CN114668958A - A drug balloon catheter with blood blocking and plaque cutting functions - Google Patents
A drug balloon catheter with blood blocking and plaque cutting functions Download PDFInfo
- Publication number
- CN114668958A CN114668958A CN202210202644.3A CN202210202644A CN114668958A CN 114668958 A CN114668958 A CN 114668958A CN 202210202644 A CN202210202644 A CN 202210202644A CN 114668958 A CN114668958 A CN 114668958A
- Authority
- CN
- China
- Prior art keywords
- unit
- balloon
- tube
- wire
- drug
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
Links
Images
Classifications
-
- 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
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
-
- 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
- A61M25/10—Balloon catheters
- A61M25/1025—Connections between catheter tubes and inflation tubes
-
- 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
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
- A61M2025/1013—Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
-
- 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
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
-
- 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
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
-
- 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
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
-
- 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
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Child & Adolescent Psychology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
本发明属于心血管内介入治疗技术领域,尤其涉及一种具有血液阻断、斑块切割功能的药物球囊导管。本发明通过在三腔管单元上设置后支架球囊单元、前封堵球囊单元、牵引用导丝以及组合三管单元的方式,达到药物球囊给血管内壁上药前血液阻断、斑块切割的目的。本发明具有以下优点:第一,三腔管单元中,一腔用于安装导丝,还有一腔用于膨胀后支架球囊单元,最后一腔用于膨胀前封堵球囊单元,保证三个动作相互独立、互不影响;第二,后支架球囊单元的表面涂覆有药物,其在药物球囊导管插入前、插入时一直收拢,减少血液对药物的冲刷、损耗。
The invention belongs to the technical field of cardiovascular interventional therapy, in particular to a drug balloon catheter with blood blocking and plaque cutting functions. In the present invention, the rear stent balloon unit, the front blocking balloon unit, the guide wire for traction and the combined three-tube unit are arranged on the three-lumen tube unit, so as to achieve blood blocking and plaque reduction before the drug balloon is applied to the inner wall of the blood vessel. The purpose of block cutting. The present invention has the following advantages: firstly, in the three-lumen tube unit, one chamber is used for installing the guide wire, another chamber is used for the stent balloon unit after inflation, and the last chamber is used for blocking the balloon unit before inflation, ensuring three These actions are independent of each other and do not affect each other; second, the surface of the rear stent balloon unit is coated with drugs, which are always closed before and during insertion of the drug balloon catheter to reduce the scouring and loss of drugs by blood.
Description
技术领域technical field
本发明属于心血管内介入治疗技术领域,尤其涉及一种具有血液阻断、斑块切割功能的药物球囊导管。The invention belongs to the technical field of cardiovascular interventional therapy, in particular to a drug balloon catheter with blood blocking and plaque cutting functions.
背景技术Background technique
血管疾病,例如血管钙化、动脉粥样硬化等,其病变表现一般都包括血管内径变狭窄,此时就需要血管介入手术,来疏通原本堵塞的血管。而血管介入手术随着神经影像学、导管技术和材料、计算机等科学的迅速发展,也已经经历了逐渐优化的多代技术。Vascular diseases, such as vascular calcification, atherosclerosis, etc., generally include the narrowing of the inner diameter of the blood vessels. At this time, vascular interventional surgery is required to clear the originally blocked blood vessels. With the rapid development of neuroimaging, catheter technology and materials, computers and other sciences, vascular interventional surgery has also experienced multiple generations of gradually optimized technologies.
1、球囊导管介入1. Balloon catheter intervention
球囊导管是一种血管内成形术的常用工具,其通过导丝和指引导管,将球囊送入血管狭窄部位,用压力扩张球囊,使斑块裂解,进而最终扩张血管、改善血液流动。但是术后有30-40%的病人,由于血管内皮损伤、平滑肌细胞过度增生以及扩张的血管缺乏支持等诸多原因,而使血管再次变狭窄。A balloon catheter is a commonly used tool for endovascular angioplasty. It uses a guide wire and a guiding catheter to deliver a balloon into the stenosis of the blood vessel, inflate the balloon with pressure, break the plaque, and finally dilate the blood vessel and improve blood flow. . However, in 30-40% of patients after surgery, the blood vessels become narrowed again due to many reasons such as vascular endothelial injury, excessive proliferation of smooth muscle cells, and lack of support for the dilated blood vessels.
2、血管支架治疗2. Vascular stent treatment
这种技术就是在上述球囊的外面,再装上网状的金属支架,仍然是通过球囊导管,将支架送至病变部位,扩张球囊后将支架永久地嵌入患者冠状动脉内膜。但是,该方式下仍然有10-20%病人的血管会由于人体的免疫反应引起平滑肌增生,最终使得支架扩张后的血管再次变狭窄。This technique is to install a mesh-shaped metal stent on the outside of the above-mentioned balloon, still through a balloon catheter, to deliver the stent to the lesion site, and then to permanently embed the stent into the coronary intima of the patient after expanding the balloon. However, in this way, the blood vessels of 10-20% of the patients still have smooth muscle hyperplasia due to the immune response of the human body, and finally the blood vessels after stent expansion will be narrowed again.
由于支架已永久地嵌入患者冠状动脉内膜,要取出已植入的支架,进行再次支架植入已不可能。Since the stent is permanently embedded in the patient's coronary intima, it is impossible to remove the implanted stent and re-stent it.
3、载药支架技术3. Drug-loaded stent technology
为解决支架植入后所引起的血管再次狭窄的问题,载药支架迅速成为近年来心血管支架植入治疗技术的主要手段。由于在金属支架表面涂覆了一层抑制平滑肌生长的药物,患者术后的血管再狭窄率可降至5%以下。In order to solve the problem of vascular restenosis caused by stent implantation, drug-loaded stents have rapidly become the main means of cardiovascular stent implantation treatment technology in recent years. Due to the coating of a layer of drugs that inhibit smooth muscle growth on the surface of the metal stent, the patient's postoperative vascular restenosis rate can be reduced to less than 5%.
但是与普通不载药的裸支架相比,载药支架十分昂贵,而且载药涂层上的高分子材料,还会让一些患者产生血栓,最终导致严重的不良反应。However, compared with ordinary bare stents without drug-loading, drug-loaded stents are very expensive, and the polymer material on the drug-loaded coating may cause thrombosis in some patients, eventually leading to serious adverse reactions.
4、药物球囊导管技术4. Drug Balloon Catheter Technology
所以更进一步的,带有药物涂层的球囊导管应运而生,其与载药支架相比,都有抑制平滑肌生长的药物,但是无需涂层高分子材料,因此也不会造成血栓等严重不良反应。Therefore, further, the balloon catheter with drug coating came into being. Compared with drug-loaded stent, it has drugs that inhibit the growth of smooth muscle, but it does not need coating polymer material, so it will not cause serious thrombosis and other serious problems. Adverse reactions.
此种球囊导管是在球囊的外表面涂覆具有治疗作用的药物,当球囊到达血管内的病变部位后,球囊通过扩张使其表面的药物涂层与血管内壁接触,药物释放并作用病变部位,从而达到治疗预防血管内再狭窄的目的。该方式即使病人的血管会再变窄堵塞,也可以再进行二次治疗。This kind of balloon catheter is coated with a therapeutic drug on the outer surface of the balloon. When the balloon reaches the diseased part of the blood vessel, the balloon is expanded to make the drug coating on the surface contact the inner wall of the blood vessel, and the drug is released and released. Act on the lesion site, so as to achieve the purpose of treatment and prevention of intravascular restenosis. In this way, even if the patient's blood vessels will be narrowed and blocked again, a second treatment can be performed.
例如专利公告号为CN205831969U、公告日为2016.12.28的中国实用新型专利,公开了一种介入治疗用内支架药物球囊,包括导管组、自膨胀支架和球囊;导管组包括套管、外管和内管;支架包括主体、近端部与远端部;内管自近端部穿入支架内并延伸至与远端部汇合固接,近端部滑动套接在内管外壁;支架位于球囊内,球囊一端固接在外管且球囊内部与外管内部相互连通,另一端与支架远端部及内管固接在一起。For example, the Chinese utility model patent with the patent announcement number of CN205831969U and the announcement date of 2016.12.28 discloses an inner stent drug balloon for interventional therapy, including a catheter group, a self-expanding stent and a balloon; A tube and an inner tube; the stent includes a main body, a proximal end and a distal end; the inner tube penetrates into the stent from the proximal end and extends to be confluent and fixed with the distal end, and the proximal end is slidably sleeved on the outer wall of the inner tube; the stent It is located in the balloon, one end of the balloon is fixedly connected to the outer tube, the inside of the balloon and the inside of the outer tube are connected with each other, and the other end is fixedly connected with the distal end of the bracket and the inner tube.
该实用新型专利中的支架药物球囊,可以实现最基本的药物球囊导管技术的效果,但是在使用过程中,仍然至少存在以下两个问题:The stent drug balloon in this utility model patent can achieve the effect of the most basic drug balloon catheter technology, but in the process of use, there are still at least the following two problems:
第一、球囊在进入血管时,球囊上的药物会与血管壁摩擦,进而大量脱落;First, when the balloon enters the blood vessel, the drug on the balloon will rub against the blood vessel wall, and then fall off in large quantities;
第二、同样是在球囊进入血管时,球囊上的药物会被血液冲洗,也是造成大量药物损失,到不了病变部位。Second, when the balloon enters the blood vessel, the drug on the balloon will be flushed by the blood, which also causes a large amount of drug loss and cannot reach the lesion.
所以综上所述,现在急需一种结构改良的新型药物球囊导管器械,保证球囊上的药物尽可能多地抵达血管病变部位。Therefore, in summary, there is an urgent need for a new type of drug balloon catheter device with improved structure to ensure that the drugs on the balloon reach the vascular lesions as much as possible.
发明内容SUMMARY OF THE INVENTION
本发明提供一种具有血液阻断、斑块切割功能的药物球囊导管,其能通过在三腔管单元上设置后支架球囊单元、前封堵球囊单元、牵引用导丝以及组合三管单元的方式,达到药物球囊给血管内壁上药前血液阻断、斑块切割的目的。The present invention provides a drug balloon catheter with blood blocking and plaque cutting functions, which can be achieved by arranging a rear stent balloon unit, a front blocking balloon unit, a guide wire for traction and a combined three-lumen tube unit on a three-lumen tube unit. The tube unit is used to achieve the purpose of blood blocking and plaque cutting before the drug balloon is applied to the inner wall of the blood vessel.
本发明解决上述问题采用的技术方案是:一种具有血液阻断、斑块切割功能的药物球囊导管,包括三腔管单元,设置在所述三腔管单元上,并用于在血管病变部位进行斑块切割、药物涂抹操作的后支架球囊单元,设置在所述三腔管单元上,并在所述后支架球囊单元展开前用于阻挡血液的前封堵球囊单元,设置在所述三腔管单元内的牵引用导丝,以及设置在所述三腔管单元插入后端,并用于对所述后支架球囊单元和前封堵球囊单元进行充泄压操作、对所述牵引用导丝进行插入安装操作的组合三管单元。The technical solution adopted by the present invention to solve the above problems is: a drug balloon catheter with blood blocking and plaque cutting functions, comprising a three-lumen tube unit, which is arranged on the three-lumen tube unit and is used for vascular lesions The rear stent balloon unit for plaque cutting and drug application operations is arranged on the three-lumen tube unit, and the front blocking balloon unit for blocking blood before the rear stent balloon unit is deployed is arranged on the A guide wire for traction in the three-lumen tube unit, and a guide wire disposed at the insertion rear end of the three-lumen tube unit, and used for performing pressure filling and decompression operations on the rear stent balloon unit and the front blocking balloon unit, The traction guide wire is a combined three-tube unit for inserting and installing operations.
进一步优选的技术方案在于:所述三腔管单元包括管用线材,设置在所述管用线材内的导丝通孔,设置在所述管用线材内,并用于对所述后支架球囊单元进行充泄压操作的治疗用孔道,设置在所述管用线材内,并用于对所述前封堵球囊单元进行充泄压操作的封堵用孔道,设置在所述治疗用孔道上的后端孔,以及设置在所述封堵用孔道上的前端孔。A further preferred technical solution is that: the three-lumen tube unit includes a tube wire, and a guide wire through hole arranged in the tube wire is arranged in the tube wire and used to inflate the rear stent balloon unit. The treatment hole for pressure relief operation is arranged in the tube wire, and the sealing hole for performing the pressure filling and relief operation on the front blocking balloon unit is arranged on the rear end hole of the treatment hole , and a front-end hole arranged on the plugging channel.
进一步优选的技术方案在于:所述后支架球囊单元包括套在所述管用线材上,覆盖所述后端孔,且两端封闭的非顺应性球囊,设置在所述非顺应性球囊外表面上的药物层,套在所述非顺应性球囊外侧,且两端分别固接所述管用线材的金属支架,以及设置在所述管用线材上,且分别位于所述后端孔两侧位置处的两个药物标记环。A further preferred technical solution is that: the rear stent balloon unit includes a non-compliant balloon sleeved on the tubing wire, covering the rear end hole, and closed at both ends, and disposed on the non-compliant balloon. The drug layer on the outer surface is sleeved on the outside of the non-compliant balloon, and the two ends are respectively fixed to the metal stent of the tube wire, and is arranged on the tube wire and is located at two ends of the rear end hole respectively. Two drug labeling rings at side locations.
进一步优选的技术方案在于:所述前封堵球囊单元包括套在所述管用线材上,覆盖所述前端孔,且两端封闭的顺应性球囊,以及设置在所述管用线材上的封堵标记环。A further preferred technical solution is that: the front blocking balloon unit includes a compliant balloon sleeved on the tube wire, covering the front end hole, and closed at both ends, and a sealing member disposed on the tube wire. Plug the marker ring.
进一步优选的技术方案在于:所述三腔管单元还包括设置在所述导丝通孔内,并用于安装所述药物标记环和封堵标记环的内管。A further preferred technical solution is that: the three-lumen tube unit further includes an inner tube disposed in the through hole of the guide wire and used for installing the drug marking ring and the blocking marking ring.
进一步优选的技术方案在于:所述组合三管单元包括对接所述导丝通孔,并用于插入所述牵引用导丝的中部管体,设置在所述中部管体上,且对接所述治疗用孔道的第一侧边管,以及设置在所述中部管体上,且对接所述封堵用孔道的第二侧边管。A further preferred technical solution is that: the combined three-tube unit includes a through hole for butt-jointing the guide wire, and is used for inserting the middle tube body of the guide wire for traction, is arranged on the middle tube body, and is connected to the treatment The first side pipe of the hole is used, and the second side pipe is arranged on the middle pipe body and connected to the hole for blocking.
进一步优选的技术方案在于:所述三腔管单元还包括设置在所述管用线材上的插入尖端,以及设置在所述插入尖端内的中部导丝孔。A further preferred technical solution is that: the three-lumen tube unit further comprises an insertion tip set on the tube wire, and a middle guide wire hole set in the insertion tip.
进一步优选的技术方案在于:所述中部导丝孔的孔径小于所述导丝通孔。A further preferred technical solution is that: the diameter of the middle guide wire hole is smaller than that of the guide wire through hole.
进一步优选的技术方案在于:所述前封堵球囊单元还包括分别设置在所述顺应性球囊两端,并用于嵌入所述管用线材的两个装配压环。A further preferred technical solution is that: the front occlusion balloon unit further includes two assembling pressure rings respectively disposed at both ends of the compliant balloon and used to embed the tubing wire.
进一步优选的技术方案在于:所述中部管体和管用线材之间还设有三腔连接软管。A further preferred technical solution is that a three-cavity connecting hose is further arranged between the middle pipe body and the pipe wire.
本发明具有以下优点。The present invention has the following advantages.
第一,三腔管单元中,一腔用于安装导丝,还有一腔用于膨胀后支架球囊单元,最后一腔用于膨胀前封堵球囊单元,保证三个动作相互独立、互不影响。First, in the three-lumen tube unit, one lumen is used to install the guide wire, another lumen is used to inflate the stent balloon unit, and the last lumen is used to block the balloon unit before expansion, so as to ensure that the three actions are independent of each other. Does not affect.
第二,后支架球囊单元的表面涂覆有药物,其在药物球囊导管插入前、插入时一直收拢,减少血液对药物的冲刷、损耗。Second, the surface of the rear stent balloon unit is coated with a drug, which is always closed before and during insertion of the drug balloon catheter, thereby reducing the scouring and loss of the drug by the blood.
第三,后支架球囊单元在打开前,前封堵球囊单元先打开,以用于在上游阻隔血液,保证后支架球囊单元上的药物尽可能多地转移到病变处,提高药物利用率。Third, before the rear stent balloon unit is opened, the front blocking balloon unit is opened first to block blood upstream, so as to ensure that the drugs on the rear stent balloon unit are transferred to the lesion as much as possible and improve the utilization of drugs. Rate.
第四,后支架球囊单元包括普通支架,其在膨大打开时可以嵌入、切割斑块,保证药物更快生效,效果更好。Fourth, the rear stent balloon unit includes a common stent, which can embed and cut the plaque when it is expanded and opened, so as to ensure that the drug takes effect faster and has a better effect.
第五,后支架球囊单元和前封堵球囊单元都具有标记结构,保证药物球囊导管的插入动作更加精准,后支架球囊单元足够对准病变部位。Fifth, both the rear stent balloon unit and the front blocking balloon unit have a marking structure, which ensures that the insertion action of the drug balloon catheter is more accurate, and the rear stent balloon unit is sufficiently aligned with the lesion site.
第六,后支架球囊单元和前封堵球囊单元方便充压、泄压操作,保证药物球囊导管方便撤出。Sixth, the rear stent balloon unit and the front blocking balloon unit are convenient for pressure inflation and pressure relief operations, ensuring that the drug balloon catheter is easily withdrawn.
第七,整个药物球囊导管的具体结构足够稳定,操作相对舒适、方便,适用于多种心血管疾病。Seventh, the specific structure of the entire drug balloon catheter is sufficiently stable, the operation is relatively comfortable and convenient, and it is suitable for various cardiovascular diseases.
附图说明Description of drawings
图1为本发明的结构示意图。FIG. 1 is a schematic structural diagram of the present invention.
图2为本发明中三腔管单元的位置结构示意图。FIG. 2 is a schematic diagram of the position structure of the three-lumen tube unit in the present invention.
图3为本发明中内管的位置结构示意图。FIG. 3 is a schematic diagram of the position structure of the inner tube in the present invention.
图4为本发明中组合三管单元的位置结构示意图。FIG. 4 is a schematic diagram of the positional structure of the combined three-pipe unit in the present invention.
图5为本发明中装配压环的安装位置示意图。FIG. 5 is a schematic diagram of the installation position of the assembling pressure ring in the present invention.
图6为本发明中三腔连接软管的位置结构示意图。FIG. 6 is a schematic diagram of the position and structure of the three-chamber connecting hose in the present invention.
附图中,各标号所代表的部件如下:三腔管单元1、后支架球囊单元2、前封堵球囊单元3、牵引用导丝4、组合三管单元5、管用线材101、导丝通孔102、治疗用孔道103、封堵用孔道104、后端孔105、前端孔106、非顺应性球囊201、金属支架202、药物标记环203、顺应性球囊301、封堵标记环302、内管107、中部管体501、第一侧边管502、第二侧边管503、插入尖端108、中部导丝孔109、装配压环303、三腔连接软管6。In the drawings, the components represented by the symbols are as follows: three-lumen tube unit 1, rear stent balloon unit 2, front blocking balloon unit 3,
具体实施方式Detailed ways
以下所述仅为本发明的较佳实施例,并非对本发明的范围进行限定。The following descriptions are only preferred embodiments of the present invention, and do not limit the scope of the present invention.
如附图1-6所示,一种具有血液阻断、斑块切割功能的药物球囊导管,包括三腔管单元1,设置在所述三腔管单元1上,并用于在血管病变部位进行斑块切割、药物涂抹操作的后支架球囊单元2,设置在所述三腔管单元1上,并在所述后支架球囊单元2展开前用于阻挡血液的前封堵球囊单元3,设置在所述三腔管单元1内的牵引用导丝4,以及设置在所述三腔管单元1插入后端,并用于对所述后支架球囊单元2和前封堵球囊单元3进行充泄压操作、对所述牵引用导丝4进行插入安装操作的组合三管单元5。As shown in the accompanying drawings 1-6, a drug balloon catheter with blood blocking and plaque cutting functions includes a three-lumen tube unit 1, which is arranged on the three-lumen tube unit 1 and is used for vascular lesions. The rear stent balloon unit 2 for plaque cutting and drug smearing operations is arranged on the three-lumen tube unit 1, and the front blocking balloon unit used to block blood before the rear stent balloon unit 2 is deployed 3, the
在本实施例中,该药物球囊导管的生产方法大体包括如下步骤。In this embodiment, the production method of the drug balloon catheter generally includes the following steps.
第一、所述三腔管单元1的三腔结构是自带的,在三腔管上首先需要打孔,保证所述后支架球囊单元2、前封堵球囊单元3可以在相应的打孔位置被充压膨大以及泄压缩小。First, the three-lumen structure of the three-lumen tube unit 1 is self-contained, and the three-lumen tube needs to be punched first to ensure that the rear stent balloon unit 2 and the front blocking balloon unit 3 can be in the corresponding position. The punching position is expanded by inflation and compressed by low pressure.
第二、在所述后支架球囊单元2的球囊表面,浸涂或者超声波喷涂药物。Second, dip-coating or ultrasonically spraying drugs on the balloon surface of the rear stent balloon unit 2 .
第三、将所述后支架球囊单元2的支架,通过激光焊接的方式,安装在所述三腔管单元1外环面上。Third, install the stent of the rear stent balloon unit 2 on the outer ring surface of the three-lumen tube unit 1 by laser welding.
第四、安装所述后支架球囊单元2、前封堵球囊单元3必要的标记结构,保证该药物球囊导管进入血管后,其位置可查可控。Fourth, the necessary marking structures of the rear stent balloon unit 2 and the front blocking balloon unit 3 are installed to ensure that after the drug balloon catheter enters the blood vessel, its position can be checked and controlled.
第五、将后支架球囊单元2、前封堵球囊单元3各自的球囊,安装在所述三腔管单元1外环面上。Fifth, install the respective balloons of the rear stent balloon unit 2 and the front blocking balloon unit 3 on the outer ring surface of the three-lumen tube unit 1 .
最后,对应连接所述组合三管单元5和三腔管单元1,保证“两腔充泄压、一腔穿入导丝”的基本功能有效。Finally, the combined three-
所述三腔管单元1包括管用线材101,设置在所述管用线材101内的导丝通孔102,设置在所述管用线材101内,并用于对所述后支架球囊单元2进行充泄压操作的治疗用孔道103,设置在所述管用线材101内,并用于对所述前封堵球囊单元3进行充泄压操作的封堵用孔道104,设置在所述治疗用孔道103上的后端孔105,以及设置在所述封堵用孔道104上的前端孔106。The three-lumen tube unit 1 includes a
在本实施例中,所述管用线材101的材质可以是现有常用的医疗级不锈钢或安全树脂,所述导丝通孔102在所述管用线材101的圆心中部,而所述治疗用孔道103、封堵用孔道104则是在圆心的两侧,两者尽量分开设置。In this embodiment, the material of the
此外,所述导丝通孔102是两端打通的,所述治疗用孔道103、封堵用孔道104则是从所述管用线材101和组合三管单元5连接端开始,开设至适当深度即可,例如:所述治疗用孔道103的开设深度为所述管用线材101长度的80%,所述封堵用孔道104的开设深度为所述管用线材101长度的95%。In addition, the guide wire through
最后,所述后端孔105被所述后支架球囊单元2的球囊完全覆盖,所述前端孔106被所述前封堵球囊单元3的球囊完全覆盖,保证两个球囊的膨大、缩小动作都有效,且相互独立。Finally, the
所述后支架球囊单元2包括套在所述管用线材101上,覆盖所述后端孔105,且两端封闭的非顺应性球囊201,设置在所述非顺应性球囊201外表面上的药物层,套在所述非顺应性球囊201外侧,且两端分别固接所述管用线材101的金属支架202,以及设置在所述管用线材101上,且分别位于所述后端孔105两侧位置处的两个药物标记环203。The rear stent balloon unit 2 includes a
在本实施例中,所述非顺应性球囊201指的就是该球囊受压到一定压力后,不再增大,也是现在血管介入手术的一种常用球囊了,其两端与所述管用线材101外环面激光焊接,其材质为PA或Pebax。In this embodiment, the
此外,所述药物层为微晶状体结构,其药物主体选用雷帕霉素、紫杉醇等免疫抑制剂,该药物层还包括异丙醇、乙腈等有机溶剂。所述非顺应性球囊201在药物层涂覆完毕后,通过球囊折叠机将自身折叠成几瓣并卷绕在一起,保证药物球囊导管加入血管时,药物不会被血液大量冲刷掉落。In addition, the drug layer is a micro-lens structure, and the drug body is selected from immunosuppressants such as rapamycin and paclitaxel, and the drug layer also includes organic solvents such as isopropanol and acetonitrile. After the
还有,所述金属支架202的材质为现有常见的具有记忆性能的镍钛合金,两端分别焊接在所述管用线材101外环面上,所述非顺应性球囊201膨大,即可展开所述金属支架202,最终具有挤压、切割血管钙化斑块的功能,挤压可以使得血管斑块变形、表面积增大,提高上药效率,而切割动作则更是挤压动作的升级。In addition, the material of the
所述前封堵球囊单元3包括套在所述管用线材101上,覆盖所述前端孔106,且两端封闭的顺应性球囊301,以及设置在所述管用线材101上的封堵标记环302。The front occlusion balloon unit 3 includes a
在本实施例中,所述封堵标记环302与药物标记环203的材质一样,都是以聚合塑料为主体,以Wu、Ba、Bi等为X光显影成分,保证该药物球囊导管的插入速度、深度,在X光的指引下可查、可控。而所述封堵标记环302与药物标记环203,都通过现有的压握机,将自身压在、固定在所述管用线材101外环面上。In this embodiment, the material of the
此外,所述顺应性球囊301在一定压力值范围内,随着所述前端孔106的充压越大,其膨大体积也是越大,保证在药物球囊导管到位,即血管斑块位于两个药物标记环203中间时,所述顺应性球囊301可以先充分膨大,在血管上游堵住血液,避免所述药物层展开过程中被血液大量冲洗、流失。In addition, within a certain pressure value range of the
最后,所述顺应性球囊301的材质为乳胶或硅胶,其两端也密封、固定在所述管用线材101外环面上,方式为绑线和金属环固定。Finally, the material of the
所述三腔管单元1还包括设置在所述导丝通孔102内,并用于安装所述药物标记环203和封堵标记环302的内管107。The three-lumen tube unit 1 further includes an
在本实施例中,所述药物标记环203、封堵标记环302有两种不同的安装方式可任选。In this embodiment, the
第一,安装在所述管用线材101外环面,和相对应球囊的内侧,该方法优点是可以省去所述内管107,缺点是如果标记环嵌入所述管用线材101外环面,则降低所述管用线材101的结构强度,如果不是嵌入,则自身凸出,两个球囊以及金属支架202就不能完全收拢至贴合管用线材101外环面。First, it is installed on the outer ring surface of the
第二,如上所述,标记环开设在所述内管107的外环面、内环面都行,此时第一种方法的缺点都不存在了,但是多出一个所述内管107结构,而且所述牵引用导丝4也需要在内穿过,整个药物球囊导管的结构复杂度和直径都增大了。Second, as mentioned above, the marking ring can be provided on the outer ring surface and the inner ring surface of the
最后,为了配合所述内管107的插入安装动作,此时的所述导丝通孔102可以在前端设置一个缩口的“台阶”,保证所述内管107具有一个固定的插入终点,这样所述药物标记环203、封堵标记环302的位置也就好定位了。Finally, in order to cooperate with the insertion and installation of the
所述组合三管单元5包括对接所述导丝通孔102,并用于插入所述牵引用导丝4的中部管体501,设置在所述中部管体501上,且对接所述治疗用孔道103的第一侧边管502,以及设置在所述中部管体501上,且对接所述封堵用孔道104的第二侧边管503。The combined three-
在本实施例中,所述组合三管单元5的材质可以是医疗级PP树脂,保证适当的硬度。而所述第一侧边管502、第二侧边管503的管口,分别连接充压用的生理盐水或造影剂,保证对应的所述非顺应性球囊201、顺应性球囊301可控地膨大和缩小。In this embodiment, the material of the combined three-
所述三腔管单元1还包括设置在所述管用线材101上的插入尖端108,以及设置在所述插入尖端108内的中部导丝孔109。The three-lumen tube unit 1 further includes an
在本实施例中,所述插入尖端108与所述管用线材101可以是后续焊接的,也可以是一开始就一体成型的,所述牵引用导丝4依次穿过所述中部管体501、导丝通孔102、中部导丝孔109,并在前端凸出,即可在药物球囊导管的插入动作中起到牵引效果。In this embodiment, the
所述中部导丝孔109的孔径小于所述导丝通孔102。The diameter of the middle
在本实施例中,所述中部导丝孔109的孔径小于所述导丝通孔102,即为形成了上述“台阶”结构,保证所述内管107的插入动作具有一个固定的终点。In this embodiment, the diameter of the middle
而且该设置方式的最大优点,即所述药物标记环203、封堵标记环302在所述内管107上的位置,就是标记环在所述管用线材101上的位置,两者无需换算。Moreover, the biggest advantage of this arrangement is that the positions of the
所述前封堵球囊单元3还包括分别设置在所述顺应性球囊301两端,并用于嵌入所述管用线材101的两个装配压环303。The front occlusion balloon unit 3 further includes two assembling pressure rings 303 respectively disposed at both ends of the
在本实施例中,所述装配压环303即为上述所述顺应性球囊301的安装环,保证所述顺应性球囊301两端固定牢固、密封足够。In this embodiment, the mounting
所述中部管体501和管用线材101之间还设有三腔连接软管6。A three-
在本实施例中,所述牵引用导丝4在药物球囊导管内安装完毕后,即可进行血管内的插入动作,此时所述组合三管单元5与所述管用线材101无需对齐,因此可以使用相对软质的所述三腔连接软管6,保证生理盐水或造影剂的加入、放出动作有效即可。In this embodiment, after the
而且所述三腔连接软管6的加入,使得原本所述管用线材101和组合三管单元5的“硬连硬”连接方式,改善为“硬软硬”连接,更加方便、密封性更高了。Moreover, the addition of the three-
最后,该药物球囊导管的大体使用方法及优点如下。Finally, the general use method and advantages of the drug balloon catheter are as follows.
第一,所述牵引用导丝4在所述插入尖端108上伸出,完成药物球囊导管的使用前安装操作。First, the
第二,在X光的监测下,将药物球囊导管插入血管,直至血管病变部位来到两个所述药物标记环203之间。Second, under the monitoring of X-rays, the drug balloon catheter is inserted into the blood vessel until the vascular lesions come between the two drug marking rings 203 .
第三,所述第二侧边管503处充压,让所述顺应性球囊301膨大,堵住血管,降低血液流动速度。Third, the
第四,所述第二侧边管503处保持住,接着在所述第一侧边管502处充压,让所述非顺应性球囊201膨大,并间接展开所述金属支架202,将血管斑块挤压、分割,将所述非顺应性球囊201表面的药物全部释放到血管病变部位。Fourth, the
第五,先将所述第二侧边管503泄压,再将所述第二侧边管503泄压,整个药物球囊导管回到一开始的状态,最后撤出即可。Fifth, the pressure of the
上面结合附图对本发明的实施方式作了详细说明,但是本发明不限于上述实施方式,在所述技术领域普通技术人员所具备的知识范围内,还可以在不脱离本发明宗旨的前提下做出各种修改。这些都是不具有创造性的修改,只要在本发明的权利要求范围内都受到专利法的保护。The embodiments of the present invention have been described in detail above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned embodiments, and within the scope of knowledge possessed by those of ordinary skill in the technical field, it can also be done without departing from the purpose of the present invention. various modifications. These are all non-creative modifications, as long as they are within the scope of the claims of the present invention, they are protected by the patent law.
Claims (10)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210202644.3A CN114668958A (en) | 2022-03-03 | 2022-03-03 | A drug balloon catheter with blood blocking and plaque cutting functions |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210202644.3A CN114668958A (en) | 2022-03-03 | 2022-03-03 | A drug balloon catheter with blood blocking and plaque cutting functions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN114668958A true CN114668958A (en) | 2022-06-28 |
Family
ID=82071936
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210202644.3A Pending CN114668958A (en) | 2022-03-03 | 2022-03-03 | A drug balloon catheter with blood blocking and plaque cutting functions |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN114668958A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115944344A (en) * | 2022-11-30 | 2023-04-11 | 广东博迈医疗科技股份有限公司 | Blocking device |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100274343A1 (en) * | 1996-08-23 | 2010-10-28 | Boston Scientific Scimed, Inc. | Catheter Support for Stent Delivery |
| CN102233155A (en) * | 2010-04-20 | 2011-11-09 | 廖品亮 | Medicinal plaque dissolving balloon catheter |
| CN208160821U (en) * | 2017-05-16 | 2018-11-30 | 恒壹(北京)医疗科技有限公司 | A kind of three sacculus dilating catheter of three chamber |
| CN109939336A (en) * | 2019-03-12 | 2019-06-28 | 杭州巴泰医疗器械有限公司 | A kind of belt supporting frame balloon catheter structure for blood vessel dilatation operation |
| CN213789516U (en) * | 2020-07-14 | 2021-07-27 | 唐强 | Guide wire cutting medicine balloon |
-
2022
- 2022-03-03 CN CN202210202644.3A patent/CN114668958A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100274343A1 (en) * | 1996-08-23 | 2010-10-28 | Boston Scientific Scimed, Inc. | Catheter Support for Stent Delivery |
| CN102233155A (en) * | 2010-04-20 | 2011-11-09 | 廖品亮 | Medicinal plaque dissolving balloon catheter |
| CN208160821U (en) * | 2017-05-16 | 2018-11-30 | 恒壹(北京)医疗科技有限公司 | A kind of three sacculus dilating catheter of three chamber |
| CN109939336A (en) * | 2019-03-12 | 2019-06-28 | 杭州巴泰医疗器械有限公司 | A kind of belt supporting frame balloon catheter structure for blood vessel dilatation operation |
| CN213789516U (en) * | 2020-07-14 | 2021-07-27 | 唐强 | Guide wire cutting medicine balloon |
Non-Patent Citations (1)
| Title |
|---|
| 李明华: "覆膜支架重建术在脑血管疾病中的临床应用", vol. 1, 30 September 2017, 上海科学技术出版社, pages: 3 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115944344A (en) * | 2022-11-30 | 2023-04-11 | 广东博迈医疗科技股份有限公司 | Blocking device |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN109381780B (en) | drug-coated balloon catheter | |
| JP6740296B2 (en) | Braided stent with expansion ring and method of delivery thereof | |
| JP4156371B2 (en) | Balloon catheter / stent delivery device with protrusions | |
| JP5775082B2 (en) | Expandable cerebrovascular sheath and method of use | |
| JP2918502B2 (en) | Balloon catheter for stent insertion | |
| US6379365B1 (en) | Stent delivery catheter system having grooved shaft | |
| US6190393B1 (en) | Direct stent delivery catheter system | |
| US7131986B2 (en) | Catheter having exchangeable balloon | |
| US10251766B2 (en) | Balloon catheters and systems and methods for delivering stents using such catheters | |
| US20050055077A1 (en) | Very low profile medical device system having an adjustable balloon | |
| CN109381783B (en) | Drug-coated balloon catheter | |
| JP2008513111A (en) | Guide catheter with embolism prevention function by proximal end occlusion | |
| CN101557854A (en) | Aneurysm coil delivery system | |
| JP2007511317A (en) | Vascular implant | |
| JPH10509071A (en) | Catheter with inflatable perfusion lumen | |
| WO2002096485A2 (en) | Exchangeable catheter | |
| KR20070055598A (en) | Two- and Double-diameter Balloon Angioplasty Catheter for Branching and Lateral Branch Vascular Anatomy | |
| JP2004522496A (en) | System and corresponding method for deploying an implantable intraluminal device | |
| JP2008509784A (en) | Blood vessel blocker | |
| CN115501024A (en) | Device for expanding a stent | |
| BR102019016190A2 (en) | STENT APPLICATION WITH EXPANSION ASSISTANCE APPLICATION WIRE | |
| WO2006071707A1 (en) | Inflatable biliary stent | |
| JP2022509927A (en) | Dual balloon catheter and how to use it | |
| WO2017120606A1 (en) | Balloon inside a guide catheter | |
| CN114668958A (en) | A drug balloon catheter with blood blocking and plaque cutting functions |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20220628 |
|
| RJ01 | Rejection of invention patent application after publication |