Novel ureteral dilatation balloon catheter

Abstract

The novel ureteral dilatation balloon catheter comprises a pressure generating device, a shell is arranged on the outer side of the pressure generating device, and a cleaning pipeline, a balloon pipeline, an electromagnetic reversing valve, a pressure sensor, an electric air pump and a battery bin are arranged in the shell of the pressure generating device; one end of a shell of the pressure generating device is fixedly connected with a balloon catheter, a support is arranged at the end, away from the pressure generating device, of the balloon catheter, a balloon is arranged on the outer side of the support, and an operation button and a suction valve are arranged on the shell of the pressure generating device. After the balloon is expanded, the stent is arranged at the ureteral stenosis lesion, so that the elastic retraction and reshaping of the ureter are reduced, and the recurrence probability of restenosis of the ureter is well solved; the stent is made of a degradable material and can be biodegraded within 6-12 months, and the possibility of secondary blockage and lesion of foreign matters is avoided due to degradation of the stent.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, in particular to a novel ureteral dilatation balloon catheter. Background Art

[0002] Ureteral dilatation balloon catheter is a common medical device, mainly used for dilation of ureteral strictures or for ureteral dilation before ureteroscopy or stone manipulation.

[0003] The existing ureteral dilatation balloon catheter has certain problems in actual treatment. The ureteral dilatation balloon catheter is inflated in the body by a balloon to dilate the narrow ureter. The problem is that the ureteral stenosis is not cured, and the probability of recurrence of ureteral stenosis is very high. After the permanent stent is placed in the narrow ureter, there is long-term biocompatibility with the ureter, and there are potential risks, such as restenosis in the stent. Studies have shown that the ureteral stenosis will generally complete the repair and remodeling of the lumen in 6-12 months, and there is no need for long-term existence after the ureteral dilatation is completed and remodeled. The commercial stents on the market are mainly braided structure stents. After the braided stent is placed in the ureter, the insufficient support stiffness will lead to large radial rebound and ureteral tissue shedding, resulting in restenosis in the ureteral stent. The ureteral dilatation balloon catheter needs to be used in conjunction with a balloon pressure pump and needs to be manually operated to ensure that the pressure reaches the working pressure of the balloon. If the pressure is too high, there is a risk of balloon rupture. It has great requirements on the operator's operating ability, and the operation process is very cumbersome and there is a risk of operating errors. Summary of the invention

[0004] In view of the deficiencies of the prior art, the present invention provides a novel ureteral dilatation balloon catheter, which can reduce the elastic retraction of the ureter, avoid the stent remaining in the ureter for a long time to cause lesions and ensure the safe expansion of the balloon.

[0005] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0006] A novel ureteral dilatation balloon catheter includes a pressure generating device, a shell is arranged outside the pressure generating device, a cleaning pipeline, a balloon pipeline, an electromagnetic reversing valve, a pressure sensor, an electric air pump and a battery compartment are arranged inside the shell of the pressure generating device, a balloon catheter is fixedly connected to one end of the shell of the pressure generating device, a bracket is arranged at the end of the balloon catheter away from the pressure generating device, a balloon is arranged outside the bracket, and an operation button and a suction valve are arranged on the shell of the pressure generating device. The bracket is arranged to facilitate the support of the balloon, and has sufficient supporting force to solve the defects of easy plastic deformation and fracture and insufficient supporting force after the balloon is expanded and opened. The balloon is arranged to facilitate the expansion of the ureteral stenosis when it is opened.

[0007] Preferably, the electromagnetic reversing valve is fixedly connected to the inside of the pressure generating device housing, and the cleaning pipeline is connected to the electromagnetic reversing valve. The electromagnetic reversing valve is provided to facilitate the control of the circulation of gas or cleaning water.

[0008] Preferably, the cleaning pipeline is passed into the balloon catheter, and the electromagnetic reversing valve is communicated with the suction valve. The cleaning pipeline is provided to facilitate the delivery of saline solution for cleaning into the ureter to clean the gravel in the ureter.

[0009] Preferably, one end of the balloon conduit is passed into the balloon, the other end of the balloon conduit is connected to the electromagnetic reversing valve, and the balloon conduit is passed into the balloon catheter. The balloon conduit is provided to facilitate the delivery of air into the balloon, so that the balloon expands and fills, thereby supporting the opening and placing it in the narrow part of the ureter.

[0010] Preferably, the pressure sensor is fixedly connected to the housing of the pressure generating device, and the detection end of the pressure sensor is passed into the balloon pipeline. The pressure sensor is provided to facilitate the detection of the gas pressure in the balloon, to avoid the balloon rupture caused by excessive gas pressure in the balloon, and to obtain a suitable expansion effect.

[0011] Preferably, the electric air pump is fixedly connected to the inside of the housing of the pressure generating device, and the electric air pump is communicated with the electromagnetic reversing valve.

[0012] Preferably, the battery compartment is fixedly connected to the inside of the pressure generating device housing, and a battery is arranged inside the battery compartment.

[0013] Preferably, a stent corrugated ring and a stent connecting bridge are provided inside the stent, and there are stent wave crests and stent wave troughs on the stent corrugated ring. By providing the structure of the stent corrugated ring and the stent connecting bridge, sufficient supporting force is ensured, and the defects of easy plastic deformation after the balloon is expanded and opened, resulting in fracture and insufficient supporting force, are solved.

[0014] Preferably, there are multiple support corrugated rings and support connecting bridges, and the support wave crests and support wave troughs are respectively connected to the two ends of the support connecting bridge.

[0015] Preferably, the operation button includes a positive pressure button, a mode 1 button, a mode 2 button and a negative pressure button. The operation button is provided to facilitate the control of the action of the ureteral dilatation balloon catheter, the positive pressure button is provided to facilitate the control of the forward rotation of the electric air pump, the negative pressure button is provided to facilitate the control of the reverse rotation of the electric air pump, the mode 1 button is provided to facilitate the control of the inflow and outflow of gas in coordination with the positive pressure button and the negative pressure button, and the mode 2 button is provided to facilitate the control of the injection and discharge of saline solution for cleaning.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] The novel ureteral dilatation balloon catheter provided by the present invention achieves the following technical effects through the cooperation of the following structures:

[0018] 1. After balloon dilation, a stent is inserted into the ureteral stenosis lesion to reduce the elastic retraction and reshaping of the ureter, which effectively solves the chance of recurrence of ureteral stenosis.

[0019] 2. The stent is made of degradable materials and will complete biodegradation within 6-12 months. The degradation of the stent avoids the possibility of re-blocking by foreign matter and causing lesions.

[0020] 3. By designing the connecting ribs of the pipe network support to be a woven support structure, the support stiffness of the support is ensured while the flexibility of the support is improved.

[0021] 4. No need to use a balloon pressure pump, the balloon can be expanded automatically. The balloon pressure is precisely controlled by a pressure sensor to ensure that the balloon is filled to the designed size. It is easy to use and more efficient, reduces the skill requirements for the operator, and avoids the medical risk of balloon rupture caused by pressure exceeding the rated bursting pressure. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 A schematic diagram of a folded state of a balloon catheter of a new type of ureteral dilatation balloon catheter;

[0023] Figure 2 A schematic diagram of a balloon catheter filling state of a new type of ureteral dilatation balloon catheter;

[0024] Figure 3 A schematic diagram of the three-dimensional structure of a balloon catheter stent of a new type of ureteral dilatation balloon catheter;

[0025] Figure 4 This is a schematic diagram of the plane expansion of the balloon stent of a new type of ureteral dilatation balloon catheter;

[0026] Figure 5 This is a schematic diagram of the internal structure of a pressure generating device of a new type of ureteral dilatation balloon catheter;

[0027] Figure 6 This is a partial enlarged view of the operating button of a new type of ureteral dilatation balloon catheter;

[0028] Figure 7 A schematic diagram of the position structure of a new type of ureteral dilatation balloon catheter when the balloon catheter is in a folded state and enters the ureter through an endoscope;

[0029] Figure 8It is a schematic diagram of the structure of a new type of ureteral dilatation balloon catheter when the balloon stent is opened by the balloon and placed in the ureteral stenosis;

[0030] Fig. 9 This is a schematic diagram of the balloon position structure during the process of cleaning the lithotripsy in the ureter using a new type of ureteral dilation balloon catheter.

[0031] Among them, 1. balloon; 2. bracket; 3. pressure generating device; 4. operation button; 5. suction valve; 201. bracket connecting bridge; 202. bracket peak; 203. bracket trough; 204. bracket waveform ring; 301. cleaning pipeline; 302. balloon pipeline; 303. electromagnetic reversing valve; 304. pressure sensor; 305. electric air pump; 306. battery compartment; 401. positive pressure button; 402. mode one button; 403. mode two button; 404. negative pressure button. DETAILED DESCRIPTION

[0032] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0033] Embodiment 1:

[0034] like Figure 1-9 As shown, an embodiment of the present invention provides a novel ureteral dilatation balloon catheter, including a pressure generating device 3, a shell is arranged outside the pressure generating device 3, a cleaning pipeline 301, a balloon pipeline 302, an electromagnetic reversing valve 303, a pressure sensor 304, an electric air pump 305 and a battery compartment 306 are arranged inside the shell of the pressure generating device 3, a balloon catheter is fixedly connected to one end of the shell of the pressure generating device 3, a bracket 2 is arranged at one end of the balloon catheter away from the pressure generating device 3, a balloon 1 is arranged outside the bracket 2, and an operating button 4 and a suction valve 5 are arranged on the shell of the pressure generating device 3. The bracket 2 is made of biodegradable material and is a novel bracket structure with a special wave-shaped woven mesh.

[0035] The operation button 4 includes a positive pressure button 401, a mode 1 button 402, a mode 2 button 403 and a negative pressure button 404. The positive pressure button 401 and the negative pressure button 404 control the forward and reverse rotation of the electric air pump 305, and the mode 1 button 402 and the mode 2 button 403 control the operation of the electromagnetic reversing valve 303.

[0036] The electric air pump 305 is fixedly connected inside the housing of the pressure generating device 3. The electric air pump 305 communicates with the electromagnetic directional valve 303. The battery compartment 306 is fixedly connected inside the housing of the pressure generating device 3, and a battery is arranged inside the battery compartment 306.

[0037] The electromagnetic directional valve 303 is fixedly connected inside the housing of the pressure generating device 3. The cleaning pipeline 301 is connected to the electromagnetic directional valve 303. The cleaning pipeline 301 leads into the balloon catheter. The electromagnetic directional valve 303 communicates with the suction valve 5.

[0038] One end of the balloon pipeline 302 leads into the balloon 1. The other end of the balloon pipeline 302 is connected to the electromagnetic directional valve 303. The balloon pipeline 302 leads into the balloon catheter. The pressure sensor 304 is fixedly connected inside the housing of the pressure generating device 3, and the detection end of the pressure sensor 304 leads into the balloon pipeline 302.

[0039] The stent 2 is internally provided with a stent corrugated ring 204 and a stent connecting bridge 201. There are stent peaks 202 and stent valleys 203 on the stent corrugated ring 204. The number of the stent corrugated rings 204 and the stent connecting bridges 201 is multiple. The stent peaks 202 and the stent valleys 203 are respectively connected to both ends of the stent connecting bridge 201. The distance value D between the stent peak 202 and the stent valley 203 in the same stent corrugated ring 204 is 0.6 - 1.5 mm, and the preferred peak-to-peak distance value is 1.0 mm. The lengths of the stent connecting bridges 201 are equal, and the length L of a single stent connecting bridge 201 is 0.6 - 1.2 mm, and the preferred length is 0.8 mm.

[0040] Working principle: The balloon catheter enters the ureter in a folded state through the endoscope and passes through the stone area. See Figure 7 , the balloon catheter is transported to the ureteral stricture segment. Press the mode one button 402, and then press the positive pressure button 401. The electric air pump 305 starts, inhales air through the suction valve 5. The inhaled gas is connected to the balloon pipeline 302 through the electromagnetic directional valve 303, and the gas is sent into the balloon 1. The balloon 1 starts to expand and gradually fills. When the pressure sensor 304 detects that the pressure of the balloon 1 reaches the rated working pressure, the electric air pump 305 runs at a low speed and enters the pressure holding state. The stent 2 is supported and opened by the balloon 1 and placed at the ureteral stricture. See Figure 8. Then insert the lithotripsy instrument through the endoscope to break the stones. At this time, the balloon 1 blocks the upper part of the ureter to prevent the gravel from spreading to the upper part of the ureter; after the lithotripsy process is completed, press the negative pressure button 404, the electric air pump 305 reverses, and the gas in the balloon 1 is quickly discharged, the balloon 1 returns to the folded state, the catheter is separated from the stent 2, and the stent 2 is placed in the narrow section of the ureter. The stent 2 supports the narrow section and plays a remodeling and repairing function. Within 6-12 months, the stent 2 gradually completes biodegradation. Press the mode 2 button 403, and then press the positive pressure button 401, and the saline solution is passed through the electromagnetic reversing valve 303 through the suction valve 5, and enters the cleaning pipe 301, and the saline solution is injected into the ureter to clean the gravel in the ureter, and then the negative pressure button 404 is pressed to suck out the gravel and saline solution. Fig. 9 After completing this process, press the negative pressure button 404 again, the electric air pump 305 stops, and the balloon catheter is taken out, completing the process of implanting the stent 2 and cleaning the ureter; the stent 2 is made of biodegradable material and has a new type of stent structure with a special wave-woven mesh to ensure sufficient supporting force, thereby solving the defect of plastic deformation after the balloon 1 is expanded and opened, resulting in breakage and insufficient supporting force.

[0041] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A novel ureteral dilatation balloon catheter, comprising a pressure generating device (3), characterized in that: A shell is arranged on the outside of the pressure generating device (3), and a cleaning pipe (301), a balloon pipe (302), an electromagnetic reversing valve (303), a pressure sensor (304), an electric air pump (305) and a battery compartment (306) are arranged inside the shell of the pressure generating device (3). A balloon catheter is fixedly connected to one end of the shell of the pressure generating device (3), and a bracket (2) is arranged on the end of the balloon catheter away from the pressure generating device (3). A balloon (1) is arranged on the outside of the bracket (2), and an operating button (4) and a suction valve (5) are arranged on the shell of the pressure generating device (3).

2. A novel ureteral dilatation balloon catheter according to claim 1, characterized in that: The electromagnetic reversing valve (303) is fixedly connected to the interior of the housing of the pressure generating device (3), and the cleaning pipeline (301) is connected to the electromagnetic reversing valve (303).

3. A novel ureteral dilatation balloon catheter according to claim 2, characterized in that: The cleaning pipeline (301) leads into the balloon catheter, and the electromagnetic reversing valve (303) is in communication with the suction valve (5).

4. The novel ureteral dilatation balloon catheter according to claim 1, characterized in that: One end of the balloon conduit (302) is passed into the balloon (1), and the other end of the balloon conduit (302) is connected to the electromagnetic reversing valve (303). The balloon conduit (302) is passed into the balloon catheter.

5. The novel ureteral dilatation balloon catheter according to claim 1, characterized in that: The pressure sensor (304) is fixedly connected to the inside of the housing of the pressure generating device (3), and the detection end of the pressure sensor (304) is connected to the balloon tube (302).

6. The novel ureteral dilatation balloon catheter according to claim 1, characterized in that: The electric air pump (305) is fixedly connected to the inside of the housing of the pressure generating device (3), and the electric air pump (305) is in communication with the electromagnetic reversing valve (303).

7. The novel ureteral dilatation balloon catheter according to claim 1, characterized in that: The battery compartment (306) is fixedly connected to the inside of the housing of the pressure generating device (3), and a battery is arranged inside the battery compartment (306).

8. The novel ureteral dilatation balloon catheter according to claim 1, characterized in that: A support wave ring (204) and a support connecting bridge (201) are arranged inside the support (2), and a support wave crest (202) and a support wave trough (203) are present on the support wave ring (204).

9. A novel ureteral dilatation balloon catheter according to claim 8, characterized in that: The number of the support wave ring (204) and the support connecting bridge (201) is multiple, and the support wave crest (202) and the support wave trough (203) are respectively connected to the two ends of the support connecting bridge (201).

10. The novel ureteral dilatation balloon catheter according to claim 1, characterized in that: The operation buttons (4) include a positive pressure button (401), a mode one button (402), a mode two button (403) and a negative pressure button (404).

Images