CN220860500U

CN220860500U - Balloon catheter and prosthetic valve delivery system

Info

Publication number: CN220860500U
Application number: CN202321922231.9U
Authority: CN
Inventors: 汪灵骥; 詹航敏; 杨夏燕; 虞奇峰
Original assignee: Chengdu Newmai Biotechnology Co ltd
Current assignee: Chengdu Newmai Biotechnology Co ltd
Priority date: 2023-07-20
Filing date: 2023-07-20
Publication date: 2024-04-30
Anticipated expiration: 2033-07-20

Abstract

The utility model discloses a balloon catheter and a prosthetic valve conveying system, which comprises an inner tube and an outer tube, wherein the inner tube is provided with a distal end and a proximal end, and the distal end of the inner tube is sleeved with a balloon; the outer tube is sleeved at the proximal end of the inner tube, a fluid channel is formed between the outer tube and the inner tube, and the fluid channel is communicated with the inside of the balloon. The distal end of the outer tube is provided with a bending section which is in signal connection with the signal generator and is configured to bend after being stimulated by the signal so as to drive the inner tube and the saccule and the artificial valve on the inner tube to deviate from the original path, thereby avoiding the guide wire from being clung to the blood vessel wall. Therefore, medical staff can control the bending condition of the bending section in time through the signal emission of the control signal generator, so that the balloon catheter can quickly and accurately avoid the obstruction on the original path, the required position can be smoothly reached, and the internal tissues of a human body are not easy to scratch.

Description

Balloon catheter and prosthetic valve delivery system

Technical Field

The utility model relates to the technical field of medical appliances, in particular to a balloon catheter and a prosthetic valve conveying system.

Background

Transcatheter aortic valve replacement procedures typically use a stiff guidewire to create a track along which a delivery system loaded with a valve is advanced through the aortic arch, across the valve, and to a target location. When the patient's aortic arch curvature is large, the stiff wire will be held against the vessel wall due to the large elastic modulus, which may lead to the following problems:

(1) Delivery systems accessed along a guidewire cannot pass through the aortic arch as the catheter compliance reaches a limit;

(2) After passing through the aortic arch, the delivery system carrying the valve is pushed along the hard guide wire and is easily blocked by the root of the aortic valve so as not to cross the valve;

(3) In the case of valve-in-valve surgery, the delivery system carrying the valve, after passing through the aortic arch, is pushed along the stiff guidewire and is easily blocked by the prior valve stent and cannot span the valve.

Therefore, the over-bending failure easily occurs only by driving the delivery system carrying the valve through the bending capability of the hard guide wire and the catheter, and the delivery system cannot be advanced continuously or takes too long time for the advancing process.

Therefore, how to improve the technical defects existing in the prior art is a problem to be solved by the person skilled in the art.

Disclosure of utility model

The utility model aims to provide a balloon catheter and a prosthetic valve conveying system, which can timely adjust a conveying path, avoid a guide wire from being clung to the wall of a blood vessel, quickly and accurately avoid the obstruction on the original path, thereby smoothly reaching a required position and being difficult to scratch internal tissues of a human body.

The technical scheme provided by the utility model is as follows:

A balloon catheter, comprising:

the inner tube is provided with a distal end and a proximal end, and the balloon is sleeved at the distal end of the inner tube;

The outer tube is sleeved at the proximal end of the inner tube, a fluid channel is formed between the outer tube and the inner tube, and the fluid channel is communicated with the inside of the balloon;

The outer tube comprises an outer tube, a signal generator and a balloon and valve, wherein the distal end of the outer tube is provided with a bending section which is in signal connection with the signal generator and is configured to bend after being stimulated by the signal so as to drive the inner tube and the balloon and valve on the inner tube to deviate from the original path.

In some embodiments, the turn section includes a body portion and a response portion connected in sequence in the outer tube circumferential direction;

The response part comprises a first electrode layer, a dielectric layer and a second electrode layer from inside to outside in sequence in the radial direction of the outer tube, and the first electrode layer and the second electrode layer are made of flexible electrode materials.

In some embodiments, the bending section is a spring coil, and the spring coil is provided with a flexible electrode layer at least towards the inner side wall of the inner tube and the outer side wall facing away from the inner tube; and

And a dielectric layer is arranged between the spring ring and the flexible electrode layer at the circumferential part of the spring ring, a response part is formed at the part of the bending section provided with the dielectric layer, and a body part is formed at the part of the bending section not provided with the dielectric layer.

In some embodiments, the outer tube is provided with a direction mark on the side where the response portion is located, or the outer tube is provided with a direction mark on the side where the outer tube is away from the response portion.

In some embodiments, the inner tube is provided with a first developer ring near the distal end of the outer tube.

In some embodiments, a first limiting piece and a second limiting piece are arranged on the outer side wall of the inner tube, and a preset distance is reserved between the first limiting piece and the second limiting piece to form a clamping station;

the prosthetic valve is sleeved outside the balloon, and the clamping station is used for limiting the prosthetic valve to move along the central axis of the inner tube.

In some embodiments, the ends of the first limiting piece and the second limiting piece, which are close to each other, are all in conical structures; and

The large end of the conical structure of the first limiting piece is arranged towards the second limiting piece, and the large end of the conical structure of the second limiting piece is arranged towards the first limiting piece.

In some embodiments, at least one second developing ring is arranged in the clamping station, and at least one second developing ring is positioned at the middle position of the clamping station in the axial direction of the inner tube;

and/or

The inner tube corresponds to the two ends of the clamping station in the axial direction of the inner tube, and third developing rings are respectively arranged at the two ends of the inner tube.

In some embodiments, the distal end of the inner tube is provided with a tapered head to guide the inner tube and the balloon and prosthetic valve on the inner tube into the patient.

In some embodiments, a guidewire lumen is disposed within the inner tube and adapted for passage of a guidewire therethrough.

The present utility model also provides a prosthetic valve delivery system comprising:

A handle and a balloon catheter provided by any one of the above;

The handle is arranged at the proximal end of the outer tube, the signal generator is arranged in the handle and is in signal connection with the bending section through a signal wire; and

The handle is provided with a control button for controlling the signal generator to emit signals;

the inner tube is internally provided with a guide wire cavity which is suitable for a guide wire to pass through.

The utility model has the technical effects that:

1. In this patent, through setting up the accent section of bending, and this accent section of bending is configured to receive signal stimulus back crooked for medical personnel can in time control the crooked condition of accent section through signal generator's signal transmission, so that the sacculus pipe can avoid the hindrance on the original route fast and accurately, thereby reach required position smoothly. In addition, the bending section can prevent the guide wire from being clung to the wall of the blood vessel, so that the possibility of scratching the internal tissues of the human body in the conveying process of the balloon catheter is reduced, and the injury is reduced. In addition, the clamping station is arranged on the outer side wall of the inner tube, so that the artificial valve can be limited, and the artificial valve can not be separated from the balloon catheter in the conveying process, so that the artificial valve can be accurately conveyed to a required position, accurate positioning is realized, and the conveying effect is better.

2. In this patent, through the position that is close to the outer tube distal end at the inner tube sets up first developing ring for medical personnel can observe the condition of transfer bend section and periphery, and the medical personnel of being convenient for will transfer bend section adjustment to suitable crooked degree, thereby makes the sacculus pipe successfully avoid all hindrance on the original route.

3. In this patent, have the distance of predetermineeing between first locating part and the second locating part to form the card station of putting. Simultaneously, the one end that first locating part and second locating part are close to each other all is the circular cone form structure, and the big end of the circular cone form structure of first locating part sets up towards the second locating part, and the big end of the circular cone form structure of second locating part sets up towards first locating part. Taking the setting of first locating part near the inner tube distal end, the setting of second locating part near the inner tube proximal end as an example, when the sacculus pipe is guided into human inside through the seal wire, the circular cone form structure of first locating part can have guide first locating part and prosthetic valve to get into human inside, avoids first locating part and prosthetic valve to be blocked outside because of the too little clearance between each tissue in the human. Meanwhile, the conical structure of the first limiting part can reduce damage to various tissues in a human body when the balloon catheter enters the human body to a certain extent, and discomfort of a patient is relieved. In contrast, when the balloon catheter is withdrawn from the human body, the conical structure of the second limiting piece can guide the second limiting piece to withdraw from the human body, and a certain space is reserved for the structure of the human body to be withdrawn later, so that the balloon catheter can be withdrawn more smoothly, and the practicability is strong. Meanwhile, the conical structure of the second limiting piece can reduce damage to various tissues in a human body when the balloon catheter is withdrawn from the human body to a certain extent, and discomfort of a patient is relieved.

4. In this patent, through setting up the second and develop the ring, and at least a second develop the ring and be located card and put station in the axial intermediate position in the interior pipe, medical personnel can judge according to the position of second develop the ring whether the prosthetic valve is in place, realizes accurate location. In contrast, the third developing ring provided in this patent can also assist the medical staff in judging the condition of the prosthetic valve and its periphery, thereby judging whether the prosthetic valve is in place. At this time, if the second developing ring and the third developing ring are combined, the second developing ring and the third developing ring can be used as a scale, and the accurate evaluation of the relative position between the artificial valve and the focus can be realized under the assistance of imaging equipment or contrast agent, that is, the specific size of the artificial valve to be regulated can be read through the second developing ring and the third developing ring, the accurate regulation of the position of the artificial valve can be realized, and then the accurate release can be realized.

5. In this patent, through setting up the conical head at the distal end of inner tube, more be favorable to medical personnel to operate and control the sacculus pipe and get into the human internal corresponding position, make the sacculus pipe be difficult to because of the too little separation in the human internal each interval between the tissue outside. Meanwhile, the arrangement of the conical head can reduce the damage to various tissues in the human body when the balloon catheter enters the human body to a certain extent, and the uncomfortable feeling of a patient is relieved.

Drawings

The utility model is described in further detail below with reference to the attached drawings and detailed description:

FIG. 1 is a cross-sectional view of a balloon catheter provided in one embodiment of the present utility model;

FIG. 2 is an enlarged view of a portion of the balloon catheter shown in FIG. 1;

FIG. 3 is a cross-sectional view of a balloon catheter provided in another embodiment of the present utility model;

FIG. 4 is an enlarged view of a portion of the balloon catheter shown in FIG. 3;

FIG. 5 is a schematic illustration of the operation of a balloon catheter;

FIG. 6 is a schematic illustration of a prior art balloon catheter being obstructed by a native aortic valve;

FIG. 7 is a schematic illustration of a balloon catheter according to the present utility model deployed through a native aortic valve;

FIG. 8 is a schematic view of a bending process of a bending section provided by the utility model;

FIG. 9 is a schematic view of a prior art balloon catheter in one instance blocked by a prior art prosthetic valve;

FIG. 10 is a schematic view of a prior art balloon catheter in another situation blocked by a prior art prosthetic valve;

FIG. 11 is a schematic illustration of a dielectric elastomer material with flexible electrodes on both sides prior to electro-deformation;

FIG. 12 is a schematic illustration of a dielectric elastomer material having flexible electrodes on both sides after electro-deformation;

FIG. 13 is a schematic view of a dielectric elastomer material prior to electro-deformation of a rigid electrode on one side and a flexible electrode on the other side;

FIG. 14 is a schematic view of a dielectric elastomer material electrolessly deformed with a rigid electrode on one side and a flexible electrode on the other side;

Fig. 15 is a schematic view of a prosthetic valve delivery system provided by the present utility model.

Reference numerals illustrate:

100. An inner tube; 110. a balloon; 120. a first limiting member; 130. a second limiting piece; 140. a clamping station; 141. a second developing ring; 150. a first developing ring; 160. a third developing ring; 170. a conical head; 180. a guidewire lumen; 190. a large end;

200. An outer tube; 210. a bending section; 211. a response unit; 2111. a dielectric layer; 212. a body portion; 213. a spring ring; 220. a direction mark;

300. A signal line;

400. A prosthetic valve;

500. Native valve

600. A guide wire;

701. A flexible electrode layer; 702. a rigid electrode layer;

800. A handle; 810. a control knob; 820. a display screen; 830. and an electric plug.

Detailed Description

In the following description, for purposes of explanation and not limitation, specific details are set forth such as the particular system architecture, techniques, etc., in order to provide a thorough understanding of the embodiments of the present application. It will be apparent, however, to one skilled in the art that the present application may be practiced in other embodiments that depart from these specific details. In other instances, detailed descriptions of well-known systems, devices, circuits, and methods are omitted so as not to obscure the description of the present application with unnecessary detail.

In order to more clearly illustrate the embodiments of the present utility model or the technical solutions in the prior art, the following description will explain the specific embodiments of the present utility model with reference to the accompanying drawings. It is evident that the drawings in the following description are only examples of the utility model, from which other drawings and other embodiments can be obtained by a person skilled in the art without inventive effort.

For simplicity of the drawing, only the parts relevant to the utility model are schematically shown in each drawing, and they do not represent the actual structure thereof as a product. Additionally, in order to simplify the drawing for ease of understanding, components having the same structure or function in some of the drawings are shown schematically with only one of them, or only one of them is labeled. Herein, "a" means not only "only this one" but also "more than one" case.

It should be further understood that the term "and/or" as used in the present specification and the appended claims refers to any and all possible combinations of one or more of the associated listed items, and includes such combinations.

In this context, it should be noted that the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected, unless explicitly stated or limited otherwise; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present utility model will be understood in specific cases by those of ordinary skill in the art.

In the embodiment shown in the drawings, indications of orientation (such as up, down, left, right, front and rear) are used to explain the structure and movement of the various components of the utility model are not absolute but relative. These descriptions are appropriate when the components are in the positions shown in the drawings. If the description of the location of these components changes, then the indication of these directions changes accordingly.

In addition, in the description of the present application, the terms "first," "second," and the like are used merely to distinguish between descriptions and are not to be construed as indicating or implying relative importance.

According to one embodiment of the present utility model, referring to fig. 1, 3 and 8, a balloon catheter may include an inner tube 100 and an outer tube 200. The inner tube 100 has a distal end and a proximal end, the proximal end near the operation end of the medical staff and the distal end far away from the operation end of the medical staff, and the distal end of the inner tube 100 is sleeved with a balloon 110; the outer tube 200 is sleeved on the proximal end of the inner tube 100, and a fluid channel is formed between the outer tube 200 and the inner tube 100, and the fluid channel is communicated with the inside of the balloon 110. At this time, the distal end of the outer tube 200 is formed with a bending section 210, the bending section 210 is in signal connection with the signal generator, and the bending section 210 is configured to bend upon being stimulated by the signal. That is, the signal generator transmits a signal, and the transmitted signal is transmitted to the bending section 210 through the signal line 300, and the bending section 210 bends after being stimulated by the signal, so as to drive the inner tube 100 and the balloon 110 and the artificial valve 400 on the inner tube 100 to deviate from the original paths.

Referring to fig. 5, in the prior art, a balloon catheter used in a transcatheter aortic valve replacement operation is mostly passed through a guide wire 600 to establish a passageway, and then passed along the guide wire 600 into the interior of the human body. In the process of balloon catheter delivery, if the aortic arch curvature of the patient is large, the guide wire 600 will be tightly attached to the vessel wall due to the large elastic modulus, so three problems are very likely to occur:

1. Balloon catheters that enter the interior of the human body along the guidewire 600 may not pass through the aortic arch due to extreme compliance itself;

2. Referring to fig. 6, the balloon catheter carrying the prosthetic valve 400, after passing through the aortic arch, is easily obstructed from crossing the valve by the root of the native valve 500;

3. referring to fig. 9 and 10, in the case of an in-valve operation, the balloon catheter carrying the prosthetic valve 400 is easily blocked from crossing the valve by the previous prosthetic valve 400 after passing through the aortic arch.

When the three conditions are met, the conveying is difficult to be completed smoothly only through the bending capability of the balloon 110 assembly self-body, on one hand, the internal tissues of a human body are easy to damage, and on the other hand, the conveying time is prolonged, so that the operation progress is influenced.

In this regard, the present embodiment provides a balloon catheter, in which the outer tube 200 is formed with the bending section 210, and compared with the balloon catheter in the prior art that is passively bent along the advancing direction of the guide wire 600, the balloon catheter of the present embodiment can actively control the bending condition of the bending section 210 by controlling the signal transmission of the signal generator, so that the balloon catheter can quickly and accurately avoid the obstruction on the original path, and thus smoothly reach the required position. It will be appreciated that the original path is the guide path originally established by the guidewire 600.

Meanwhile, the bending section 210 can prevent the guide wire 600 from being clung to the vessel wall, so that the balloon catheter is not easy to scratch the internal tissues of a human body in the conveying process, the operation safety is higher, and the method has clinical value. Wherein a guidewire lumen 180 is provided within the inner tube 100, adapted for passage of a guidewire 600 therethrough.

Specifically, the outer sidewall of the inner tube 100 is formed with a clamping station 140, and the prosthetic valve 400 is sleeved outside the balloon 110. At this time, the clamping station 140 can be used for limiting the movement of the prosthetic valve 400 along the central axis of the inner tube 100, so that the prosthetic valve 400 is limited, the prosthetic valve 400 is prevented from being separated from the balloon catheter in the conveying process, and thus, the prosthetic valve 400 can be accurately conveyed to a required position, accurate positioning is achieved, and the conveying effect is better. When the prosthetic valve 400 is delivered to the appropriate location, fluid enters the balloon 110 through the fluid passageway, expanding the balloon 110, and thus expanding the prosthetic valve 400, completing placement.

In one embodiment, the signal generator is mounted inside the handle 800 and is in signal connection with the bending section 210 through the signal line 300, and meanwhile, the handle 800 is further provided with a control button for controlling the signal generator to emit a signal. The signal generated by the signal generator may be continuous or intermittent, and is not limited herein, and is within the scope of the present utility model.

At this time, the medical staff can start or close the stimulation signal directly through the control button on the handle 800, and when the bending section 210 receives the stimulation signal, the bending section generates a corresponding degree of bending, and the bending can enable the balloon catheter to obtain a force deviating from the original guiding path, so that the instrument avoids the obstruction and can be pushed smoothly.

Referring to fig. 6 to 8, taking case 2 as an example, when the balloon catheter is blocked by the root of the native valve 500 in the delivery process and cannot span the valve, a medical staff can start the signal generator to transmit a signal through the control button on the handle 800, so that the balloon catheter is converted from the original path a to the new path b, and then passes through the middle part of the native valve 500 to complete the valve-span, and the practicability is strong.

Specifically, the bending section 210 includes a body portion 212 and a response portion 211 sequentially connected in the circumferential direction of the outer tube 200, the response portion 211 is made of a material with a stimulus response function, and is manufactured by a special structural design, and then is connected with the body portion 212 through a certain process (such as hot pressing, hot melt welding, bonding, etc.), so that a tubular structure is formed by the two. Finally, the tubular structure is joined to a conventional catheter by a process (e.g., hot pressing, hot melt welding, bonding, etc.) to form the completed outer tube 200. The functional materials with stimulus response mainly comprise shape memory alloy and composite materials thereof, liquid crystal elastomer and composite materials thereof, functional polymer composite materials and the like. The stimulation signals are classified into electric driving materials, magnetic driving materials, thermal driving materials, optical driving materials and the like, and the driving materials of different signal types have different mechanisms for deformation.

Referring to fig. 11 and 12, the response portion 211 of the bending section 210 provided in the present embodiment is made of an electrically driven material, and at this time, the response portion 211 of the bending section 210 may be understood as a dielectric elastomer, and a "sandwich" type composite structure formed by the dielectric material and electrodes on both sides, similar to a parallel plate capacitor. When voltage is applied, charges are generated and accumulated on the electrodes on two sides of the dielectric material, the charges on the same surface are mutually repelled, the charges on different surfaces are mutually attracted, maxwell stress is generated, the material is contracted along the direction of an electric field, and the whole material stretches perpendicular to the direction of the electric field. When the voltage on both sides is removed, the dielectric material returns to its undeformed state, which can be considered as conversion of electrical energy to mechanical energy. Maxwell stress is related to the magnitude of the applied field strength, the greater the maxwell stress and the more work the dielectric elastomer is doing to the outside.

Maxwell stress can be expressed as σ _z:

Wherein the method comprises the steps of

Epsilon ₀ -vacuum dielectric constant, epsilon ₀＝8.85×10^-12 F/m

Epsilon _r dielectric constant of dielectric elastomer

U-voltage

Thickness of T-dielectric elastomer

In general, in order to generate larger driving deformation, the dielectric material needs to have a lower elastic modulus and a higher dielectric constant, and in order to avoid the limitation of the electrode on the deformation of the dielectric material, a flexible electrode material is generally adopted.

Referring to fig. 13 and 14, if the dielectric elastomer is provided with the flexible electrode layer 701 and the rigid electrode layer 702 on both sides, the dielectric elastomer is bent only toward the rigid electrode layer 702 due to the deformation restriction of the rigid electrode. Therefore, in the response portion 211 of the present embodiment, the dielectric elastomer is formed, the electrodes disposed on both sides of the dielectric material are flexible electrodes, and the dielectric elastomer is made of silicone rubber or acrylic. The specific properties of both the silicone rubber and the acrylic are shown in table 1.

Table 1 table of references to properties of silicone rubber and acrylic acid

In one particular embodiment, the responsive portion 211 of the tuning section 210 includes a first electrode layer, a dielectric layer 2111, and a second electrode layer in that order from inside to outside in the radial direction of the outer tube 200 to form the dielectric elastomer structure described above. Thus, when the healthcare worker activates the stimulation signal through the control button on the handle 800, the response part 211 on the bending section 210 contracts in the electric field direction after receiving the stimulation signal, that is, the response part 211 contracts in the central axis direction of the outer tube 200 after receiving the stimulation signal. Because the body portion 212 of the bending section 210 cannot be deformed by the stimulus signal, after the response portion 211 is contracted, the length of the response portion 211 in the central axis direction of the outer tube 200 is smaller than the length of the body portion 212 in the central axis direction of the outer tube 200, so that the whole bending section 210 bends towards the side where the response portion 211 is located, and further the inner tube 100 and the balloon 110 and the prosthetic valve 400 on the inner tube 100 are driven to deviate from the original path.

The bending degree of the bending section 210 can be changed by changing the size of the input stimulation signal, and for this purpose, an adjusting knob or an adjusting button can be provided on the handle 800 to control the size of the input stimulation signal, so as to adjust the bending degree of the bending section 210.

Specifically, the outer tube 200 is provided with a direction mark 220 on the side where the response portion 211 is located, when a medical staff uses the handle 800 to control the bending section 210 to bend, the medical staff can twist the outer tube 200 first to make the direction mark 200 on the outer tube face the bending section 210 to need to bend, and then uses the handle 800 to start a stimulus signal to make the bending section bend towards the required direction, so that the instrument avoids the obstruction and makes the pushing smoothly.

Of course, in actual production, the direction mark 200 may also be provided on the side of the outer tube 200 facing away from the response portion 211. At this time, the medical staff twists the outer tube 200 to make the direction mark 200 deviate from the bending direction of the bending section 210, and then starts the stimulation signal by the handle 800 to bend the bending section towards the required direction, so that the instrument avoids the obstruction and can be pushed smoothly.

In one embodiment, the bending section 210 may also be a coil 213, the coil 213 being provided with a flexible electrode layer 701 at least towards the inner side wall of the inner tube 100 and away from the outer side wall of the inner tube 100. In addition, a dielectric layer 2111 is only partially sandwiched between the spring coil 213 and the flexible electrode layer 701 in the circumferential direction, and at this time, a portion of the bending section 210 where the dielectric layer 2111 is sandwiched can be used as a dielectric elastomer to form a response portion 211; the portion of the bending section 210 where the dielectric layer 2111 is not provided is the body portion 212.

Specifically, the dielectric layer 2111 has a semicircular arc structure in the circumferential direction of the spring ring 213, so that a response portion 211 having a semicircular arc structure is formed on the bending section 210; or a plurality of dielectric layers 2111 are arranged at intervals along the circumferential direction of the spring ring 213, and a plurality of response parts 211 are formed along the circumferential direction of the bending section 210, so that the bending section 210 with multiple degrees of freedom is obtained. Wherein the distal and proximal ends of the spring ring 213 are preferably provided with flexible electrode layers 701, i.e. the spring ring 213 is enclosed inside a tubular flexible electrode layer 701.

In contrast, a direction marker 220 may be provided on the side of the outer tube 200 where the responsive portion 211 is located, or on the side of the outer tube 200 where the responsive portion 211 is located, so that the healthcare worker confirms the bending direction of the bending section 210 according to the direction marker 220. Meanwhile, an adjusting knob or an adjusting button may be further provided on the handle 800 to adjust and control the bending degree of the bending section 210.

Among these, the direction marks 220 mentioned in the above embodiments are preferably provided around 1/6 circumference of the outer side wall of the outer tube 200.

Preferably, the first developing ring 150 is disposed at a position of the inner tube 100 near the distal end of the outer tube 200, so that a medical staff can observe the bending section 210 and the periphery thereof, thereby adjusting the bending section 210 to a proper bending degree, and making the balloon catheter successfully avoid all the obstacles on the original path.

Specifically, the outer sidewall of the inner tube 100 is provided with a first limiting member 120 and a second limiting member 130, and a preset distance is provided between the first limiting member 120 and the second limiting member 130, so as to form the clamping station 140. At this time, the prosthetic valve 400 is sleeved on the balloon 110 and is located between the first limiting member 120 and the second limiting member 130.

The first limiting member 120 is a boss disposed around the outer sidewall of the inner tube 100, or a plurality of bosses are sequentially disposed along the circumferential direction of the inner tube 100 to form the first limiting member 120; in contrast, the second limiting member 130 is a boss disposed around the outer sidewall of the inner tube 100, or a plurality of bosses are sequentially disposed along the circumferential direction of the inner tube 100 to form the second limiting member 130, which is not limited herein, so long as the first limiting member 120 and the second limiting member 130 can form the clamping station 140 to limit the axial movement of the prosthetic valve 400 along the inner tube 100, which is within the scope of the present utility model.

Preferably, the first limiting member 120 and the second limiting member 130 are all in conical structures at the ends close to each other, and the large end 190 of the conical structure of the first limiting member 120 is disposed towards the second limiting member 130, and the large end 190 of the conical structure of the second limiting member 130 is disposed towards the first limiting member 120.

Taking the first limiting member 120 being disposed near the distal end of the inner tube 100 and the second limiting member 130 being disposed near the proximal end of the inner tube 100 as an example, when the balloon catheter is guided into the human body by the guide wire 600, the conical structure of the first limiting member 120 can guide the first limiting member 120 and the prosthetic valve 400 into the human body, so as to avoid the first limiting member 120 and the prosthetic valve 400 from being blocked outside due to too small gaps between tissues in the human body. Meanwhile, the conical structure of the first limiting member 120 can reduce damage to various tissues in a human body when the balloon catheter enters the human body to a certain extent, and reduce uncomfortable feeling of a patient.

In contrast, when the balloon catheter is withdrawn from the human body, the conical structure of the second limiting member 130 can guide the second limiting member 130 to withdraw from the human body, and a certain space is reserved for the structure of the human body to be withdrawn later, so that the balloon catheter can be withdrawn more smoothly, and the practicability is strong. Meanwhile, the conical structure of the second limiting member 130 can also reduce the damage to various tissues in the human body and reduce the uncomfortable feeling of the patient to a certain extent when the balloon catheter is withdrawn from the human body.

Further, at least one second developing ring 141 is disposed in the clamping station 140, and the at least one second developing ring 141 is located at an intermediate position of the clamping station 140 in the axial direction of the inner tube 100. At this time, the medical staff can judge whether the prosthetic valve 400 is in place according to the position of the second developing ring 141, so as to realize accurate positioning.

Further, the number of the second developing rings 141 is three, one of the second developing rings 141 is located at the middle position of the clamping station 140 in the axial direction of the inner tube 100, and the remaining two second developing rings 141 are symmetrically disposed with respect to the second developing ring 141 located at the middle position. At this time, a distance is formed between every two adjacent developing rings, the medical staff can further use the three second developing rings 141 as a scale, and accurate evaluation of the relative position between the prosthetic valve 400 and the focus is realized under the assistance of imaging equipment or contrast agent, that is, the specific size of the prosthetic valve 400 to be adjusted is read out through two distances formed between the three second developing rings 141, so that accurate adjustment of the position of the prosthetic valve 400 is realized, and accurate release is further realized.

Still further, the inner tube 100 is provided with the third developing rings 160 at the two ends of the inner tube 100 corresponding to the clamping stations 140, respectively, so as to assist the medical staff in judging the condition of the artificial valve 400 and the periphery thereof, thereby judging whether the artificial valve 400 is in place.

In contrast, if the second developing ring 141 and the third developing ring 160 are combined, the medical staff can also use the second developing ring 141 and the third developing ring 160 as the scales, and accurately evaluate the relative position between the prosthetic valve 400 and the focus with the help of the imaging device or the contrast agent, so as to realize accurate release.

In a preferred embodiment, the distal end of the inner tube 100 is provided with a tapered head 170, which is more advantageous for a medical staff to handle the balloon catheter into a corresponding position in the human body, so that the balloon catheter is not easily blocked outside due to too small gaps between tissues in the human body. Meanwhile, the arrangement of the conical head 170 can reduce the damage to various tissues in the human body when the balloon catheter enters the human body to a certain extent, and reduce the uncomfortable feeling of a patient.

Referring to fig. 15, the present utility model also provides a prosthetic valve delivery system comprising a handle 800 and a balloon catheter as provided in any of the embodiments described above. Handle 800 is provided at the proximal end of outer tube 200; the signal generator is installed inside the handle 800 and is connected with the bending section 210 through the signal line 300. At the same time, the handle 800 is also provided with a control button for controlling the signal generator to emit a signal. The signal generated by the signal generator may be continuous or intermittent, and is not limited herein, and is within the scope of the present utility model.

In addition, a guide wire lumen 180 is provided in the inner tube 100, and is adapted for the passage of a guide wire 600 therethrough, the guide wire 600 being used to guide a balloon catheter into the interior of the human body.

In this embodiment, the medical staff can directly start or close the stimulation signal through the control button on the handle 800, and when the bending section 210 receives the stimulation signal, the bending section generates a corresponding degree of bending, and the bending can enable the balloon catheter to obtain a force deviating from the original guiding path, so that the instrument avoids the obstruction and can be pushed smoothly.

The bending degree of the bending section 210 can be changed by changing the size of the input stimulation signal, and for this purpose, an adjusting knob or an adjusting button can be provided on the handle 800 to control the size of the input stimulation signal, so as to adjust the bending degree of the bending section 210. In particular, transcatheter aortic valve replacement is exemplified using the prosthetic valve delivery system provided by the present utility model. The medical staff selects the right femoral artery as the access blood vessel, and the following steps are sequentially carried out according to the general flow of the transcatheter aortic valve replacement: vascular puncture, angiography, guidewire 600 transvalve, guidewire 600 exchange, hard guidewire 600 track establishment, pre-dilation balloon 110 access, balloon 110 pre-dilation, valve delivery system access, valve 400 placement. When the balloon catheter provided by the utility model encounters a condition that the guide path is blocked in the process of advancing along the track of the guide wire 600, the signal generator is started through the signal switch button on the handle 800, and the signal generator emits a signal, so that the bending section 210 bends. Wherein, medical personnel can change the signal intensity emitted by the signal generator through the adjusting knob or the adjusting button, thereby adjusting and controlling the bending degree of the bending section 210. Simultaneously, the medical staff observes and properly moves the instrument on the DSA (Digital Subtraction Angiography, digital subtraction-angiography) perspective, avoids the obstacle and pushes the instrument to the target position.

In one embodiment, the switch button and the adjusting knob or adjusting button may be integrated into one control knob 810, and the signal generator is turned off when the control knob 810 is in the initial position, and the signal generator can emit a signal when the control knob 810 is turned. In contrast, the control knob 810 is rotated at different angles, and the signal strength emitted by the signal generator is also different, so that the medical staff can rotate the control knob 810 according to the required bending degree of the balloon catheter. When the control knob 810 is rotated to a position where the rotation can not be continued, the signal strength emitted by the signal generator is maximum; when the control knob 810 is re-rotated to the initial position, the signal generator is turned off.

Specifically, the handle 800 is further provided with a display screen 820 for displaying the bending degree of the balloon catheter, so that the medical staff can control the bending of the balloon catheter more accurately through the control knob 810, and the practicability is high.

In addition, an electrical port 830 may be provided on the handle 800 for external power access to enable operation of the prosthetic valve delivery system.

In the foregoing embodiments, the descriptions of the embodiments are focused on, and the parts of a certain embodiment that are not described or depicted in detail may be referred to in the related descriptions of other embodiments.

It should be noted that the above embodiments can be freely combined as needed. The foregoing is merely a preferred embodiment of the present utility model and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the present utility model, which are intended to be comprehended within the scope of the present utility model.

Claims

1. A balloon catheter, comprising:

The outer tube comprises an outer tube body, a signal generator and a balloon and a prosthetic valve, wherein the distal end of the outer tube body is provided with a bending section which is connected with the signal generator in a signal way, and the bending section is configured to bend after being stimulated by the signal emitted by the signal generator so as to drive the inner tube body and the balloon and the prosthetic valve on the inner tube body to deviate from the original path.

2. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,

The bending section comprises a body part and a response part which are sequentially connected in the circumferential direction of the outer tube;

3. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,

The bending section is a spring ring, and a flexible electrode layer is arranged on the spring ring at least towards the inner side wall of the inner tube and the outer side wall of the inner tube; and

4. The balloon catheter of claim 2 or 3, wherein,

The outer tube is located one side that response portion is located is equipped with the direction mark, perhaps, the outer tube deviates from one side that response portion is located is equipped with the direction mark.

5. The balloon catheter of any one of claims 1-3,

The inner tube is provided with a first developing ring at a position close to the distal end of the outer tube.

6. The balloon catheter of any one of claims 1-3,

The outer side wall of the inner pipe is provided with a first limiting piece and a second limiting piece, and a preset distance is reserved between the first limiting piece and the second limiting piece to form a clamping station;

7. The balloon catheter of claim 6, wherein the balloon catheter is configured to move,

One end of the first limiting piece and one end of the second limiting piece, which are close to each other, are in conical structures; and

8. The balloon catheter of claim 6, wherein the balloon catheter is configured to move,

At least one second developing ring is arranged in the clamping station, and at least one second developing ring is positioned at the middle position of the clamping station in the axial direction of the inner tube;

and/or

9. The balloon catheter of any one of claims 1-3,

The distal end of the inner tube is provided with a conical head for guiding the inner tube and the balloon and the artificial valve on the inner tube into the body of the patient.

10. A prosthetic valve delivery system, comprising:

a handle and the balloon catheter of any one of claims 1-9;