CN111760171A

CN111760171A - Freezing expansion sacculus of inner support

Info

Publication number: CN111760171A
Application number: CN202010526790.2A
Authority: CN
Inventors: 孙加源; 张雪艳; 杨迟; 徐彬凯; 袁海滨; 顾川佳
Original assignee: AccuTarget MediPharma Shanghai Corp Ltd; Shanghai Chest Hospital
Current assignee: AccuTarget MediPharma Shanghai Corp Ltd; Shanghai Chest Hospital
Priority date: 2020-06-09
Filing date: 2020-06-09
Publication date: 2020-10-13

Abstract

The invention provides a freezing expansion sacculus of an inner stent, which comprises: the balloon is connected with the adjusting cavity through the catheter, and a first air hole and a second air hole are formed in the adjusting cavity; the balloon, the catheter and the regulation cavity are exhausted through the first air hole or the balloon is inflated with air to be expanded; a stent disposed within the balloon and/or the catheter; an adjustment assembly for urging the stent to move between the balloon and the catheter; when the saccule is not expanded, the stent is positioned in the catheter and is in a contracted state, after the saccule is expanded, the stent is pushed to move into the saccule by the adjusting component, and the stent is expanded and supported on the inner wall of the saccule; the air inlet pipe penetrates through the saccule, the catheter and the adjusting cavity, and the bracket is sleeved outside the air inlet pipe; one end of the air inlet pipe is positioned in the balloon, the other end of the air inlet pipe is communicated with the second air hole, and refrigerant gas is input into the balloon through the second air hole and the air inlet pipe.

Description

Freezing expansion sacculus of inner support

Technical Field

The invention relates to the technical field of medical instrument design, in particular to a cryo-dilatation balloon for an inner stent.

Background

The airway, esophagus or blood vessel are narrowed due to various causes, and the current treatment methods for the stenosis of the airway, esophagus or blood vessel are balloon dilatation, stent, cryoablation, thermal ablation and the like. Balloon expansion and stent treatment focus on physical expansion of the stenosis, while cryoablation and thermal ablation focus on treatment of the lesion at the stenosis. In the case of airway stenosis, to reduce the formation of granulation tissue hyperplasia and scar contracture and avoid long-term complications, the clinical practice should try to select a treatment that is less irritating to local tissues, where metal stents are most irritating to local tissues, silicone stents and thermal ablations such as laser, electrocautery, etc. are less irritating, balloon dilation, and again, the least irritating is cryotherapy. The thermal ablation technique itself can cause a heavier and wider range of damage to the airways during treatment, causing severe granulation tissue hyperplasia and scarring, leading to complications and high recurrence rates; the balloon dilatation treatment is simple to operate, has fewer long-term complications, has a non-lasting effect and is easy to relapse; compared with thermal ablation, the freezing treatment does not promote granulation tissue proliferation and is not easy to cause cartilage damage, so the freezing treatment can avoid airway wall damage, rarely causes complications of airway softening and collapse, is a simple and safe treatment method and is suitable for various types of stenosis, but the existing airway freezing products are only limited to single-point treatment, and for airway stenosis with a large treatment surface, the operation is particularly complicated and time-consuming.

The single treatment method is difficult to achieve a satisfactory effect, so that multiple methods are often required in clinic, such as balloon expansion combined freezing treatment, and after balloon expansion, local freezing treatment is supplemented to significantly reduce collagen deposition at the airway injury and inhibit scar formation.

The existing expansion saccule has no freezing function, can only perform temporary expansion on a narrow part singly, and cannot treat pathological changes or inhibit complications. The existing freezing balloon often only has a freezing function, and the pressure generated in the balloon in the freezing process is far lower than the pressure required by the expansion treatment, so the freezing balloon cannot realize effective expansion on the narrow part. If a freezing structure is simply added into the existing expansion balloon, after the balloon is expanded at high pressure, the balloon is reduced by opening the low pressure after freezing, so that the balloon cannot be attached or tightly attached to the cavity wall, and finally the diseased part cannot be effectively frozen.

Disclosure of Invention

In view of the problems of the background art, the present invention provides an inner stent cryo-expansion balloon, comprising:

the balloon is connected with the adjusting cavity through the catheter, and a first air hole and a second air hole are formed in the adjusting cavity; the balloon, the catheter and the regulation cavity are exhausted through the first air hole or the balloon is inflated with air to be expanded;

a stent disposed within the balloon and/or the catheter;

an adjustment assembly for urging the stent to move between the balloon and the catheter; when the saccule is not expanded, the stent is positioned in the catheter and is in a contracted state, after the saccule is expanded, the stent is pushed to move into the saccule by the adjusting component, and the stent is expanded and supported on the inner wall of the saccule;

the air inlet pipe penetrates through the saccule, the catheter and the adjusting cavity, and the bracket is sleeved outside the air inlet pipe; one end of the air inlet pipe is positioned in the balloon, the other end of the air inlet pipe is communicated with the second air hole, and refrigerant gas is input into the balloon through the second air hole and the air inlet pipe.

Preferably, the balloon catheter also comprises a guide wire tube which is arranged in the balloon, the catheter and the adjusting cavity in a penetrating manner, and the bracket is sleeved outside the guide wire tube; one end of the wire guide pipe extends into the balloon and is connected with the front end of the balloon, and the other end of the wire guide pipe is led out from the leading-out hole in the adjusting cavity.

Preferably, the adjusting assembly comprises a bracket guide pipe, an adjusting pipe and a shifting lever, the bracket guide pipe is positioned in the guide pipe, the adjusting pipe is positioned in the adjusting cavity, and the air inlet pipe and the thread guide pipe are arranged in the bracket guide pipe and the adjusting pipe in a penetrating manner; one end of the bracket conduit is connected with the bracket, and the other end of the bracket conduit is connected with the adjusting pipe;

an inner adjusting groove is formed in the adjusting cavity, one end of the deflector rod is connected with the adjusting pipe, and the other end of the deflector rod extends out of the adjusting cavity from the inner adjusting groove; and the shifting lever is shifted to drive the bracket guide pipe to move along the axial direction of the guide pipe through the adjusting pipe.

Preferably, a sealing structure for preventing air leakage from the inner adjusting groove is arranged between the adjusting pipe and the inner wall of the adjusting cavity.

Preferably, the sealing structure comprises two first sealing rings sleeved on the adjusting pipe, the inner ring of each first sealing ring is installed on the adjusting pipe, and the outer ring of each first sealing ring is in contact sealing with the inner wall of the adjusting cavity; the two first sealing rings are arranged on two sides of the inner adjusting groove.

Preferably, one end of the air inlet pipe, which is positioned in the balloon, is connected with a spiral air inlet pipe, and an air outlet hole is arranged on the spiral air inlet pipe.

Preferably, a plurality of air outlets are uniformly distributed on the spiral air inlet pipe along the axial direction and the radial direction of the spiral air inlet pipe.

Preferably, one end of the adjusting cavity is connected with the conduit, the other end of the adjusting cavity is provided with a plug end connected with an external device, and the first air hole and the second air hole are both arranged on the plug end.

Preferably, the plug end comprises a middle convex part and a step part arranged on the outer ring of the middle convex part, the second air hole is arranged on the middle convex part, and the first air hole is arranged on the step part; and second sealing rings are arranged on the side walls of the middle convex part and the step part.

Preferably, the expansion force of the stent is greater than or equal to the expansion force of the balloon.

Preferably, the maximum expanded diameter of the stent is greater than the maximum expanded diameter of the balloon.

Preferably, the bracket comprises a bracket front end, a bracket middle section and a bracket rear end which are connected in sequence; after the stent is expanded, the middle section of the stent is used for expanding and supporting the balloon, and the expanded maximum diameter of the middle section of the stent is larger than the maximum expanded diameter of the balloon.

Preferably, after the stent is expanded, the maximum expanded diameter of the stent front end is smaller than the minimum expanded diameter of the balloon.

Preferably, the rear end of the stent is always positioned in the catheter in a contracted state during the moving or expanding process of the stent.

Preferably, the device also comprises a temperature measuring device for measuring the temperature inside the saccule in real time and a pressure measuring device for measuring the pressure inside the saccule in real time.

Preferably, the refrigerant gas is carbon dioxide or nitrous oxide or argon or nitrogen or liquid nitrogen.

Due to the adoption of the technical scheme, compared with the prior art, the invention has the following advantages and positive effects:

the internal support freezing expansion balloon provided by the invention can realize balloon expansion and freezing treatment simultaneously, and simultaneously realizes the balloon auxiliary supporting function after the freezing treatment starts through the arrangement of the support, so that the problem of balloon contraction caused by low pressure during the freezing treatment is prevented, the diameter of the balloon does not change along with the change of the internal pressure of the balloon, and the balloon is ensured to be subjected to full adherence treatment during the freezing treatment.

Drawings

The above and other features and advantages of the present invention will be more clearly understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

FIG. 1 is a cross-sectional view of an unused state of an internal stent cryo-expansion balloon provided by the present invention;

FIG. 2 is a cross-sectional view taken along line A-A of FIG. 1;

FIG. 3 is a top view of the cryo-dilation balloon of the present invention with an inner stent in use;

fig. 4 is a schematic view showing the stent of the present invention in an expanded state.

Description of the symbols:

1. a balloon part, 11-a balloon, 12-a catheter, 13-a guide wire tube, 131-a guide wire tube head part, 132-a guide wire outlet, 14-an air inlet tube, 141-a spiral air inlet tube, 142-an air outlet hole, 15-an adjusting cavity, 151-an inner adjusting groove, 152-a pressure measuring hole, 153-a temperature measuring hole, 16-a plug end, 161-a second air hole, 162-a first air hole, 163, 164-a second sealing ring, 165-an outlet hole, 17-a pressure measuring joint, 18-a pressure measuring hose, 19-a temperature measuring line, 191-a temperature measuring point, 2-a bracket part, 21-a bracket, 22-a bracket catheter, 23-an adjusting tube, 231-a deflector rod, 232-a first sealing ring, 3-a circuit board, 31-a lead wire and 4-a shell, 41-outer regulating groove, 5-bending protector, 6-electric plug and 61-plug cable.

Detailed Description

The present invention will be described in more detail below with reference to the accompanying drawings, which illustrate embodiments of the invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. In the drawings, the size and relative sizes of layers and regions may be exaggerated for clarity.

It should be noted that all the directional indicators (such as up, down, left, right, front, and rear … …) in the embodiment of the present invention are only used to explain the relative position relationship between the components, the movement situation, etc. in a specific posture (as shown in the drawing), and if the specific posture is changed, the directional indicator is changed accordingly.

Referring to fig. 1-4, the invention provides an inner stent freezing expansion balloon, which mainly comprises an expansion balloon part 1 and a stent part 2; the balloon part 1 comprises a balloon 11, a catheter 12, an adjusting cavity 15 and an air inlet pipe 14, and the stent part 2 mainly comprises a stent 21 and an adjusting component. The balloon 11 is connected with the adjusting cavity 15 through the catheter 12, and the adjusting cavity 15 is provided with a first air hole 162 and a second air hole 161; the air in the saccule 11, the catheter 12 and the adjusting cavity 15 is discharged or the saccule 11 is inflated by air to expand through the first air hole 162; the stent 21 is placed inside the balloon 11 and/or the catheter 12; the adjusting component is used for pushing the bracket 21 to move between the balloon 11 and the catheter 12; when the balloon 11 is not expanded, the stent 21 is positioned in the catheter 12 and is in a contracted state, after the balloon 11 is expanded, the stent 21 is pushed to move into the balloon 11 through the adjusting assembly, and the stent 21 is expanded and supported on the inner wall of the balloon 11; the air inlet pipe 14 penetrates through the balloon 11, the catheter 12 and the adjusting cavity 15, and the bracket 21 is sleeved outside the air inlet pipe 14; one end of the air inlet pipe 14 is positioned in the balloon, the other end is communicated with the second air hole 161, and refrigerant gas is input into the balloon through the second air hole 161 and the air inlet pipe 14.

In the present embodiment, as shown in fig. 1, the balloon 11 is an expansion balloon, and the balloon 11 can realize single-stage expansion or multi-stage expansion, which is not limited herein. The rear end of the balloon 11 is connected and communicated with the front end of the catheter 12, the connection part is sealed, and the sealing mode can be realized by glue sealing and the like, and the connection part is not limited; the rear end of the conduit 12 is coaxially connected and communicated with the adjusting cavity 15, and the same connection is sealed, and the sealing mode can be realized by glue sealing and the like, which is not limited here.

In this embodiment, the internal stent cryo-dilatation balloon further comprises a guidewire tube 13, which is inserted into the balloon 11, the catheter 12 and the adjustment cavity 15, and the stent 21 is sleeved outside the guidewire tube 13; one end of the guide wire tube 13 (i.e., the guide wire tube head 131) extends into the balloon 11 and is connected to the front end of the balloon 11, and the other end of the guide wire tube 13 (i.e., the guide wire outlet 132) is led out from an outlet hole 165 on the self-adjusting cavity 15. In the embodiment, the guide wire is extended into the guide wire tube 13 from the guide wire outlet 132 and extended to the guide wire tube head 131 when the balloon 11 is used to deliver the balloon to the stenosis region to be treated along the guide wire path by the arrangement of the guide wire tube 13.

Of course, the guide wire tube 13 can be omitted in other embodiments, and is not limited herein. The purpose of the guide wire is to provide directional guidance in the blind area of the endoscope, and if the lesion is located in the field of view of the endoscope, the guide wire is not needed. In embodiments where the guidewire tube 13 is omitted, the balloon may be passed to and through the lesion under guidance of the endoscope lens image. Omitting the surgical procedure of the guide wire tube: balloon suction → endoscope guiding balloon in place → inflation and expansion → stent pushing forward, supporting balloon → stop expansion → freezing → stent withdrawing → stop freezing → balloon suction → balloon extraction.

In the present embodiment, the adjusting assembly includes a bracket guide 22, an adjusting tube 23, and a shift lever 231, the bracket guide 22 is located in the guide 12 and can move axially relative to the guide 12, the adjusting tube 23 is located in the adjusting cavity 15 and can move relative to the adjusting cavity 15; the air inlet pipe 14 and the guide wire pipe 13 movably penetrate through the bracket guide pipe 22 and the adjusting pipe 23; one end of the bracket conduit 22 is connected with the bracket 21, and the other end is coaxially connected and communicated with the adjusting pipe 23 so as to allow the air inlet pipe 14 and the guide wire pipe 13 to penetrate through; an inner adjusting groove 151 is arranged on the adjusting cavity 15, the salt field direction of the inner adjusting groove 151 is parallel to the moving direction of the bracket 21, one end of the deflector rod 231 is connected with the adjusting pipe 23, and the other end of the deflector rod 231 extends out of the adjusting cavity from the inner adjusting groove 151, so that an operator can move the deflector rod 231; toggling the toggle rod 231 causes the adjustment tube 23 to move axially, thereby moving the stent catheter 22 axially along the catheter 12, and the stent catheter 22 further moves the stent 21 into or out of the balloon 11.

Further, a sealing structure is disposed between the adjusting tube 23 and the inner wall of the adjusting cavity 15 for preventing air leakage from the inner adjusting groove 151, for example, preventing return air in the adjusting cavity 15 from leaking from the inner adjusting groove 151. Specifically, the sealing structure in this embodiment includes two first sealing rings 232 sleeved on the adjusting pipe 23, an inner ring of the first sealing ring 232 is installed in an installation groove on the adjusting pipe 23, and an outer ring is in contact with and sealed with an inner wall of the adjusting cavity 15, and meanwhile, the two sealing rings can move relative to each other; two first sealing rings 232 are disposed at both sides of the inner adjusting groove 151, thereby achieving sealing at the inner adjusting groove 151. Of course, in other embodiments, the structural form of the sealing structure may also be adjusted according to specific situations, and is not limited herein.

In this embodiment, as shown in fig. 4, the stent 21 is a net structure with elasticity, and when it is contracted by external force (e.g. the catheter 12 is folded), it will expand by its own elasticity when the external force disappears.

The material of the stent can be memory alloy such as nickel-titanium alloy, which has good elasticity and is convenient to recover, and the memory alloy still needs to have elasticity at low temperature generated by corresponding refrigerant gas, for example, when carbon dioxide is used as the refrigerant gas, the memory alloy still needs to have elasticity at minus 50 ℃.

Further, the stent 12 is divided into three sections, namely a stent front end 212, a stent straight section 211 and a stent rear end 213 which are connected in sequence; the straight section 211 of the stent is used for expanding and supporting the balloon 11, the memory diameter of the straight section 211 of the stent is larger than the maximum expansion diameter of the balloon, so that the stent still has a certain radial supporting force under the maximum expansion diameter of the balloon, and the radial supporting force under the expansion state of the stent is equivalent to the expansion force of the balloon.

The stent leading end 212 is in a semi-contracted state to prevent a large resistance from being generated between the stent leading end 212 and the balloon 11 or causing damage to the balloon 11 during the stent advancing process. The semi-contracted state of the stent leading end 212 may be the memory shape itself of the memory alloy, the memory diameter of the stent leading end 212 is smaller than the minimum expanded diameter of the balloon 11 and larger than the wound outer diameter of the spiral inlet tube 141; the semi-contracted state of the stent front end 212 can also be formed by at least one elastic ring which can be recovered into the catheter 12 along with the stent straight section 211, and the maximum expanded diameter of the elastic ring is smaller than the minimum expanded diameter of the balloon 11 and larger than the wound outer diameter of the spiral air inlet pipe 141; the semi-contracted state of the frame forward end 212 may also be bounded by a non-elastic ring having a diameter less than the inner diameter of the conduit 12 and greater than the wound outer diameter of the helical air inlet tube 141.

The stent rear end 213 is always positioned in the catheter 12 during the front-back adjustment process of the stent 21, so that the stent 21 can be smoothly recovered after expansion or the expansion-recovery process can be repeated, the stent rear end 213 can be the memory shape of the memory alloy, and can also be bound in the catheter 12, namely the memory diameter of the stent rear end 213 is not more than the memory diameter of the stent straight section 211 and is more than the inner diameter of the catheter 12.

In this embodiment, a spiral air inlet tube 141 is connected to one end of the air inlet tube 14 located in the balloon 11, and an air outlet 142 is disposed on the spiral air inlet tube 141. Furthermore, a plurality of air outlets 142 are uniformly distributed on the spiral air inlet pipe 141 along the axial direction and the radial direction thereof; in the embodiment, through the design of the structure, the refrigerant gas is uniformly sprayed to the balloon along the axial direction and the radial direction, so that the surface temperature of the balloon is uniform.

In this embodiment, one end of the adjustment cavity 15 is connected to the conduit 12, and the other end is provided with a plug end 16 connected to an external device, and the first air hole 162 and the second air hole 161 are both provided on the plug end. Further, the plug end includes a middle convex portion and a step portion disposed at an outer circumference of the middle convex portion, the second air hole 161 is disposed at the middle convex portion, and the first air hole 162 is disposed at the step portion; the second seal ring 163 is disposed on the side wall of the middle convex portion, and the second seal ring 162 is disposed on the side wall of the stepped portion.

Wherein, the specific external device may be a host (not shown in the figure) capable of performing the functions of vacuum pumping, gas filling, refrigerant gas input, etc.; the second sealing ring 163 and the second sealing ring 162 are used to separate the first air hole 162 and the second air hole 161 after the adjusting cavity 15 is inserted into a socket on the main machine through the plug end during operation.

In this embodiment, the cryo-dilatation balloon of the inner stent is further provided with a temperature measuring device and a pressure measuring device.

Specifically, the temperature measuring device comprises a temperature measuring line 19 and a temperature measuring point 191; the temperature measuring point 191 is fixed on the outer surface of the wire guide tube 13 in the balloon 11, the temperature measuring point 191 is a temperature measuring head, such as an infrared temperature measuring head or a welding point of two wires of a thermocouple wire, and the like, and the specific temperature measuring head is adopted and can be adjusted according to the requirement; one end of the temperature measuring wire 19 is connected with the temperature measuring point 191, the other end of the temperature measuring wire is led out of the temperature measuring hole 153 in the adjusting cavity 15 to the outside of the adjusting cavity 15, and the temperature measuring hole 153 is filled with glue for sealing; the other end of the temperature measuring line 19 extends out of the adjusting cavity 15 and then is connected with the electric plug 6 through a plug cable 61, the electric plug 6 is connected with a temperature testing module in the host, and the temperature testing module converts an electric signal acquired and transmitted by the temperature measuring head or the temperature measuring line 19 into a real-time temperature value. The temperature measuring device is arranged in the embodiment, so that the temperature inside the balloon can be monitored in real time, and whether the freezing function works normally is indicated.

The pressure measuring device comprises a pressure measuring joint 17 and a pressure measuring hose 18 which are arranged outside the adjusting cavity 15, the pressure measuring head is communicated with a space between the front end of the adjusting guide pipe 23 and the adjusting cavity 15 through a pressure measuring hole 152 on the bridging cavity 15, one end of the pressure measuring hose 18 is connected with the pressure measuring head 17, the other end of the pressure measuring hose 18 is connected to the circuit board 3, and the circuit board 3 is connected to the plug cable 61 to realize the connection with the electric plug 6; the gap between the catheter 12 and the holder catheter 22, the space between the front end of the adjustment catheter 23 and the adjustment chamber 15, the pressure connection 17, the pressure hose 18 form a pressure measurement path. The circuit board 18 at least comprises a pressure sensor and an analog front end, and optionally further comprises a microprocessor, the pressure measuring hose 18 is connected with the pressure sensor, the pressure sensor is used for collecting pressure signals, the analog front end is used for amplifying, calibrating, temperature compensating and digitizing electric signals output by the pressure sensor, the microprocessor is used for converting digital signals output by the analog front end into real-time pressure values, the lead 31 is used for power input and signal output of the circuit board 18, the lead 31 is connected with the electric plug 6, and the electric plug is connected with a main control board in the host. Due to the sealing effect of the first sealing ring 232, no air flow exists in the pressure measuring path in the non-adjustment state, so that the pressure measured at the circuit board 18 is the static pressure inside the balloon 11 or near the inside of the balloon 11. The setting of pressure measurement device is passed through to this embodiment, but the inside pressure of real time monitoring sacculus for the expansion process is more accurate, the freezing process is safer.

In this embodiment, a bending protection member 5 is further sleeved on the outer side wall of the conduit 12 for protecting the conduit 12 and preventing the conduit from bending.

In this embodiment, the outer sidewall of the adjusting cavity 15 is further sleeved with a casing 4, and the pressure measuring device is also covered in the casing 4; the housing 4 extends over the bend 5 towards one end of the conduit 12 and over and connects to the plug end 16 at the other end; an outer adjusting groove 41 which is convenient for the deflector rod 231 to extend out is arranged on the shell 4 corresponding to the inner adjusting groove 151.

The working process of the stent cryo-dilatation balloon provided by the invention is further described as follows:

(guide wire positioning → balloon suction → guide wire balloon in place → inflation expansion → stent pushing forward, balloon support → stop expansion → freezing → stent withdrawing → stop freezing → balloon suction → balloon removal)

Referring to FIG. 1, prior to the start of the procedure, lever 231 is positioned at the rearmost end of inner adjustment slot 151, with bracket 21 compressed within the forward end of catheter 12; after the operation is started, the guide wire is guided to the narrow part through a certain guiding means and passes through the narrow area, then the plug end 16 is connected with the socket of the host end, and the air in the balloon 11 is pumped out through the guide wire tube 22, the adjusting tube 23 and the first air hole 162 through the vacuum suction of the host end, so that the balloon 11 is in a contracted state;

then, in a state where the guide wire is fixed, the guide wire is inserted from the guide wire tube head 131, and the balloon 11 is guided to the stenosis region to be treated along the guide wire path, and the guide wire tube head 131 is passed through the stenosis section so that the balloon 11 is positioned at the stenosis section. Next, the balloon dilatation function is started from the host end, and gas with set pressure enters the balloon 11 through the first air hole 162, the adjusting tube 23 and the guide wire tube 22, so that the balloon 11 is inflated, and the expansion of the narrow section is realized;

after the expansion time is up, the shifting rod 231 is shifted forwards along the inner adjusting groove 151, the shifting rod 231 drives the stent catheter 22 to move through the adjusting tube 23, the stent catheter 22 drives the stent 21 to move forwards, in the process of pushing the stent 21 out of the catheter 12, the part of the stent 21 located in the balloon 11 is expanded, the shifting rod 231 is pushed forwards to the bottom, most of the stent 21 is located in the balloon 11 and is released to be tightly attached to the inner wall of the balloon 11, the balloon expansion is stopped at the moment, the freezing function is started, the air return channel at the host end is opened, meanwhile, high-pressure refrigerant gas enters the balloon 11 from the second air hole 161 through the air inlet pipe 14, the high-pressure gas is changed into low-temperature and low-pressure gas through the throttling function of the air outlet hole 142, the low pressure cannot continuously maintain the expansion state of the balloon 11, but the support function of the stent 21 enables the balloon 11, at the moment, the outer surface of the saccule 11 is still tightly attached to the narrow section, the throttled low-temperature gas is uniformly sprayed to the inner surface of the saccule 11, and a large amount of heat is absorbed from the tissue of the narrow section outside the saccule 11, so that the cryotherapy is completed; the refrigerating fluid after the cold energy is released is discharged through the wire guide pipe 22, the adjusting pipe 23 and the first air hole 162;

after the treatment is finished, the driving lever 231 is pulled backwards, the driving lever 231 drives the bracket 21 to move backwards, the bracket 21 is compressed when entering the catheter 12 backwards until the whole bracket 21 is compressed into the catheter 12, then the freezing function is stopped, and at the moment, an expansion freezing cycle is finished;

the procedure may be repeated multiple times to expand the cryocycle to enhance the therapeutic effect. After the operation is finished, the vacuum suction at the end of the host machine is started, and the saccule 11 can be taken out after being fully contracted.

It will be appreciated by those skilled in the art that the invention can be embodied in many other specific forms without departing from the spirit or scope thereof. Although embodiments of the present invention have been described, it is to be understood that the present invention should not be limited to those precise embodiments, and that various changes and modifications can be effected therein by one skilled in the art without departing from the scope or spirit of the invention as defined by the appended claims.

Claims

1. An internal stent cryo-expansion balloon, comprising:

a stent disposed within the balloon and/or the catheter;

2. The internal stent cryo-dilatation balloon of claim 1, further comprising a guidewire tube inserted into the balloon, the catheter and the adjustment cavity, wherein the stent is sleeved outside the guidewire tube; one end of the wire guide pipe extends into the balloon and is connected with the front end of the balloon, and the other end of the wire guide pipe is led out from the leading-out hole in the adjusting cavity.

3. The inner stent cryo-expansion balloon according to claim 1 or 2, wherein the adjustment assembly comprises a stent catheter, an adjustment tube and a deflector rod, the stent catheter is located in the catheter, the adjustment tube is located in the adjustment cavity, and the air inlet tube and the guide wire tube are arranged in the stent catheter and the adjustment tube in a penetrating manner; one end of the bracket conduit is connected with the bracket, and the other end of the bracket conduit is connected with the adjusting pipe;

4. The internal stent cryo-expansion balloon of claim 3, wherein a sealing structure is provided between the adjustment tube and the inner wall of the adjustment cavity to prevent air leakage from the inner adjustment groove.

5. The internal stent cryo-dilatation balloon of claim 4 wherein the sealing structure comprises two first sealing rings sleeved on the adjustment tube, wherein the inner ring of the first sealing ring is mounted on the adjustment tube, and the outer ring of the first sealing ring is in contact sealing with the inner wall of the adjustment cavity; the two first sealing rings are arranged on two sides of the inner adjusting groove.

6. The internal stent cryo-expansion balloon according to claim 1, wherein a spiral air inlet tube is connected to the end of the air inlet tube located inside the balloon, and air outlets are arranged on the spiral air inlet tube.

7. The stent cryo-dilatation balloon of claim 6 wherein the helical gas inlet tube has a plurality of gas outlets evenly distributed along the axial and radial directions thereof.

8. The internal stent cryo-expansion balloon of claim 1, wherein the adjustment chamber is connected to the catheter at one end and to an external device at the other end, and wherein the first and second air holes are disposed at the plug end.

9. The internal stent cryo-expansion balloon of claim 8, wherein the plug end comprises a central protrusion and a step disposed at an outer circumference of the central protrusion, the second gas hole is disposed at the central protrusion, and the first gas hole is disposed at the step; and second sealing rings are arranged on the side walls of the middle convex part and the step part.

10. The stent cryo-dilation balloon of claim 1, wherein the stent expansion force is equal to or greater than the balloon expansion force.

11. The stent cryo-expansion balloon of claim 1, wherein the maximum expanded diameter of the stent is greater than the maximum expanded diameter of the balloon.

12. The internal stent cryo-expansion balloon of claim 11, wherein the stent comprises a stent front end, a stent middle section, and a stent rear end connected in series; after the stent is expanded, the middle section of the stent is used for expanding and supporting the balloon, and the expanded maximum diameter of the middle section of the stent is larger than the maximum expanded diameter of the balloon.

13. The stent cryo-expansion balloon of claim 12, wherein after expansion of the stent, the maximum expanded diameter of the stent tip is less than the minimum expanded diameter of the balloon.

14. The stent cryo-expansion balloon of claim 12, wherein the stent trailing end is always inside the catheter in a contracted state during the stent movement or expansion.

15. The stent cryo-dilatation balloon of claim 1 or 12 further comprising a temperature measuring device for real-time measurement of balloon internal temperature and a pressure measuring device for real-time measurement of balloon internal pressure.