CN114225189B - An intraocular imaging balloon catheter - Google Patents
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- 238000003384 imaging method Methods 0.000 title claims abstract description 127
- 239000000523 sample Substances 0.000 claims abstract description 39
- 239000007788 liquid Substances 0.000 claims abstract description 12
- 239000002356 single layer Substances 0.000 claims abstract description 4
- 239000007924 injection Substances 0.000 claims description 10
- 238000002347 injection Methods 0.000 claims description 10
- 238000007789 sealing Methods 0.000 claims description 4
- 230000005540 biological transmission Effects 0.000 claims description 3
- 238000001514 detection method Methods 0.000 abstract description 11
- 238000002604 ultrasonography Methods 0.000 abstract description 5
- 230000002093 peripheral effect Effects 0.000 abstract description 3
- 208000031481 Pathologic Constriction Diseases 0.000 abstract 2
- 208000037804 stenosis Diseases 0.000 abstract 2
- 230000036262 stenosis Effects 0.000 abstract 2
- 230000000149 penetrating effect Effects 0.000 abstract 1
- 238000010586 diagram Methods 0.000 description 4
- 238000012014 optical coherence tomography Methods 0.000 description 4
- 238000013146 percutaneous coronary intervention Methods 0.000 description 4
- 210000004204 blood vessel Anatomy 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 2
- 238000009434 installation Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000002504 physiological saline solution Substances 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 101001121408 Homo sapiens L-amino-acid oxidase Proteins 0.000 description 1
- 102100026388 L-amino-acid oxidase Human genes 0.000 description 1
- 101100012902 Saccharomyces cerevisiae (strain ATCC 204508 / S288c) FIG2 gene Proteins 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000010410 layer Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
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- A—HUMAN NECESSITIES
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- 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
- A61M25/1002—Balloon catheters characterised by balloon shape
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0062—Arrangements for scanning
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- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6852—Catheters
- A61B5/6853—Catheters with a balloon
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
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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
- A61M25/10181—Means for forcing inflation fluid into the balloon
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Abstract
Description
技术领域Technical Field
本发明涉及球囊导管技术领域,主要涉及一种内成像球囊导管。The invention relates to the technical field of balloon catheters, and mainly to an internal imaging balloon catheter.
背景技术Background Art
现有技术中,一种内成像技术与球囊导管结合的例子:声学成像球囊导管,由一次性液体约束护套形成,该护套支撑高保真柔性驱动轴,该驱动轴在其端部上承载超声换能器并且包括可膨胀的扩张球囊。An example of an intra-imaging technique combined with a balloon catheter in the prior art is an acoustic imaging balloon catheter, which is formed by a disposable liquid-constrained sheath supporting a high-fidelity flexible drive shaft that carries an ultrasound transducer on its end and includes an inflatable dilatation balloon.
现有技术的不足在于:其一,球囊内部双腔结构,增加了导管的外径,不利于进入更小更狭窄部位;其二,当探头在球囊内部成像时,超声必须透过内管和球囊双层壁垒,对超声的穿透性和准确性要求较高;其三,球囊充盈后的扩张作用可能会影响对位置的判断。The shortcomings of the existing technology are: first, the double-cavity structure inside the balloon increases the outer diameter of the catheter, which is not conducive to entering smaller and narrower parts; second, when the probe is imaging inside the balloon, the ultrasound must pass through the double-layer barrier of the inner tube and the balloon, which requires high penetration and accuracy of the ultrasound; third, the expansion effect of the balloon after filling may affect the judgment of the position.
因此,如何提供一种尺寸小、内成像扫描精准的内成像球囊导管是本领域技术人员需要解决的问题。Therefore, how to provide an internal imaging balloon catheter with small size and precise internal imaging scanning is a problem that needs to be solved by those skilled in the art.
发明内容Summary of the invention
本发明的目的是提供一种内成像扫描探测更精准、尺寸更小的内成像球囊导管。The object of the present invention is to provide an internal imaging balloon catheter with more accurate internal imaging scanning detection and smaller size.
为实现上述目的,本发明提供一种内成像球囊导管,包括:导丝管,设有导丝腔,导丝腔用以穿设导丝;To achieve the above-mentioned object, the present invention provides an internal imaging balloon catheter, comprising: a guidewire tube, provided with a guidewire cavity, the guidewire cavity being used to pass a guidewire;
成像管,设于导丝管一端,且与导丝管同向延伸;An imaging tube is arranged at one end of the wire guide tube and extends in the same direction as the wire guide tube;
球囊,局部套设于导丝管外周,且和成像管连通以扩张球囊;The balloon is partially sheathed on the outer periphery of the guide wire tube and is connected to the imaging tube to expand the balloon;
内成像探头,设于成像管内背离球囊的一端。The internal imaging probe is arranged at one end of the imaging tube away from the balloon.
可选地,内成像探头包括:换能器和驱动轴,换能器可跟随驱动轴沿成像管的长度方向旋转移动。Optionally, the internal imaging probe includes: a transducer and a driving shaft, and the transducer can rotate and move along the length direction of the imaging tube following the driving shaft.
可选地,成像管连接有用以控制内成像探头的手柄。Optionally, a handle for controlling the internal imaging probe is connected to the imaging tube.
可选地,手柄包括:用以连接驱动轴的接头和用以注入液体的注射孔。Optionally, the handle includes: a joint for connecting the drive shaft and an injection hole for injecting liquid.
可选地,接头与注射孔之间设置有用以防止液体渗出的密封圈。Optionally, a sealing ring is provided between the joint and the injection hole to prevent liquid from leaking out.
可选地,内成像探头还可选用OCT探头,以实现内成像扫描。Optionally, the internal imaging probe may also be an OCT probe to achieve internal imaging scanning.
相对于上述背景技术,本发明设置有:导丝管、成像管、球囊和内成像探头;上述导丝管与成像管连接且不连通。上述球囊局部套设于导丝管的外周面,且导丝管保留有未被套设的部分;上述成像管通过在导丝管未被套设部分的外表面设置细小的腔道与球囊的内部连通,操作者可通过向成像管内输入液体使球囊实现扩张,扩张的球囊可为内成像球囊导管撑开狭窄的工作位置,以便内成像球囊导管进行移动和后续操作。上述内成像探头设置在成像管内部背离球囊的一端,如此设置保证了内成像探头的扫描探测只需要穿透成像管内壁即可。上述导丝管开设有用于穿设导丝的导丝腔,上述导丝腔的其中一端开设在导丝管背离成像管的端面上,其另一端开设在导丝管的侧壁上,导丝腔的中间段贯穿球囊内部且不与其连通,用于实现导丝的侧面穿刺。上述导丝管与成像管同向延伸,因此导管的直径可以设置的很小,可满足直达一些狭窄的工作位置,同时因为内成像探头设置在球囊外侧,其进行扫描探测观察只需要透过成像管的单层管壁,对超声的损耗更小;并且,球囊的扩张不会影响内成像探头的探测位置,二者结合提高了内成像的准确性。Compared with the above background technology, the present invention is provided with: a guide wire tube, an imaging tube, a balloon and an internal imaging probe; the guide wire tube is connected to the imaging tube and is not connected. The balloon is partially sheathed on the outer peripheral surface of the guide wire tube, and the guide wire tube retains a part that is not sheathed; the imaging tube is connected to the inside of the balloon by setting a small cavity on the outer surface of the part of the guide wire tube that is not sheathed, and the operator can expand the balloon by inputting liquid into the imaging tube, and the expanded balloon can open the narrow working position for the internal imaging balloon catheter to facilitate the movement and subsequent operation of the internal imaging balloon catheter. The internal imaging probe is arranged at one end of the imaging tube away from the balloon, and such arrangement ensures that the scanning detection of the internal imaging probe only needs to penetrate the inner wall of the imaging tube. The guide wire tube is provided with a guide wire cavity for inserting a guide wire, one end of which is opened on the end surface of the guide wire tube away from the imaging tube, and the other end is opened on the side wall of the guide wire tube, and the middle section of the guide wire cavity passes through the inside of the balloon and is not connected with it, so as to realize the side puncture of the guide wire. The guide wire tube and the imaging tube extend in the same direction, so the diameter of the catheter can be set very small, which can meet the needs of reaching some narrow working positions. At the same time, because the internal imaging probe is arranged on the outside of the balloon, it only needs to pass through the single-layer tube wall of the imaging tube for scanning, detection and observation, which causes less loss of ultrasound; and the expansion of the balloon will not affect the detection position of the internal imaging probe. The combination of the two improves the accuracy of internal imaging.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的实施例,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,还可以根据提供的附图获得其他的附图。In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying creative work.
图1为本发明实施例所提供的内成像球囊导管的截面图;FIG1 is a cross-sectional view of an internal imaging balloon catheter provided by an embodiment of the present invention;
图2为本发明实施例所提供的内成像探头的结构示意图;FIG2 is a schematic diagram of the structure of an internal imaging probe provided by an embodiment of the present invention;
图3为本发明实施例所提供的内成像球囊导管与手柄的外部安装示意图。FIG. 3 is a schematic diagram of the external installation of the internal imaging balloon catheter and the handle provided in an embodiment of the present invention.
其中:in:
1-导丝管、2-成像管、3-球囊、4-内成像探头、41-换能器、42-驱动轴、5-手柄、51-接头、52-注射孔。1-guidewire tube, 2-imaging tube, 3-balloon, 4-internal imaging probe, 41-transducer, 42-driving shaft, 5-handle, 51-connector, 52-injection hole.
具体实施方式DETAILED DESCRIPTION
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
为了使本技术领域的技术人员更好地理解本发明方案,下面结合附图和具体实施方式对本发明作进一步的详细说明。In order to enable those skilled in the art to better understand the scheme of the present invention, the present invention is further described in detail below in conjunction with the accompanying drawings and specific implementation methods.
参考说明书附图1,附图1为本发明实施例所提供的内成像球囊导管的截面图,包括:导丝管1、成像管2、球囊3和内成像探头4;上述导丝管1与成像管2连接且不连通,二者之间的通道可通过且不仅限于通过胶料隔开。上述球囊3局部套设于导丝管1的外周面,且导丝管1保留有未被套设的部分;上述成像管2通过在导丝管1未被套设部分的外表面设置细小的腔道与球囊3的内部连通,操作者可通过向成像管2内输入液体使球囊3实现扩张,扩张的球囊3可为内成像球囊导管撑开狭窄的工作位置,以便内成像球囊导管进行移动和后续操作。上述内成像探头4设置在成像管2内部,且设置在背离球囊3的一端,如此设置保证了内成像探头4的扫描探测只需要穿透成像管2内壁即可。上述导丝管1开设有用于穿设导丝的导丝腔,上述导丝腔的其中一端开设在导丝管1背离成像管2的端面上,其另一端开设在导丝管1的侧壁上,导丝腔的中间段贯穿球囊3内部且不与其连通,用于实现导丝的侧面穿刺。上述导丝管1与成像管2同向延伸,因此导管的直径可以设置的很小(≤3.3F),可满足直达一些狭窄的工作位置,同时因为内成像探头4设置在球囊3外侧,其进行扫描探测观察只需要透过成像管2的单层管壁,对扫描的能量损耗更小;并且,球囊3的扩张不会影响内成像探头4的探测位置,二者结合提高了内成像的准确性。Referring to Figure 1 of the specification, Figure 1 is a cross-sectional view of the internal imaging balloon catheter provided by an embodiment of the present invention, including: a guide wire tube 1, an imaging tube 2, a balloon 3 and an internal imaging probe 4; the guide wire tube 1 is connected to the imaging tube 2 but not connected, and the passage between the two can be separated by and is not limited to being separated by a rubber material. The balloon 3 is partially sleeved on the outer peripheral surface of the guide wire tube 1, and the guide wire tube 1 retains a portion that is not sleeved; the imaging tube 2 is connected to the inside of the balloon 3 by setting a small cavity on the outer surface of the portion that is not sleeved by the guide wire tube 1. The operator can expand the balloon 3 by injecting liquid into the imaging tube 2. The expanded balloon 3 can expand the narrow working position of the internal imaging balloon catheter so that the internal imaging balloon catheter can be moved and subsequently operated. The internal imaging probe 4 is arranged inside the imaging tube 2 and at the end away from the balloon 3. Such an arrangement ensures that the scanning detection of the internal imaging probe 4 only needs to penetrate the inner wall of the imaging tube 2. The guidewire tube 1 is provided with a guidewire cavity for inserting a guidewire, one end of the guidewire cavity is provided on the end face of the guidewire tube 1 away from the imaging tube 2, and the other end is provided on the side wall of the guidewire tube 1, and the middle section of the guidewire cavity passes through the interior of the balloon 3 and is not connected thereto, so as to realize the side puncture of the guidewire. The guidewire tube 1 and the imaging tube 2 extend in the same direction, so the diameter of the catheter can be set very small (≤3.3F), which can meet the requirements of reaching some narrow working positions directly, and because the internal imaging probe 4 is arranged outside the balloon 3, it only needs to pass through the single-layer wall of the imaging tube 2 for scanning, detection and observation, which has less energy loss for scanning; and the expansion of the balloon 3 will not affect the detection position of the internal imaging probe 4, and the combination of the two improves the accuracy of internal imaging.
当本申请的内成像球囊导管应用于PCI(经皮冠状动脉介入治疗)手术中时:导丝从设置在导丝管1端面上的导丝腔进入,并从导丝管1的侧壁穿出,内成像球囊导管顺着导丝进入目标血管,将生理盐水从成像管2进入球囊3将其充盈扩张,而设置在球囊3一侧的内成像探头4可以接到外界的控制系统,在球囊3充盈扩张的同时对血管内部进行扫描探测,也可以将球囊3收缩后,将内成像球囊导管前伸,使内成像探头4在球囊3扩张后的血管内进行探测。When the internal imaging balloon catheter of the present application is used in a PCI (percutaneous coronary intervention) operation: the guidewire enters from the guidewire cavity arranged on the end face of the guidewire tube 1, and passes through the side wall of the guidewire tube 1, and the internal imaging balloon catheter enters the target blood vessel along the guidewire, and physiological saline enters the balloon 3 from the imaging tube 2 to fill and expand it, and the internal imaging probe 4 arranged on one side of the balloon 3 can be connected to an external control system to scan and detect the inside of the blood vessel while the balloon 3 is filled and expanded, and the internal imaging balloon catheter can also be extended forward after the balloon 3 is contracted, so that the internal imaging probe 4 can detect inside the blood vessel after the balloon 3 is expanded.
上述球囊3在PCI手术中实施的一般情况下,为减少成像盲区会将长度设置的较短,其平直段的长度一般需要≤5mm。In general, when the above-mentioned balloon 3 is implemented in a PCI operation, the length is set shorter to reduce the imaging blind area, and the length of the straight section thereof is generally required to be ≤5 mm.
进一步地,参考说明书附图2,图2为本发明实施例所提供的内成像探头的结构示意图,包括:上述内成像探头4包括:换能器41和驱动轴42;上述换能器41安装在驱动轴42面向导丝管1的一端,且可跟随驱动轴42沿成像管2的长度方向旋转和移动;可根据驱动轴42的移动范围改变换能器41的探测范围。Further, referring to Figure 2 of the specification, Figure 2 is a schematic diagram of the structure of the internal imaging probe provided in an embodiment of the present invention, including: the above-mentioned internal imaging probe 4 includes: a transducer 41 and a driving shaft 42; the above-mentioned transducer 41 is installed at one end of the driving shaft 42 facing the guide wire tube 1, and can rotate and move along the length direction of the imaging tube 2 following the driving shaft 42; the detection range of the transducer 41 can be changed according to the moving range of the driving shaft 42.
进一步地,上述成像管2背离导丝管1的一端设置有手柄5,手柄5用于连接外部的控制系统与内成像探头4,控制内成像探头4实现超声成像并将成像数据反馈至外部系统,以供操作者观察。Furthermore, a handle 5 is provided at one end of the imaging tube 2 away from the guide wire tube 1, and the handle 5 is used to connect the external control system with the internal imaging probe 4, control the internal imaging probe 4 to realize ultrasonic imaging and feed back the imaging data to the external system for observation by the operator.
进一步地,参考说明书附图3,图3为本发明实施例所提供的内成像球囊导管与手柄的外部安装示意图,包括:上述手柄5包括:接头51和注射孔52,上述接头51用于连接驱动轴42,并向其传递旋转和移动的控制信号;上述注射孔52与成像管2连通,操作者可通过向成像管2和球囊3内部注入液体,在实现球囊3扩张的同时确保成像管2内部的内成像探头4被液体传输介质覆盖,协助其完成超声成像。例如在PCI手术中,上述液体可选用生理盐水作为超声成像的介质,消除损伤人体的风险。Further, referring to Figure 3 of the specification, Figure 3 is a schematic diagram of the external installation of the internal imaging balloon catheter and the handle provided by the embodiment of the present invention, including: the handle 5 includes: a joint 51 and an injection hole 52, the joint 51 is used to connect the drive shaft 42 and transmit the control signal of rotation and movement to it; the injection hole 52 is connected to the imaging tube 2, and the operator can inject liquid into the imaging tube 2 and the balloon 3 to ensure that the internal imaging probe 4 inside the imaging tube 2 is covered by the liquid transmission medium while expanding the balloon 3, so as to assist it in completing ultrasonic imaging. For example, in PCI surgery, the liquid can use physiological saline as the medium for ultrasonic imaging to eliminate the risk of damaging the human body.
进一步地,上述接头51和注射孔52之间设置有密封圈,接头51和注射孔52均与成像管2连通,因此设置密封圈防止注入的液体从接头51中渗出影响到外界设备。Furthermore, a sealing ring is provided between the joint 51 and the injection hole 52 , and both the joint 51 and the injection hole 52 are connected to the imaging tube 2 , so the sealing ring is provided to prevent the injected liquid from leaking out of the joint 51 and affecting external equipment.
进一步地,上述内成像探头还可选用OCT(光学相干断层成像技术)探头,OCT探头实现的内成像检测无需依靠液体作为传导介质,简化了设备的复杂程度。Furthermore, the above-mentioned internal imaging probe may also be an OCT (optical coherence tomography) probe. The internal imaging detection realized by the OCT probe does not need to rely on liquid as a conductive medium, which simplifies the complexity of the equipment.
需要说明的是,在本说明书中,诸如第一和第二之类的关系术语仅仅用来将一个实体与另外几个实体区分开来,而不一定要求或者暗示这些实体之间存在任何这种实际的关系或者顺序。It should be noted that, in this specification, relational terms such as first and second are merely used to distinguish one entity from other entities, but do not necessarily require or imply any actual relationship or order between these entities.
以上对本发明所提供的内成像球囊导管进行了详细介绍。本文中应用了具体个例对本发明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发明的方法及其核心思想。应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以对本发明进行若干改进和修饰,这些改进和修饰也落入本发明权利要求的保护范围内。The above is a detailed introduction to the intra-imaging balloon catheter provided by the present invention. Specific examples are used in this article to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea. It should be pointed out that for ordinary technicians in this technical field, without departing from the principle of the present invention, several improvements and modifications can be made to the present invention, and these improvements and modifications also fall within the scope of protection of the claims of the present invention.
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