Disclosure of Invention
In view of the problems in the background art, the present invention provides an inner stent freeze-expanded 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 air in the balloon, the catheter and the adjusting cavity is exhausted through the first air hole or the balloon is inflated with air to expand the balloon;
A stent disposed within the balloon and/or the catheter;
the device comprises a balloon, an adjusting component, a support, a catheter, a control device and a control device, wherein the balloon is used for expanding the balloon, the adjusting component is used for pushing the support to move between the balloon and the catheter, when the balloon is not expanded, the support is positioned in the catheter and is in a contracted state, after the balloon is expanded, the support is pushed to move into the balloon through the adjusting component, and the support is expanded and supported on the inner wall of the balloon;
The air inlet pipe is arranged in the balloon, the catheter and the adjusting cavity in a penetrating mode, the support is sleeved on the outer side of the air inlet pipe, one end of the air inlet pipe is located 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 device further comprises a wire guide tube which is arranged in the balloon, the catheter and the adjusting cavity in a penetrating mode, the support is sleeved on the outer side of the wire guide tube, one end of the wire guide tube extends into the balloon and is connected with the front end of the balloon, and the other end of the wire guide tube is led out from the leading-out hole in the adjusting cavity.
Preferably, the adjusting component comprises a bracket guide pipe, an adjusting pipe and a deflector rod, wherein 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 wire guide pipe are arranged in the bracket guide pipe and the adjusting pipe in a penetrating way;
An inner adjusting groove is formed in the adjusting cavity, one end of the deflector rod is connected with the adjusting pipe, the other end of the deflector rod extends out of the adjusting cavity from the inner adjusting groove, and the deflector rod is stirred to drive the support catheter to move along the axial direction of the catheter 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, an inner ring of each first sealing ring is mounted on the adjusting pipe, an outer ring of each first sealing ring is in contact sealing with the inner wall of the adjusting cavity, and 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 outlet holes 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 guide pipe, 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, the first air hole is arranged on the step part, and the side walls of the middle convex part and the step part are respectively provided with a second sealing ring.
Preferably, the expansion force of the stent is equal to or greater than 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 stent comprises a stent front end, a stent middle section and a stent rear end which are sequentially connected, wherein after the stent is expanded, the stent middle section is used for expanding a supporting balloon, and the maximum diameter of the expanded stent middle section is larger than the maximum expansion diameter of the balloon.
Preferably, after the stent is expanded, the maximum expanded diameter of the front end of the stent is smaller than the minimum expanded diameter of the balloon.
Preferably, the rear end of the bracket is always positioned in the catheter in a contracted state in the moving or expanding process of the bracket.
Preferably, the device also comprises a temperature measuring device for measuring the internal temperature of the balloon in real time and a pressure measuring device for measuring the internal pressure of the balloon in real time.
Preferably, the refrigerant gas is carbon dioxide or nitrous oxide or argon or nitrogen or liquid nitrogen.
Compared with the prior art, the invention has the following advantages and positive effects due to the adoption of the technical scheme:
The inner stent freezing and expanding balloon can simultaneously realize balloon expansion and freezing treatment, and simultaneously realize the auxiliary supporting function of the balloon after the freezing treatment is started through the setting of the stent, thereby preventing the problem of balloon contraction caused by low pressure during the freezing treatment, ensuring that the balloon diameter is not changed along with the change of the internal pressure, and ensuring the full adherence treatment of the balloon during the freezing treatment.
Detailed Description
The invention will be described in more detail hereinafter with reference to the accompanying drawings showing 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 directional indicators (such as up, down, left, right, front, and rear are used in the embodiments of the present invention) are merely for explaining the relative positional relationship, movement conditions, and the like between the components in a certain specific posture (as shown in the drawings), and if the specific posture is changed, the directional indicators are changed accordingly.
Referring to fig. 1-4, the invention provides an inner stent freezing and expanding balloon, which mainly comprises an expanding balloon part 1 and a stent part 2, wherein 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 guide pipe 12, a first air hole 162 and a second air hole 161 are formed in the adjusting cavity 15, the air in the balloon 11, the guide pipe 12 and the adjusting cavity 15 is discharged through the first air hole 162 or inflated into the balloon 11 to expand, the support 21 is arranged in the balloon 11 and/or the guide pipe 12, the adjusting component is used for pushing the support 21 to move between the balloon 11 and the guide pipe 12, when the balloon 11 is not expanded, the support 21 is in a contracted state in the guide pipe 12, after the balloon 11 is expanded, the support 21 is pushed to move into the balloon 11 through the adjusting component and is expanded and supported on the inner wall of the balloon 11, the air inlet pipe 14 is arranged in the balloon 11, the guide pipe 12 and the adjusting cavity 15 in a penetrating mode, the support 21 is sleeved outside the air inlet pipe 14, one end of the air inlet pipe 14 is arranged in the balloon, the other end of the air inlet pipe 14 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.
The inner stent freezing and expanding balloon can simultaneously realize balloon expansion and freezing treatment, and simultaneously realize the auxiliary supporting function of the balloon after the freezing treatment is started through the setting of the stent, thereby preventing the problem of balloon contraction caused by low pressure during the freezing treatment, ensuring that the balloon diameter is not changed along with the change of the internal pressure, and ensuring the full adherence treatment of the balloon during the freezing treatment.
In the present embodiment, as shown in fig. 1, the balloon 11 is an inflatable balloon, and the balloon 11 can achieve single-stage inflation or multi-stage inflation, without limitation. The rear end of the balloon 11 is connected and communicated with the front end of the catheter 12, the joint is sealed, the sealing mode can be realized by means of glue sealing and the like, the sealing mode is not limited herein, the rear end of the catheter 12 is coaxially connected and communicated with the adjusting cavity 15, the same joint is sealed, the sealing mode can be realized by means of glue sealing and the like, and the sealing mode is not limited herein.
In this embodiment, the inner stent freezing and expanding balloon further comprises a wire guide tube 13 penetrating through the balloon 11, the catheter 12 and the adjusting cavity 15, wherein the stent 21 is sleeved outside the wire guide tube 13, one end of the wire guide tube 13 (i.e. the wire guide tube head 131) extends into the balloon 11 and is connected with the front end of the balloon 11, and the other end of the wire guide tube 13 (i.e. the wire guide outlet 132) is led out from an outlet hole 165 on the adjusting cavity 15. In this embodiment, by the arrangement of the guide wire tube 13, in use, the guide wire is extended into the guide wire tube 13 from the guide wire outlet 132 and to the guide wire tube head 131, and the balloon 11 is delivered to the stricture area to be treated along the guide wire path.
Of course, the placement of the guidewire tube 13 may be omitted in other embodiments, as well, without limitation. 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 need not be used. In embodiments where the guidewire tube 13 is omitted, it is only necessary to reach and pass the balloon through the lesion under guidance of the endoscope lens image. The operation flow of the wire guide tube is omitted, namely, balloon suction, endoscope guiding of the balloon in place, inflation and expansion, forward pushing of the stent, supporting of the balloon, stopping of expansion, freezing, stent withdrawing, stopping of freezing, balloon suction and balloon extraction.
In this embodiment, the adjusting assembly includes a support tube 22, an adjusting tube 23, and a deflector rod 231, the support tube 22 is located in the tube 12 and can move axially relative to the tube 12, the adjusting tube 23 is located in the adjusting cavity 15 and can move axially relative to the adjusting cavity 15, the air inlet tube 14 and the wire tube 13 are movably arranged in the support tube 22 and the adjusting tube 23 in a penetrating mode, one end of the support tube 22 is connected with the support 21, the other end of the support tube 22 is coaxially connected with the adjusting tube 23 and communicated with the air inlet tube 14 and the wire tube 13, 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 support 21, one end of the deflector rod 231 is connected with the adjusting tube 23, 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 dial the deflector rod 231 can dial the adjusting tube 23 to move axially, and thus drive the support tube 22 to move axially along the tube 12, and the support tube 22 further drive the support 21 to extend or extend into or out of the balloon 11.
Further, a sealing structure is provided between the adjusting pipe 23 and the inner wall of the adjusting chamber 15, for preventing air leakage from the inner adjusting groove 151, for example, preventing return air in the adjusting chamber 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, the inner rings of the first sealing rings 232 are installed in the installation groove on the adjusting pipe 23, the outer rings are in contact with and sealed with the inner wall of the adjusting cavity 15, and meanwhile, the two first sealing rings 232 are arranged on two sides of the inner adjusting groove 151, so that sealing at the inner adjusting groove 151 is achieved. Of course, in other embodiments, the structural form of the sealing structure may be modified according to the specific situation, which is not limited herein.
In this embodiment, as shown in fig. 4, the support 21 is a net structure with elasticity, which can be contracted under the action of external force (such as the folding of the catheter 12), and can be expanded under the action of self-elasticity after the external force is eliminated.
Wherein, the bracket material can be selected from memory alloy such as nickel-titanium alloy, which has better elasticity and is convenient to recycle, the memory alloy needs to have elasticity at low temperature corresponding to the refrigerant gas, for example, when carbon dioxide is used as the refrigerant gas, the memory alloy needs to have elasticity at-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 sequentially connected, wherein the stent straight section 211 is used for expanding the supporting balloon 11, the memory diameter of the stent straight section 211 is larger than the maximum expanding diameter of the balloon, so that the stent still has a certain radial supporting force under the maximum expanding diameter of the balloon, and the radial supporting force under the expanding state of the stent is equivalent to the expanding force of the balloon.
The stent front end 212 is in a semi-contracted state to prevent a large resistance between the stent front end 212 and the balloon 11 or damage to the balloon 11 during the forward pushing of the stent. The semi-contracted state of the front end 212 of the stent can be the memory shape of the memory alloy, the memory diameter of the front end 212 of the stent is smaller than the minimum expansion 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 front end 212 of the stent can also be formed by being bound by at least one elastic ring, the elastic ring can be recovered into the inside of the catheter 12 along with the straight section 211 of the stent, the maximum expansion diameter of the elastic ring is smaller than the minimum expansion diameter of the balloon 11 and larger than the wound outer diameter of the spiral air inlet pipe 141, and the semi-contracted state of the front end 212 of the stent can also be formed by being bound by an inelastic ring, and the diameter of the inelastic ring is smaller than the inner diameter of the catheter 12 and larger than the wound outer diameter of the spiral air inlet pipe 141.
The rear end 213 of the stent is always located inside the catheter 12 during the fore-and-aft adjustment of the stent 21, so that the stent 21 can be successfully recovered after expansion or the expansion-recovery process can be repeated, and the rear end 213 of the stent can be the memory shape of the memory alloy itself or can be bound in the catheter 12, i.e. the memory diameter of the rear end 213 of the stent is not larger than the memory diameter of the straight section 211 of the stent and larger than the inner diameter of the catheter 12.
In the present embodiment, a spiral air inlet pipe 141 is connected to one end of the air inlet pipe 14 located in the balloon 11, and an air outlet hole 142 is arranged on the spiral air inlet pipe 141. Further, the spiral air inlet pipe 141 is uniformly provided with a plurality of air outlet holes 142 along the axial direction and the radial direction, and the design of the structure enables the refrigerant gas to be 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 adjusting chamber 15 is connected to the conduit 12, 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 comprises a middle convex part and a step part arranged on the outer ring of the middle convex part, the second air hole 161 is arranged on the middle convex part, the first air hole 162 is arranged on the step part, the second sealing ring 163 is arranged on the side wall of the middle convex part, and the second sealing ring 162 is arranged on the side wall of the step part.
The specific external device may be a host (not shown in the figure) capable of implementing functions such as vacuumizing, inflating, and inputting refrigerant gas, and the second sealing ring 163 and the second sealing ring 162 are used for implementing separation between the first air hole 162 and the second air hole 161 after the adjusting cavity 15 is plugged into a socket on the host through a plug end during operation.
In the embodiment, the inner bracket freezing and expanding saccule is also provided with a temperature measuring device and a pressure measuring device.
Specifically, the temperature measuring device comprises a temperature measuring wire 19 and a temperature measuring point 191, wherein the temperature measuring point 191 is fixed on the outer surface of a 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, which temperature measuring head is specifically adopted and can be adjusted according to requirements, one end of the temperature measuring wire 19 is connected with the temperature measuring point 191, the other end of the temperature measuring wire 19 is led out of the adjusting cavity 15 from a temperature measuring hole 153 on the adjusting cavity 15, the temperature measuring hole 153 is filled with glue and sealed, the other end of the temperature measuring wire 19 extends out of the adjusting cavity 15 and then is connected with an electrical plug 6 through a plug cable 61, the electrical plug 6 is connected with a temperature testing module in a host, and the temperature testing module converts an electrical signal acquired and transmitted by the temperature measuring head or the temperature measuring wire 19 into a real-time temperature value. The temperature measuring device is arranged, so that the temperature inside the balloon can be monitored in real time, and whether the freezing function works normally or not 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, wherein 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, the circuit board 3 is connected to the plug cable 61 to realize the connection with the electric plug 6, and a pressure measuring path is formed by the clearance between the guide pipe 12 and the support guide pipe 22, the space between the front end of the adjusting guide pipe 23 and the adjusting cavity 15, the pressure measuring joint 17 and the pressure measuring hose 18. The circuit board 18 at least comprises a pressure sensor and an analog front end, and optionally also 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 wire 31 is used for power input and signal output of the circuit board 18, the wire 31 is connected with the electric plug 6, and the electric plug is connected with a main control board inside the host. Because of the sealing action of the first sealing ring 232, no air flow exists in the pressure measuring path in the non-adjusting state, and therefore, 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 pressure measurement device is arranged, so that the pressure inside the balloon can be monitored in real time, and the expansion process is more accurate and the freezing process is safer.
In this embodiment, the outer side wall of the catheter 12 is further sleeved with a bending protecting member 5 for protecting the catheter 12 from bending.
In this embodiment, a housing 4 is further sleeved on the outer side wall of the adjusting cavity 15, and the pressure measuring device is also covered in the housing 4, one end of the housing 4, which faces the conduit 12, extends to cover the bending-protecting member 5, the other end extends to cover the plug end 16 and is connected with the bending-protecting member, and an outer adjusting slot 41 which is convenient for the pulling rod 231 to extend is arranged on the housing 4 corresponding to the inner adjusting slot 151.
The working process of the inner stent freezing and expanding saccule provided by the invention is further described below, and the working process is specifically as follows:
(guide wire positioning, balloon suction, guide wire guiding the balloon in place, inflating and expanding, pushing the stent forwards, supporting the balloon, stopping expanding, freezing, withdrawing the stent, stopping freezing, balloon suction and balloon extraction)
Referring to fig. 1, a deflector rod 231 is positioned at the rearmost end of an inner adjusting groove 151 before an operation is started, and at this time, a stent 21 is compressed inside the front end of a catheter 12, after the operation is started, a guide wire is guided to a narrow place through a certain guiding means and passes through a narrow area, then a plug end 16 is connected with a socket at a host end, and air in a balloon 11 is drawn out through a guide wire tube 22, an adjusting tube 23 and a first air hole 162 by vacuum suction at the host end, so that the balloon 11 is in a contracted state;
Next, the guide wire is inserted from the guide wire head 131 in a fixed state, and the balloon 11 is guided to the stricture area to be treated along the guide wire path, and the guide wire head 131 needs to pass through the stricture area, so that the position of the balloon 11 is just in the stricture area. Then, the balloon expanding function is started from the host end, and the gas with set pressure enters the balloon 11 through the first gas hole 162, the regulating tube 23 and the wire guide tube 22, so that the balloon 11 is inflated, and the expansion of the narrow section is realized;
After the expansion time is reached, the deflector rod 231 is stirred forwards along the inner adjusting groove 151, the deflector rod 231 drives the support guide tube 22 to move through the adjusting tube 23, the support guide tube 22 drives the support 21 to move forwards, the part of the support 21 positioned in the balloon 11 is expanded in the process of pushing the support 21 out of the guide tube 12, after the deflector rod 231 is pushed forwards to the bottom, most of the support 21 is positioned in the balloon 11 and released and clings to the inner wall of the balloon 11, at the moment, the expansion of the balloon is stopped, the freezing function is started, an air return channel at the host end is opened, simultaneously, high-pressure refrigerant gas enters the balloon 11 from the second air hole 161 through the air inlet tube 14, the high-pressure gas is changed into low-temperature low-pressure gas through the throttling effect of the air outlet hole 142, the low-pressure gas can not keep the expansion state of the balloon 11 continuously, but the support effect of the support 21 ensures that the balloon 11 in the low-pressure state can not shrink and become small, at the moment, the outer surface of the balloon 11 is still clings to a narrow section, the throttled low-temperature gas is uniformly sprayed to the inner surface of the balloon 11, a large amount of the air is discharged from the balloon 11 through the narrow section outside the balloon 11, and the large amount of the air flow is discharged from the air inlet tube 14 through the air inlet tube 23 and the air outlet tube 162 after the heat absorption and the cooling tube is discharged from the air tube is adjusted;
After the treatment is completed, the deflector rod 231 is pulled backwards, the deflector rod 231 drives the support 21 to move backwards, the support 21 is compressed when entering the catheter 12 backwards, the whole support 21 is compressed into the catheter 12, then the freezing function is stopped, and at the moment, one expansion freezing cycle is finished;
The surgical procedure may repeat the expansion freeze cycle multiple times to enhance the therapeutic effect. After the operation is finished, the vacuum suction at the host end is started, and the balloon 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 these embodiments, but that variations and modifications can be made by one skilled in the art within the spirit and scope of the present invention as hereinafter defined in the appended claims.