CN114073810A - Developing ring and balloon dilatation catheter using same - Google Patents

Developing ring and balloon dilatation catheter using same Download PDF

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Publication number
CN114073810A
CN114073810A CN202010998024.6A CN202010998024A CN114073810A CN 114073810 A CN114073810 A CN 114073810A CN 202010998024 A CN202010998024 A CN 202010998024A CN 114073810 A CN114073810 A CN 114073810A
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CN
China
Prior art keywords
balloon
developing
catheter
micro
bubble
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Pending
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CN202010998024.6A
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Chinese (zh)
Inventor
常永焕
董永华
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Zhishan Interventional Ablation Technology Research Institute Nanjing Co ltd
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Zhishan Interventional Ablation Technology Research Institute Nanjing Co ltd
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Priority to CN202010998024.6A priority Critical patent/CN114073810A/en
Publication of CN114073810A publication Critical patent/CN114073810A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1079Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/32General characteristics of the apparatus with radio-opaque indicia

Abstract

The invention discloses a balloon dilatation catheter, comprising: the tip is arranged at the most distal end of the balloon dilatation catheter and is used for firstly entering the blood vessel when the balloon dilatation catheter is inserted into the blood vessel; the inner catheter is an elongated cylindrical tube, extends along the axial direction of the balloon dilatation catheter and is inserted at one side of the tip end; the balloon is sleeved on the inner catheter, is positioned on one side close to the far end of the balloon dilatation catheter and is connected with the tip, wherein a plurality of developing rings are arranged on the inner catheter in the balloon, each developing ring has unique different characteristics, and the characteristics can be identified by acoustics or X rays. Compared with the prior art, the balloon dilatation catheter has good developing performance and high visibility, and is easy to position particularly during interventional therapy guided by ultrasound.

Description

Developing ring and balloon dilatation catheter using same
Technical Field
The invention relates to a developing ring, and also relates to a balloon dilatation catheter using the developing ring, belonging to the technical field of interventional medical instruments.
Background
Currently, means for treating a stenosis of an autologous or artificial arteriovenous fistula include a surgical operation and an interventional therapy, and among them, the interventional therapy is very convenient, minimally invasive, and can be repeated, and the vascular resources of a hemodialysis patient can be maximally reserved, and thus, the method is favored in recent years. The interventional therapy refers to Percutaneous Angioplasty (PTA), which is a technique of dilating a narrowed blood vessel using a balloon catheter to restore a vascular access. When the PTA balloon is expanded, the operation can be performed under X-ray or ultrasonic guidance, and thus the balloon expansion catheter is required to have developability. In the fourth part of the national pharmaceutical industry standard YY0285.4-2017, it is also mentioned that a balloon dilatation catheter must be detectable under radiation.
However, the developing rings adopted in the prior art usually mark both ends of the balloon, and the developing marks at both ends have poor developing performance, so that the position of the balloon dilatation catheter in the blood vessel cannot be accurately positioned.
Disclosure of Invention
The invention provides a developing ring.
Another object of the present invention is to provide a balloon dilatation catheter using the developing ring.
In order to achieve the purpose, the invention adopts the following technical scheme:
according to a first aspect of embodiments of the present invention, there is provided a development ring for a balloon dilatation catheter, the development ring being provided with a micro-bubble cavity in a circumferential direction, the micro-bubble cavity containing a solid substance or a micro-bubble solid substance capable of generating a harmless gas to a human body by contacting with a body fluid.
According to a second aspect of embodiments of the present invention, there is provided a balloon dilation catheter comprising:
the tip is arranged at the most distal end of the balloon dilatation catheter and is used for firstly entering the blood vessel when the balloon dilatation catheter is inserted into the blood vessel;
the inner catheter is an elongated cylindrical tube, extends along the axial direction of the balloon dilatation catheter and is inserted at one side of the tip end;
a saccule which is sleeved on the inner catheter, is positioned at one side close to the far end of the saccule dilating catheter and is connected with the tip end,
wherein, on the inner catheter in the sacculus, a plurality of developing rings are arranged, each developing ring has unique different characteristics, and the characteristics can be identified by acoustics or X rays.
Preferably, the developing rings are different in size at a plurality of positions.
Wherein preferably the number of developing rings at each of the plurality of developing rings is different.
Preferably, the developing ring is provided with a micro-bubble cavity, and substances which can generate gas when being contacted with body fluid are sealed in the micro-bubble cavity.
Preferably, the number or position of the micro-bubble cavities of the multiple developing rings is different.
Wherein preferably, the micro-bubble cavity of the developing ring contains solid substances or micro-bubble solid substances which can be contacted with body fluid to generate harmless gas for human body.
Wherein preferably, the solid material of the microbubbles in the microbubble cavities is gelatin sponge.
Wherein preferably the lumen of the microbubbles is sealed with an adhesive.
Preferably, the plurality of developer rings each have a different size, number, or number or location of microbubble cavities.
Compared with the prior art, the balloon dilatation catheter has good developing performance, can simply and accurately distinguish the positions of different developing rings, and is easy to position particularly when interventional therapy guided by ultrasound is adopted. Moreover, by providing different features on different developer rings, the developer rings can be clearly identified both acoustically and by X-rays.
Drawings
FIG. 1 is a front view of a balloon dilation catheter in accordance with embodiments of the present invention;
FIG. 2 is an enlarged view of a portion of FIG. 1;
FIG. 3 is a cross-sectional view taken along A-A of FIG. 2;
FIG. 4 is an enlarged view of another visualization ring of the balloon dilation catheter of an embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element.
It will be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "inner," "outer," and the like, refer to an orientation or positional relationship as shown in the drawings for convenience in describing the application and to simplify the description, and do not indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be considered as limiting the application.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless specifically limited otherwise.
As shown in fig. 1 and 2, the balloon dilatation catheter in the embodiment of the present invention includes a tip 1, a balloon 2, an inner catheter 3, a visualization portion 4, an outer catheter 5, a catheter reinforcement member 6, and a handle 7.
For convenience of explanation, one end on the right side in the drawings will be referred to as a right end, and one end on the left side will be referred to as a left end.
The tip 1 is disposed at the most distal, also the rightmost end, of the balloon dilation catheter, and when the balloon dilation catheter is pushed into a blood vessel, the blood vessel is entered first from the tip 1. In order to reduce trauma to the vessel during use, the tip surface should be smooth and have a taper.
The inner catheter 3 is an elongated cylindrical hollow tube extending in the axial direction of the balloon dilatation catheter and inserted at one side of the tip 1, i.e. the left end of the tip 1. At the position where the balloon 2 (to be described in detail later) is provided on the inner catheter 3, there is provided a side hole (not shown) for injecting gas or liquid into the balloon to inflate or deflate the balloon 2. The number and position of the side holes are designed to minimize adverse effects on the catheter and tissue damage.
The balloon 2 is sleeved on the inner catheter 3 and is positioned at one side close to the far end of the balloon dilatation catheter and connected with the tip 1.
The outer catheter 5 is also an elongated cylindrical hollow tube extending in the axial direction of the balloon dilatation catheter. The outer catheter 5 is sleeved on the inner catheter 3, and the right end of the outer catheter is connected with the left end of the balloon 2 which is also sleeved on the inner catheter 3, namely, the balloon 2 and the outer catheter 5 are sequentially sleeved outside the inner catheter 3 from right to left. As shown in FIG. 3, the cross section of the outer conduit 5 sleeved on the inner conduit 3 is in two concentric circles. The inner and outer tubes 3, 5 are made of nylon.
The left end of the outer catheter 5 and the left end of the inner catheter 3 are simultaneously inserted on the right side of the catheter reinforcement 6. The left side of the catheter reinforcement 6 is connected to the handle 7, and the catheter reinforcement 6 serves to more firmly fix the outer catheter 5 and the inner catheter 3 to the handle 7. The handle 7 is used for the doctor to operate the balloon dilatation catheter. The handle 7 may also be connected to an external device, such as a syringe or needle, at its leftmost end. The handle 7 is made of ABS material.
Wherein, on the inner catheter 3 positioned inside the balloon 2, a developing part 4 is provided, the developing part 4 comprises a plurality of developing rings with preset distances therebetween, and each developing ring is different from each other. The difference can be different sizes, different quantities, different materials and the like, so that each developing ring can be independently and uniquely identified under the ultrasonic or ray (any developing ring is detected by the ultrasonic or ray, and can uniquely correspond to the developing ring according to the difference). In other words, each developer ring has unique and distinct characteristics.
The first developing ring 41, the second developing ring 42 and the third developing ring 43 are arranged in this order from the proximal end to the distal end, i.e., from the right to the left in fig. 1 and 2. In the embodiment of the present invention, the first developing ring 41 is located at a position corresponding to the rightmost end of the balloon 2, the third developing ring 43 is located at a position corresponding to the leftmost end of the balloon 2, and the second developing ring 42 is located at a position corresponding to the middle of the balloon 2.
These visualization portions 4 are provided so that the position of the balloon 2 can be detected under radiation or ultrasound when the balloon dilatation catheter is inserted into the body. The developing unit 4 functions as a developing ring fitted to the inner pipe 3. As shown in fig. 4, the developing ring is a hollow circular ring having a predetermined thickness, a diameter slightly larger than that of the inner guide tube 3, and is fitted over the inner guide tube 3 and fixed to the outer surface of the inner guide tube 3.
Specifically, as shown in fig. 2, the first developing ring 41 is composed of one developing ring, the second developing ring 42 is composed of two developing rings, and the third developing ring 43 is composed of three developing rings. By providing a different number of visualization rings, markings can be made at three different locations on the balloon 2 so that the position of the balloon is accurately detected under radiation or ultrasound. That is, the position of one developing ring is detected to determine the distal end of the balloon (the right end of the balloon in fig. 1 and 2), the position of two developing rings is detected to determine the middle of the balloon, and the position of three developing rings is detected to determine the proximal end of the balloon (the left end of the balloon in fig. 1 and 2). The position of the entire balloon can be accurately determined by the 3-part development. The number of the developing rings can be changed according to actual requirements, but the three developing rings are provided with different numbers of developing rings so as to distinguish the positions of the marking balloons.
Alternatively, a micro bubble chamber 141 may be provided in the development ring 14 of the second embodiment of the present invention. The micro bubble chamber 141 may be one or a plurality of micro bubble chambers distributed along the outer circumference of the developing ring 14. Moreover, the micro lumens 141 may be non-uniformly distributed about the periphery of the developer ring 14 or may be uniformly distributed, such that the micro lumens 14 of the developer ring 14 are distributed differently to exhibit different acoustically discernable characteristics.
The micro-bubble cavities 141 may contain solid substances (powder or particles) such as sodium bicarbonate that can generate harmless gas to the human body by contacting with body fluid, or contain solid substances such as gelatin sponge, and the powder or particles may be enclosed in the micro-bubble cavities 141 by a binder such as gelatin-based binder or chitosan-based binder. If powders or particles such as sodium bicarbonate are contained which are to be contacted with body fluids, the thickness of the adhesive is required not only to satisfy the fixation function, but also to satisfy the requirement that the powders or particles in the micro bubble chamber 141 can be dissolved or decomposed in a short time when the body fluid is encountered in vivo, so that the powders or particles in the micro bubble chamber 141 are released to generate gas. If micro bubbles of gelatin sponge are contained, the thickness of the adhesive is only required to meet the requirement of fixing the gelatin sponge. Since the B-mode ultrasonic is sensitive to gas, the position of the developing ring can be identified according to the difference of the gas release amount. For example, the first imaging ring is without a microbubble cavity; the developing ring at the second position is provided with three micro-bubble cavities; the third developing ring is provided with six micro-bubble cavities.
The developing ring provided by the invention can have different characteristic combinations so as to realize accurate identification of the first developing ring, the second developing ring and the third developing ring by utilizing a B-ultrasonic image at an angle. Specific combinations are shown in table 1, for example:
Figure BDA0002693288380000051
Figure BDA0002693288380000061
TABLE 1 various combinations of developer rings
As indicated above, the features of the various embodiments of the present invention may be provided in a variety of combinations, and the size, number, or lumen of the plurality of visualization rings may be different so long as each visualization ring has a unique, distinct feature that is acoustically identifiable.
The developing ring in the embodiment of the invention is made of 304 stainless steel and titanium steel. Although the above embodiments are described with acoustically recognizable, i.e. B-mode, application scenarios, it will be understood by those skilled in the art that each imaging ring has a unique and distinct feature and X-rays can recognize the feature, and such designs can be used in X-ray application scenarios.
In order to more accurately place the balloon dilatation catheter, a guide wire is used as a guide, and a guide wire cavity (not shown) is further provided in the balloon dilatation catheter, and the guide wire is inserted into the inner tube.
When the doctor pushes the balloon dilatation catheter slowly into the body, the balloon is in an unfilled state as shown in fig. 1 and 2, and at the moment, the medical stent is sleeved on the surface of the balloon, which is wrapped by the balloon. The whole placing process is carried out under the detection of rays or ultrasound, after the developing part in the balloon dilatation catheter is accurately positioned, normal saline or a proper amount of gas is injected into the inner catheter through the injector to fill the balloon, after the dilatation is finished, the normal saline or the gas in the inner catheter is extracted through the injector to shrink the balloon to restore the original shape, and then the balloon dilatation catheter is slowly pulled out to finish the balloon blood vessel dilatation. Meanwhile, after the stent is placed, the operation of placing the medical stent in the blood vessel by using the balloon can be realized.
The external equipment connected with the balloon dilatation catheter of the embodiment of the invention, the specific operation of connecting and disassembling the external equipment and the like adopt the existing equipment and conventional means which meet the standards of the national people's republic of China medical industry, and are not described again here.
According to the balloon dilatation catheter provided by the embodiment of the invention, the three developing rings are arranged on the inner catheter arranged in the balloon and respectively used as marks at the two ends and the middle of the balloon, so that the position of the balloon can be accurately detected under the radiation or ultrasonic. And moreover, the developing rings at multiple positions are arranged into the developing rings with different characteristics, so that the detection precision of the developing rings under rays or ultrasound is improved, and the accuracy of positioning the balloon is improved.
The developing ring and the balloon dilatation catheter using the same according to the present invention are described in detail above. It will be apparent to those skilled in the art that any obvious modifications thereof can be made without departing from the spirit of the invention, which infringes the patent right of the invention and bears the corresponding legal responsibility.

Claims (10)

1. The utility model provides a development ring that sacculus expansion pipe was used which characterized in that:
the developing ring is provided with a micro-bubble cavity in the circumferential direction, and solid matters or micro-bubble solid matters which can contact with body fluid to generate harmless gas of a human body are accommodated in the micro-bubble cavity.
2. A balloon dilation catheter, comprising:
the tip is arranged at the most distal end of the balloon dilatation catheter and is used for firstly entering the blood vessel when the balloon dilatation catheter is inserted into the blood vessel;
an inner catheter which is an elongated cylindrical tube extending in the axial direction of the balloon dilatation catheter and inserted at one side of the tip;
a balloon sleeved on the inner catheter and positioned at one side close to the far end of the balloon dilatation catheter and connected with the tip end,
wherein, on the inner catheter inside the sacculus, a plurality of developing rings are arranged, each developing ring has unique and different characteristics, and the characteristics can be identified by acoustics or X rays.
3. The balloon dilation catheter according to claim 2, wherein:
the developing rings at the plurality of positions are different in size.
4. The balloon dilation catheter according to claim 2 or claim 3, wherein:
in the plurality of developing rings, the number of developing rings is different at each position.
5. The balloon dilation catheter according to claim 2, wherein:
the developing ring is provided with a micro-bubble cavity, and substances which can generate gas when contacting with body fluid are sealed in the micro-bubble cavity.
6. The balloon dilation catheter according to claim 5, wherein:
the number or the position of the micro-bubble cavities of the multiple developing rings are different.
7. The balloon dilation catheter according to claim 2, wherein:
the micro-bubble cavity of the developing ring contains solid matters or micro-bubble solid matters which can be contacted with body fluid to generate harmless gas for human bodies.
8. The balloon dilation catheter according to claim 7, wherein:
the microbubble solid matter within the microbubble cavity is gelatin sponge.
9. The balloon dilation catheter according to claim 8, wherein:
the lumen of the microbubbles is sealed with an adhesive.
10. A balloon dilation catheter according to any one of claims 2 to 3 or 5 to 7 wherein:
in the plurality of developer rings, each developer ring has a different size, number, or number or location of micro-bubble lumens.
CN202010998024.6A 2020-09-21 2020-09-21 Developing ring and balloon dilatation catheter using same Pending CN114073810A (en)

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN202355682U (en) * 2011-11-16 2012-08-01 常州市久虹医疗器械有限公司 Balloon dilatation catheter with visual developing device
CN203591303U (en) * 2013-11-25 2014-05-14 王红军 Expansion separator
CN204352312U (en) * 2014-12-04 2015-05-27 上海市同济医院 A kind of myoelectricity guiding entry needle strengthening ultrasonic development
CN208959096U (en) * 2018-06-08 2019-06-11 徐州亚太科技有限公司 It is a kind of through chest Sacculus dilating catheter of bicuspid valve component
CN110025872A (en) * 2018-01-12 2019-07-19 美敦力公司 A kind of sacculus dilating catheter of the lower developability of enhancing ultrasound
CN209404913U (en) * 2018-08-28 2019-09-20 广州纵途医疗科技有限公司 A kind of balloon catheter for expanding vertebra
CN110681034A (en) * 2019-11-06 2020-01-14 上海慧达医疗器械有限公司 Circulating medicine perfusion catheter
CN111658969A (en) * 2020-06-16 2020-09-15 郑州大学第一附属医院 Balloon catheter with balloons with two asymmetric ends

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN202355682U (en) * 2011-11-16 2012-08-01 常州市久虹医疗器械有限公司 Balloon dilatation catheter with visual developing device
CN203591303U (en) * 2013-11-25 2014-05-14 王红军 Expansion separator
CN204352312U (en) * 2014-12-04 2015-05-27 上海市同济医院 A kind of myoelectricity guiding entry needle strengthening ultrasonic development
CN110025872A (en) * 2018-01-12 2019-07-19 美敦力公司 A kind of sacculus dilating catheter of the lower developability of enhancing ultrasound
CN208959096U (en) * 2018-06-08 2019-06-11 徐州亚太科技有限公司 It is a kind of through chest Sacculus dilating catheter of bicuspid valve component
CN209404913U (en) * 2018-08-28 2019-09-20 广州纵途医疗科技有限公司 A kind of balloon catheter for expanding vertebra
CN110681034A (en) * 2019-11-06 2020-01-14 上海慧达医疗器械有限公司 Circulating medicine perfusion catheter
CN111658969A (en) * 2020-06-16 2020-09-15 郑州大学第一附属医院 Balloon catheter with balloons with two asymmetric ends

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