CN118490966A - Anchored medical catheter with controllable bending - Google Patents
Anchored medical catheter with controllable bending Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
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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
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
- A61M25/10184—Means for controlling or monitoring inflation or deflation
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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
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22001—Angioplasty, e.g. PCTA
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22055—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation with three or more balloons
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22065—Functions of balloons
- A61B2017/22069—Immobilising; Stabilising
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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
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1072—Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
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Abstract
本发明涉及一种可控弯的锚定医疗导管,属于医疗器械技术领域,包括导管座、导管、第一操作管和第二操作管;导管座的内腔与导管连通,第一操作管和第二操作管分别嵌入在导管座但不与导管座内腔连通,且位于导管座的两侧;第一操作管安装有控制组件,控制组件穿过第一操作管安装在导管的远端;第二操作管设置有锚定组件,锚定组件从第二操作管处延伸至导管的远端,且锚定组件位于控制组件的近端;控制组件用于控制导管远端转弯,锚定组件用于增强导管的穿透力并适应导管的转弯;控制组件能够带动导管在血管内进弯曲前进,提高导管在血管内的通过性,锚定组件还能够适应导管的弯曲,更好的贴合在血管。
The invention relates to an anchored medical catheter with controllable bending, which belongs to the technical field of medical devices, and comprises a catheter seat, a catheter, a first operating tube and a second operating tube; the inner cavity of the catheter seat is communicated with the catheter, the first operating tube and the second operating tube are respectively embedded in the catheter seat but are not communicated with the inner cavity of the catheter seat, and are located on both sides of the catheter seat; the first operating tube is installed with a control component, and the control component passes through the first operating tube and is installed at the distal end of the catheter; the second operating tube is provided with an anchoring component, the anchoring component extends from the second operating tube to the distal end of the catheter, and the anchoring component is located at the proximal end of the control component; the control component is used to control the turning of the distal end of the catheter, and the anchoring component is used to enhance the penetration of the catheter and adapt to the turning of the catheter; the control component can drive the catheter to bend and advance in a blood vessel, thereby improving the passability of the catheter in the blood vessel, and the anchoring component can also adapt to the bending of the catheter and better fit the blood vessel.
Description
技术领域Technical Field
本发明属于医疗器械技术领域,具体涉及一种可控弯的锚定医疗导管。The invention belongs to the technical field of medical devices, and in particular relates to a controllable bending anchored medical catheter.
背景技术Background Art
介入治疗是临床上针对于肿瘤性病变和血管性病变常用的治疗方法,其有创伤小、恢复快的优点,对患者手术创伤相对较小、术后恢复较快,在临床上应用比较广泛。Interventional therapy is a commonly used treatment method for tumor lesions and vascular lesions in clinical practice. It has the advantages of less trauma and faster recovery. The surgical trauma to patients is relatively small and the postoperative recovery is faster. It is widely used in clinical practice.
介入导管的通过性和去除病变能力之间存在着密切的关系。通过性指的是导管在血管或其他体内通道环中顺畅前进的能力,而去除病变能力则是指导管在到达病变部位后,利用导丝有效地执行治疗操作,如切除、栓塞或消融病变组织。There is a close relationship between the permeability and lesion removal capability of interventional catheters. Permeability refers to the ability of the catheter to smoothly advance in blood vessels or other in vivo channel rings, while lesion removal capability refers to the ability of the catheter to effectively perform treatment operations such as resection, embolization or ablation of lesion tissue using the guide wire after reaching the lesion site.
导管的软硬度对其通过性和去除病变能力有一定影响,而过硬的导管因其强度够,因此在血管内去除病变的能力强,但是在穿刺过程中可能会增加在血管或通道环中的摩擦和阻力,造成血管损伤;而较软的导管其强度较弱,去除病变的能力稍弱,但是其弯曲能力强,在穿刺过程中能够减少与血管的摩擦,避免血管损伤。The hardness of the catheter has a certain impact on its permeability and ability to remove lesions. A catheter that is too hard has a strong ability to remove lesions in blood vessels, but it may increase friction and resistance in the blood vessels or channel rings during the puncture process, causing vascular damage. A softer catheter has weaker strength and slightly weaker ability to remove lesions, but it has strong bending ability, which can reduce friction with the blood vessels during the puncture process and avoid vascular damage.
球囊导管的主要用途为配合支架进行病变血管的预扩和后扩,对于简单狭窄病变也可行单纯球囊扩张进行治疗,目前临床使用的球囊扩张导管在通过长段的迂曲、弥漫钙化特别严重的血管时,推送力不足,无法顺利通过病变血管,导致治疗此类病变的手术成功率低。The main purpose of balloon catheters is to cooperate with stents to pre-dilate and post-dilate diseased blood vessels. Simple stenosis lesions can also be treated with simple balloon dilatation. The balloon dilatation catheters currently used in clinical practice have insufficient pushing force when passing through long sections of tortuous, diffusely calcified blood vessels and are unable to pass through the diseased blood vessels smoothly, resulting in a low surgical success rate for treating such lesions.
因此,为了实现导管通过性以及去除病变能力之间的平衡,起到较好的治疗效果,对较软的介入导管进行改进,达到更好的治疗效果。Therefore, in order to achieve a balance between catheter permeability and lesion removal ability and to achieve better treatment effects, the softer interventional catheters are improved to achieve better treatment effects.
发明内容Summary of the invention
本发明提供了一种可控弯的锚定医疗导管,解决现有技术中存在介入导管通过性以及去除病变能力难以实现平衡的问题。The present invention provides a controllable-bending anchoring medical catheter, which solves the problem in the prior art that it is difficult to achieve a balance between the passability of an interventional catheter and the ability to remove lesions.
本发明的目的可以通过以下技术方案实现:The purpose of the present invention can be achieved through the following technical solutions:
一种可控弯的锚定医疗导管,包括导管座、导管、第一操作管和第二操作管;所述导管座的内腔与所述导管连通,所述第一操作管和所述第二操作管分别嵌入在所述导管座但不与所述导管座内腔连通,且位于所述导管座的两侧;A controllable bending anchoring medical catheter comprises a catheter seat, a catheter, a first operating tube and a second operating tube; the inner cavity of the catheter seat is connected to the catheter, the first operating tube and the second operating tube are respectively embedded in the catheter seat but not connected to the inner cavity of the catheter seat, and are located on both sides of the catheter seat;
所述第一操作管安装有控制组件,所述控制组件穿过所述第一操作管安装在所述导管的远端;所述第二操作管设置有锚定组件,所述锚定组件从第二操作管处延伸至所述导管的远端,且所述锚定组件位于所述控制组件的近端;所述控制组件用于控制所述导管远端转弯,所述锚定组件用于增强导管的穿透力并适应所述导管的转弯。The first operating tube is equipped with a control assembly, which passes through the first operating tube and is installed at the distal end of the catheter; the second operating tube is provided with an anchor assembly, which extends from the second operating tube to the distal end of the catheter, and the anchor assembly is located at the proximal end of the control assembly; the control assembly is used to control the turning of the distal end of the catheter, and the anchor assembly is used to enhance the penetration force of the catheter and adapt to the turning of the catheter.
优选的,所述导管包括由内至外依次设置的内层、金属层、包覆层和外管层;所述内层为爽滑性的高分子层,所述内层材料为LLDPE、PTFE、HDPE的一种;所述金属层材料为不锈钢、镍钛合金、钴镍合金的一种或多种组合;所述包覆层材料为聚酰胺、聚醚嵌段聚酰胺、聚氨酯弹性体的一种或多种混合物。Preferably, the catheter includes an inner layer, a metal layer, a coating layer and an outer tube layer arranged in sequence from the inside to the outside; the inner layer is a lubricating polymer layer, and the inner layer material is one of LLDPE, PTFE, and HDPE; the metal layer material is one or more combinations of stainless steel, nickel-titanium alloy, and cobalt-nickel alloy; the coating layer material is one or more mixtures of polyamide, polyether block polyamide, and polyurethane elastomer.
优选的,所述金属层为挂扣式的连接结构;金属层是由多个不同长度的金属件组成,从导管近端到远端,所述金属件的长度依次递减。Preferably, the metal layer is a hook-type connection structure; the metal layer is composed of a plurality of metal pieces of different lengths, and the lengths of the metal pieces decrease successively from the proximal end to the distal end of the catheter.
优选的,所述包覆层从所述导管近端到远端材料硬度依次降低。Preferably, the hardness of the coating layer material decreases from the proximal end to the distal end of the catheter.
优选的,所述锚定组件包括进气管、球囊件和压管囊,所述进气管用于将气体或液体导入球囊件,以实现对球囊件的充气和放气操作,所述球囊件设置在所述外管层,所述压管囊用于提高所述球囊件的弯曲性,所述球囊件用于锚固在血管壁;所述球囊件包括第一球囊、第二球囊,所述第一球囊和所述第二球囊均设置在所述外管层,所述外管层设置有与所述第一球囊和所述第二球囊分别连通的两个进气孔,所述压管囊设置在所述第一球囊和所述第二球囊之间。Preferably, the anchoring assembly includes an air inlet tube, a balloon member and a pressure tube balloon, the air inlet tube is used to introduce gas or liquid into the balloon member to realize inflation and deflation operations of the balloon member, the balloon member is arranged in the outer tube layer, the pressure tube balloon is used to improve the bending property of the balloon member, and the balloon member is used to anchor in the blood vessel wall; the balloon member includes a first balloon and a second balloon, the first balloon and the second balloon are both arranged in the outer tube layer, the outer tube layer is provided with two air inlet holes respectively connected to the first balloon and the second balloon, and the pressure tube balloon is arranged between the first balloon and the second balloon.
优选的,所述球囊件处于充盈状态时径向截面为对称的不规则圆弧。Preferably, when the balloon is in a filled state, the radial cross section is a symmetrical irregular arc.
优选的,所述球囊件材料为聚氨酯、硅胶、乙烯-辛烯聚烯烃弹性体的一种或多种混合物。Preferably, the balloon material is a mixture of polyurethane, silicone, ethylene-octene polyolefin elastomer or more.
优选的,所述控制组件包括固定件、螺纹传送件、控制装置外壳、调弯丝、通道环和金属环;所述金属环设置在所述导管远端,且与所述内层固定连接;所述通道环设置在所述金属层和所述包覆层之间,所述外壳安装在所述第一操作管,所述外壳与所述螺纹传送件连接,所述固定件固定设置在所述调弯丝的一端,所述调弯丝穿过所述螺纹传送件与所述固定件固定连接。Preferably, the control assembly includes a fixing part, a threaded transmission part, a control device housing, a bending adjustment wire, a channel ring and a metal ring; the metal ring is arranged at the distal end of the catheter and is fixedly connected to the inner layer; the channel ring is arranged between the metal layer and the coating layer, the housing is installed on the first operating tube, the housing is connected to the threaded transmission part, the fixing part is fixedly arranged at one end of the bending adjustment wire, and the bending adjustment wire passes through the threaded transmission part and is fixedly connected to the fixing part.
优选的,所述金属环材料为不锈钢材料,所述通道环材料为LLDPE、PTFE、HDPE的一种。Preferably, the metal ring material is stainless steel, and the channel ring material is one of LLDPE, PTFE and HDPE.
优选的,所述导管远尖端设有显影标记环,所述显影标记环的材料为铂铱合金,铂钨合金、钽中的一种。Preferably, the distal tip of the catheter is provided with a developing marker ring, and the material of the developing marker ring is one of platinum-iridium alloy, platinum-tungsten alloy and tantalum.
本发明的有益效果为:The beneficial effects of the present invention are:
控制组件能够带动导管在血管内进弯曲前进,提高导管在血管内的通过性,其次,锚定组件能够弥补导管具有较高通过性后较低去除病变能力,使得导管同时具有高通过性和高去除病变能力,其次,锚定组件还能够适应导管的弯曲,更好的贴合在血管,增强锚定效果,提高治疗效果。The control component can drive the catheter to bend and move forward in the blood vessel, thereby improving the catheter's permeability in the blood vessel. Secondly, the anchoring component can make up for the catheter's high permeability but low lesion removal ability, so that the catheter has both high permeability and high lesion removal ability. Secondly, the anchoring component can also adapt to the curvature of the catheter, better fit the blood vessel, enhance the anchoring effect, and improve the treatment effect.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
为了便于本领域技术人员理解,下面结合附图对本发明作进一步的说明。In order to facilitate understanding by those skilled in the art, the present invention is further described below with reference to the accompanying drawings.
图1为本发明在一实施例中提供的医疗导管结构示意图;FIG1 is a schematic diagram of the structure of a medical catheter provided in one embodiment of the present invention;
图2为本发明在一实施例中提供的锚定组件安装结构示意图;FIG2 is a schematic diagram of an anchor assembly installation structure provided in one embodiment of the present invention;
图3为本发明在一实施例中提供的控制组件结构示意图;FIG3 is a schematic diagram of the structure of a control component provided in one embodiment of the present invention;
图4为本发明在一实施例中提供的导管结构示意图;FIG4 is a schematic diagram of a catheter structure provided in one embodiment of the present invention;
图例:1、导管座;2、导管;21、内层;22、金属层;23、包覆层;24、外管层;31、第一操作管;32、第二操作管;4、控制组件;41、固定件;42、螺纹传送件;43、控制装置外壳;44、调弯丝;45、通道环;46、金属环;5、锚定组件;51、进气管;52、球囊件;521、第一球囊;522、第二球囊;53、压管囊;6、金属件。Legend: 1. Catheter seat; 2. Catheter; 21. Inner layer; 22. Metal layer; 23. Coating layer; 24. Outer tube layer; 31. First operating tube; 32. Second operating tube; 4. Control assembly; 41. Fixing part; 42. Threaded transmission part; 43. Control device housing; 44. Bending wire; 45. Channel ring; 46. Metal ring; 5. Anchoring assembly; 51. Air inlet pipe; 52. Balloon part; 521. First balloon; 522. Second balloon; 53. Pressure tube balloon; 6. Metal part.
具体实施方式DETAILED DESCRIPTION
为更进一步阐述本发明为实现预定发明目的所采取的技术手段及功效,以下结合附图及较佳实施例,对依据本发明的具体实施方式、结构、特征及其功效,详细说明如下。In order to further explain the technical means and effects adopted by the present invention to achieve the predetermined invention purpose, the specific implementation methods, structures, features and effects of the present invention are described in detail below in conjunction with the accompanying drawings and preferred embodiments.
如图1-图4所示,一种可控弯的锚定医疗导管,包括导管座1、导管2、第一操作管31和第二操作管32;导管座1的内腔与导管2连通,第一操作管31和第二操作管32分别嵌入在导管座1但不与导管座1内腔连通,且位于导管座1的两侧;As shown in FIGS. 1 to 4 , a controllable bending anchoring medical catheter comprises a catheter seat 1, a catheter 2, a first operating tube 31 and a second operating tube 32; the inner cavity of the catheter seat 1 is connected to the catheter 2, and the first operating tube 31 and the second operating tube 32 are respectively embedded in the catheter seat 1 but not connected to the inner cavity of the catheter seat 1, and are located on both sides of the catheter seat 1;
第一操作管31安装有控制组件4,控制组件4穿过第一操作管31安装在导管2的远端;第二操作管32设置有锚定组件5,锚定组件5从第二操作管32处延伸至导管2的端部,且锚定组件5位于控制组件4的近端;控制组件4用于控制导管2远端转弯,锚定组件5用于增强导管的穿透力并适应导管2的转弯;在第一操作管31中控制组件4,使得在控制组件4的作用下,带动导管2穿过弯曲的血管到达血管的病变区域,导管2远端到达目标位置后,在第二操作管32端操控锚定组件5,而锚定组件5设置在导管2的外端,使得锚定组件5的延伸部分紧贴血管壁,能够将导管2固定在血管病变的区域,随后,利用导丝对血管内的病变组织进行清理,去除,而锚定组件5能够在清除病变组织的过程中为远端的导管2锚定,增强到管道的去除病变能力;由于导管2穿越弯曲复杂的血管系统时,导管2的弯曲性能好,因而其在血管内的通过性较好,能够减少在穿刺过程中与血管的摩擦,降低并发症的风险,其次,导管2到达病变区域后,再通过第二操作端控制锚定组件5以充盈的状态将导管2锚定在病变区域,增强导管2远端的去除病变能力,且如果病变区域的范围较大时,还可以通过第二操作管32端减少锚定组件5的充盈状态,使得导管2再次前进,进行清除,如果病变范围需要转弯时,通过控制组件4控制导管2的转向,将导管2调转至未清理的病变区域,导管2转弯后,锚定组件5也能够适应导管2的弯曲,即锚定组件5随着导管2一起弯曲,同样能够将导管2锚定在转弯区域,实现对导管2的充分锚定效果;总之,控制组件4能够带动导管2在血管内弯曲前进,提高导管2在血管内的通过性,其次,锚定组件5能够弥补导管2具有较高通过性后较低去除病变能力性,使得导管2同时具有高通过性和高去除病变能力,其次,锚定组件5还能够适应导管2的弯曲,更好地贴合在血管,增强锚定效果,提高治疗效果。The first operating tube 31 is equipped with a control component 4, which passes through the first operating tube 31 and is installed at the distal end of the catheter 2; the second operating tube 32 is provided with an anchoring component 5, which extends from the second operating tube 32 to the end of the catheter 2, and the anchoring component 5 is located at the proximal end of the control component 4; the control component 4 is used to control the turning of the distal end of the catheter 2, and the anchoring component 5 is used to enhance the penetration of the catheter and adapt to the turning of the catheter 2; the control component 4 in the first operating tube 31, so that under the action of the control component 4, the catheter 2 is driven to pass through the curved blood vessel to reach the diseased area of the blood vessel, and the catheter 2 After the distal end reaches the target position, the anchoring assembly 5 is manipulated at the end of the second operating tube 32, and the anchoring assembly 5 is arranged at the outer end of the catheter 2, so that the extended part of the anchoring assembly 5 is close to the blood vessel wall, and the catheter 2 can be fixed in the area of vascular lesions. Subsequently, the diseased tissue in the blood vessel is cleaned and removed using a guide wire, and the anchoring assembly 5 can anchor the distal end of the catheter 2 during the process of clearing the diseased tissue, thereby enhancing the ability of the pipeline to remove lesions; since the catheter 2 has good bending performance when passing through a complex and curved vascular system, it has good passability in the blood vessel, which can reduce the risk of puncture. The friction with the blood vessels during the process can reduce the risk of complications. Secondly, after the catheter 2 reaches the lesion area, the second operating end is used to control the anchoring component 5 to anchor the catheter 2 in the lesion area in a filled state, thereby enhancing the lesion removal ability of the distal end of the catheter 2. If the lesion area is large, the filling state of the anchoring component 5 can be reduced by the second operating tube 32 end, so that the catheter 2 can move forward again for cleaning. If the lesion range needs to turn, the control component 4 is used to control the steering of the catheter 2 to turn the catheter 2 to the uncleaned lesion area. After the catheter 2 turns, the anchoring component 5 is also It can adapt to the bending of the catheter 2, that is, the anchoring component 5 bends with the catheter 2, and can also anchor the catheter 2 in the turning area, thereby achieving a sufficient anchoring effect on the catheter 2; in short, the control component 4 can drive the catheter 2 to bend and advance in the blood vessel, thereby improving the permeability of the catheter 2 in the blood vessel. Secondly, the anchoring component 5 can make up for the lower lesion removal ability of the catheter 2 after having high permeability, thereby making the catheter 2 have both high permeability and high lesion removal ability. Secondly, the anchoring component 5 can also adapt to the bending of the catheter 2, better fit the blood vessel, enhance the anchoring effect, and improve the treatment effect.
总之,控制组件4使得导管2能够精确弯曲,确保医生能够准确到达目标区域;通过精确控制和增强穿透力,这种导管2设计有助于医生更高效地清除血管堵塞,从而提高手术成功率;精确的手术操作减少了误伤血管壁和其他组织的可能性,进而防止了并发症的发生,通过整合控制组件4和锚定组件5,它不仅能够精确控制导管2的弯曲,还能增强导管2在血管内的穿透力,从而提高手术的精确性和成功率。In summary, the control component 4 enables the catheter 2 to bend precisely, ensuring that the doctor can accurately reach the target area; through precise control and enhanced penetration, this catheter 2 design helps the doctor to clear blood vessel blockages more efficiently, thereby improving the success rate of the operation; precise surgical operations reduce the possibility of accidental injury to the blood vessel wall and other tissues, thereby preventing the occurrence of complications. By integrating the control component 4 and the anchoring component 5, it can not only accurately control the bending of the catheter 2, but also enhance the penetration of the catheter 2 in the blood vessel, thereby improving the accuracy and success rate of the operation.
在一实施例中,导管2包括由内至外依次设置的内层21、金属层22、包覆层23和外管层24;内层21为爽滑性的高分子层,的内层21材料为LLDPE、PTFE、HDPE的一种;的金属层22材料为不锈钢、镍钛合金、钴镍合金的一种或多种组合;包覆层材料为聚酰胺、聚醚嵌段聚酰胺、聚氨酯弹性体的一种或多种混合物;内层21采用爽滑性的高分子材料,具体为LLDPE(线性低密度聚乙烯),这种材料具有优良的润滑性,能够减少导管2在血管内的摩擦,降低对血管内壁的损伤,同时也有利于导丝和其他器械在导管2内的顺畅通过;金属层22采用不锈钢和镍钛合金的组合;不锈钢提供了良好的结构支撑,而镍钛合金则赋予导管2优异的形状记忆功能,使导管2在弯曲后能够迅速恢复原状,这种组合既保证了导管2的强度,又提供了良好的柔韧性;包覆层23采用聚酰胺和聚氨酯弹性体的混合物,聚酰胺增强了导管2的耐磨性和抗冲击性,而聚氨酯弹性体则提供了优异的弹性和生物相容性,这种混合材料的使用使得导管2在保持足够强度的同时,也具备良好的柔韧性和生物安全性;外管层24采用医用级别的聚氯乙烯材料,这种材料具有优良的耐腐蚀性、耐磨性和生物相容性,能够保护导管2内部的各层结构,同时防止与血管壁的粘连。In one embodiment, the catheter 2 includes an inner layer 21, a metal layer 22, a coating layer 23 and an outer tube layer 24 which are arranged in sequence from the inside to the outside; the inner layer 21 is a lubricating polymer layer, and the material of the inner layer 21 is one of LLDPE, PTFE, and HDPE; the material of the metal layer 22 is one or more combinations of stainless steel, nickel-titanium alloy, and cobalt-nickel alloy; the coating layer material is one or more mixtures of polyamide, polyether block polyamide, and polyurethane elastomer; the inner layer 21 is made of a lubricating polymer material, specifically LLDPE (linear low-density polyethylene), which has excellent lubricity, can reduce the friction of the catheter 2 in the blood vessel, reduce damage to the inner wall of the blood vessel, and is also conducive to the smooth passage of the guide wire and other instruments in the catheter 2; the metal layer 22 is made of stainless steel and nickel The stainless steel provides good structural support, while the nickel-titanium alloy gives the catheter 2 an excellent shape memory function, so that the catheter 2 can quickly return to its original shape after bending. This combination not only ensures the strength of the catheter 2, but also provides good flexibility. The coating layer 23 adopts a mixture of polyamide and polyurethane elastomer. The polyamide enhances the wear resistance and impact resistance of the catheter 2, while the polyurethane elastomer provides excellent elasticity and biocompatibility. The use of this mixed material enables the catheter 2 to maintain sufficient strength while also having good flexibility and biosafety. The outer tube layer 24 adopts medical-grade polyvinyl chloride material, which has excellent corrosion resistance, wear resistance and biocompatibility, can protect the internal structure of the catheter 2, and prevent adhesion to the blood vessel wall.
在一实施例中,金属层22为挂扣式的连接结构;金属层22是由多个不同长度的金属件6组成,从导管2近端到远端,金属件6的长度依次递减,使得导管2在弯曲时能够呈现出更加自然和流畅的曲线,近端较长的金属件6提供了足够的支撑和稳定性,而远端较短的金属件6则使得导管2远端更加灵活,易于在血管中弯曲和转向;挂扣式的连接结构使得每个金属件6都能够独立地响应外部控制力,从而实现对导管2弯曲程度和方向的精确控制;医生可以根据手术需要,通过操作控制组件4来精确调整导管2的弯曲状态,使其能够顺利穿越复杂的血管结构,到达目标位置;金属件6的长度递减,但整体金属层22仍然能够保持一定的结构强度和稳定性,确保了导管2在弯曲过程中不会过度扭曲或变形,从而保持手术操作的稳定性和安全性。In one embodiment, the metal layer 22 is a hook-and-loop connection structure; the metal layer 22 is composed of a plurality of metal pieces 6 of different lengths, and the lengths of the metal pieces 6 decrease successively from the proximal end to the distal end of the catheter 2, so that the catheter 2 can present a more natural and smooth curve when bending, and the longer metal piece 6 at the proximal end provides sufficient support and stability, while the shorter metal piece 6 at the distal end makes the distal end of the catheter 2 more flexible and easy to bend and turn in the blood vessel; the hook-and-loop connection structure enables each metal piece 6 to independently respond to the external control force, thereby achieving precise control of the bending degree and direction of the catheter 2; the doctor can accurately adjust the bending state of the catheter 2 by operating the control component 4 according to the needs of the operation, so that it can smoothly pass through the complex vascular structure and reach the target position; the length of the metal piece 6 decreases, but the overall metal layer 22 can still maintain a certain structural strength and stability, ensuring that the catheter 2 will not be excessively twisted or deformed during the bending process, thereby maintaining the stability and safety of the surgical operation.
综上,金属层22采用挂扣式的连接结构,并且由多个不同长度的金属件6组成的设计,能够显著增强导管2的弯曲灵活性、精确控制弯曲程度和方向、保持稳定性,并适应不同血管形态;这些效果共同提升了血管介入治疗的精确性和安全性。In summary, the metal layer 22 adopts a hook-type connection structure and is designed to be composed of multiple metal parts 6 of different lengths, which can significantly enhance the bending flexibility of the catheter 2, accurately control the degree and direction of bending, maintain stability, and adapt to different vascular morphologies; these effects together improve the accuracy and safety of vascular interventional treatment.
在一实施例中,包覆层23从导管2近端到远端材料硬度依次降低;随着包覆层23材料硬度的逐渐降低,导管2远端变得更加柔软和柔顺,由于包覆层23硬度逐渐降低,导管2在弯曲时能够呈现出更加平滑的过渡,避免了因硬度突变而引起的应力集中和导管2扭曲,这种平滑过渡有助于保持导管2在弯曲过程中的稳定性和可靠性,提高手术的精确性;近端较硬的包覆23提供了足够的结构支撑和保护,而远端较软的包覆层23则增强了导管2的柔顺性和适应性,这种结构设计使得导管2在保持整体强度和稳定性的同时,也具备了良好的弯曲性能和柔顺性,从而优化了导管2在血管介入治疗中的整体性能;金属层22作为导管2的结构支撑,其不同长度的金属件6设计使得导管2在弯曲时能够呈现出自然流畅的曲线,而包覆,23材料硬度的逐渐降低,则进一步增强了导管2在弯曲过程中的柔顺性和平滑性。这种组合使得导管2在弯曲时能够协调一致地响应操作,提高了手术的精确性和稳定性。In one embodiment, the hardness of the coating 23 material decreases from the proximal end to the distal end of the catheter 2; as the hardness of the coating 23 material gradually decreases, the distal end of the catheter 2 becomes softer and more compliant. Since the hardness of the coating 23 gradually decreases, the catheter 2 can present a smoother transition when bending, avoiding stress concentration and distortion of the catheter 2 caused by sudden changes in hardness. This smooth transition helps to maintain the stability and reliability of the catheter 2 during the bending process and improve the accuracy of the operation; the harder coating 23 at the proximal end provides sufficient structural support and protection, while the softer coating 23 at the distal end enhances the flexibility and adaptability of the catheter 2. This structural design enables the catheter 2 to have good bending performance and flexibility while maintaining overall strength and stability, thereby optimizing the overall performance of the catheter 2 in vascular interventional treatment; the metal layer 22 serves as the structural support of the catheter 2, and its metal parts 6 of different lengths are designed to enable the catheter 2 to present a natural and smooth curve when bending, and the gradual decrease in the hardness of the coating 23 material further enhances the flexibility and smoothness of the catheter 2 during the bending process. This combination enables the catheter 2 to respond to the operation in a coordinated manner when bending, thereby improving the accuracy and stability of the operation.
在一实施例中,锚定组件5包括进气管51、球囊件52和压管囊53,球囊件52设置在外管层24,压管囊53用于提高球囊的弯曲性,球囊件52用于锚固在血管壁;球囊件52包括第一球囊521、第二球囊522,第一球囊521和第二球囊522均设置在外管层24,外管层24设置有与第一球囊521和第二球囊522分别连通的两个进气孔,压管囊53设置在第一球囊521和第二球囊522之间;进气管51是一个精细的管状结构,用于将气体或液体导入球囊件52,以实现对球囊件52的充气和放气操作,进气管51的一端与球囊件52相连通,另一端则延伸至导管2的近端,方便医生在手术过程中进行控制;球囊件52由第一球囊521和第二球囊522组成,二者均设置在外管层24的外表面,直接与血管壁接触;第一球囊521和第二球囊522的材质通常为柔软且可膨胀的医用材料,如硅胶或乳胶,以确保在充气后能够紧密贴合血管壁,实现稳定锚固,值得说明的是,球囊件52为在穿刺进入血管后进行充气贴合血管;外管层24上设有两个进气孔,分别与第一球囊521和第二球囊522连通,压管囊53设置在第一球囊521和第二球囊522之间,其主要作用是在球囊充气时提供额外的支撑和弯曲性,压管囊53的材质具有一定的弹性和柔韧性,能够在受到外力时发生形变,从而帮助球囊更好地适应血管的形态和弯曲度;由于导管2需要在血管中弯曲前行,形状大小血管的限制,因此,现有的介入治疗用导管2多为结构以及制作工艺简单可实现为主;因此,压管囊53设置在第一球囊521和第二球囊522之间,可以通过简单的制作工艺即可完成制作,例如,详见第一球囊521和第二球囊522一体加工成型后再加工压管件,制作流程简单可实现。In one embodiment, the anchoring assembly 5 includes an air inlet tube 51, a balloon member 52 and a tube pressure balloon 53. The balloon member 52 is arranged on the outer tube layer 24. The tube pressure balloon 53 is used to improve the bending property of the balloon. The balloon member 52 is used to anchor on the blood vessel wall. The balloon member 52 includes a first balloon 521 and a second balloon 522. The first balloon 521 and the second balloon 522 are both arranged on the outer tube layer 24. The outer tube layer 24 is provided with two air inlet holes respectively connected to the first balloon 521 and the second balloon 522. The tube pressure balloon 53 is arranged between the first balloon 521 and the second balloon 522. The air inlet tube 51 is a fine tubular structure used to introduce gas or liquid into the balloon member 52 to achieve the inflation and deflation of the balloon member 52. One end of the air inlet tube 51 is connected to the balloon member 52, and the other end extends to the proximal end of the catheter 2, which is convenient for the doctor to control during the operation. The balloon member 52 is composed of a first balloon 521 and a second balloon 522, both of which are arranged on the outer surface of the outer tube layer 24 and directly contact the blood vessel wall. The material of the first balloon 521 and the second balloon 522 is usually soft and can be The expanded medical material, such as silicone or latex, is used to ensure that it can closely fit the blood vessel wall after inflation to achieve stable anchoring. It is worth noting that the balloon member 52 is inflated and fits the blood vessel after puncturing into the blood vessel; the outer tube layer 24 is provided with two air inlet holes, which are respectively connected to the first balloon 521 and the second balloon 522. The pressure tube balloon 53 is arranged between the first balloon 521 and the second balloon 522. Its main function is to provide additional support and bendability when the balloon is inflated. The material of the pressure tube balloon 53 has a certain elasticity and flexibility and can be used in the body. When external force is applied, the balloon is deformed, thereby helping the balloon to better adapt to the shape and curvature of the blood vessel. Since the catheter 2 needs to bend and move forward in the blood vessel, the shape and size of the blood vessel are limited. Therefore, the existing catheters 2 for interventional treatment are mostly simple in structure and manufacturing process. Therefore, the compression tube balloon 53 is arranged between the first balloon 521 and the second balloon 522, and can be manufactured through a simple manufacturing process. For example, the first balloon 521 and the second balloon 522 are integrally processed and formed, and then the compression tube parts are processed. The manufacturing process is simple and can be realized.
在一实施例中,第一球囊521和第二球囊522处于充盈状态时两者的径向截面为连续的为对称的不规则圆弧,即第一球囊521和第二球囊522的外周为凸起和内凹交替,使得球囊件52锚定在血管内时,既能贴合血管壁,锚定导管2,又不影响血管的血液流动,凸起部与血管壁接触,血液则从内凹流动。In one embodiment, when the first balloon 521 and the second balloon 522 are in a filled state, the radial cross-sections of the two are continuous, symmetrical irregular arcs, that is, the outer peripheries of the first balloon 521 and the second balloon 522 are alternately convex and concave, so that when the balloon member 52 is anchored in the blood vessel, it can fit the blood vessel wall and anchor the catheter 2 without affecting the blood flow in the blood vessel, and the convex part contacts the blood vessel wall, and the blood flows from the concave part.
在一实施例中,的球囊材料为聚氨酯、硅胶、乙烯-辛烯聚烯烃弹性体的一种或多种混合物;聚氨酯、硅胶和乙烯-辛烯聚烯烃弹性体等材料均具有良好的生物相容性,能够减少与血管壁等生物组织的排异反应和炎症发生。这有助于降低手术过程中的并发症风险,提高患者的舒适度;同时具有出色的弹性和回弹性,使得球囊在充盈和放气过程中能够迅速响应,并保持稳定的形状。这有助于确保球囊在锚定过程中能够紧密贴合血管壁,提高锚定的稳定性和可靠性。In one embodiment, the balloon material is a mixture of one or more polyurethane, silicone, and ethylene-octene polyolefin elastomer; polyurethane, silicone, and ethylene-octene polyolefin elastomer all have good biocompatibility and can reduce rejection and inflammation with biological tissues such as blood vessel walls. This helps to reduce the risk of complications during surgery and improve patient comfort; at the same time, it has excellent elasticity and resilience, so that the balloon can respond quickly during filling and deflation and maintain a stable shape. This helps to ensure that the balloon can fit closely to the blood vessel wall during anchoring and improve the stability and reliability of anchoring.
在一实施例中,控制组件4包括固定件41、螺纹传送件42、控制装置外壳43、调弯丝44、通道环45和金属环46;金属环46设置在导管2远端,且与内层21固定连接;通道环45设置在金属层22和包覆层之间,外壳安装在第一操作管31,外壳与传送件螺纹连接,固定件41固定设置在调弯丝44的一端,调弯丝44穿过传动件与固定件41固定连接;固定件41被固定设置在调弯丝44的一端,起到了关键的固定和支撑作用,调弯丝44的另一端穿过传送件与固定件41紧密连接,形成了稳定的力学结构。通过旋转外壳和传送件,医生可以方便地调整调弯丝44在通道环45内的位置,从而实现导管2远端的弯曲;通过旋转控制装置外壳43和螺纹传送件42,医生可以精确调整调弯丝44在通道环45内的位置,从而实现导管2远端的精确弯曲。这种精确的弯曲控制有助于提高手术的精确性和可靠性,确保导管2能够准确到达目标位置;金属环46与内层21的紧密固定连接以及通道环45的合理设置,使得导管2在弯曲时能够保持稳定的结构形态,减少了因弯曲而产生的形变和扭曲。综上,本实施例中的控制组件4结构设置具有精确的弯曲控制、稳定的操作性能和易于操作和管理等好处。In one embodiment, the control assembly 4 includes a fixing member 41, a threaded transmission member 42, a control device housing 43, a bending wire 44, a channel ring 45 and a metal ring 46; the metal ring 46 is arranged at the distal end of the catheter 2 and is fixedly connected to the inner layer 21; the channel ring 45 is arranged between the metal layer 22 and the coating layer, the housing is installed on the first operating tube 31, the housing is threadedly connected to the transmission member, the fixing member 41 is fixedly arranged at one end of the bending wire 44, and the bending wire 44 passes through the transmission member and is fixedly connected to the fixing member 41; the fixing member 41 is fixedly arranged at one end of the bending wire 44, playing a key fixing and supporting role, and the other end of the bending wire 44 passes through the transmission member and is tightly connected to the fixing member 41, forming a stable mechanical structure. By rotating the housing and the transmission member, the doctor can easily adjust the position of the bending wire 44 in the channel ring 45, thereby realizing the bending of the distal end of the catheter 2; by rotating the control device housing 43 and the threaded transmission member 42, the doctor can accurately adjust the position of the bending wire 44 in the channel ring 45, thereby realizing the accurate bending of the distal end of the catheter 2. This precise bending control helps to improve the accuracy and reliability of the operation and ensure that the catheter 2 can accurately reach the target position; the tight and fixed connection between the metal ring 46 and the inner layer 21 and the reasonable arrangement of the channel ring 45 enable the catheter 2 to maintain a stable structural form when bending, reducing deformation and distortion caused by bending. In summary, the structural arrangement of the control component 4 in this embodiment has the advantages of precise bending control, stable operating performance, and easy operation and management.
在一实施例中,金属环46材料为不锈钢材料,通道环45材料为LLDPE、PTFE、HDPE的一种;不锈钢材料作为金属环46的选择,具有高强度、高耐腐蚀性和良好的可加工性,不锈钢金属环46能够确保导管2在弯曲时保持稳定的形态和结构,抵抗外部环境的腐蚀,同时易于加工成所需形状,满足精确控制导管2弯曲的需求。In one embodiment, the material of the metal ring 46 is stainless steel, and the material of the channel ring 45 is one of LLDPE, PTFE, and HDPE; stainless steel material is selected as the metal ring 46, which has high strength, high corrosion resistance and good processability. The stainless steel metal ring 46 can ensure that the catheter 2 maintains a stable shape and structure when bending, resists corrosion from the external environment, and is easy to be processed into a desired shape, meeting the requirement of precisely controlling the bending of the catheter 2.
在一实施例中,导管2尖端设有显影标记环,显影标记环的材料为铂铱合金,铂钨合金、钽中的一种;导管2尖端的显影标记环是一个重要的功能部件,它使用铂铱合金、铂钨合金或钽等金属材料制成。这些材料具有优异的生物相容性、高密度和良好的X射线透过性。当导管2被插入患者体内进行手术时,显影标记环的存在使得医生可以通过X射线或其他医学影像设备清晰地观察到导管2尖端的位置;由于铂铱合金、铂钨合金和钽的高密度特性,它们在X射线照射下能够产生明显的影像,从而确保医生能够准确地定位导管2尖端。这种定位精度的提升对于血管介入手术至关重要,能够帮助医生避免误伤血管或其他组织,提高手术的安全性和成功率;同时,这些金属材料还具有良好的耐腐蚀性,能够在体内长时间保持稳定,不会因为腐蚀而产生有害物质。In one embodiment, the tip of the catheter 2 is provided with a developing marker ring, and the material of the developing marker ring is one of platinum-iridium alloy, platinum-tungsten alloy, and tantalum; the developing marker ring at the tip of the catheter 2 is an important functional component, which is made of metal materials such as platinum-iridium alloy, platinum-tungsten alloy or tantalum. These materials have excellent biocompatibility, high density and good X-ray transmittance. When the catheter 2 is inserted into the patient's body for surgery, the presence of the developing marker ring allows the doctor to clearly observe the position of the tip of the catheter 2 through X-rays or other medical imaging equipment; due to the high density characteristics of platinum-iridium alloy, platinum-tungsten alloy and tantalum, they can produce obvious images under X-ray irradiation, thereby ensuring that the doctor can accurately locate the tip of the catheter 2. This improvement in positioning accuracy is crucial for vascular intervention surgery, which can help doctors avoid accidental injury to blood vessels or other tissues and improve the safety and success rate of surgery; at the same time, these metal materials also have good corrosion resistance, can remain stable in the body for a long time, and will not produce harmful substances due to corrosion.
以上所述,仅是本发明的较佳实施例而已,并非对本发明作任何形式上的限制,虽然本发明已以较佳实施例揭示如上,然而并非用以限定本发明,任何本领域技术人员,在不脱离本发明技术方案范围内,当可利用上述揭示的技术内容做出些许更动或修饰为等同变化的等效实施例,但凡是未脱离本发明技术方案内容,依据本发明的技术实质对以上实施例所作的任何简介修改、等同变化与修饰,均仍属于本发明技术方案的范围内。The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Although the present invention has been disclosed as a preferred embodiment as above, it is not used to limit the present invention. Any technical personnel in this field can make some changes or modify the technical contents disclosed above into equivalent embodiments without departing from the scope of the technical solution of the present invention. However, any brief modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention are still within the scope of the technical solution of the present invention.
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