CN215780888U

CN215780888U - Balloon dilatation catheter

Info

Publication number: CN215780888U
Application number: CN202121928036.8U
Authority: CN
Inventors: 王翠翠
Original assignee: Jiangsu Changyida Medical Technology Co ltd; Shanghai Suchang Medical Technology Co ltd
Current assignee: Jiangsu Changyida Medical Technology Co ltd; Shanghai Suchang Medical Technology Co ltd
Priority date: 2021-08-17
Filing date: 2021-08-17
Publication date: 2022-02-11
Anticipated expiration: 2031-08-17

Abstract

The utility model relates to the field of medical instruments, in particular to a balloon dilatation catheter which comprises a balloon body and a conveying assembly, wherein the balloon body extends axially, two ends of the balloon body are open, the conveying assembly comprises an inner tube and an outer tube, the inner tube penetrates through the balloon body through the openings at the two ends of the balloon body, a wire guide cavity, a first liquid through cavity and a first liquid outlet cavity which are not communicated with each other are arranged in the outer tube, the wire guide cavity is communicated with the inner tube, the first liquid through cavity is communicated with an inner cavity of the balloon body, a first tail end of the first liquid outlet cavity is a liquid inlet, a second tail end of the first liquid outlet cavity is a liquid outlet, and the liquid outlet is close to the balloon body and is not communicated with the inner cavity of the balloon body. The balloon dilatation catheter has the function of radiography, the cavity channel for introducing the contrast liquid can be opened immediately after the balloon body is expanded, the injury to the cerebral vessels can be reduced, the operation time can be shortened, the dosage of the contrast agent can be reduced, and the medical expense can be reduced.

Description

Balloon dilatation catheter

Technical Field

The utility model relates to the field of medical instruments, in particular to a balloon dilatation catheter.

Background

The nerve intervention is to diagnose and treat the pathological changes affecting the human neurovascular system by specific methods such as selective radiography, embolism, dilation forming, mechanical clearance, drug delivery and the like by adopting an intravascular catheter operation technology under the support of a Digital Subtraction Angiography (DSA) system. The nerve intervention treatment is a method for treating neck or intracranial vascular diseases by puncturing femoral artery or femoral vein and reaching neck or intracranial blood vessels by using a special balloon catheter.

Neural intervention is primarily associated with cerebral vessels, and is more difficult to implement than cardiovascular intervention. Cerebral vessels are thinner than cardiovascular vessels, and cerebral arteries are thin, long, tortuous, and lack elastic pulsation.

The prior art has the following defects: 1) in the traditional treatment method, the balloon needs to use an angiography catheter to determine the effect of the balloon-expanded lesion after working, and various catheters, guide wires and balloons can be frequently switched in an operation, so that cerebral vessels can be damaged to different degrees; 2) the traditional method prolongs the operation time while treating and replacing the device, so that doctors can be exposed to the rays for a long time.

SUMMERY OF THE UTILITY MODEL

In view of the above-mentioned drawbacks of the prior art, it is an object of the present invention to provide a balloon dilation catheter which solves the problems of the prior art.

In order to achieve the above and other related objects, the present invention provides a balloon dilatation catheter, which includes a balloon body and a delivery assembly, wherein the balloon body extends axially and has two open ends, the delivery assembly includes an inner tube and an outer tube, the inner tube penetrates through the balloon body through the openings at the two ends of the balloon body, a guidewire cavity, a first liquid through cavity and a first liquid outlet cavity which are not communicated with each other are arranged in the outer tube, the guidewire cavity is communicated with the inner tube, the first liquid through cavity is communicated with an inner cavity of the balloon body, a first end of the first liquid outlet cavity is a liquid inlet, a second end of the first liquid outlet cavity is a liquid outlet, and the liquid outlet is close to the balloon body and is not communicated with the inner cavity of the balloon body.

Preferably, a liquid outlet hole piece communicated with the liquid outlet opening of the first liquid outlet cavity is arranged at the liquid outlet opening of the first liquid outlet cavity. The liquid outlet piece comprises an inflow section, a transition section and an outflow section which are sequentially connected, the inflow section is communicated with the first liquid outlet cavity, the transition section is in transition towards the axial direction far away from the first liquid outlet cavity, and the outlet of the outflow section faces towards the outer surface of the balloon body. The transition section is in right-angle transition or arc transition.

Preferably, the conveying assembly further comprises a connecting pipe, a second liquid through cavity and a second liquid outlet cavity are arranged in the connecting pipe, the second liquid through cavity is communicated with the first liquid through cavity, and the second liquid outlet cavity is communicated with the first liquid outlet cavity.

Preferably, the conveying assembly further comprises a hypotube, a third liquid through cavity and a third liquid outlet cavity are arranged in the hypotube, the third liquid through cavity is communicated with the second liquid through cavity, and the third liquid outlet cavity is communicated with the second liquid outlet cavity.

Preferably, the balloon dilatation catheter is an intracranial contrast balloon dilatation catheter.

As described above, the balloon dilatation catheter of the present invention has the following advantageous effects: the balloon dilatation catheter has the function of radiography, the cavity channel for introducing the contrast liquid can be opened immediately after the balloon body is dilated, the guide wire and the angiography catheter do not need to be replaced like the prior art, and the injury to the cerebral vessels caused by replacing the guide wire, the catheter and the balloon can be reduced; meanwhile, the operation time is shortened, and the time of exposing a doctor in rays is shortened; and because the contrast position is closer to the focus position, compared with a contrast catheter, the utility model can reduce the dosage of the contrast agent and lower the medical cost.

Drawings

Fig. 1 is a schematic view of the balloon dilation catheter of the present invention in its entirety.

Fig. 2 is an enlarged schematic view of one of the segments of the balloon dilation catheter of the present invention.

Fig. 3 shows a schematic cross-sectional view of the outer tube at B-B in fig. 1, the three views showing three different embodiments of the outer tube.

Fig. 4 is a partially enlarged view of the drainage hole, in which a is the drainage direction of the first drainage lumen of the balloon dilatation catheter of the present invention and b is the drainage direction of the first drainage lumen of the balloon dilatation catheter of the prior art.

Fig. 5 shows a schematic cross-sectional view of the outer tube at a-a in fig. 1, the three views showing three different embodiments of the outer tube.

FIG. 6 is a schematic cross-sectional view of the connecting tube at C-C in FIG. 1, showing three different embodiments of the connecting tube.

FIG. 7 is a schematic cross-sectional view of the hypotube at D-D in FIG. 1, showing three different embodiments of the hypotube.

Description of the element reference numerals

1 balloon body

21 inner pipe

22 outer tube

221 guide wire cavity

222 first liquid through cavity

223 first liquid outlet cavity

2231 liquid outlet hole piece

2231a inflow section

2231b transition section

2231c outflow segment

23 connecting pipe

231 second liquid-passing cavity

232 second liquid outlet cavity

24 sea wave tube

241 third-way liquid cavity

242 third liquid outlet cavity

25 tip

3Y-shaped seat

31 first connecting member

32 second connecting piece

4 developing mark

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will become apparent to those skilled in the art from the present disclosure.

Please refer to the attached drawings. It should be understood that the structures, ratios, sizes, and the like shown in the drawings and described in the specification are only used for matching with the disclosure of the specification, so as to be understood and read by those skilled in the art, and are not used to limit the conditions under which the present invention can be implemented, so that the present invention has no technical significance, and any structural modification, ratio relationship change, or size adjustment should still fall within the scope of the present invention without affecting the efficacy and the achievable purpose of the present invention. In addition, the terms "upper", "lower", "left", "right", "middle" and "one" used in the present specification are for clarity of description, and are not intended to limit the scope of the present invention, and the relative relationship between the terms and the terms is not to be construed as a scope of the present invention.

The term "proximal" in this application generally refers to the end of the corresponding component that is near the operator, e.g., the lower end in fig. 1; "distal end" means the end of the counterpart remote from the operator, e.g. the upper end in fig. 1.

As shown in fig. 1, the application provides a sacculus expansion pipe, sacculus expansion pipe includes sacculus body 1 and delivery unit, 1 axial extension of sacculus body and both ends opening, delivery unit includes inner tube 21 and outer tube 22, inner tube 21 warp the opening at sacculus body 1 both ends runs through sacculus body 1, be equipped with each other not communicating wire guide chamber 221, first logical liquid chamber 222 and first play liquid chamber 223 in the outer tube 22, wire guide chamber 221 and inner tube 21 intercommunication, first logical liquid chamber 222 and sacculus body 1's inner chamber intercommunication, first end that goes out liquid chamber 223 is liquid inlet, and the second is terminal to be liquid outlet, the nearly sacculus body 1 of liquid outlet and the inner chamber intercommunication with sacculus body 1.

The balloon body 1 is made of a heat-shrinkable elastomer. The heat-shrinkable elastomer is selected from nylon, Pebax or polyurethane. The balloon body 1 is prepared by adopting a blow molding process.

The proximal end of the balloon body 1 is fixedly connected with the inner tube 21 and/or the outer tube 22 by laser welding or thermal welding. In one embodiment, the distal end of the balloon body 1 is fixedly connected to both the distal end of the inner tube 21 and the tip 25. The fixed connection is selected from laser welding or heat welding and other processes.

In one embodiment, the inner tube 21 is fabricated by co-extrusion of three layers of material. Typically, the inner tube 21 has an inner layer of HDPE, a middle layer of low density medical grade polyethylene, and an outer layer of Pebax 7233. The inner tube 21 formed by three layers of materials has better hardness and smoothness.

In one embodiment, the inner tube 21 is a single lumen tube structure.

In one embodiment, the proximal end of the inner tube 21 is fixedly attached to the distal end of the guidewire lumen 221 by laser welding or heat welding.

The inner tube 21 is communicated with the guide wire cavity 221 and is commonly used for passing a delivery guide wire during the delivery of the balloon dilatation catheter. The common specifications of the delivery guide wire are 0.014inch, 0.018inch, 0.035inch and the like.

In one embodiment, the outer tube 22 is constructed of a single layer of material. The material of the outer tube 22 is, for example, Pebax 7233.

Three different shapes of the first liquid passing chamber 222 and the first liquid outlet chamber 223 are shown in fig. 3.

The liquid outlet of the first liquid outlet cavity 223 is close to the balloon body 1 and is not communicated with the inner cavity of the balloon body 1, so that the liquid in the first liquid outlet cavity 223 can flow to a lesion position through the end opening of the first liquid outlet cavity for radiography. The situation that the contrast liquid flows out from the hole on the liquid outlet cavity wall (namely the direction b in figure 4) to impact the blood vessel and mechanically damage the blood vessel can be avoided. That is, the flowing direction of the contrast medium in the present invention optimizes the direction perpendicular to the blood vessel (i.e., the direction b in fig. 4) to the direction parallel to the blood vessel (i.e., the direction a in fig. 4) in the prior art, and changes the flow direction of the contrast medium, thereby reducing the impact of the contrast medium on the blood vessel when flowing out and protecting the blood vessel from mechanical damage.

In the preferred embodiment shown in fig. 2 to 4, the liquid outlet hole 2231 is disposed at the liquid opening of the first liquid outlet chamber 223 and communicated with the first liquid outlet chamber. The liquid outlet piece 2231 comprises an inflow section 2231a, a transition section 2231b and an outflow section 2231c which are connected in sequence, wherein the inflow section 2231a is communicated with the first liquid outlet cavity 223, the transition section is transited to the axial direction far away from the first liquid outlet cavity 223, and the outlet of the outflow section 2231c faces the outer surface of the balloon body 1.

The transition section 2231b is a right angle transition (as shown in the right side of fig. 4) or an arc transition (as shown in the left side of fig. 4). One end of the liquid outlet hole part 2231 is fixedly connected with the first liquid outlet cavity 223. The fixed connection is selected from laser welding, spot gluing or thermal welding.

The material of the liquid outlet piece 2231 is selected from medical grade PC, Nylon, Pebax and other high molecular materials. The liquid outlet piece 2231 is used for guiding the outflow of the contrast liquid, and the right-angle conversion structure or the cambered surface structure of the liquid outlet piece 2231 enables the outflow position of the contrast liquid to be closer to the blood vessel wall, so that the impact of the contrast liquid on the blood vessel when the contrast liquid flows out can be further reduced, and the blood vessel is protected from mechanical damage.

In one embodiment, the conveying assembly further includes a connecting pipe 23, a second liquid passing cavity 231 and a second liquid outlet cavity 232 are arranged in the connecting pipe 23, the second liquid passing cavity 231 is communicated with the first liquid passing cavity 222, and the second liquid outlet cavity 232 is communicated with the first liquid outlet cavity 223. The connecting pipe 23 and the outer pipe 22 are fixedly connected to realize the communication of the cavities. The fixed connection is selected from laser welding or thermal welding.

The connection tube 23 is made of a single layer material. The material of the connecting tube 23 is selected from Nylon12, L25, ML21 or Nylon 11. In one embodiment, the connection tube 23 is prepared by an extrusion process using the aforementioned materials.

In an embodiment, the conveying assembly further includes a hypotube 24, a third liquid passing cavity 241 and a third liquid outlet cavity 242 are arranged in the hypotube 24, the third liquid passing cavity 241 is communicated with the second liquid passing cavity 231, and the third liquid outlet cavity 242 is communicated with the second liquid outlet cavity 232. The hypotube 24 and the connecting tube 23 are fixedly connected to communicate with each other. The fixed connection is selected from laser welding or thermal welding or spot gluing.

The hypotube 24 is obtained by cutting a variable-diameter spiral line by using a laser cutting mode by taking a medical stainless steel metal pipe as a main body. The above-described structure provides the hypotube 24 with rigidity and bending resistance.

The shapes of the guidewire lumen 221, the first fluid passage lumen 222 and the first fluid outlet lumen 223, the second fluid passage lumen 231 and the second fluid outlet lumen 232, and the third fluid passage lumen 241 and the third fluid outlet lumen 242 are not particularly limited in this application, and for example, the cross section is circular, elliptical, fan-shaped, etc. However, the shapes of the cavities which are communicated with each other are matched with each other, and particularly, the shape of the wire guide cavity 221 is matched with that of the cavity of the inner tube 21; the third liquid passing cavity 241 and the second liquid passing cavity 231 are matched with the first liquid passing cavity 222 in cavity shape; the third liquid outlet cavity 242 and the second liquid outlet cavity 232 are matched with the first liquid outlet cavity 223 in cavity shape.

In one embodiment, the balloon dilation catheter further comprises a Y-shaped seat 3. The Y-shaped seat 3 can be selected from the catheter seats in the prior art. And a first connecting piece 31 and a second connecting piece 32 which are fixedly connected with the third liquid passing cavity 241 and the third liquid outlet cavity 242 respectively are arranged on the Y-shaped seat 3. The fixed connection is selected from epoxy glue adhesion, UV curing and the like.

The Y-shaped seat 3 may be connected to a pressure pump for injecting contrast media.

In one embodiment, the delivery assembly further comprises a tip 25, the tip 25 being fixedly attached to the distal end of the inner tube 21. The fixed connection is selected from laser welding or heat welding and other processes.

The material of the tip 25 is selected from any one or more of the following: pebax2533, Pebax3533, Pebax5533, Nylon 12L25, ML 21. The tip 25 is flexible and small in size to facilitate passage through the site of the thrombotic lesion. The tip 25 is tapered. The tip 25 has a length of 3 to 5mm and an outer diameter of 0.3 to 0.6 mm.

The balloon dilatation catheter further comprises a developing mark 4, wherein the developing mark 4 is a developing element arranged on the outer wall of the inner tube 21, or the inner tube 21 is provided with the developing mark 4. Preferably, the development mark 4 is a development element arranged on an inner pipe section inside the balloon body 1, or the development mark 4 is formed on the inner pipe section inside the balloon body 1. The developing member may be a metal ring. The developing member is provided in plurality. The number of the developing members is two, for example. Both developing elements are located on the inner tube section inside the balloon body 1. The inner tube section inside the balloon body 1 may be made of a material having a developing function to form the developing mark 4, or by coating a developer on the inner tube section inside the balloon body 1, winding a developing wire, or forging the inner tube 21, or the like. The material of the developing wire is selected from gold, platinum, tantalum metal, radiopacity, PtW alloy or PtIr alloy.

The balloon dilatation catheter is an intracranial angiography balloon dilatation catheter.

The balloon dilatation catheter needs to be matched with auxiliary devices such as a balloon pressurization device in the prior art for use, and the specific use method is as follows:

after entering the balloon body 1 through the inner tube 21, the delivery guide wire passes out from the end of the guide wire cavity 221 near the connecting tube 23, as shown near a-a in fig. 1. The tip 25 enters a lesion part along the guide wire, an operator can indicate the position of the balloon body 1 through X-ray fluoroscopy, and the balloon dilatation catheter is guided to enter a blood vessel so as to be positioned at the lesion part of the blood vessel; then, a first connecting piece 31 connected with the Y-shaped seat 3 inputs contrast liquid into a third liquid passing cavity 241 through a balloon pressurizing device, the contrast liquid enters the balloon body 1 from the far end of the first liquid passing cavity 222 through a connecting pipe 23 and the first liquid passing cavity 222 to expand the balloon body 1, so that a narrow plaque of a lesion part is extruded, a blood vessel lumen is expanded, the contrast liquid filled in the balloon body 1 is convenient for an operator to observe the complete shape of the whole balloon in a blood vessel, and after the balloon body 1 is expanded, negative pressure is generated through the balloon pressurizing device to shrink the balloon body 1; after the balloon body 1 is contracted, the second connecting piece 32 connected with the Y-shaped seat 3 is controlled by the balloon pressurizing device, contrast liquid is injected, the contrast liquid flows out from the liquid outlet piece 2231 to a lesion position for radiography, and the balloon dilatation catheter is removed after radiography.

In conclusion, the balloon dilatation catheter of the utility model combines the radiography function, and simultaneously has the hypotube with the double-cavity structure and the outer tube with the triple-cavity structure, the pathological change effect of the balloon body after dilatation can be determined by radiography after implantation, the combination of the functions of the balloon dilatation catheter and the radiography function can reduce the operation time with high probability, reduce the time for exposing rays, reduce the dosage of the contrast agent, and certainly also can reduce the medical expense of patients, and simultaneously, the liquid outlet piece changes the flow direction of the contrast agent to reduce the impact of the contrast agent on blood vessels when flowing out, thereby protecting the blood vessels from mechanical damage. Therefore, the utility model effectively overcomes various defects in the prior art and has high industrial utilization value.

The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the utility model. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims

1. The utility model provides a sacculus expansion pipe, a serial communication port, sacculus expansion pipe includes sacculus body (1) and delivery assembly, sacculus body (1) axial extension and both ends opening, delivery assembly includes inner tube (21) and outer tube (22), inner tube (21) warp the opening at sacculus body (1) both ends runs through sacculus body (1), be equipped with each other not communicating wire guide chamber (221), first logical liquid chamber (222) and first play liquid chamber (223) in outer tube (22), wire guide chamber (221) and inner tube (21) intercommunication, first logical liquid chamber (222) and the inner chamber intercommunication of sacculus body (1), the first end of first play liquid chamber (223) is liquid inlet, and the second is terminal to be liquid outlet, the nearly sacculus body (1) of liquid outlet and the inner chamber intercommunication with sacculus body (1) not.

2. The balloon dilatation catheter as claimed in claim 1, wherein a liquid outlet piece (2231) is arranged at the liquid opening of the first liquid outlet cavity (223) and communicated with the first liquid outlet cavity, the liquid outlet piece (2231) comprises an inflow section (2231a), a transition section (2231b) and an outflow section (2231c) which are sequentially connected, the inflow section (2231a) is communicated with the first liquid outlet cavity (223), the transition section (2231b) is transited to a direction far away from the axial direction of the first liquid outlet cavity (223), and the outflow section (2231c) has an outlet facing the outer surface of the balloon body (1).

3. The balloon dilation catheter of claim 2, wherein the transition section (2231b) is selected from a right angle transition or an arc transition.

4. The balloon dilatation catheter according to claim 1, wherein the delivery assembly further comprises a connecting tube (23), a second liquid through cavity (231) and a second liquid outlet cavity (232) are arranged in the connecting tube (23), the second liquid through cavity (231) is communicated with the first liquid through cavity (222), and the second liquid outlet cavity (232) is communicated with the first liquid outlet cavity (223).

5. The balloon dilation catheter according to claim 4, wherein the delivery assembly further comprises a hypotube (24), a third lumen (241) and a third lumen (242) are disposed within the hypotube (24), the third lumen (241) is in communication with the second lumen (231), and the third lumen (242) is in communication with the second lumen (232).

6. The balloon dilatation catheter according to claim 5, wherein the guidewire lumen (221) matches the lumen shape of the inner tube (21); and/or the shapes of the third liquid passing cavity (241), the second liquid passing cavity (231) and the first liquid passing cavity (222) are matched; and/or the cavity shapes of the third liquid outlet cavity (242), the second liquid outlet cavity (232) and the first liquid outlet cavity (223) are matched.

7. The balloon dilatation catheter according to claim 5 further comprising a Y-shaped seat (3), wherein the Y-shaped seat (3) is provided with a first connector (31) and a second connector (32) which are fixedly connected with the third liquid through cavity (241) and the third liquid out cavity (242), respectively.

8. The balloon dilation catheter according to claim 1 wherein the delivery assembly further comprises a tip (25), the tip (25) being fixedly connected to the distal end of the inner tube (21).

9. The balloon dilation catheter according to claim 8, wherein the distal end of the balloon body (1) is fixedly connected with both the distal end of the inner tube (21) and the tip (25).

10. The balloon dilatation catheter according to claim 1 further comprising a visualization mark (4), wherein the visualization mark (4) is a visualization element provided on an outer wall of the inner tube (21) or the inner tube (21) is formed with the visualization mark (4).

11. A balloon dilation catheter according to any one of claims 1 to 10 wherein the balloon dilation catheter is an intracranial contrast balloon dilation catheter.