CN218961567U

CN218961567U - Radial artery catheter

Info

Publication number: CN218961567U
Application number: CN202222634244.8U
Authority: CN
Inventors: 高洪亮; 魏家允; 梁栋; 吕怡然
Original assignee: Eco Medical Devices Beijing Co ltd
Current assignee: Eco Medical Devices Beijing Co ltd
Priority date: 2022-10-08
Filing date: 2022-10-08
Publication date: 2023-05-05
Anticipated expiration: 2032-10-08

Abstract

The utility model relates to a radial artery catheter. The radial artery catheter comprises a distal soft section pipeline, a middle support section pipeline and a proximal rigid section pipeline along the length direction; the middle support section pipeline comprises a middle passage and at least one balloon arranged outside the middle passage along the radial direction; the balloon is communicated with a balloon expanding pipeline; the intermediate passage is denoted as a side a on one side and as B side on the other side of its axial section. The medical instrument is transported in the nerve access path through the radial artery and the problem that the lower detection distance of the middle support section pipeline is uncontrollable when the distal end is controlled is solved through the arrangement of the saccule, and the control stability of the distal end medical instrument is improved.

Description

Radial artery catheter

Technical Field

The utility model belongs to the field of medical appliances, and particularly relates to a radial artery catheter.

Background

The intervention operation through the radial artery access can relieve the pain of patients and improve the postoperative comfort level of the patients, and is a commonly used access mode at present. In the radial artery access process, the radial artery catheter is pushed into the contralateral common carotid artery or subclavian artery under the action of the guiding catheter, and then after the guiding catheter is retracted, a curve is formed at the aortic arch to obtain the radial artery access nerve access. Based on the established radial access, the operator can deliver corresponding medical devices to the diseased vessel as needed.

In the process of delivering medical devices in the established radial artery neuroaccess, due to the aortic arch position, the formed curve is not supported, and the control of the distal medical devices by the proximal operator often becomes difficult, such as the inability to effectively transmit the pushing force, torque force, etc. of the proximal end.

Accordingly, there is a need in the art to develop a device that addresses the difficulty of controlling a distal medical instrument by a proximal operator in an effort to address the problem.

Disclosure of Invention

In view of the deficiencies of the prior art, it is an object of the present application to provide a radial catheter comprising a distal soft segment tube, a middle support segment tube, and a proximal rigid segment tube along a length;

the middle support section pipeline comprises a middle passage and at least one balloon arranged outside the middle passage along the radial direction; the balloon is communicated with a balloon expanding pipeline;

the intermediate passage is denoted as a side a on one side and as B side on the other side of its axial section.

The intermediate support section line according to the present application is understood to be present entirely within the space of the aortic arch after the establishment of the transradial neural access, while the balloon is inflated in the aortic arch. In addition, it should be noted that the balloon described herein should have an expanded diameter that is less than the inner diameter of the aortic arch to ensure that the aortic arch is not fully occluded.

According to the medical device, through the arrangement of the saccule, after the radial artery nerve access passage is established, the middle support section pipeline has a larger outer diameter, so that the downward detection distance of the middle support section pipeline when the medical device is conveyed and controlled at the far end in the radial artery nerve access passage is reduced, the operation displacement of the far-end medical device is smaller, and the pushing force is more stable.

The shaft section means a section through the axis of the intermediate passage.

In a preferred embodiment, the balloon is configured to expand radially to the a-side more than to the B-side.

In the preferred technical scheme, the balloon is designed into an asymmetric expansion structure, and the balloon can be expanded towards the bottom direction of the aortic arch (namely, towards the side A) so as to reduce the downward detection distance of the middle support section pipeline in the medical instrument conveying and operating process, ensure that enough blood flow space is reserved on the side B, and reduce the risk of ischemia.

Preferably, the maximum radial expansion distance of the balloon to the A side is 1.5 to 5 times the maximum radial expansion distance to the B side.

In a further preferred technical scheme, the middle part of the balloon is a sizing section along the axial direction; the distal end of the balloon is configured to have a first enlarged end having a maximum radial expansion distance greater than a maximum radial expansion distance of the sizing section; the proximal portion of the balloon is configured with a second enlarged end having a maximum radial expansion distance that is greater than the maximum radial expansion distance of the sizing section.

Because the aortic arch is bent, and the middle supporting section pipeline is bent opposite to the aortic arch, most of the supporting points are in the form of supporting points, and the supporting points are easy to displace and unstable in the process of conveying or operating medical equipment; in the preferred technical scheme, the first expansion end and the second expansion end are arranged to increase the point position of the support or the area of the support to a certain extent, so that the stability of the conveying or the operation of the medical instrument is improved.

Preferably, the balloon assumes a curved state after inflation.

Illustratively, the balloon includes any one of a compliant balloon, a semi-compliant balloon, and a non-compliant balloon. Preferably the balloon is a non-compliant balloon and is in a curved state after inflation.

The bending shape of the balloon in a bending state after the balloon is inflated is matched with the bending shape formed by the middle support section pipeline after the nerve access path of the radial artery is established.

In a cross-sectional view along a tangential plane perpendicular to the radial artery catheter axis, which is used for dividing the axial section of the A side and the B side, as a reference plane, the distance perpendicular to the reference plane is greater than the distance parallel to the reference plane after the balloon is inflated.

Preferably, the distal soft segment pipe sequentially comprises a first transition pipe and a distal part pipe from near to far, wherein the first transition pipe and the distal part pipe are communicated with the middle support segment pipe; the pipe walls of the far-end soft section pipeline, the middle passage and the first transition pipeline all comprise a PTFE inner layer, a high polymer outer layer and a metal reinforcing layer embedded between the PTFE inner layer and the high polymer outer layer; the pipe wall of the distal end pipeline only comprises a PTFE inner layer and a macromolecule outer layer.

Illustratively, the polymeric outer layer described herein may be selected from polyether block polyimide materials; the metal reinforcing layer can be selected from a metal woven layer, a laser engraving reinforcing layer, an industrialized liquid crystal polymer woven layer and the like.

Preferably, the outer wall of the intermediate passage is provided with a developing member.

Further preferably, the outer wall of the intermediate passage is provided with developing members corresponding to both ends and the middle of the balloon.

The arrangement of the developing component can enable an operator to better see the position of the pipeline of the middle supporting section, the position of the balloon and the like. The developing member may use any of wound developing filaments, embedded developing sheets, sleeved developing rings, and the like available to those skilled in the art.

Preferably, the intermediate passageway is configured such that after the radial catheter has been completed with the passageway established, the intermediate passageway has a length that is capable of fully accessing the aortic arch.

Compared with the prior art, the application has the following beneficial effects:

according to the medical device, through the arrangement of the balloon, the downward detection distance of the middle support section pipeline when the medical device is conveyed and remotely controlled in the radial artery nerve access passage is reduced, and in the preferred scheme, the problem that the middle support section pipeline is detected downward when the medical device is conveyed and remotely controlled in the radial artery nerve access passage is solved, and the control stability of the remote medical device is improved.

Drawings

FIG. 1 is a schematic diagram of a prior art transradial neural access;

FIG. 2 is a schematic illustration of the construction of a radial artery access path established by the radial artery catheter provided in example 1;

FIG. 3 is a schematic cross-sectional view of the radial artery catheter intermediate support section line 200 according to example 1 in a contracted state;

FIG. 4 is a schematic cross-sectional view of the radial artery catheter intermediate support section line 200 provided in example 1 in an expanded state;

FIG. 5 is a schematic diagram of one implementation of the radial artery catheter provided in example 1;

FIG. 6 is a schematic cross-sectional view of balloon inflation according to still another embodiment of example 1

Fig. 7 is a schematic diagram of an implementation of the radial artery catheter provided in embodiment 2.

Detailed Description

The following description of the present utility model will further illustrate the technical solution of the present utility model in conjunction with the specific embodiments, but should be construed as merely embodying the spirit and explanation of the technical solution of the present utility model, and should not be construed as limiting the scope of the present utility model.

The present disclosure is described in further detail below with reference to the drawings and examples. It is to be understood that the specific embodiments described herein are merely illustrative of the utility model and are not limiting of the utility model. It should be noted that, for convenience of description, only the portions related to the present utility model are shown in the drawings.

In the description of the present application, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and the like are to be construed broadly and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium. The specific meaning of the terms in this application will be understood by those of ordinary skill in the art as the case may be.

In the description of the present application, it is to be understood that the terms "distal" and "proximal" herein are to be understood as being viewed from the direction of the operator, the "distal" being the end remote from the operator and the "proximal" being the end close to the operator. The term "axial" should be understood herein as the direction of stent advancement or the length of the guidewire and "radial" should be understood as the perpendicular direction to the "axial".

In the description of the present application, it should be noted that, without conflict, embodiments of the present disclosure and features of the embodiments may be combined with each other.

As shown in fig. 1 (fig. 1 is a schematic diagram of a prior art transradial neural access), the transradial neural access line 1 passes through the radial artery 2 to the aortic arch 3 and advances to the contralateral common carotid artery 4. When medical instruments (such as a bracket, an embolism instrument and the like) are conveyed in the radial artery nerve access passage, the position of the radial artery nerve access pipeline 1 is unstable due to no supporting position at the aortic arch, and the condition of inferior detection occurs, so that the pushing or operation of the medical instruments is influenced.

Example 1

As shown in fig. 2 to 4 (fig. 2 is a schematic structural view of a radial artery access passageway established through a radial artery by the radial artery catheter provided in example 1; fig. 3 is a schematic sectional structural view of a contracted state of a radial artery catheter intermediate support section line 200 provided in example 1; fig. 4 is a schematic sectional view of an expanded state of a radial artery catheter intermediate support section line 200 provided in example 1), example 1 provides a radial artery catheter including a distal end soft section line 100, an intermediate support section line 200 and a proximal end rigid section line 300 in a longitudinal direction;

the intermediate support section line 200 includes an intermediate passage 210 in a radial direction, and a balloon 220 disposed outside the intermediate passage 210; the balloon is configured to expand radially to the a-side more than to the B-side; the balloon 220 is in communication with a balloon inflation line 240.

Illustratively, the maximum radial expansion distance of balloon 220 to the A-side is 1.5-5 times, e.g., 2-fold, 3-fold, 4-fold, etc., greater than the maximum radial expansion distance to the B-side. Those skilled in the art can choose and design according to the actual situation.

In a preferred implementation, the balloon 220 is a non-compliant balloon and is in a curved state after inflation. Those skilled in the art may inflate balloon 220 by passing an inflation fluid (e.g., saline, etc.) through balloon inflation line 240 into balloon 220.

In other alternative implementations, the balloon 220 may also be selected from a compliant balloon or a semi-compliant balloon. But the non-compliant balloon will retain better in the flexed state after inflation.

The radial artery catheter provided in example 1 was used as follows:

(1) Under the guidance of the guiding catheter, the radial artery catheter is pushed from the radial artery access path to the aortic arch along the radial artery, and is pushed to the contralateral common carotid artery along the line of the guiding catheter;

(2) After the intermediate passage 210 of the intermediate support section pipeline 200 of the radial artery catheter reaches the aortic arch, physiological saline is introduced into the balloon 220 through the balloon dilation pipeline 240, so that the balloon 220 is inflated to an inflated state;

(3) The guiding catheter is withdrawn from the body, and the establishment of a nerve access path through the radial artery is completed;

(4) Medical instruments (such as stents, embolic instruments and the like) are delivered to a vascular lesion through the established neural access path for operation;

(5) After the medical device is completely operated, the balloon 220 is contracted through the balloon expansion pipeline 240, and the radial artery catheter is withdrawn from the body.

As shown in fig. 5 (fig. 5 is a schematic structural diagram of one implementation of the radial artery catheter provided in embodiment 1), in embodiment 1, the distal soft segment pipeline 100, the middle support segment pipeline 200 and the proximal rigid segment pipeline 300 are in a layered structure, and may be designed by the following exemplary structures:

the distal soft segment pipeline 100 sequentially comprises a first transition pipeline 110 and a distal segment pipeline 120 which are communicated with the middle support segment pipeline 200 from near to far;

the walls of the proximal rigid section pipe 300, the intermediate passage 210 and the first transition pipe 110 each comprise an inner PTFE layer, an outer polymer layer, and a metal reinforcing layer embedded between the inner PTFE layer and the outer polymer layer; the pipe wall of the distal end pipeline only comprises a PTFE inner layer and a macromolecule outer layer.

It should be noted that the design of the above-mentioned layered structure is only one implementation, and those skilled in the art may also modify the design of the wall of the distal end pipe as required, for example, by designing the wall of the distal end pipe to include an inner PTFE layer and an outer polymer layer from inside to outside, and wire winding wires embedded between the inner PTFE layer and the outer polymer layer.

The radial catheter illustrated in fig. 5 is in a post-access condition, and in one implementation, the radial catheter described herein has no pre-shaped configuration of the intermediate support section tube 200 prior to access.

In addition, it should be noted that, after the radial catheter is configured to access (i.e., after the radial catheter is configured to access), the intermediate access 210 is configured to: the length of the intermediate passage is such that it can pass completely into the aortic arch. That is, after the radial catheter is completely routed, the intermediate passageway 210 is completely located at the aortic arch so that the balloon 220 can reach a predetermined position and expand, thereby providing support to the aortic arch.

In embodiment 1, the outer wall of the intermediate passage may be further provided with developing means, such as developing means 211 provided at both ends and the middle of the balloon 220 at the outer wall of the intermediate passage 210.

In yet another implementation, as shown in fig. 6 (fig. 6 is a schematic cross-sectional structural diagram of balloon inflation in yet another implementation of embodiment 1), after balloon 220 is inflated, in a cross-sectional view perpendicular to the radial catheter axis, the length of the axial section (dashed line in the figure) perpendicular to the cut a-side and B-side is greater than the length parallel to the axial section. The balloon 220 is disposed outside the intermediate passage 210, and the balloon 220 communicates with a balloon inflation line 240, as in example 1.

Example 2

As shown in fig. 7 (fig. 7 is a schematic structural diagram of one implementation of the radial artery catheter provided in embodiment 2), embodiment 2 provides yet another radial artery catheter, which differs from embodiment 1 only in that the shape of the balloon 220 is designed according to the following requirements:

the middle part of the balloon 220 is a sizing section 221; the distal end of the balloon is configured to have a first enlarged end 222, the first enlarged end 222 having a maximum radial expansion distance greater than the maximum radial expansion distance of the sizing section 221; the proximal portion of the balloon 220 is configured with a second enlarged end 223, the second enlarged end 223 having a maximum radial expansion distance that is greater than the maximum radial expansion distance of the sizing section 221.

Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present utility model, and not for limiting the same; although the utility model has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the utility model.

Claims

1. The radial artery catheter is characterized by comprising a distal soft section pipeline, a middle supporting section pipeline and a proximal rigid section pipeline along the length direction;

2. The radial catheter of claim 1, wherein the balloon is configured to expand radially to the a-side more than to the B-side.

3. The radial catheter of claim 2, wherein the maximum radial expansion of the balloon to the a-side is 1.1-5 times the maximum radial expansion to the B-side.

4. The radial catheter of claim 1, wherein the balloon middle portion is a sizing section in an axial direction; the distal end of the balloon is configured to have a first enlarged end having a maximum radial expansion distance greater than a maximum radial expansion distance of the sizing section; the proximal portion of the balloon is configured with a second enlarged end having a maximum radial expansion distance that is greater than the maximum radial expansion distance of the sizing section.

5. The radial catheter of claim 1, wherein the balloon assumes a curved state after inflation.

6. The radial catheter of claim 1, wherein the distal flexible section tube comprises, in order from proximal to distal, a first transition tube and a distal tube in communication with the intermediate support section tube;

the pipe walls of the near-end rigid section pipeline, the middle passage and the first transition pipeline all comprise a PTFE inner layer, a high polymer outer layer and a metal reinforcing layer embedded between the PTFE inner layer and the high polymer outer layer; the pipe wall of the distal end pipeline only comprises a PTFE inner layer and a macromolecule outer layer.

7. The radial catheter of claim 1, wherein an outer wall of the intermediate passageway is provided with a visualization component.

8. The radial catheter of claim 1, wherein the outer wall of the intermediate passageway defines visualization elements corresponding to the ends and middle of the balloon.

9. The radial catheter of claim 1, wherein the intermediate passageway is configured such that after the radial catheter has been completed, the intermediate passageway has a length that is capable of fully accessing the aortic arch.