肢体静脉回流、操作方便、成本低等优点。
Description
本申请涉及医疗设备领域,具体涉及一种双球囊导管鞘。
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下腔静脉滤器来防止血栓脱落的情况下实施静脉取栓术,但是此种方法的治疗安全性差,过程复杂,费用高。
本发明的目的在于提供一种双球囊导管鞘,该技术方案具有使下肢深静脉血栓的取栓手术治疗更安全、更简便、费用更低的优点。
本发明所采取的技术方案是:
本申请提供一种双球囊导管鞘,该双端导管鞘包括:导管鞘管、双球囊导管鞘外部接口,该鞘管的外壁设置有两个球囊,该双球囊导管鞘外部接口设置有第一通道、第二通道和第三通道,其中,第一通道与该第一球囊连通,该第一通道能够对该第一球囊充气或放气,该第二通道与该第二球囊连通,该第二通道能够对该第二球囊充气或放气,第三通道为鞘管主通道,与鞘管外部接口的冲洗通道和导管置入口相连。所述鞘管壁上还设置第三通道通液部,该第三通道的第一球囊远端与下腔静脉连通,该通液部位于第二球囊的近端,使第一球囊远端的下腔静脉与第二球囊近端的髂静脉血液联通。
可选的,所述通液部为通孔或有滤网的通孔。
本发明的有益效果是,在普通导管鞘鞘管增加两个球囊和一个通液部,这样,在该双球囊导管鞘的鞘管的两个球囊为放气状态时,伸入患者的下腔静脉,不会影响双球囊导管鞘伸入血管。当伸入到患者的下腔静脉内时,该第一球囊通过通道充气,这样球囊充气后会将下腔静脉封堵,第二球囊通过第二通道充气,将健侧的髂静脉封堵,此时,从患者的患侧静脉或小隐静脉穿刺置入如图2所示的普通导管鞘进行Angiojet吸栓治疗,由于此时下腔静脉和另一侧的髂静脉已经封堵,因此不会让栓子脱落到下腔静脉和健侧的髂静脉,而该双球囊导管鞘具有血液流通通道,健侧下肢静脉的血液可以通过通液部316以及通道2流入到下腔静脉。当血栓抽吸完毕以后,将该双球囊放气,则该球囊恢复成原来的大小,这样可以将双球囊导管鞘整体从体内取出。此种结构简单,并且静脉血栓清理时可以完全防止血栓脱落入下腔静脉,并且相对于滤器方案防止血栓脱落,此种结构在术后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。
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。
图1为人的下肢静脉系结构示意图。
图2为一种普通导管鞘的结构示意图。
图3 现行的用下腔静脉滤器的防止血栓脱落方案示意图。
图4 为本发明提供的双球囊导管鞘的结构示意图。
图5 用双球囊导管鞘防止血栓脱落的手术示意图。
具体实施方式
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。
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。
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。
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、右下肢深静脉11以及左下肢深静脉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,右下肢深静脉11或左下肢深静脉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22和第二接口21,当导管鞘的末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(见图3),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21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。但是此种方式具有二个问题,第一个问题:吸栓过程中必然有部分血栓会绕过导管鞘而到达下腔静脉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突然死亡。第二个问题:如果病人患侧血栓范围广泛,经髂静脉延伸至下腔静脉下端,则不合适用如图2所示的导管鞘从健侧的下肢静脉穿入,然后弯至患侧的下肢静脉中抽吸栓塞,因为该操作中可导致患侧髂静脉或下腔静脉下端血栓脱落。
为了解决手术中血栓脱落的问题, 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,见图3。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,可通过该腔静脉滤器对脱落的部分血栓进行拦截以达到防止肺栓塞的目的,但是现有的下腔静脉滤器为镂空结构,该镂空结构只能过滤较大的血栓,对于较小的血栓无法拦截,因此吸栓手术中仍有较多血栓脱落到肺动脉。另外,安置于体内的下腔静脉过滤器为一次性用品,并且有30%-40%左右的患者的滤器术后无法取出。如果滤器无法取出,这样下腔静脉滤器本身更容易诱发血栓,需要病人终生口服药物抗凝治疗。并且下腔静脉滤器的价格非常昂贵,单个下腔静脉滤器的价格都超过1万元人民币,这对于患者的经济压力很大。
图3提供了一种滤器防血栓脱落工作示意图,如图3所示,导管鞘88的导丝升入血栓80位置后,对血栓进行清理,但是在骼静脉其血流是向上的,即向下腔静脉的方向流动,这样,脱落的血栓会穿过滤器81进入到下腔静脉。
参阅图4,图4提供了一种双球囊导管鞘,该双球囊导管鞘包括:鞘管30、双球囊导管鞘外部接口31,该鞘管30的外壁设置有两个球囊,该双球囊导管鞘外部接口31设置有第一通道311、第二通道312和第三通道,其中,第一通道311与该第一球囊301连通,该第一通道311能够对该第一球囊301充气或放气,该第二通道312与该第二球囊302连通,该第二通道312能够对该第二球囊302充气或放气,第三通道为鞘管主通道,与鞘管外部接口的冲洗通道和导管置入口相连,鞘管壁上有一个通液部316。鞘管30管壁还设置有通液部316,该通液部316位于第二球囊的近端。当两个球囊都打气膨胀后,患侧的下肢静脉的血液通过通液部316以及第三通道流入患者的下腔静脉。
本申请提供了一种双球囊导管鞘,该双球囊导管鞘包括:末端安置有阻断第一球囊,球囊充气口位于鞘头端(体外端),中间安置有阻断第二球囊(位于鞘中部)。该双球囊导管鞘为三通道装置,通道1为第一球囊充气通道;通道2为第二球囊充气通道。通道3隔绝了两个球囊之间的空间,并为远端球囊的远端和近侧球囊的近端建立连接血流的通道。本申请提供的技术方案可完全预防深静脉取栓手术中的血栓脱落,使安全、便捷、低费用的深静脉取栓手术成为可能。
本申请的原理为(见图5),在普通导管鞘鞘管外部增加了两个球囊,管壁增加一个通液部。在该双球囊导管鞘的鞘管末端伸入患者的下腔静脉时,两个球囊为放气状态,不会影响双球囊导管鞘伸入血管,当伸入到患者的下腔静脉内时,该第一球囊通过通道充气,这样球囊充气后会将下腔静脉封堵,第二球囊通过第二通道充气,将健侧的髂静脉封堵,此时,从患者的患侧静脉或小隐静脉穿刺置入普通导管鞘,并导入Angiojet取栓导管进行吸栓。由于此时下腔静脉和另一侧的髂静脉已经封堵,因此不会让栓塞进入到下腔静脉和另一侧的髂静脉,另一侧髂静脉的血液可以通过通液部316以及通道2流入到下腔静脉。当血栓抽吸完毕以后,将两个球囊放气,则球囊恢复成原来的大小,这样可以随着双球囊导管鞘取出。双侧髂静脉恢复正常流入下腔静脉状态。此种结构简单,在Angiojet吸栓手术中充分防止了患侧血栓的脱落,甚至可以充分防止部分下腔静脉血栓脱落,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。
可选的,上述通液部316为通孔或有滤网的通孔。
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。
Claims (3)
- 一种双球囊导管鞘,其特征在于,所述双球囊导管鞘包括:导管鞘管、双球囊导管鞘外部接口,该鞘管的外壁设置有两个球囊,该双球囊导管鞘外部接口设置有第一通道、第二通道和第三通道,其中,第一通道与该第一球囊连通,该第一通道能够对该第一球囊充气或放气,该第二通道与该第二球囊连通,该第二通道能够对该第二球囊充气或放气,第三通道为鞘管主通道,与鞘管外部接口的冲洗通道和导管置入口相连,鞘管壁上有一个通液部。
- 根据权利要求1所述的双球囊导管鞘,其特征在于,所述第三通道设置有通液部,该第三通道的第一球囊远端侧与下腔静脉连通,该通液部位于第二球囊的近端,使第一球囊远端的下腔静脉与第二球囊近端的髂静脉血液联通。
- 根据权利要求2所述的双球囊导管鞘,其特征在于, 所述通液部为通孔或有滤网的通孔。
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