CN113797426A - Balloon dilatation catheter - Google Patents

Abstract

The invention relates to a balloon dilatation catheter, which comprises a balloon, wherein the balloon is provided with a perfusion cavity and at least one fluid channel, the fluid channel is extended in the axial direction of the balloon in a communicating manner, and the fluid channel is not communicated with the perfusion cavity. Utilize the sacculus expansion pipe carries the support to intravascular, the sacculus expansion and strut the in-process of support, fluid passage supplies blood circulation, avoids blocking the blood flow completely and arouses the short-term high pressure, and then avoids causing the damage to the vascular wall, and avoids arousing the support aversion.

Description

Balloon dilatation catheter

Technical Field

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

Background

The saccule dilating catheter is one kind of soft catheter with expandable saccule in the head end and is used in dilating narrow hollow organs, such as blood vessel, digestive tract, urinary tract, etc. under the guidance of image. Balloon dilatation catheters can be used for post-stent implantation dilatation to ensure complete stent expansion and adherence, optimal minimum lumen diameter, stent adherence to the wall to fully facilitate uniform drug absorption, and stent malapposition can lead to thrombosis and subacute thrombosis (SATs).

The stent implanted into the aorta is usually a self-expanding stent, but the self-expanding stent often has the problems of poor adherence, internal leakage, bird's beak and the like after being implanted, and the treatment effect is influenced. If the existing balloon dilatation catheter is used for expanding the stent implanted in the aorta, the blood flow of the aorta is completely blocked after the aorta is expanded due to the fact that the blood flow rate of the aorta is high, the blood pressure of the aorta is too high, the stent is further caused to shift, damage is caused to the blood vessel, and if aneurysm exists in the aorta, the interlayer of the aneurysm is very easily torn due to the large blood pressure.

Disclosure of Invention

The invention aims to solve the technical problem that when an existing balloon dilatation catheter is used for expanding a stent implanted in a main artery, the blood flow rate of the main artery is high, and the blood flow of thoracic aorta is completely blocked after balloon dilatation, so that the blood pressure of the main artery is too high, the stent is displaced, and the blood vessel is damaged.

In order to solve the technical problem, the invention provides a balloon dilatation catheter, which comprises a balloon and a catheter, wherein the balloon is provided with a perfusion cavity and at least one fluid channel, the fluid channel is extended in a communicated manner along the axial direction of the balloon, and the fluid channel is not communicated with the perfusion cavity; the sacculus cover is located on the surface of pipe and along the axial extension of pipe, the pipe has the edge the axial extension's of pipe annotates liquid passageway, annotate the liquid passageway with fill the chamber intercommunication, be used for to fill the chamber and pour into filling agent.

Optionally, the perfusion lumen is disposed around a circumference of the fluid channel.

Optionally, the balloon has one of the fluid channels, and the fluid channel is disposed coaxially with the perfusion lumen.

Optionally, the radial cross-section of the fluid channels is circular and the sum of the diameters of all the fluid channels is greater than or equal to 5 mm.

Optionally, the body wall of the balloon on which the catheter sleeve is sleeved is provided with a liquid through hole or at least two liquid through holes arranged along the axial direction of the catheter, and the liquid injection channel is communicated with the perfusion cavity through the liquid through holes.

Optionally, the perfusion chamber has a catheter channel extending through the perfusion chamber in the axial direction thereof, the catheter passing out of the catheter channel; or the conduit exits the fluid channel and is connected to the body wall of the perfusion chamber.

Optionally, the radial cross section of the liquid injection channel is crescent-shaped.

Optionally, the catheter further has a guide wire channel arranged in parallel with the infusion channel, the guide wire channel extending through the catheter in the axial direction and being used for the guide wire to pass through.

Optionally, the area of the radial cross-section of the infusion channel is greater than or equal to the area of the radial cross-section of the guide wire channel.

Optionally, still include the connecting pipe, the connecting pipe sets up the near-end of pipe, just the connecting pipe includes first branch pipe and second branch pipe, first branch pipe with seal wire passageway intercommunication, the second branch pipe with annotate the liquid passageway intercommunication.

Compared with the prior art, the balloon dilatation catheter has the following advantages:

the balloon dilatation catheter of the present invention includes a balloon having a perfusion lumen and a fluid channel that extends through the balloon in an axial direction thereof, and the fluid channel is not communicated with the perfusion lumen. After the balloon is expanded in a blood vessel, the balloon plays a role of expanding a stent, and meanwhile, the fluid channel can be used for blood circulation. Therefore, when the balloon dilatation catheter is used for expanding the stent, on one hand, the position of the stent can be effectively adjusted, so that the stent is tightly attached to the inner wall of the blood vessel, the treatment effect is improved, and on the other hand, the problems of stent displacement, blood vessel damage and the like caused by short-term increase of blood pressure can be avoided.

Drawings

FIG. 1 is a schematic structural view of a balloon dilation catheter provided in accordance with one embodiment of the present invention;

FIG. 2 is a schematic view of a balloon dilation catheter provided in accordance with an embodiment of the present invention as it is expanded in a blood vessel;

FIG. 3 is a radial cross-sectional view of a catheter of a balloon dilation catheter provided in accordance with an embodiment of the present invention;

fig. 4 is a schematic view illustrating a connection relationship between a connection tube and a catheter of a balloon dilatation catheter according to an embodiment of the present invention.

[ reference numerals are described below ]:

100-balloon dilatation catheter;

110-balloon;

111-fluid channel, 112-perfusion lumen;

120-a catheter;

121-a guide wire channel, 122-a liquid injection channel and 123-a liquid through hole;

130-connecting tube;

131-a first branch, 132-a second branch;

140-a developing element;

200-guide wire.

Detailed Description

The invention provides a balloon dilatation catheter, which comprises a balloon and a catheter, wherein the balloon is provided with a perfusion cavity and at least one fluid channel, the fluid channel continuously extends along the axial direction of the balloon, and the fluid channel is not communicated with the perfusion cavity; the sacculus cover is located on the surface of pipe and along the axial extension of pipe, the pipe has the edge the axial extension's of pipe annotates liquid passageway, annotate the liquid passageway with fill the chamber intercommunication, be used for to fill the chamber and pour into filling agent. The balloon dilatation catheter is delivered into a blood vessel of a patient, the stent can be expanded after the balloon dilatation, so that the stent can be better attached to the inner wall of the blood vessel, and blood can flow through the fluid channel so as to avoid completely blocking blood flow after the balloon dilatation.

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.

As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations. The same or similar reference numbers in the drawings identify the same or similar elements.

As used herein, the terms "proximal" and "distal" refer to the relative orientation, relative position, and orientation of elements or actions with respect to one another from the perspective of a clinician using the medical device, and although "proximal" and "distal" are not intended to be limiting, the term "proximal" generally refers to the end of the medical device that is closer to the clinician during normal operation, and the term "distal" generally refers to the end that is first introduced into a patient.

Fig. 1 shows a schematic structural view of a balloon dilation catheter provided in accordance with an exemplary embodiment. As shown in fig. 1, theballoon dilation catheter 100 includes aballoon 110, theballoon 110 has aperfusion cavity 112 and at least onefluid channel 111, thefluid channel 111 is extended in the axial direction of theballoon 110 in a communicating manner, and thefluid channel 111 is not communicated with theperfusion cavity 112. Delivering theballoon dilatation catheter 100 into a blood vessel of a patient, enabling theballoon 110 to reach a position where a stent is implanted, after theballoon 110 is expanded, theballoon 110 expands the stent, so that the stent is more attached to the blood vessel wall, and blood in the blood vessel circulates in thefluid channel 111, so that theballoon 110 is prevented from completely blocking blood flow.

Further, theperfusion lumen 112 is disposed around the circumference of thefluid channel 111 so that theballoon 110 can be fully expanded and provide sufficient support to the stent. The number of thefluid passages 111 may be one, or two or more. Preferably, theballoon 110 has onefluid passage 111, and theperfusion chamber 112 may be coaxially disposed with thefluid passage 111, so that theballoon 110 provides a uniform supporting force in a circumferential direction after being expanded. In other embodiments, theballoon 110 has at least twofluid channels 111, and thefluid channels 111 are spaced apart from each other.

Theballoon 110 may be a cylindrical structure after expansion to conform to the shape of a blood vessel. The outer diameter of the expandedballoon 110 is set according to actual needs, and the outer surface of the expandedballoon 110 can be tightly attached to the inner wall of the blood vessel. After theballoon 110 is expanded, the radial cross section of thefluid channel 111 may be circular, rectangular, irregular, etc., and the shape of the radial cross section of thefluid channel 111 is not limited in the present invention. Preferably, after theballoon 110 is expanded, the radial section of thefluid channel 111 may be circular, and when the number of thefluid channels 111 is one, the diameter of thefluid channel 111 is greater than or equal to 5 mm; when the number of thefluid passages 111 is at least two, the sum of the diameters of all thefluid passages 111 is greater than or equal to 5mm, so as to ensure unobstructed blood flow in the blood vessel.

In this embodiment, the material of theballoon 110 is not limited, and may be any one of polyethylene terephthalate (PET), nylon (Polyamide), Polyethylene (PE), Pebax, polyurethane, and the like. There is no limitation on the axial length of theballoon 110, and it may be set as desired, for example, the axial length of theballoon 110 is set between 10mm and 100 mm.

With continued reference to fig. 1 in conjunction with fig. 3, theballoon dilation catheter 100 further includes acatheter 120, and theballoon 110 is disposed on an outer surface of thecatheter 120 and extends along an axial direction of thecatheter 120. Thecatheter 120 has opposite proximal and distal ends, and theballoon 110 is fitted over the outer surface of the distal end of thecatheter 120. In some embodiments, theperfusion lumen 112 has a conduit channel therein that extends through theperfusion lumen 112 in an axial direction thereof, and theconduit 120 exits the conduit channel. In other embodiments, theconduit 120 exits thefluid channel 111 and one side of theconduit 120 is connected to the body wall of theperfusion chamber 112.

Further, thecatheter 120 has aguidewire channel 121 and aninfusion channel 122 arranged in parallel. Wherein theguide wire channel 121 extends through thecatheter 120 in the axial direction and is used for theguide wire 200 to pass through, as shown in fig. 2. The distal end of notesliquid passageway 122 is the blind end, justpipe 120 cover is equipped with be equipped with logicalliquid hole 123 on the body wall ofsacculus 110, notesliquid passageway 122 passes through logicalliquid hole 123 with it communicates to fillchamber 112. In this way, theinfusion channel 122 can be used to inject a filling agent, such as a contrast agent, into theperfusion lumen 112, thereby causing theballoon 110 to expand. The number of the liquid throughholes 123 may be one, or may be two or more, and two or more of the liquid throughholes 123 are arranged along the axial direction of theguide tube 120. In addition, in this embodiment, thecatheter 120 may be connected to theballoon 110 by any suitable means, such as adhesive, heat pressing, etc.

Preferably, with reference to fig. 3, in the present embodiment, on the radial cross section of thecatheter 120, the cross section of theguide wire channel 121 is circular, the cross section of theinjection channel 122 is crescent-shaped, and theguide wire channel 121 is located on the concave side of theinjection channel 122, so as to facilitate forming on thecatheter 120. Preferably, the area of the radial cross section of theinjection channel 122 is greater than or equal to the area of the radial cross section of theguide wire channel 121.

With continued reference to fig. 1 in conjunction with fig. 4, the outer surface of thecatheter 120 is smooth, and the distal end extends to the outside of theballoon 110 and is designed to be a tapered tip to facilitate thecatheter 120 to travel through the blood vessel to carry theballoon 110 to a predetermined location. Theballoon dilation catheter 100 further comprises a connectingtube 130, the connectingtube 130 being disposed at the proximal end of thecatheter 120. Theconnection pipe 130 is generally designed in a Y-shaped configuration and includes afirst branch pipe 131 and asecond branch pipe 132. Wherein thefirst branch tube 131 is communicated with theguide wire channel 121 for the guide wire to pass through. Preferably, the lumen of thefirst branch tube 131 is in smooth transitional communication with theguidewire channel 121. One end of thesecond branch pipe 132 is communicated with an external injector, the other end is communicated with theliquid injection channel 122, and preferably, the inner cavity of thesecond branch pipe 132 is communicated with theliquid injection channel 122 in a smooth transition mode.

Referring back to fig. 1, theballoon dilation catheter 100 further includes avisualization element 140 for marking the location of theballoon 110 within the patient to aid in the positioning of theballoon 110. The developingelement 140 may be at least two developing rings disposed on thecatheter 120, and at least two developing rings are distributed at two axial ends of theballoon 110 for marking the position of theentire balloon 110.

Theballoon dilatation catheter 100 provided by the embodiment of the invention can be used for dilatation after stent implantation, on one hand, theballoon 110 can be used for dilatation of the stent, so that the position of the stent can be effectively adjusted, the stent is tightly attached to the inner wall of a blood vessel, and the treatment effect is improved; on the other hand, thefluid channel 111 ensures smooth blood flow, and can avoid the problems of stent displacement, blood vessel damage and the like caused by short-term increase of blood pressure.

Hereinafter, a process of re-expanding the stent after the stent implantation using the balloon catheter 10 will be described with reference to fig. 2, in which arrows indicate a flow direction of blood, and the stent is not shown.

First, theguidewire 200 is pre-implanted in the femoral artery. Theguidewire channel 121 of thecatheter 120 is then threaded over theguidewire 200. Next, the operator conveys theballoon 110 along theguide wire 200 into the stent under the monitoring of a developing device such as X-ray. Then, the operator injects a contrast medium into thesecond branch tube 132 by using an injector, the contrast medium enters theinjection channel 122 along thesecond branch tube 132 and enters theperfusion cavity 122 through the liquid throughhole 123, so that theballoon 110 is expanded to support the stent from the inside of the stent, and the stent is re-expanded until the stent is attached to the inner wall of the blood vessel. During this process, the blood flow of the aorta is continuously circulated in thefluid channel 111 of theballoon 110. By adjusting the amount of contrast agent, the degree of expansion of theballoon 110 can be adjusted, and the posture of the stent can be adjusted to be tightly attached to the inner wall of the blood vessel. Finally, the contrast agent is aspirated through the syringe, causing theballoon 110 to contract and withdrawing theballoon dilation catheter 100 out of the body along the guidewire.

The balloon dilatation catheter provided by the embodiment of the invention comprises a balloon and a catheter, wherein the balloon is provided with a perfusion cavity and at least one fluid channel, the fluid channel is extended in the axial direction of the balloon in a penetrating way, and the fluid channel is not communicated with the perfusion cavity. The sacculus cover is established on the surface of pipe and follow the axial extension of pipe, the pipe has the edge the axial extension's of pipe annotates the liquid passageway, annotate the liquid passageway with fill the chamber intercommunication, in order to be used for to fill the chamber and pour into filling agent. And utilizing the balloon dilatation catheter to re-expand the stent after the stent implantation so as to adjust the posture of the stent, so that the stent is tightly attached to the inner wall of the blood vessel, and blood in the blood vessel circulates through the fluid channel in the process. That is, the saccule can not completely block blood flow in the expansion process, so that the phenomenon that the blood pressure is sharply increased to cause stent displacement or damage to the inner wall of a blood vessel is avoided.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims (10)

1. A balloon dilatation catheter comprising a balloon and a catheter, wherein the balloon is provided with a perfusion cavity and at least one fluid channel, the fluid channel is penetratingly extended along the axial direction of the balloon, and the fluid channel is not communicated with the perfusion cavity; the sacculus cover is located on the surface of pipe and along the axial extension of pipe, the pipe has the edge the axial extension's of pipe annotates liquid passageway, annotate the liquid passageway with fill the chamber intercommunication, be used for to fill the chamber and pour into filling agent.

2. The balloon dilation catheter of claim 1 wherein the perfusion lumen is disposed circumferentially around the fluid channel.

3. The balloon dilation catheter of claim 1 wherein said balloon has one said fluid passage and said fluid passage is disposed coaxially with said perfusion lumen.

4. The balloon dilation catheter of claim 1 wherein the fluid channels are circular in radial cross-section and the sum of the diameters of all of the fluid channels is greater than or equal to 5 mm.

5. The balloon dilatation catheter as claimed in claim 1, wherein the wall of the catheter sheath on which the balloon is mounted is provided with a liquid through hole or at least two liquid through holes arranged along the axial direction of the catheter, and the liquid injection channel is communicated with the perfusion cavity through the liquid through holes.

6. The balloon dilation catheter according to claim 1 wherein the perfusion lumen has a catheter passage therein extending through an axial direction of the perfusion lumen, the catheter passing out of the catheter passage; or

The conduit exits the fluid passageway and is connected to the body wall of the perfusion chamber.

7. The balloon dilation catheter of claim 1 wherein the radial cross-section of the liquid injection channel is crescent shaped.

8. The balloon dilation catheter according to claim 1, wherein the catheter further has a guide wire channel disposed in parallel with the fluid injection channel, the guide wire channel extending through an axial direction of the catheter and adapted for passage of a guide wire therethrough.

9. The balloon dilation catheter of claim 8 wherein the area of the radial cross section of the fluid injection channel is greater than or equal to the area of the radial cross section of the guidewire channel.

10. The balloon dilation catheter according to claim 8 further comprising a connecting tube disposed at a proximal end of the catheter, the connecting tube including a first branch in communication with the guide wire channel and a second branch in communication with the infusion channel.

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