CN111529899A

CN111529899A - Expandable balloon

Info

Publication number: CN111529899A
Application number: CN202010327970.8A
Authority: CN
Inventors: 冼展超; 曾乐朋; 林冉
Original assignee: Shenzhen Xianjianxinkang Medical Electronics Co ltd
Current assignee: Shenzhen Xianjianxinkang Medical Electronics Co ltd
Priority date: 2020-04-23
Filing date: 2020-04-23
Publication date: 2020-08-14

Abstract

The invention relates to an expandable balloon, which comprises a catheter and a balloon which are connected, wherein a charging and discharging cavity and a guide wire cavity are formed in the catheter, and the charging and discharging cavity and the guide wire cavity extend along the axial direction of the catheter and are not communicated with each other; the balloon is provided with a pressure charging cavity which is communicated with the pressure charging and discharging cavity; wherein, be equipped with the infusion line in the sacculus, infusion line and the chamber of pressurizing each other not communicate, and the relative both ends of infusion line are opened respectively in the surface of sacculus, and when the sacculus was expanded in the blood vessel, blood can pass through from infusion line. According to the expandable balloon, the balloon is internally provided with the infusion channel which is not communicated with the pressurizing cavity of the balloon, the two opposite ends of the infusion pipeline are respectively opened on the outer surface of the balloon, when the balloon is expanded in a blood vessel, blood can pass through the infusion pipeline, so that the balloon can maintain better expansion performance and can be supplied with blood circulation through the infusion pipeline, and the phenomenon that the balloon is expanded in the blood vessel for too long time to block the blood vessel is avoided.

Description

Expandable balloon

Technical Field

The invention relates to the technical field of interventional medical devices, in particular to an expandable balloon.

Background

Stenosis, occlusion caused by atherosclerosis is a disease with high disability rate and high mortality rate. For vascular diseases, especially arteriosclerosis, stenosis and occlusive diseases, vascular interventional therapy techniques are one of the main treatment methods. At present, the blood vessel intervention treatment mainly comprises a stent implantation operation and a medicine balloon dilatation operation, the balloon dilatation operation can not be separated no matter which technique is applied, namely, an expandable balloon is sent to a lesion part, plaque is extruded outside a blood vessel through the inflated and expanded balloon to enlarge the diameter of an inner cavity of the blood vessel, and finally a stent support lumen is implanted in the lesion part or medicines are locally used to inhibit the hyperplasia of the intima of the blood vessel, so that the purpose of treating the stenosis of the blood vessel is achieved.

In the current interventional technology, certain requirements are imposed on the balloon expansion time, for example, in the stent placement process, the balloon expansion is insufficient, which leads to poor adherence of the stent, and may further induce an acute stent thrombosis event, even endanger the life safety of a patient, and for example, in the drug balloon treatment process, the drug balloon expansion is insufficient or the time is too short, and the drug cannot be effectively absorbed by the intima of the blood vessel. Therefore, in order to make the stent to be attached to the wall by more sufficient expansion or the drug of the drug balloon to be absorbed by the intima of the blood vessel more sufficiently, the balloon expansion time must be prolonged as much as possible.

However, in the implementation of the balloon dilatation, sufficient balloon dilatation will cause the interruption of the blood flow of the corresponding blood vessels to cause myocardial ischemia, so when treating coronary blood with a wider blood supply range, such as left main stem lesion or right coronary ostial lesion or dominant-anterior branch lesion, the myocardial ischemia with a wide range may cause the pause and damage of the myocardium and further cause the hemodynamic instability, and once the condition occurs, the operation of balloon dilatation will be forced to be interrupted, which may cause poor adherence of the stent or insufficient drug release.

Disclosure of Invention

In view of this, there is a need for an expandable balloon to effectively expand a blood vessel while avoiding blood flow interruption due to vessel occlusion.

An expandable balloon, comprising:

the catheter is internally provided with a charging and discharging cavity and a guide wire cavity, and the charging and discharging cavity and the guide wire cavity extend along the axial direction of the catheter and are not communicated with each other;

the balloon is provided with a pressurizing cavity, the balloon is connected with the catheter, and the pressurizing cavity is communicated with the charging and discharging cavity;

wherein, be equipped with the infusion pipeline in the sacculus, infusion pipeline and the chamber of pressurizing each other do not communicate, the relative both ends of infusion pipeline open respectively in the surface of sacculus, when the sacculus is expanded in the blood vessel, blood can pass through from the infusion pipeline.

In one of the embodiments, a tubular support is connected to the infusion line, said tubular support being able to radially support the infusion line.

In one embodiment, the infusion tube is formed by enclosing a flexible membrane, and the tubular support is embedded inside the flexible membrane.

In one of the embodiments, the tubular support is attached to the inner wall of the infusion line.

In one embodiment, the tubular support is woven from metal wires, or the tubular support is a metal threaded tube.

In one embodiment, when the tubular support is woven using metal wires, the metal wires used have a diameter of 45 μm to 55 μm.

In one embodiment, said infusion line is in plurality, a plurality of said infusion lines being uniformly distributed on a circumference centred on the axis of said balloon.

In one embodiment, the wall thickness h of the infusion line is 50 μm to 100 μm, the inner diameter D of the infusion line is 200 μm to 250 μm, and the outer diameter D of the infusion line is 300 μm to 400 μm.

In one embodiment, the guide wire cavity and the charging and discharging cavity are in a coaxial nested cavity structure.

In one embodiment, the proximal end of the catheter is connected to an inflation device via a connector, the inflation device being capable of injecting gas or liquid through the connector into the inflation and deflation lumen to inflate the inflation lumen of the balloon, causing the balloon to expand.

The invention provides an expandable balloon, which comprises a catheter and a balloon connected with the catheter, wherein an inflation and deflation cavity of the catheter is communicated with a inflation cavity of the balloon, so that gas or liquid can be injected into the inflation cavity by utilizing the inflation and deflation cavity of the catheter to expand the balloon, an infusion channel which is not communicated with the inflation cavity of the balloon is arranged in the balloon, two opposite ends of the infusion channel are respectively opened on the outer surface of the balloon, when the balloon is expanded in a blood vessel, blood can pass through the infusion channel, so that the balloon can maintain better expansion performance and can supply blood circulation through the infusion channel, and the blockage of the blood vessel caused by overlong expansion time of the balloon in the blood vessel is avoided.

Drawings

FIG. 1 is a schematic representation of the construction of an inflatable balloon according to an embodiment of the present invention;

FIG. 2 is a partial schematic structural view of the expandable balloon structure shown in FIG. 1;

FIG. 3 is a schematic cross-sectional view taken along line I-I of FIG. 2, showing the guidewire lumen and the loading and unloading lumen of the catheter in a coaxially nested lumen configuration;

fig. 4 is a schematic structural view of an embodiment of an expandable balloon in which a tubular support in the balloon is a metal threaded tube.

Detailed Description

To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

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 intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as the "proximal end", the end farther from the operator is referred to as the "distal end", and the "proximal end" and the "distal end" of any component of the medical device are defined according to this principle. "axial" generally refers to the length of the medical device as it is being delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions for any component of the medical device in accordance with this principle.

Referring to fig. 1, an inflatable balloon 100 according to an embodiment of the present application includes a balloon 10 and a catheter 20.

The balloon 10 is attached to the distal end of a catheter 20, and the proximal end of the catheter 20 is connected to an external device (not shown) via a connector 30. For example, in some embodiments, the external device is an inflation device capable of injecting gas or liquid through the catheter 20 into the balloon 10 to expand the balloon 10, and the connector 30 is a connector attached to the proximal end of the catheter 20, such that the inflation device conveniently communicates with the catheter 20 by being connected to the connector.

As shown in FIGS. 2 and 3, the catheter 20 has an inflation and deflation lumen 21 and a guidewire lumen 22 formed therein. The inside of the balloon 10 is communicated with the charging and discharging cavity 21, specifically, the balloon 10 is provided with a charging cavity 11, the balloon 10 is connected with the catheter 20, and the charging cavity 11 is communicated with the charging and discharging cavity 21. This allows the inflation or deflation of the balloon 10 through the inflation or deflation lumen 21 of the catheter 20 to inflate the balloon.

The guidewire lumen 22 is adapted to receive a guidewire 101. specifically, the guidewire 101 can be passed axially through the guidewire lumen 22 and out the distal end of the catheter 20 to guide the movement of the balloon 10 with the guidewire 101 to a location in the vessel where distending support is desired. It should be noted that the inflation/deflation chamber 21 and the guidewire chamber 22 both extend along the axial direction of the catheter 20 and are not communicated with each other, so as to ensure the sealing property of the communication between the inflation/deflation chamber 21 and the pressurization chamber 11, and avoid the gas or liquid leaking from the guidewire chamber 22 to affect the expansion effect of the balloon 10 when the inflation/deflation chamber 21 injects gas or liquid into the pressurization chamber 11.

As shown in fig. 2 and fig. 3, an infusion tube 12 is disposed in the balloon 10, the infusion tube 12 is not communicated with the pressure-filling chamber 11, and then the pressure-filling chamber 11 is filled with gas or liquid, so that when the balloon 10 is expanded, the infusion tube 12 will not leak, and a better expansion effect of the balloon 10 is maintained.

Opposite ends of the infusion line 12 are open to the outer surface of the balloon 10, respectively, so that blood can pass through the infusion line 12 when the balloon 10 is expanded within the blood vessel. That is, the balloon 10 is used to expand in the blood vessel to maintain a better expansion performance, and the infusion tube 12 of the balloon 10 can still provide blood for flowing, so as to avoid the balloon 10 expanding in the blood vessel for a long time to block the blood vessel.

In this embodiment, the infusion tube 12 is disposed in the balloon 10, so that the dilatation time in the blood vessel can be prolonged without affecting the dilatation performance of the balloon 10, and the defect of blocking the blood vessel can be avoided, and then the drug balloon 10 adopting the structure of the balloon 10 can strive for more time for drug absorption, that is, the effective absorption of the drug by the blood vessel can be promoted, so as to improve the usability of the balloon 10.

In some embodiments, the guidewire cavity 22 and the charging and discharging cavity 21 are coaxially nested cavity structures, and specifically, the cavity wall forming the charging and discharging cavity 21 is sleeved on the cavity wall forming the guidewire cavity 22, so that the coaxial nested cavity structure is adopted, while the guidewire cavity 22 and the charging and discharging cavity 21 are not communicated with each other, the compactness of the overall structure of the catheter 20 is improved, and the catheter 20 is small and exquisite as a whole.

In embodiments where the proximal end of the catheter 20 is connected to the inflation device by a connector 30, the inflation device can inject a gas or liquid through the connector 30 into the inflation and deflation lumen 21 to inflate the inflation lumen 11 of the balloon 10, causing the balloon 10 to expand. The filling device may be a pressure pump, or may be of other structures as long as gas or liquid can be injected into the inflation cavity 11 of the balloon 10 through the inflation and deflation cavity 21, and is not limited herein.

In some embodiments, a tubular support 13 is connected to the infusion line 12, the tubular support 13 can radially support the infusion line 12, that is, the tubular support 13 can provide a supporting force in the infusion line 12, so that when the balloon 10 is expanded, the infusion line 12 is not compressed by the pressure of the gas or liquid injected into the pressurizing cavity 11 of the balloon 10, and the shape of the infusion line 12 is maintained, thereby facilitating the blood circulation and reducing the risk of blood vessel occlusion.

In some embodiments, the infusion line 12 is formed by a flexible membrane so that the infusion line 12 has a good compliance to avoid scratching the vessel wall as the balloon 10 enters the vessel. Tubular support 13 inlays inside the flexible membrane material to sacculus 10 is after the endovascular expansion, and blood flow passes infusion pipeline 12 in order to maintain unobstructed while of blood flow, and the inside tubular support piece of flexible membrane material can avoid contacting with blood, and like this, tubular support piece's selection material just need not to consider biocompatibility, and selects the better material of support performance.

In other embodiments, the tubular support 13 is attached to the inner wall of the infusion line 12, so as to provide a better support effect for the infusion line 12, maintain the shape of the infusion line 12, facilitate the smooth blood flow through the infusion line 12, and reduce the risk of blockage caused by the balloon 10 expanding in the blood vessel for a longer time.

In some embodiments, the tubular support 13 is braided with a metal wire, such that the tubular support 13 has a certain elasticity and flexibility to smoothly move along the blood vessel to avoid scratching the blood vessel wall during implantation of the balloon 10 in the blood vessel.

In embodiments where the tubular support 13 is woven from wire, the wire used has a diameter of 45 μm to 55 μm, for example, in some embodiments, the tubular support 13 is woven from wire having a diameter of 50 μm. The tubular supporting body 13 woven by the metal wires with the diameter of 45-55 μm is selected, so that the flexibility is not influenced by the over-thick metal wires, the blood vessels are easily scratched, and meanwhile, the phenomenon that the infusion pipeline 12 cannot be well radially supported due to the over-thin metal wires is avoided.

In other embodiments, as shown in fig. 4, the tubular support 13 comprises a metal threaded tube 131, which allows to obtain a good support in the radial direction for the blood to pass through in order to maintain the morphology of the infusion line 12, while the metal threaded tube 131 has good bending properties to move smoothly with the balloon 10 inside the vessel to the position where the expansion is suitably required.

In one embodiment, the wall thickness h of the infusion line 12 is 50 μm to 100 μm, the inner diameter D of the infusion line 12 is 200 μm to 250 μm, and the outer diameter D of the infusion line 12 is 300 μm to 400 μm. For example, the wall thickness h of the infusion line 12 is 75 μm, the inner diameter d of the infusion line 12 is 225 μm, so that the infusion line 12 can have a sufficient pore size to allow blood to pass through, and the wall thickness h is controlled in the range of 50 μm to 100 μm, so that the wall thickness h is not too thick to affect the overall inflation and deflation performance of the balloon 10, and is not too thin to be easily collapsed by the pressure of the inflation lumen 11.

In some embodiments, the infusion line 12 is in plurality, the infusion lines 12 being evenly distributed over a circumference centered on the axis of the balloon 10.

It should be noted that, as shown in fig. 1 and fig. 2, the distal end of the catheter 20 is provided with one or more charging and discharging ports 201, the charging and discharging ports 201 are communicated with the charging and discharging cavity 21, and with the cooperation of the catheter 20 and the balloon 10, the charging and discharging ports 201 are located inside the balloon 10, that is, the charging and discharging ports 201 are located in the charging cavity 11 of the balloon 10, so that the charging and discharging cavity 21 of the catheter 20 is communicated with the charging cavity 11 of the balloon 10. With this arrangement, gas or liquid inflated within the inflation and deflation lumen 21 can be delivered along the inflation and deflation lumen 21 to the distal end of the catheter 20 and from the inflation and deflation port 201 into the interior of the balloon 10 to inflate the balloon 10.

The section of the catheter 20 distal to the interior of the balloon 10 may be provided with a visualization ring 102 so that when the balloon 10 is implanted in a blood vessel, the balloon 10 may be pushed into place according to the visualization ring 102. The number of the developing rings 102 may be 1 or more than 1, and is not limited herein.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. An expandable balloon, comprising:

2. The expandable balloon according to claim 1, wherein a tubular support is connected to the infusion line, the tubular support being capable of radially supporting the infusion line.

3. The expandable balloon according to claim 2, wherein the infusion line is formed by a surrounding flexible membrane, and the tubular support is embedded inside the flexible membrane.

4. The expandable balloon according to claim 2, wherein the tubular support is connected to the inner wall of the infusion line.

5. The expandable balloon of any one of claims 2-4, wherein the tubular support is braided with a wire or is a metal threaded tube.

6. The expandable balloon of claim 5, wherein when the tubular support is braided with wires, the wires are 45-55 μm in diameter.

7. The expandable balloon according to claim 1, wherein the infusion line is in plurality, distributed uniformly on a circumference centred on the axis of the balloon.

8. The expandable balloon according to claim 7, wherein the wall thickness h of the infusion line is comprised between 50 and 100 μm, the inner diameter D of the infusion line is comprised between 200 and 250 μm and the outer diameter D of the infusion line is comprised between 300 and 400 μm.

9. The expandable balloon of claim 1, wherein the guidewire lumen and the fill-and-unload lumen are coaxially nested lumen structures.

10. The expandable balloon of claim 1, wherein the proximal end of the catheter is connected to an inflation device via a connector, the inflation device being capable of injecting gas or liquid into the inflation and deflation lumen via the connector to inflate the inflation lumen of the balloon to cause expansion of the balloon.