CN112472968A

CN112472968A - Ultrasonic nicking catheter

Info

Publication number: CN112472968A
Application number: CN202011395426.3A
Authority: CN
Inventors: 周友明; 张志军; 钟观生; 包俊伟; 李斌
Original assignee: Brosmed Medical Co ltd
Current assignee: Brosmed Medical Co ltd
Priority date: 2020-12-03
Filing date: 2020-12-03
Publication date: 2021-03-12

Abstract

The invention discloses an ultrasonic nicking catheter, which comprises a catheter seat, a stress tube, a catheter, a balloon, a tip and an ultrasonic generation component, wherein the balloon can be inflated by injecting a medium into an inner cavity of the catheter seat, thread fine teeth made of a high polymer material are wound and attached to the outer surface of the balloon, the thread fine teeth on the outer surface of the balloon can improve pushing performance and play an anchoring role in a blood vessel, the ultrasonic generation component is positioned in the middle of the tube wall of the distal tip of the balloon catheter, the ultrasonic nicking catheter reaches a diseased part in the blood vessel, and the thread fine teeth of the balloon are propped open to be embedded into the diseased part with the narrow blood vessel and fixed, and when medicine is injected for treatment, the ultrasonic generation component at the distal end of the balloon generates ultrasonic waves to directionally disperse medicine coming out of the tip, so.

Description

Ultrasonic nicking catheter

Technical Field

The invention relates to the technical field of medical instruments, in particular to an ultrasonic nicking catheter.

Background

Endovascular calcification is the deposition of calcium salts on the inner wall of blood vessels, causing the loss of intima of blood vessels to grow plaques, resulting in stenosis of blood vessels. Intravascular stenosis is a pathological manifestation of atherosclerosis, hypertension, diabetic vasculopathy, vascular injury, chronic kidney disease, aging and the like. Intravascular stenosis is one of the important factors of high morbidity and mortality of cardiovascular and cerebrovascular diseases, which is liable to myocardial ischemia, left ventricular hypertrophy and heart failure, and causes thrombosis and plaque rupture.

At present, during clinical interventional therapy, a lesion position needing to be treated is generally reached through a guide wire, then a dilatation balloon catheter is put into the lesion position to open a narrow lesion blood vessel, and then other catheters are put into the lesion position to achieve the purpose of treatment; when severe calcified lesions are encountered, the conventional balloon catheter assembly is difficult to pass through the calcified lesions, and then, the treatment effect is poor.

Disclosure of Invention

The invention aims to provide an ultrasonic nicking catheter aiming at severe stenosis in a blood vessel, which can break calcified plaques in the blood vessel, reduce the use of instruments, increase the capability of the catheter to pass through lesions, simultaneously can prop open a balloon for anchoring, and the medicine flowing out of the tip of the catheter is treated by the emitted ultrasonic directional administration, thereby improving the success of interventional therapy.

In order to achieve the purpose, the technical scheme adopted by the invention is as follows: an ultrasonic nicking catheter comprises a catheter seat, a stress tube, a catheter, a balloon and a tip, wherein the catheter seat, the stress tube, the catheter, the balloon and the tip are sequentially connected from a near end to a far end, the balloon can be inflated by injecting a medium into an inner cavity of the catheter seat, threads are wound on the peripheral surface of the balloon, and an ultrasonic wave generating component which can at least emit ultrasonic waves is arranged in the tip.

In the technical scheme, the ultrasonic generating component is embedded in the pipe wall of the tip.

In the technical scheme, the distance between the ultrasonic generation component and the distal end of the tip is 0.05-10 mm.

In the technical scheme, the thread form of the thread is triangular, rectangular or trapezoidal with the vertex having rounded corner transition.

Among the above-mentioned technical scheme, the screw thread is solid or hollow, and protruding screw thread and sacculus be integrated into one piece or for the concatenation shaping.

In the technical scheme, the thread form angle of the thread is 0-85 degrees, the thread form height is 0.01-5mm, and the thread lead angle is 30-90 degrees.

In the technical scheme, the near end and the far end in the balloon are respectively provided with a platinum-iridium mark developing ring.

In the technical scheme, the angle between the tangent of the outer surface of the ultrasonic generation component and the axial direction of the balloon catheter is 0-75 degrees.

In the technical scheme, the catheter base is provided with an external interface which is connected with an ultrasonic generation controller for controlling the operation of the ultrasonic components, and the external interface is electrically connected with the ultrasonic generation components through leads which are embedded in the catheter base, the catheter and the tip end in sequence.

In the above technical scheme, the thread is made of a high polymer material, such as nylon, PP, TPU or PE.

The invention has the beneficial effects that: the fine tooth winding of screw thread that has macromolecular material on the sacculus of supersound nick pipe is attached to the surface of sacculus, inject the medium through the pipe seat after, the fine tooth of screw thread of sacculus surface can be salient, the fine tooth of screw thread of sacculus surface can improve propelling movement nature, the fine tooth of screw thread can increase the trafficability characteristic in stenosis when the sacculus is rotatory, the fine tooth of screw thread struts together after the sacculus struts in blood vessel, play ordinary expansion sacculus and the effect of cutting the sacculus, the fine tooth of screw thread can be anchored in blood vessel after the sacculus struts, make things convenient for other apparatus operations and directional position to administer the treatment. The ultrasonic wave generating component is located in the middle of the wall thickness of the far-end tip tube of the balloon catheter, generates ultrasonic wave vibration to act on calcified plaque on the inner wall of a blood vessel, and simultaneously, the ultrasonic wave disperses the medicine uniformly in a directional mode after administration, so that the absorption of the medicine to a lesion part is facilitated, and the blood vessel treatment and repair level is improved.

Drawings

Fig. 1 is a schematic view of the overall structure of an ultrasonic scoring catheter of the present invention.

Figure 2 is a schematic view of the distal portion of an ultrasonic scoring catheter of the present invention.

Fig. 3 is a partially enlarged schematic view of the ultrasonic wave generating device of the present invention at the tip position.

Detailed Description

In order to make the objects, technical solutions and advantages of the present application more apparent, the present application will be described and illustrated below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present application and are not intended to limit the present application. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments provided in the present application without any inventive step are within the scope of protection of the present application. Moreover, it should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another.

Reference in the specification to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the specification. The appearances of the phrase in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Those of ordinary skill in the art will explicitly and implicitly appreciate that the embodiments described herein may be combined with other embodiments without conflict.

Unless defined otherwise, technical or scientific terms referred to herein shall have the ordinary meaning as understood by those of ordinary skill in the art to which this application belongs. Reference to "a," "an," "the," and similar words throughout this application are not to be construed as limiting in number, and may refer to the singular or the plural. The present application is directed to the use of the terms "including," "comprising," "having," and any variations thereof, which are intended to cover non-exclusive inclusions; for example, a process, method, system, article, or apparatus that comprises a list of steps or modules (elements) is not limited to the listed steps or elements, but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus. Reference to "connected," "coupled," and the like in this application is not intended to be limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. Reference herein to "a plurality" means greater than or equal to two. "and/or" describes an association relationship of associated objects, meaning that three relationships may exist, for example, "A and/or B" may mean: a exists alone, A and B exist simultaneously, and B exists alone. Reference herein to the terms "first," "second," "third," and the like, are merely to distinguish similar objects and do not denote a particular ordering for the objects.

Referring to fig. 1, an ultrasonic scoring catheter of the present embodiment includes: the catheter comprises a catheter seat luer connector, a stress tube 4, a catheter 10, a balloon 5 and a tip 7 which are sequentially connected from a near end to a far end, wherein the balloon 5 can be inflated by injecting a medium into an inner cavity of the catheter seat luer connector, threaded fine teeth 9 are wound on the outer circumferential surface of the balloon 5, and an ultrasonic wave generating component 11 capable of at least emitting ultrasonic waves is arranged in the tip 7. The near end and the far end of the inner tube 6 in the balloon 5 are respectively provided with a platinum iridium mark developing ring 8. The utility model provides a sacculus pipe includes inner tube 6 and outer tube (pipe 10 promptly), and inner tube 6 sets up in the inside of outer tube, and the seal wire can be held to the lumen of inner tube 6, and the lumen of outer tube expands the inside passageway of sacculus 5 for providing medium business turn over, and the periphery and the seal welding that inner tube 6 was located to the both ends cover of sacculus 5 are in the same place. As shown in the figure, the catheter seat luer channel 1 is a guide wire cavity, so that the balloon catheter can conveniently reach a lesion position along with a guide wire, and when a medicament is injected, the catheter seat luer channel 1 is a medicament administration channel; the catheter seat Ruhr cavity 2 is conveniently expanded by inflating the balloon 5 through the catheter 10, the near end of the balloon 5 is hermetically welded with the far end of the catheter 10, the far end of the balloon 5 is hermetically welded with the inner tube 6, and the far end of the inner tube 6 extends out of the balloon to form a tip 7. In particular, after external gas or fluid is injected through catheter hub luer lumen 2, balloon 5 is inflated after the gas or fluid is introduced. The catheter seat Ruhr cavity 3 is used as an external interface, so that a buried lead is conveniently connected with the outside.

Referring to fig. 2, the balloon 5 is positioned in a blood vessel through the developing ring 8, a circle of thread fine teeth 9 made of high polymer materials are arranged on the outer surface of the balloon, the balloon 5 is expanded, so that the thread fine teeth 9 attached to the outer surface of the balloon 5 are expanded together, the thread fine teeth 9 attached to the surface of the balloon 5 can enhance the support performance of the balloon, the expansibility and the trafficability of the stenotic lesion are improved, the thread fine teeth 9 are attached to the inner wall of the blood vessel and fixed on one position without sliding, the operation of other instruments is facilitated, calcified plaques in the blood vessel can be expanded, and a narrow passage of the blood vessel is opened.

In example 1, in order to improve the support and the passage of the balloon 5, the thread fine teeth 9 attached to the surface of the balloon may be: a common sacculus 5 is formed firstly, then the formed solid thread fine teeth 9 are adhered to the surface of the common sacculus 5 in a bonding mode, when gas or liquid is injected, the sacculus 5 is expanded, the thread fine teeth 9 on the surface of the sacculus are also expanded, and the thread fine teeth 9 support the sacculus to be pushed forward.

In example 2, the thread 9 may be hollow, the thread 9 may be integral with the balloon 5, the balloon 5 may be folded together with the thread 9 before use, and when the balloon 5 is inflated by injecting gas or liquid through the catheter hub luer, the inside of the thread 9 may be pushed open by the gas or liquid.

The ultrasonic wave generating component 11 mainly comprises a piezoelectric ceramic transducer, a temperature sensor and a control electronic component, realizes the functions of sending ultrasonic waves and measuring temperature, and transmits electric power and signals through a lead.

Referring to fig. 3, the ultrasonic wave generating component 11 is disposed at the middle layer of the wall of the tip 7 (i.e. the distal end of the inner tube 6), the end of the tip 7 is conical and forms an angle of 0-75 ° with the axis of the catheter, and the angle can ensure that the injected drugs are intensively excited and uniformly dispersed, so that the emitted ultrasonic waves can be conveniently applied to a severe calcified lesion region of a blood vessel; the distance from the end face of the most front end of the inner tube 6 is 0.05-10mm, the distance enables the ultrasonic generating element 11 not to be exposed outside, the risk during pushing operation in blood vessels is reduced, and the ultrasonic generating elements can be one group or multiple groups which surround a circle and are arranged in a conical shape.

The catheter seat Ruhr cavity 3 is connected to the ultrasonic generation component 11 through a connecting wire inside the wall of the inner tube 6 as an external interface, and an external power supply, an ultrasonic control generator and a related display are connected with the external interface on the catheter seat, so that the external controller can control the on-off of the ultrasonic generation component 11 and the working states of the ultrasonic generation component, such as the frequency and the working voltage for sending ultrasonic.

In some of these embodiments, the thread profile of the thread thinning 9 is triangular, rectangular or trapezoidal with rounded transitions at the crests. The thread form angle of the thread fine thread 9 is 0-85 degrees, the thread form height is 0.01-5mm, and the thread lead angle is 30-90 degrees. And the thread fine teeth 9 are made of high polymer materials such as nylon, PP, TPU or PE. The tooth-shaped angle is the angle between the convex rectangular edge and the axial direction of the catheter, and the contact surface of anchoring movement to the vessel wall is small; the tooth form height is limited to protect the wall of the blood vessel from being damaged little, the thread lead angle is convenient to move, and the resistance is small.

The ultrasonic scoring catheter is used for removing serious calcified lesion in blood vessel and directional administration therapy, and comprises the following steps:

(1) the guiding wire is firstly led into the calcified lesion part, when the guiding wire is not passed through the serious calcified lesion part, the guiding wire is firstly led into the drug delivery expansion saccule along the guiding wire through the inner cavity of the inner tube 6 to reach the lesion part, the ultrasonic generating component is connected to generate ultrasonic waves, some calcified plaques are shattered, and then the guiding wire continues to move forwards.

(2) The inner cavity of the inner tube 6 sends the folded saccule 5 to the position of the calcified plaque which is scheduled to be treated along the guide wire, if the plaque is too hard, the saccule 5 can be expanded in advance, and then the saccule is screwed to advance according to the direction of the thread fine teeth 9 to extrude and cut the calcified plaque on the blood vessel wall.

(3) And introducing fluid into the catheter holder luer cavity 2, and enabling the fluid to enter the balloon 5, so that the balloon 5 is inflated after being filled with the fluid, and the thread fine teeth 9 on the surface of the balloon 5 are expanded until the balloon 5, the thread fine teeth 9 and the calcified blood vessel wall are attached to each other.

(4) The external ultrasonic wave controls the generator to work, controls the ultrasonic wave generating component 11 to emit ultrasonic waves, and the ultrasonic waves directly act on the calcification spots, so that the calcification spots are stripped on the inner wall of the blood vessel, and the aim of removing the calcification spots in the blood vessel is fulfilled.

(5) When the far end of the balloon 5 reaches the lesion position, the guide wire is pulled out through anchoring of the fine thread 9 on the balloon, the catheter hub luer cavity 1 is filled with the medicine, the medicine is filled into the blood vessel through the inner tube, the ultrasonic wave generation component 11 is started to emit ultrasonic waves, the ultrasonic waves directionally vibrate and disperse the medicine, and the absorption of the medicine on the blood vessel wall is increased.

In conclusion, the thread fine teeth 9 are attached to the surface of the filled balloon 5 of the drug delivery expansion balloon, when a guide wire is too short, the balloon catheter can be screwed to advance, so that plaque on the vessel wall is squeezed, and meanwhile, the thread fine teeth 9 can play a role in anchoring positions, so that operation of other instruments is facilitated; the front end of the catheter 6 is provided with a component 7 capable of generating ultrasonic waves, and the generated ultrasonic waves directly act on calcified lesion sites, so that the aim of removing calcified plaques is fulfilled; after the saccule reaches the pathological change position, the saccule is opened, the medicine is injected, the ultrasonic generator is started, and the medicine is directionally vibrated and dispersed to achieve the purpose of treatment.

The above examples are intended to illustrate rather than to limit the invention, and all equivalent changes and modifications made by the methods described in the claims of the present invention are intended to be included within the scope of the present invention.

Claims

1. An ultrasonically scoring catheter, comprising: the ultrasonic wave generator comprises a catheter base, a stress tube, a catheter, a balloon and a tip, wherein the catheter base, the stress tube, the catheter, the balloon and the tip are sequentially connected from a near end to a far end, the balloon can be inflated by injecting a medium into an inner cavity of the catheter base, threads are wound on the peripheral surface of the balloon, and an ultrasonic wave generating component which can at least emit ultrasonic waves is arranged in the tip.

2. The ultrasonic scoring catheter of claim 1, wherein: the ultrasonic generating component is embedded in the pipe wall of the tip.

3. The ultrasonic scoring catheter of claim 1, wherein: the distance between the ultrasonic generation component and the far end of the tip is 0.05-10 mm.

4. The ultrasonic scoring catheter of claim 1, wherein: the thread form of the thread is triangular, rectangular or trapezoidal with rounded corner transition at the crest.

5. The ultrasonic scoring catheter of claim 1, wherein: the screw thread is solid or hollow, just the protruding screw thread with the sacculus is integrated into one piece or for the concatenation shaping.

6. The ultrasonic scoring catheter of claim 1, wherein: the thread form angle of the thread is 0-85 degrees, the thread form height is 0.01-5mm, and the thread lead angle is 30-90 degrees.

7. The ultrasonic scoring catheter of claim 1, wherein: the near end and the far end in the sacculus are respectively provided with a platinum iridium mark developing ring.

8. The ultrasonic scoring catheter of claim 1, wherein: the axial angle between the outer surface of the ultrasonic generation component and the balloon catheter is 0-75 degrees.

9. The ultrasonic scoring catheter of claim 1, wherein: the catheter seat is provided with an external interface which is connected with an ultrasonic wave generation controller for controlling the operation of the ultrasonic wave component, and the external interface is electrically connected with the ultrasonic wave generation component through leads which are sequentially embedded in the catheter seat, the catheter and the tip.

10. The ultrasonic scoring catheter of claim 1, wherein: the thread is made of high polymer materials, and is made of nylon, PP, TPU or PE.