WO2022198807A1

WO2022198807A1 - Implantable catheter, use method, and preparation method for implantable catheter

Info

Publication number: WO2022198807A1
Application number: PCT/CN2021/099685
Authority: WO
Inventors: 许冠哲; 林俊淑; 章泽波; 巴劲伟; 高猛; 叶乐
Original assignee: 杭州未名信科科技有限公司; 浙江省北大信息技术高等研究院
Priority date: 2021-03-26
Filing date: 2021-06-11
Publication date: 2022-09-29
Also published as: CN113181514A

Abstract

The present invention relates to the field of medical devices, and specifically disclosed are an implantable catheter, a use method, and a preparation method for the implantable catheter. The implantable catheter comprises: a catheter body having a proximal end and a distal end, wherein the catheter body is internally provided with a guidewire cavity channel, an inflatable cavity channel and a wire cavity channel which are independent from each other, the guidewire cavity channel being internally provided with a guidewire; a pressure sensor, which is arranged on the catheter body, is connected to a wire in the wire cavity channel, and is used for monitoring the pressure of implanted tissue in real time; and a balloon, which is arranged on the catheter body and is in communication with the inflatable cavity channel. The pressure sensor is integrated on the catheter body, thereby realizing direct measurement of the pressure in the implanted tissue; and the structure of the catheter is simplified, thereby reducing the diameter of the catheter.

Description

Implantable catheter, method of use and method of making the same

technical field

The invention relates to the field of medical devices, and specifically discloses an implantable catheter, a use method and a preparation method thereof.

Background technique

The traditional implantable flotation catheter has 4-6 cavities, including air-filled cavities, guide wire cavities, thermistor cavities, blood oxygen saturation cavities, and 2-4 blood extraction cavities. Implantable flotation catheters can be punctured from the patient's subclavian vein, internal jugular vein or femoral vein, inserted for a certain distance, by inflating the balloon to make it float along the blood, through the heart, to the implanted position, through The blood in the corresponding position is drawn out through the catheter to the external transducer for pressure measurement, so as to realize the function of pressure monitoring. This method not only has poor pressure measurement accuracy, but also easily leads to infection of patients. In addition, at present, traditional catheters and their coatings mostly use PVC+heparin coatings, but the heparin coatings are prone to fall off and then fail during use.

SUMMARY OF THE INVENTION

The present invention aims to solve the above-mentioned technical problems in the related art at least to a certain extent. To this end, the present invention proposes an implantable catheter, a method for use and a method for preparing the same to solve at least one of the above-mentioned technical problems.

In order to achieve the above object, a first aspect of the present invention provides an implantable catheter, comprising:

a tube body with a proximal end and a distal end, and the tube body is provided with an air-filled lumen and a guide wire lumen which are independent of each other;

a pressure sensor, arranged on the tube body and connected to the wire in the wire lumen, for real-time monitoring of the pressure of the implanted tissue;

The balloon is arranged on the tube body and communicated with the inflation lumen.

A second aspect of the present invention provides a method for preparing an implantable catheter, comprising the following steps:

Fix the base to the corresponding position of the pipe body, and open a wire lead-out hole on the pipe body;

fixing the pressure sensor on the base;

Guide the wire to the vicinity of the pressure sensor through the wire lumen and wire lead-out hole, and weld the wire and the pressure sensor;

Dispensing and encapsulating the welding parts to protect the welding parts;

The tube body is covered with a film to form a film layer, and a layer of hydrophilic coating is sprayed on the film-coated tube body; the film layer on the pressure sensor is removed to expose the sensing area of the pressure sensor.

A third aspect of the present invention provides a method for using an implantable catheter, comprising the following steps:

Insert a guide wire, use X-ray imaging to determine the position of the guide wire, and then guide the tube body into the tissue through the guide wire;

Or implant the tube into the tissue, and use the waveform on the ECG monitor to determine the position of the tube.

In addition, the implantable catheter of the present invention may also have the following additional technical features:

According to some embodiments of the present invention, the pressure sensor is arranged on the distal end of the tubular body and/or on the outer wall surface of the tubular body, and the balloon is arranged adjacent to the pressure sensor at the distal end of the tubular body.

According to some embodiments of the present invention, the tube body is further provided with a guide wire lumen independent of the inflation tube and the guide wire lumen, the guide wire lumen is provided with a guide wire, and the implantable catheter further includes:

A base, connected to the distal end or disposed on the surface of the tube body between the distal end and the proximal end, is used for fixing the pressure sensor on the tube body.

According to some embodiments of the present invention, the base is connected to the distal end, the base comprising:

a cylindrical seat body, an annular groove is formed on the seat body, an installation groove for installing the pressure sensor is formed along the height direction of the seat body, and the installation groove is communicated with the groove;

The arc-shaped head is protrudingly arranged on the seat body;

a first plug connector, plugged with the distal end;

The second plug is fixed in the guide wire lumen.

According to some embodiments of the present invention, the head and the annular groove are connected by an annular smooth transition surface.

a cylindrical seat body, the seat body is provided with a mounting slot for installing the pressure sensor and a placement slot for placing the adapter plate, and the mounting slot is communicated with the placement slot;

The arc-shaped head is protrudingly arranged on the seat body;

a first plug connector, plugged with the distal end;

The second plug is fixed in the guide wire lumen.

According to some embodiments of the present invention, an accommodating groove for accommodating the pressure sensor is formed on the surface of the pipe body.

According to some embodiments of the present invention, the base is located at the bottom of the accommodating groove.

According to some embodiments of the present invention, the material of the tube body is selected from any one of PP, PE, PA, TPU, PEBAX, and PI, and the material of the balloon is selected from any one of PE, PA, and TPU. The pressure sensor is selected from any one of a piezoresistive pressure sensor, a piezoelectric pressure sensor, and a capacitive pressure sensor, and the material of the base is selected from any one of metal, ceramic, and glass, so The tube body is sequentially covered with a film layer and a hydrophilic coating, and the material of the film layer is selected from any one of PET, PU, and PVDF.

According to some embodiments of the present invention, securing the pressure sensor on the base includes the following steps:

A part of the pressure sensor is glued on the installation groove, the other part is suspended, and the glue is contacted with the diaphragm of the pressure sensor through the installation groove.

Compared with the prior art, the present invention has the following beneficial effects:

By integrating the pressure sensor on the tube body, the direct measurement of the pressure in the implanted tissue is realized, the structure of the catheter is simplified, and the diameter of the catheter is reduced. In addition, the material of the catheter in the present invention is any one of PP, PE, PA, TPU, PEBAX and PI, which solves the problem of poor biocompatibility of the traditional PVC-made pulmonary artery floating catheter.

Description of drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present invention, and for those of ordinary skill in the art, other drawings can also be obtained according to the structures shown in these drawings without creative efforts.

1 is a schematic structural diagram of an implantable catheter in an embodiment of the present invention;

2 is a cross-sectional view of a tube body of a guidewireless implantable catheter according to an embodiment of the present invention;

3 is a cross-sectional view of a tubular body of a guidewire-type implantable catheter in an embodiment of the present invention;

4 is a cross-sectional view of FIG. 3 with a second base installed;

5a is a front view of a first pressure sensor in an embodiment of the present invention;

Fig. 5b is a side view of the first pressure sensor in an embodiment of the present invention;

5c is a cross-sectional view of the first pressure sensor in an embodiment of the present invention;

6a is a front view of a first pressure sensor in another embodiment of the present invention;

Fig. 6b is a side view of the first pressure sensor in another embodiment of the present invention;

6c is a cross-sectional view of the first pressure sensor in another embodiment of the present invention;

7a is a cross-sectional view of schematic diagram 1 after the assembly of the second pressure sensor and the second base in an embodiment of the present invention;

Fig. 7b is a schematic diagram 2 after the assembly of the second pressure sensor and the second base in an embodiment of the present invention;

8a is a cross-sectional view 1 of a first base in an embodiment of the present invention;

8b is a cross-sectional view 2 of the first base in an embodiment of the present invention;

9a is a cross-sectional view 1 of a first base in another embodiment of the present invention;

9b is a cross-sectional view 2 of the first base in another embodiment of the present invention;

9c is a cross-sectional view 3 of the first base in another embodiment of the present invention;

FIG. 9d is a cross-sectional view 4 of the first base in another embodiment of the present invention.

The realization, functional characteristics and advantages of the present invention will be further described with reference to the accompanying drawings in conjunction with the embodiments.

Detailed ways

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 by the embodiments set forth herein. Rather, these embodiments are provided so that the present disclosure will be more thoroughly understood, and will fully convey the scope of the present 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" can also be intended to include the plural forms unless the context clearly dictates otherwise. The terms "comprising", "comprising" and "having" are inclusive and thus indicate the presence of stated features, elements and/or components, but do not exclude the presence or addition of one or more other features, elements, components , and/or their combination.

In the description of the present invention, unless otherwise expressly specified and limited, the terms "arrangement" and "connection" should be understood in a broad sense, for example, it may be a fixed connection, a detachable connection, or an integral connection; it may be a Directly connected or indirectly connected through an intermediary. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

In addition, the terms "first" and "second" are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature defined as "first", "second", may expressly or implicitly include one or more of that feature. In the description of the present invention, "plurality" means at least two, such as two, three, etc., unless otherwise expressly and specifically defined.

For ease of description, spatially relative terms such as "bottom", "front", "top" may be used herein to describe the relationship of one element or feature to another element or feature as shown in the figures. ", "Tilt", "Down", "Top", "Inside", "Horizontal", "Outside", etc. This spatially relative term is intended to include different orientations of the mechanism in use or operation in addition to the orientation depicted in the figures. For example, if the mechanism in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "above the other elements or features" above features". Thus, the example term "below" can encompass both an orientation of above and below.

1-8b, an embodiment of the present invention provides an implantable catheter 100, the implantable catheter 100 includes a tube body 10, a first pressure sensor 11, two second pressure sensors 12, The balloon 13, the first base 14 for supporting and protecting the first pressure sensor 11, the second base 15 for supporting and protecting the second pressure sensor 12, the inflation syringe 16, the sensor wire adapter 17, the inflation cavity The adaptor 18, the guide wire lumen adaptor 19 and the pressure monitor, wherein the tube body 10 has a proximal end and a distal end, as shown in FIG. 2, the implantable catheter in this embodiment may be a guidewireless implant In other words, the tube body 10 is provided with an inflatable lumen 102 and a guide wire lumen 103 that are independent of each other, but this embodiment is not limited to this. As shown in FIGS. 3-4 , in this embodiment The implantable catheter can also be a guide wire type implantable catheter. In this way, the tube body 10 is further provided with a guide wire lumen 101 which is independent from the inflation lumen 102 and the guide wire lumen 103. The guide wire lumen 101 It is used to place the guide wire. A guide wire is placed in the guide wire lumen 103. The first pressure sensor 11 and the second pressure sensor are used to monitor the pressure of the implanted tissue in real time. One end of the guide wire is connected to the first pressure sensor 11 and the second pressure sensor 12. The other end of the wire is connected to the pressure monitor to output the pressure value of the implanted tissue in real time.

It is worth mentioning that the implantable catheter of this embodiment can be used to measure central venous pressure, right atrial pressure, right ventricular pressure, pulmonary artery diastolic pressure, pulmonary artery systolic pressure, mean pulmonary artery pressure, pulmonary artery wedge pressure, etc. The absolute pressure values read by the first pressure sensor 11 and the second pressure sensor 12 are transmitted to the pressure monitor, and are displayed as actual pressure values in the blood vessel after data processing. By adjusting the first base 14 and the second base 15, the implantable catheter can use pressure sensors of different sizes as pressure monitoring components.

In this embodiment, as shown in FIG. 8 , the first pressure sensor 11 is fixed on the first base 14 , and the first base 14 is connected to the distal end of the tube body 10 for fixing the first pressure sensor 11 on the first base 14 . At the distal end of the tube body 10, the second pressure sensor 12 is fixed on the second base 15, and the second base 15 is fixed on the surface of the tube body between the distal end and the proximal end of the tube body 10, for connecting the second pressure sensor 12 is fixed on the outer wall surface of the pipe body 10, and the second base 15 fixes the second pressure sensor 12 on the middle section of the pipe body 10. Specifically, the first base 14 and the second base 15 are fixed by glue On the tube body 10 , the first pressure sensor 11 and the second pressure sensor 12 are fixed on the first base 14 and the second base 15 by adhesive.

It is worth mentioning that the second pressure sensor 12 can also be directly fixed on the tube body 10 without using the second base 15 (which will be described in detail below).

In the present invention, as shown in Figs. 5a-6c, the first pressure sensor 11 is divided into a direct lead-out type sensor and a switch lead-out type sensor according to the lead-out method of the first pressure sensor 11. The type sensor needs to be realized by installing an adapter board on the first base 14 , and FIGS. 5a-5c are the direct lead-out type sensor, and FIGS. 6a-6c are the transition lead-out type sensor.

Specifically, in an embodiment of the present invention, for the direct-extraction sensor shown in FIGS. 5a-5c, as shown in FIGS. 8a-9d, the first base 14 may include: a cylindrical seat 140, an arc head 141 , the first plug 142 and the second plug 143 , wherein an annular groove 1401 is formed on the seat body 140 , and a mounting groove 1402 for installing the first pressure sensor 11 is formed along the height direction of the seat body 140 , and the installation groove 1402 is communicated with the groove 1401; the head 141 is protrudingly arranged on the base body 140, the first plug 142 is plugged with the distal end of the tube body 10, and the second plug 143 is fixed to the guide wire lumen 101.

Further, the head 141 is connected with the annular groove 1401 through an annular smooth transition surface 144 .

Specifically, in another embodiment of the present invention, for the switch-out type sensor shown in FIGS. 6a-6c, as shown in FIGS. 9a-19d, the first base 14 may include: a cylindrical seat 140, an arc The base body 140 is provided with a mounting slot 1402 for mounting the first pressure sensor 11 and a placement slot for placing the adapter plate 1403, and the installation slot 1402 communicates with the placement slot 1403; the arc-shaped head 141 is protruded on the seat body 140; the first plug 142 is inserted into the distal end of the tube body 10, the second The connector 143 is fixed in the guide wire lumen 101 .

It should be noted that, the first pressure sensor 11 and the second pressure sensor 12 may be one type of sensor, that is, the second pressure sensor 12 can be divided into a direct lead-out type sensor and a transfer type according to the lead-out manner of the second pressure sensor 12 For the lead-out sensor, it should be noted that the transfer lead-out sensor needs to be realized by installing an adaptor board on the second base 15. Figures 5a-5c are direct lead-out sensors, and Figures 6a-6c are transfer lead-out sensors. .

Specifically, in an embodiment of the present invention, for the direct-extraction sensor shown in FIG. 4 , as shown in FIG. 2 , an accommodating groove for accommodating the second pressure sensor 12 is opened on the outer wall surface of the pipe body 10 . 104. The second pressure sensor 11 is directly bonded in the accommodating groove 104 .

In another embodiment of the present invention, for the direct lead-out type sensor shown in Figs. 6a-6c, as shown in Figs. A second base 15 is installed on the bottom of the slot 104 , and the second pressure sensor 12 is installed on the second base 15 .

It should be noted that the material of the tube body 10 is selected from any one of PP, PE, PA, TPU, PEBAX, and PI, the material of the balloon 13 is selected from any one of PE, PA, and TPU, and the first pressure The sensor 11 and the second pressure sensor 12 can be selected from any of a piezoresistive pressure sensor, a piezoelectric pressure sensor, and a capacitive pressure sensor, respectively, and the materials of the first base 14 and the second base 15 are selected from metal Or any one of ceramics and glass, the tube body 10 is covered with a film layer and a hydrophilic coating in sequence, and the material of the film layer is selected from any one of PET, PU, and PVDF.

In this embodiment, the first pressure sensor 11 and the second pressure sensor 12 are installed on the first base 14 and the second base 15 respectively, which improves the fixing strength of the pressure sensor on the pipe body 10 and avoids the first pressure sensor 11 , the second pressure sensor 12 falls off, thereby improving the accuracy of the data measurement of the pressure sensor.

In the actual use of the above-mentioned guide wire implantable catheter, the guide wire is firstly inserted, the position of the guide wire is determined by X-ray imaging, and then the catheter is guided into the body; when the guide wire type implantable catheter is used, it can be The catheter is implanted in the body, and the waveform on the ECG monitor is used to determine the position of the catheter. When the pulmonary artery implantable catheter involved in the present invention is used as a guide wire-free catheter for interventional catheterization, since its head and side bases are made of metal, imaging under X-rays can still be achieved, so it can improve the performance of the guide wire-free catheter. Reliability of pulmonary artery catheters during cannulation.

The steps of packaging the first pressure sensor 11 and the second pressure sensor 12 on the tube body 10 will be described in detail below through Embodiments 1-4.

Example 1

This example involves a method for installing a single first pressure sensor with a size of no more than 1mm×1mm×0.5mm on a pipe body, which specifically includes the following steps:

The first step is to seal the inflatable cavity at the distal end of the tube body, and the sealing distance does not exceed 3cm;

In the second step, the first base shown in Figures 8a-9d is connected to the distal end of the tube body by means of AB glue, and a hole is made on the side wall of the tube body to reserve a lumen for the guide wire the through channel;

The third step is to operate under a microscope, use photosensitive UV glue to glue the first pressure sensor to the first base of the distal end, and guide the lead wire into the guide wire cavity through the hole on the side wall;

The fourth step is to use a silicone sleeve to protect the position where the sensor is installed on the tube body with a protective adhesive to ensure air tightness;

The fifth step is to spray the PVP hydrophilic coating on the outer layer of the tube to increase the hydrophilicity of the catheter;

The sixth step, remove the heat shrink film at the first pressure sensor to expose the sensor sensing area;

The seventh step is to punch a hole at a distance of no more than 5cm from the distal end, pass through to the inflatable cavity, and install the balloon by ultrasonic welding;

The eighth step is to install the sensor wire adapter, the inflation lumen adapter and the guide wire lumen adapter on the proximal end of the tube body.

Example 2

This embodiment relates to a method for installing a first pressure sensor and a second pressure sensor with a size of no more than 1mm×1mm×0.5mm on the pipe body, that is, the first pressure sensor is installed at the distal end of the pipe body, and the side wall of the pipe body is installed Two second pressure sensors for a total of three sensors. Specifically include the following steps:

The first step is to seal the inflatable cavity at the distal end of the tube body, and the sealing distance is not more than 3cm;

In the second step, the first base described in Figures 8a-9d is connected to the distal end of the tube body by means of AB glue; and a hole is made on the side wall of the tube body to reserve a connection with the guide wire lumen. through channel;

The third step is to operate under the microscope, use photosensitive UV glue to glue the first pressure sensor on the first base, and guide the lead wire into the wire cavity through the hole on the side wall;

The fourth step is to open a groove of no more than 1mm×1mm×3mm and slightly larger than the size of the second pressure sensor on the side wall of the pipe body at a distance of 15cm and 25cm from the distal end, for placing two second pressure sensors. , the wires of the two sensors are also guided into the wire lumen through the through holes;

The fifth step, use PVDF heat shrinkable tube to heat shrink the tube body to ensure air tightness;

The sixth step is to spray the PVP hydrophilic coating on the outer layer of the pipe to increase the hydrophilicity of the catheter;

The seventh step is to remove the heat shrinkable film at the first pressure sensor and the second pressure sensor to expose the sensor sensing area;

The eighth step is to punch a hole about 5cm away from the distal end, pass through to the inflatable cavity, and install the balloon by ultrasonic welding;

The ninth step is to install the sensor wire adapter, the inflation lumen adapter and the guide wire lumen adapter on the proximal end of the tube body.

Example 3

This embodiment relates to a method for installing a first pressure sensor with a size not exceeding 2mm×2mm×1mm on a pipe body, which specifically includes the following steps:

The third step is to operate under a microscope, use photosensitive UV glue to glue the first pressure sensor to the first base, and use the same method to glue an adapter board behind the first pressure sensor;

The fourth step is to use a gold wire ball bonder to connect one end of the adapter board with the interface end of the first pressure sensor through a gold wire, then solder the copper wire on the adapter board, and guide the outgoing copper wire through the hole on the side wall. into the guide wire lumen;

The fifth step is to cover and cure the welding part with an appropriate amount of UV glue for protective packaging;

The sixth step, use PET heat shrinkable tube to heat shrink the tube body to ensure air tightness;

The seventh step is to spray the PVP hydrophilic coating on the outer layer of the tube to increase the hydrophilicity of the catheter;

The eighth step, remove the heat shrink film at the first pressure sensor to expose the sensor sensing area;

The ninth step is to punch a hole about 5cm away from the distal end, pass through to the inflatable cavity, and install the balloon by ultrasonic welding;

The tenth step is to install the sensor wire adapter, the inflation lumen adapter and the guide wire lumen adapter on the proximal end of the tube body.

Example 4

This embodiment relates to a method for installing a first pressure sensor and a second pressure sensor with a size not exceeding 2mm×2mm×1mm on the pipe body, that is, the first pressure sensor is installed at the distal end of the pipe body, and the two pressure sensors are installed on the side wall of the pipe body. A second pressure sensor, a total of three sensors. Specifically include the following steps:

The sixth step, open a groove no more than 1.5mm × 1.5mm × 3mm and slightly larger than the sensor size on the side wall of the tube body at a distance of no more than 15cm and no more than 25cm from the distal end. It shows that the second base is bonded in the groove with AB glue, and then the two second pressure sensors are glued and fixed and lead wire welded, and the wires of these two sensors are also guided into the wire cavity through the through holes;

The seventh step, use PET heat shrinkable tube to heat shrink the tube body to ensure air tightness;

The eighth step is to spray the PVP hydrophilic coating on the outer layer of the tube to increase the hydrophilicity of the tube;

The ninth step, remove the heat shrink film at the second pressure sensor to expose the sensor sensing area;

The tenth step is to punch a hole at a distance of no more than 5cm from the distal end, pass through to the inflatable cavity, and install the balloon by ultrasonic welding;

The eleventh step is to install the sensor wire adapter, the inflation lumen adapter and the guide wire lumen adapter on the proximal end of the tube body.

It should be noted that when the pressure sensor is fixed on the base, a part of the pressure sensor can be glued to the installation groove, and the other part can be suspended, and then the glue can be contacted with the diaphragm of the pressure sensor through the installation groove, so that The stability of fixing the pressure sensor in the installation groove can be improved.

The above description is only a preferred embodiment of the present invention, but the protection scope of the present invention is not limited to this. Substitutions should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

An implantable catheter, characterized in that, comprising:

The tube body has a proximal end and a distal end, and the tube body is provided with an inflatable lumen and a guide wire lumen which are independent of each other;

a pressure sensor, arranged on the tube body and connected to the wire in the wire lumen, for real-time monitoring of the pressure of the implanted tissue;

The balloon is arranged on the tube body and communicated with the inflation lumen.
The implantable catheter according to claim 1, wherein the pressure sensor is disposed on the distal end of the tube body and/or on the outer wall surface of the tube body, and the balloon is adjacent to the tube body The remote pressure sensor is set.
The implantable catheter according to claim 2, wherein a guide wire lumen is further provided in the tube body, which is independent from the inflation pipe and the guide wire lumen, and a guide wire is arranged in the guide wire lumen, so The implantable catheter also includes:

A base, connected to the distal end or disposed on the surface of the tube body between the distal end and the proximal end, is used for fixing the pressure sensor on the tube body.
The implantable catheter of claim 3, wherein the base is connected to the distal end, the base comprising:

a cylindrical seat body, an annular groove is formed on the seat body, an installation groove for installing the pressure sensor is formed along the height direction of the seat body, and the installation groove is communicated with the groove;

The arc-shaped head is protrudingly arranged on the seat body;

a first plug connector, plugged with the distal end;

The second plug is fixed in the guide wire lumen.
The implantable catheter according to claim 4, wherein the head and the annular groove are connected by an annular smooth transition surface.
The implantable catheter of claim 3, wherein the base is connected to the distal end, the base comprising:

a cylindrical seat body, the seat body is provided with a mounting slot for installing the pressure sensor and a placement slot for placing the adapter plate, and the mounting slot is communicated with the placement slot;

The arc-shaped head is protrudingly arranged on the seat body;

a first plug connector, plugged with the distal end;

The second plug is fixed in the guide wire lumen.
The implantable catheter according to claim 3, wherein an accommodating groove for accommodating the pressure sensor is formed on the surface of the pipe body.
The implantable catheter according to claim 7, wherein the base is located at the bottom of the accommodating groove.
The implantable catheter according to claim 3, wherein the material of the tube body is selected from any one of PP, PE, PA, TPU, PEBAX, and PI, and the material of the balloon is selected from PE , any one of PA, TPU, described pressure sensor is selected from any one in piezoresistive pressure sensor, piezoelectric pressure sensor, capacitive pressure sensor, the material of described base is selected from metal or ceramic, Any of the glass, the tube body is covered with a film layer and a hydrophilic coating in sequence, and the material of the film layer is selected from any one of PET, PU, and PVDF.
The preparation method of the implantable catheter according to any one of claims 3-9, characterized in that, comprising the following steps:

Fix the base to the corresponding position of the pipe body, and open a wire lead-out hole on the pipe body;

fixing the pressure sensor on the base;

Guide the wire to the vicinity of the pressure sensor through the wire lumen and wire lead-out hole, and weld the wire and the pressure sensor;

Dispensing and encapsulating the welding parts to protect the welding parts;

A film is formed on the tube body to form a film layer, and a layer of hydrophilic coating is sprayed on the tube body after the film coating is completed;

Remove the film on the pressure sensor to expose the sensing area of the pressure sensor.
The method for preparing an implantable catheter according to claim 10, wherein fixing the pressure sensor on the base comprises the following steps:

A part of the pressure sensor is glued on the installation groove, the other part is suspended, and the glue is contacted with the diaphragm of the pressure sensor through the installation groove.
The using method of the described implantable catheter of any one of claim 3-9, is characterized in that, comprises the following steps:

Insert a guide wire, use X-ray imaging to determine the position of the guide wire, and then guide the tube body into the tissue through the guide wire;

Or implant the tube into the tissue, and use the waveform on the ECG monitor to determine the position of the tube.