CN110917470B

CN110917470B - Balloon catheter

Info

Publication number: CN110917470B
Application number: CN201910995109.6A
Authority: CN
Inventors: 张�雄; 龙汉; 吴星宇; 房金锋
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-10-18
Filing date: 2019-10-18
Publication date: 2022-05-20
Anticipated expiration: 2039-10-18
Also published as: CN110917470A

Abstract

The present invention relates to a balloon catheter, comprising: a first catheter having a guide lumen; the proximal end of the second catheter is connected with the distal end of the first catheter, and the inner cavity of the second catheter is communicated with the guide cavity; an inflation tube, one end of which is connected to the distal end of the first catheter tube and the other end of which is connected to the second catheter tube; and an expandable balloon, the filling tube being disposed through the balloon, upon filling, compressing and elastically deforming the second catheter. According to the balloon catheter provided by the embodiment of the invention, after the distal end of the balloon catheter moves to the part to be fenestrated of the covered stent, the balloon can be expanded through the filling tube, so that the second catheter is extruded and is stressed to be bent, and the angle of the distal end of the second catheter is adjusted, therefore, the positioning accuracy of the distal end of the balloon catheter can be improved, and the piercing angle of the piercing part can be controlled more accurately.

Description

Balloon catheter

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a balloon catheter.

Background

In recent decades, stent-graft endoluminal isolation has been widely used for lesions such as aneurysms and arterial dissections of thoracic and abdominal aorta, but when a stent-graft is used for endoluminal isolation of a specific lesion site such as an aortic arch, a celiac trunk, bilateral renal arteries or superior mesenteric artery, the stent-graft tends to cover a branch vessel on the artery, which affects blood supply to the branch vessel. For the situation, in-situ windowing is usually performed on the covered stent in the operation process by a laser or mechanical mode at present, so that the covered stent generates an expected hole, then the branch stent is conveyed to the hole to be butted with the covered stent, and blood supply of the branch blood vessel is realized through the branch stent.

When the in-situ windowing is carried out on the covered stent, the catheter is firstly conveyed to a position, to be windowed, of the covered stent, then the puncture component penetrates out of the far end of the catheter, and the covered membrane of the covered stent is perforated. In the prior art, the positioning accuracy of the far end of the catheter is low, and particularly when the catheter is bent, the far end of the catheter is easy to deviate from the middle position of the blood vessel, so that the puncture position is not ideal, the far end of the catheter is even propped against the blood vessel wall, and the puncture part directly punctures the blood vessel wall after penetrating out from the far end of the catheter. As shown in fig. 1, when the catheter 10 ' passes through a curved blood vessel, the catheter 10 ' is likely to stick to the blood vessel wall, and the distal end of the catheter 10 ' cannot be positioned at the middle position of the blood vessel during puncture, so that the puncture position is not ideal, and the blood vessel wall is punctured.

Disclosure of Invention

In view of the above problems, it is an object of the present invention to at least solve the problem of low positioning accuracy of the distal end of a catheter in the prior art. The purpose is realized by the following technical scheme:

the embodiment of the invention provides a balloon catheter, which comprises: a first catheter having a guide lumen; a second catheter having a proximal end connected to the distal end of the first catheter and a lumen in communication with the guide lumen; a filling tube, one end of the filling tube being connected to the distal end of the first catheter and the other end of the filling tube being connected to the second catheter; and an expandable balloon, the filling tube being disposed through the balloon, upon filling, compressing and elastically deforming the second catheter.

In some embodiments of the present invention, an end of the second conduit is provided with a development mark having a development length of not less than 1 mm.

In some embodiments of the invention, the junction of the filling tube and the second catheter is located on a proximal side of the visualization marker.

In some embodiments of the invention, the number of balloons and filling tubes is two, each filling tube passing through a respective one of the balloons, the two balloons being disposed on opposite sides of the second catheter.

In some embodiments of the invention, the center of one of the balloons lies on a first plane perpendicular to the axis of the second catheter, the center of the other balloon lies on a second plane perpendicular to the axis of the second catheter, the first and second planes are not coplanar; alternatively, the centers of the two balloons are located on the same plane perpendicular to the axis of the second catheter.

In some embodiments of the invention, the number of said balloons and said filling tubes is three, each of said filling tubes passing through a respective one of said balloons, three of said balloons being disposed around said second catheter.

In some embodiments of the invention, the centers of three of the balloons are located on a first plane, a second plane, and a third plane, respectively, perpendicular to the axis of the second catheter, wherein at least one of the first plane, the second plane, and the third plane is not coplanar with the others; alternatively, the centers of the three balloons are located on the same plane perpendicular to the axis of the second catheter.

In some embodiments of the invention, the balloon and the filling tube are both one in number, and the second catheter is predisposed in a natural state with a bending angle at which it approaches the balloon.

In some embodiments of the present invention, the first catheter further has a filling lumen, the lumen of the filling tube is communicated with the filling lumen, and the filling tube is provided with a through hole for communicating the lumen of the filling tube with the lumen of the balloon.

In some embodiments of the invention, the balloon catheter further comprises a connector secured to the proximal end of the first catheter, the connector having a first connector in communication with the inflation lumen and a second connector in communication with the guide lumen.

The invention has the advantages that:

according to the balloon catheter provided by the embodiment of the invention, the filling tube is arranged between the far end of the first catheter and the far end of the second catheter, the filling tube penetrates through the balloon, and after the far end of the balloon catheter moves to the part, to be fenestrated, of the covered stent, the balloon can be expanded through the filling tube, so that the second catheter is extruded and stressed to be bent, and further the angle of the far end of the second catheter is adjusted.

Drawings

The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like reference numerals are used to refer to like parts throughout the drawings. In the drawings:

FIG. 1 is a schematic view of a prior art catheter passing through a curved vessel;

FIG. 2 is a schematic structural view of a balloon catheter in accordance with one embodiment of the present invention;

FIG. 3 is a schematic view of a section A-A of a second catheter of the balloon catheter shown in FIG. 2;

FIG. 4 is a schematic view of the balloon catheter of FIG. 2 with a second catheter compressed by a balloon;

FIG. 5 is a schematic view of the balloon catheter of FIG. 2 with the second catheter compressed by another balloon;

FIG. 6 is a schematic view of the balloon catheter of FIG. 2 as it passes through a curved vessel;

fig. 7 is a schematic structural view of a balloon catheter according to a second embodiment of the present invention;

FIG. 8 is a schematic structural view of a balloon catheter according to a third embodiment of the present invention;

FIG. 9 is a schematic view of a section B-B of a second catheter of the balloon catheter shown in FIG. 8;

FIG. 10 is a schematic view of the positional relationship of the balloon catheter of FIG. 8 and a second catheter;

fig. 11 is a schematic structural view of a balloon catheter according to a fourth embodiment of the present invention.

Detailed Description

Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless specifically identified as an order of performance. It should also be understood that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For convenience of description, spatially relative terms, such as "inner", "outer", "lower", "below", "upper", "above", and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" can include both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

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.

As shown in fig. 2, one of the embodiments of the present invention proposes a balloon catheter 100, the balloon catheter 100 including a first catheter 10, a second catheter 20, a filling tube 30 and a balloon 40. Specifically, the first catheter 10 has a guiding lumen 11, the guiding lumen 11 is used for guiding a puncturing member (e.g. a guide wire), the proximal end of the second catheter 20 is connected with the distal end of the first catheter 10, and the inner lumen of the second catheter 20 is communicated with the guiding lumen 11, so that the puncturing member can finally pass out of the distal end of the second catheter 20 under the guidance of the guiding lumen 11 and the inner lumen of the second catheter 20. One end of the filling tube 30 is connected to the distal end of the first catheter 10, the other end of the filling tube 30 is connected to the second catheter 20, the balloon 40 is an expandable balloon, the filling tube 30 is arranged in the balloon 40 in a penetrating mode, and the balloon 40 can extrude the second catheter 20 after filling and enable the second catheter 20 to be elastically deformed.

When the balloon catheter 100 according to the embodiment of the invention is used, after the distal end of the balloon catheter 100 is moved to the fenestrated part of the stent graft, the balloon 40 can be expanded through the filling tube, the balloon 40 can press the second catheter 20 in the expansion process, so that the second catheter 20 is stressed to bend, and when the second catheter 20 is bent, the angle of the distal end of the second catheter 20 can be changed, so that the penetrating angle of the puncturing part can be changed. Further, by controlling the degree of expansion of the balloon 40, the angle of the distal end of the second catheter 20 can be controlled, whereby the accuracy of positioning the distal end of the balloon catheter 100 can be improved, and the angle of penetration of the piercing member can be controlled more precisely.

Further, the second catheter 20 may be made of an elastomeric material, whereby the second catheter 20 may be deformed after being compressed by the balloon 40 after expansion, and may be restored to an original state when the second catheter 20 is no longer compressed by the balloon 40 after the balloon 40 is depressurized.

Further, the filling tube 30 may be made of an elastic material, whereby the filling tube 30 may be deformed accordingly when a force is applied, thereby providing sufficient space for the balloon to expand, and the filling tube 30 may return to the initial state when the force on the filling tube 30 is removed.

Specifically, the elastic material used to make the second conduit 20 and the filling tube 30 may be TPU (Thermoplastic polyurethane elastomers), tpe (Thermoplastic elastomer), styrene butadiene rubber, silicone rubber, etc., which can make the second conduit 20 and the filling tube 30 have high elasticity.

Further, as shown in fig. 2 and 3, the first catheter 10 further has a filling lumen 12, the lumen of the filling tube 30 is communicated with the filling lumen 12, and the filling tube is provided with a through hole 31 for communicating the lumen of the filling tube 30 with the lumen of the balloon 40. The inflation lumen 12 and the inflation tube 30 constitute a flow path for the inflation medium, that is, the balloon 40 can be inflated with the inflation medium (e.g., gas or liquid) through the inflation lumen 12 and the inflation tube 30, thereby achieving inflation of the balloon 40, and by controlling the amount of inflation medium inflated, the degree of inflation of the balloon 40 can be controlled.

Specifically, the through hole 31 is formed in a manner including, but not limited to, manual cutting, automated cutting, integrated machining, and the like; the connection of the balloon 40 to the filling tube 30 includes, but is not limited to, laser welding, heat welding, glue bonding, etc.

Further, with reference to fig. 4 to 6, the number of the balloons 40 and the filling tubes 30 is two, each filling tube 30 is penetrated from a corresponding one of the balloons 40, and the two balloons 40 are disposed on opposite sides of the second catheter 20. In this embodiment, after the balloon catheter 100 is moved to the fenestrated portion of the stent graft, one of the balloons 40 may be slightly inflated to an inflated state, and then the other balloon 40 may be inflated, so that the other balloon 40 presses the second catheter 20 to bend the second catheter 20 under force. If the bending angle is too small, the second catheter 20 may be further bent by further inflating the other balloon 40, and if the bending angle is too large, the adjustment may be made by reducing the amount of inflation of the other balloon 40. After the bending angle of the second catheter 20 is adjusted, the second catheter 20 is anchored in the blood vessel by the one balloon 40 and the other balloon 40.

It will be appreciated that the number of filling chambers 12 is the same as the number of filling tubes 30, such that each filling chamber 12 and a respective one of the filling tubes 30 constitutes a flow path for the filling medium.

Further, the centers of the two balloons 40 are located on the same plane perpendicular to the axis of the second catheter 20, and the degree of influence of the magnitude of the interference of the two balloons 40 on the bending angle of the second catheter 20 is the same. In this embodiment, when the one balloon 40 is inflated, the filling tube 30 connected to it bends, the tangent at the connection point of the filling tube 30 and the second catheter 20 forms an angle a (as shown in fig. 2) with the central axis of the second catheter 20 in the straight state, and when the other balloon 40 is inflated, the filling tube 30 connected to it bends, and the tangent at the connection point of the filling tube 30 and the second catheter 20 forms an angle b with the central axis of the second catheter 20 in the straight state, so that the angle a is 0 ° < a < 90 °, and the angle b is 0 ° < b < 90 °.

Further, the balloon 40 may be made of a thermoplastic elastomer, and since the material of the thermoplastic elastomer is soft and the expansion ratio of the material is large, the balloon 40 can be rapidly expanded, and the flexibility of the balloon 40 and the anchoring force between the balloon 40 and the vessel wall can be increased. In addition, the thermoplastic elastomer has better elasticity, so that the balloon 40 has smaller contour size before expansion or after pressure relief, the balloon catheter 100 can pass through a severely bent part, and the balloon catheter 100 is not easy to cause vascular injury when being withdrawn.

Further, a developing mark 60 is provided on the first catheter 10 and/or the second catheter 20, and the developing mark 60 can be clearly developed under the X-ray irradiation for precise positioning in the operation. Specifically, the development mark 60 may be a development substance (e.g., barium sulfate) attached to the first catheter 10 and/or the second catheter 20, or may be a development ring mounted on the first catheter 10 and/or the second catheter 20, and the development ring may be made of platinum, tantalum, iridium, or the like.

In a preferred embodiment, at least one visualization marker 60 is disposed at the distal end of the second catheter 20, and the visualization marker 60 has a visualization length of 1mm or more, so that the bent state of the second catheter 20 can be observed through the visualization marker 60. Specifically, the junction of the filling tube 30 and the second catheter 20 is located on the side of the visualization marker 60 near the proximal end of the first catheter 10 to avoid the junction from affecting the visualization effect of the visualization marker 60.

Further, the first catheter tube 10 may be a multi-lumen tube or a combination of a plurality of independent single-lumen tubes, and when the first catheter tube 10 is a combination of a plurality of independent single-lumen tubes, one of the single-lumen tubes is integrated with the second catheter tube 20. Preferably, the first catheter 10 is made of a highly flexible polymer material, such as TPU, TPE, PEBAX (polyether block polyamide), etc., whereby it may be the distal end of the first catheter 10 that has good bending properties to facilitate passage through a complex curved blood vessel.

Further, the balloon catheter 100 further comprises a connector 50 fixed to the proximal end of the first catheter 10, the connector 50 having a first connector 51 communicating with the filling lumen 12 and a second connector 52 communicating with the guiding lumen 11, the first connector 51 being for connecting a supply of filling medium (e.g., a gas supply, a liquid supply, etc.), and the second connector 52 being for inserting the puncturing member. Preferably, the material of the linker 50 includes, but is not limited to, PC (polycarbonate), PE (polyethylene), ABS (acrylonitrile-butadiene-styrene copolymer), and the like.

It will be appreciated that the number of first connectors 51 is equal to the number of inflation lumens, i.e. each first connector 51 communicates with a corresponding one of the inflation lumens, thereby enabling each first connector 51 to fill a corresponding one of the balloons 40 with inflation medium.

As shown in fig. 7, the second embodiment of the present invention provides a balloon catheter 100, which has substantially the same structure as the first embodiment except for the position of the balloon 40.

Specifically, the number of balloons 40 and filling tubes 30 is two, the center of one balloon 40 is located on a first plane perpendicular to the axis of the second catheter 20, the center of the other balloon 40 is located on a second plane perpendicular to the axis of the second catheter 20, and the first plane and the second plane are not coplanar, i.e., the centers of the two balloons 40 are axially displaced.

The method for adjusting the bending angle of the second guide tube 20 in this embodiment is the same as that in the first embodiment, and therefore, the description thereof is omitted. It should be noted that, because the centers of the two balloons 40 are located on different planes perpendicular to the axis of the second catheter 20, the centers of the two balloons 40 are arranged in an axially staggered manner, that is, the two balloons 40 are axially staggered from each other, so that the overall profile size of the balloon catheter 100 can be smaller, and the passing performance is better.

As shown in fig. 8 to 10, a third embodiment of the present invention provides a balloon catheter 100 which is substantially identical in structure to the first embodiment except for the number and positions of the balloons 40 and the filling tubes 30.

Specifically, the number of the balloons 40 and the filling tubes 30 is three, each filling tube 30 is penetrated from a corresponding one of the balloons 40, and the three balloons 40 are disposed around the second catheter 20. In this embodiment, after the balloon catheter 100 is moved to the fenestrated portion of the stent graft, two of the balloons 40 may be slightly inflated to an inflated state, and then the third balloon 40 may be inflated, so that the third balloon 40 inflates and presses the second catheter 20, and the second catheter 20 is forced to bend. If the angle of bending is too small, the third balloon 40 may be inflated further to bend the second catheter 20 further. If the angle of curvature is too large, adjustment may be made by reducing the amount of inflation of the third balloon 40.

Additionally, if a deviation in the direction of bending from the desired direction of bending is found, the third balloon 40 may be deflated and one of the two balloons 40 may be inflated to inflate it and compress the second catheter 20 to change the direction of bending of the second catheter 20.

Finally, after the bending angle of the second catheter 20 is adjusted, the second catheter 20 is anchored in the blood vessel by the three balloons 40.

It can be seen that the balloon catheter 100 of the present embodiment can realize the spatial turning of the second catheter 20 in any direction by controlling the filling amount of the different balloons 40.

Further, the three filling tubes 30 may be equally spaced around the second catheter tube 20, and in this case, the three balloons 40 are also equally spaced in the circumferential direction around the second catheter tube 20. Thereby facilitating a more secure anchoring of the second catheter 20 within the blood vessel.

In some embodiments, the centers of the three balloons 40 lie on the same plane perpendicular to the axis of the second catheter 20. In other embodiments, the centers of the three balloons 40 lie in a first plane, a second plane, and a third plane, respectively, perpendicular to the axis of the second catheter 20, at least one of the first plane, the second plane, and the third plane not being coplanar with the others. That is, at least one of the three balloons 40 is axially offset from the other two balloons 40, specifically, only one balloon 40 may be axially offset from the other two balloons 40, or the three balloons 40 may be axially offset two by two. When the three balloons 40 are arranged so as to be offset two by two in the axial direction, the overall profile size of the balloon catheter 100 can be made smaller, thereby making the passing performance better.

As shown in fig. 11, the fourth embodiment of the present invention proposes a balloon catheter 100 which has substantially the same structure as that of the first embodiment except that the number of the balloons 40 and the filling tubes 30 is different.

In particular, the number of balloons 40 and filling tubes 30 is one each. In this embodiment, the second catheter 20 is initially preset with a bending angle at which the second catheter 20 approaches the balloon 40. In other words, in the initial state, the distal end of the second catheter 20 forms an included angle c with the central axis of the second catheter 20 in the straight state, and the included angle c satisfies: 0 < c < 90, and the filling tube 30 is also preset with a bending angle whereby inflation of the balloon 40 bends the second catheter 20 in the other direction, thereby effecting adjustment of the angle of the distal end of the second catheter 20.

In this embodiment, the tangent to the filling tube 30 at the point of connection to the second catheter tube 20 forms an angle d with the central axis of the second catheter tube 20 when it is in the straight state, with 0 < d < 45.

The balloon catheter 100 of the present embodiment is simpler in structure and easier to implement than the first embodiment.

The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A balloon catheter, comprising:

a first catheter having a guide lumen and an inflation lumen;

a second catheter having a proximal end connected to the distal end of the first catheter and a lumen in communication with the guide lumen;

an inflation tube, one end of the inflation tube being connected to the distal end of the first catheter tube, the other end of the inflation tube being connected to the second catheter tube, the lumen of the inflation tube being in communication with the inflation lumen; and

an expandable balloon, the filling tube being disposed through the balloon such that the balloon is located between the two ends of the filling tube; the balloon is provided with a through hole which enables the inner cavity of the filling tube to be communicated with the inner cavity of the balloon, and the balloon extrudes the second catheter after being filled and enables the second catheter to elastically deform.

2. A balloon catheter according to claim 1, wherein an end portion of the second catheter is provided with a visualization mark having a visualization length of not less than 1 mm.

3. A balloon catheter according to claim 2, wherein the junction of the filling tube and the second catheter is located on the proximal side of the visualization marker.

4. A balloon catheter according to claim 1, wherein the number of said balloons and said filling tubes are two, each of said filling tubes passing through a respective one of said balloons, said two balloons being disposed on opposite sides of said second catheter.

5. A balloon catheter according to claim 4, wherein the centre of one of said balloons lies in a first plane perpendicular to the axis of said second catheter and the centre of the other of said balloons lies in a second plane perpendicular to the axis of said second catheter, said first and second planes being non-coplanar;

alternatively, the centers of the two balloons are located on the same plane perpendicular to the axis of the second catheter.

6. A balloon catheter according to claim 1, wherein the number of said balloons and said filling tubes are three each, each of said filling tubes being pierced from a corresponding one of said balloons, three of said balloons being disposed around said second catheter.

7. A balloon catheter according to claim 6, wherein the centers of three of said balloons are located on a first plane, a second plane and a third plane, respectively, perpendicular to the axis of said second catheter, wherein at least one of said first plane, said second plane and said third plane is not coplanar with the others;

alternatively, the centers of the three balloons are located on the same plane perpendicular to the axis of the second catheter.

8. A balloon catheter according to claim 1, wherein the number of said balloon and said filling tube is one, and said second catheter is predisposed with a bending angle in a natural state, under which said second catheter approaches said balloon.

9. A balloon catheter according to claim 1, further comprising a connector fixed to a proximal end of the first catheter, the connector having a first connector in communication with the inflation lumen and a second connector in communication with the guide lumen.